Laboratory Information Management System (LIMS) in the Microbiology Lab

By: Paul Dudley

Today’s microbiology laboratories can generate an extensive amount of data across a variety of technologies.  Labs are tasked with providing  test results and information that is vital to the success of the organization and the safety of its products.   Of course, businesses and consumers demand efficiency – the goal is not only to provide safe products, but to provide them as quickly as possible.  As labs are updated and become more modern, better methods of data management and record keeping may be necessary in order to maintain or improve efficiency.  Luckily, there is a means to achieve this: Laboratory Information Management Systems, or LIMS. [1]

LIMS are software-based information systems that allows labs to track and share data within their environment.  There are numerous LIMS software applications, both open-source and proprietary.  But all have the same general goal – to help streamline data management to improve efficiency while reducing overhead costs.  LIMS can provide significant time savings for all people involved in a project by improving data access.  [3]

Example diagram showing the concept behind a Laboratory Information Management System and how data & information can be shared within a laboratory environment.

There are many advantages that the incorporation of a Laboratory Information Management System has over a more manual, traditional laboratory.  Some of these include improved efficiency, the ability to go paperless, cost reduction, and compliance.  Keep in mind, there are quite a few options when it comes to implementing a LIMS system, and whether it was initially an open-source application or a purchased program, a great deal of customization is usually implemented.  So when we talk about advantages, some may be more often utilized than others.  But any of these features can be of great benefit, depending on the wants and needs of the individual lab.

Efficiency

Improved efficiency is easily recognized when you eliminate the potential for errors from manual data entry.  The greater the amount of samples being processed and the total workload, the greater the chance for an error.  On the other hand, LIMS streamlines data entry by automating the process.  This results in less downtime, faster access to data, and the ability for the LIMS to grow with the increasing needs of the lab.

Paperless

Some LIMS programs will authorize users to either modify existing reports or create new ones.  Also, web-based applications can interface with the LIMS so users don’t need to work directly with the LIMS itself but rather can work with just the reporting modules that in turn query the database [5] .  QC Management can use LIMS for scheduling and Certificates of Analysis.  Another great ‘paperless’ feature of LIMS is the ability of some programs to hold all pricing information for tests, which allows invoices to be produced for online access or as PDF documents [5] .  There are many examples of projects for implementing a paperless lab and how they benefited their labs, and one example showed a 30-40% gain in resources as a result of going paperless [6] .

Cost Reduction

When it comes to management at an executive level, the proof is in the bottom line.  Successful businesses rely on effective cost management.  Total costs of operations come in many forms, including labor, resources, downtime, time-to-market,  and more.  LIMS can impact many of these costs of doing business.  For example, one laboratory that implemented a LIMS system reduced its capital investment by 50%, while productivity rose at multiple laboratories [3] .  Another lab saw a 50% increase in throughput two years after implementing their LIMS [7] .  When you consider the time savings, efficiency, and the resulting improvements in time-to-market, LIMS can significantly contribute to overall improvements in cost management.

Compliance

Product safety continues to be scrutinized in every market – including Food & Beverage, Nutraceutical, Cosmetics, and Pharmaceuticals.  Regulatory requirements are implemented to help reduce the risk of contamination, and different products and ingredients require different requirements.  This makes LIMS very essential.  LIMS can assist in real-time monitoring and Quality Control.  Workflows can be managed, samples logged, and tests can be checked against protocols and procedures to ensure compliance.  Out-of-spec samples can be reported automatically and flagged.   Reports can be automatically generated, and access to this information can be quickly gained by QC.  The overall increase in a structured approach via LIMS ensures compliance as business grows and throughput needs increase.

Neogen Corporation provides Rapid Microbiology Method (RMM) platforms such as BioLumix and Soleris.  Both systems can interface and exist within a LIMS environment.  For more information, visit http://www.mybiolumix.com or go to www.neogen.com.

The BioLumix system provides a single platform for all microbiology assays available for that system, allowing a large variety of tests without the need of additional equipment.  And its versatile – the modular design allows it to grow to meet throughput needs.   Results of tests for assays such as Total Aerobic Count, Yeast & Mold, Salmonella, and many more can be obtained within 24-48 hours.  Tests are be monitored in real time, and a Certificate of Analysis is automatically generated.  The system validates to USP <51>, <61>, <62>, <2021>, <2022>, and <2023> [9] .  In addition, Environmental Monitoring and Water Testing can be performed on the same platform.

Other advantages of the BioLumix System:

• Fully automated, easy to use.
• Faster sample preparation
• Faster turnaround time
• Fully Validated - the system comes complete with IQ, OQ, PQ and all SOP  documentation
• Outstanding support

As mentioned before, there are too many LIMS vendors to mention in this document.  Some applications will be better suited than others for your specific needs.  http://www.Limswiki.org has an extensive list of vendors that provide LIMS systems, and they even break out the vendors by industry.  So if you are looking for something more suited for Cosmetics, or for Food & Beverage, you can find those subcategories within that site.  It’s not the end-all be-all of resources, but it might be a good place to start.

SOURCES:
1. http://www.thermoscientific.com/content/tfs/en/products/lab-information-management-systems-lims.html
2. http://www0.cs.ucl.ac.uk/staff/B.Tagger/LimsPaper.pdf
3. http://khemia.com/clients/case-studies/
4. Ruth Eden, Ph. D., Neogen Corp.
5. Food Quality Magazine (http://www.foodquality.com/details/article/5621151/The_Paperless_Microbiology_Laboratory.html?tzcheck=1)
6. http://www.labmanager.com/laboratory-technology/2010/01/the-paperless-lab?fw1pk=2#.VIISO8mRJtY
7. http://www.labnews.co.uk/features/taking-lims-to-a-hire-level/
8. http://www.scientific-computing.com/features/feature.php?feature_id=246
9. http://www.mybiolumix.com/BioLumix-System-rapid-microbiological-methods

 

The Relevance of USP Methodology in Microbiology for dietary supplements and cosmetic products – Part 2

By: Jennifer Johnson

Routine microbiological testing carried out by the Nutraceutical,
dietary supplements, cosmetics and toiletry manufacturing industries is determined by regulatory requirements. This applies not only to what should be tested and when, but also to the methods that should be used. Whether the final product is sterile or non-sterile, the bioburden exists from the raw materials, throughout the process and/or within the product’s environment (e.g. water) to the final product. A critical review of the overall microbiological process will determine whether the final product will meet its acceptance criteria. In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Whether you are testing a raw material, an in-process sample, final product, or the environment, you should be aware of the critical role that microorganisms play throughout the process. You should also be familiar with the various microbiological related documents needed to determine whether the SOPs, validations, and regulatory body documents are being maintained to assure the control required to permit the final product to enter the marketplace as safe.

The Unites States Pharmacopeia (USP) is a non-governmental organization. Their documents are recognized as an official compendia book of methods and standards for Pharmaceutical, nutraceutical, dietary supplements, cosmetics, and toiletries. The USP offers a variety of documents such as monographs (published standards) and general chapters. General chapters with numbers 1000 are considered informational chapters.

Nutritional and Dietary Supplement USP Chapters
Since June 25, 2010, all dietary supplement manufacturers have been required to comply with the Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP’s) according to the guidance outlined in USP chapters,, and.

<2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements – This chapter provides tests for the estimation of the number of viable aerobic microorganisms present in nutritional supplements, from raw materials to the finished products.

<2022> Microbiological Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements -
Good manufacturing practices require that objectionable organisms be absent from non-sterile nutritional and dietary products. A microorganism can be considered objectionable if it represents a potential health hazard to the user who is using the product as directed, or if it is capable of growing in the product.

<2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements - The development of the formulation of nutritional or dietary supplements includes an evaluation of raw materials and their suppliers and the contribution made to the products by each ingredient and the manufacturing processes. Guidelines to help determine the appropriate tests to establish the microbial content of each ingredient are found in chapter.

The BioLumix system can perform all of the microbiological assays needed to get the finished product to the marketplace faster than traditional methods.

1. Microbial results can be generated in 24-48 hours in assays such as Total Aerobic Count, Yeast and Mold, Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa while utilizing one system.
2. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference.
3. The BioLumix system has software that is 21 CFR Part 111 compliant and BioLumix generates a customized validation book for each of its customers that include: Installation qualification (IQ), Operational qualification (OQ), and Performance qualification (PQ).

For more information click here.

Cosmetic and Toiletry USP Chapters
There are three USP chapters that are most important to the cosmetics and toiletry industries, <51>, <61> and <62>:

<51> Antimicrobial Effectiveness Testing - The ultimate purpose of the Preservative Efficacy Test (PET) is to determine the effectiveness of the preservative(s) present in a cosmetic or toiletry product. USP Chapter describes the type of products to be tested (categories), the specified microorganisms to be used for testing, and the inoculum and log reduction amounts required per category of product. The product to be tested is inoculated with a high number of bacteria, yeast, and mold, and the reduction in the initial inoculum amount is calculated over a 28 day period.

<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests - Suitability testing is performed in order to verify that the method utilized eliminates the effect of any antimicrobial properties of the product. Therefore, the media diluent combination does not inhibit the recovery and growth of microorganisms, if present in the sample. The goal of the suitability testing is to establish the ability of the test to detect microorganisms in the presence of product. The suitability described in USP verifies the validity of the testing method by showing the recovery of microorganisms in presence of the product.

Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms – Suitability testing using USP is performed by using selective media to detect various organisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant gram-negative bacteria, Clostridia, Salmonella and Candida albicans in the presence of the product. The samples are first enriched by incubating in Trypticase Soy Broth (TSB) or another appropriate neutralizing media, and then streaked onto selective agars for the determination of presence of specified or the objectionable microorganisms.

The Relevance of USP Methodology in Microbiology in Pharmaceuticals

The Relevance of USP Methodology in Microbiology in Pharmaceuticals

By Jennifer Johnson

Routine microbiological testing carried out by the pharmaceutical, cosmetics and toiletry manufacturing industries is determined by regulatory requirements. This applies not only to what should be tested and when, but also to the methods that should be used. Whether the final product is sterile or non-sterile, the bioburden exists from the raw materials, throughout the process and/or within the product’s environment (e.g. water) to the final product. A critical review of the overall microbiological process will determine whether the final product will meet its acceptance criteria. In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Whether you are testing a raw material, an in-process sample, final product, or the environment, you should be aware of the critical role that microorganisms play throughout the process. You should also be familiar with the various microbiological related documents needed to determine whether the SOPs, validations, and regulatory body documents are being maintained to assure the control required to permit the final product to enter the marketplace as safe.

The Unites States Pharmacopeia (USP) is a non-governmental organization. Their documents are recognized as an official compendia book of methods and standards for Pharmaceutical, nutraceutical, dietary supplements, cosmetics, and toiletries. The USP offers a variety of documents such as monographs (published standards) and general chapters. General chapters with numbers <1000 are mandatory chapters and numbers >1000 are considered informational chapters.

Pharmaceutical USP Chapters

USP offers some standardized test methodologies and material specifications relating to microbiological quality and control so as to ensure product quality and safety.

<1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use – It is suggested that certain categories of products should be tested routinely for total microbial count and for specified indicator microbial contamination.  The relevant tests for determining the total count of viable aerobic microorganisms and the total combined yeast and mold count and for detection and identification of designated species are given under Microbial Limit Tests <61>.

<1115> – Bioburden Control of Nonsterile Drug Substances and Products – This chapter deals with the bioburden of non-sterile drug substances and products. The chapter states that the biggest manufacturing risk for these products is the ingredient water.  Process water is the single most important risk factor contributing to the contamination of nonsterile products.  The purified waters that are used in manufacturing are deionized and do not contain chlorine that helps control microbial growth.  Purified water is capable of supporting growth of gram negative rod shaped bacteria and many different molds.

For more information, click here.

<1116> Microbiological Control and Monitoring of Aseptic Processing Environments – The purpose of this chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage forms, and to the establishment, maintenance, and control of the microbiological quality of controlled environments.

For more information, click here.

<1117> Microbiological Best Laboratory Practices - This general information chapter outlines what is needed to improve the effectiveness, efficiency and inspection-readiness of a Microbiology Laboratory in respect to media preparation, microbiological cultures, lab equipment, laboratory layout, lab records, interpretation of results, training, and documentation.

<1223> Validation of Alternative Microbial Methods – The purpose of this chapter is to provide guidance for validating methods for use as alternatives to the official compendial microbiological methods.  Validation of microbiological methods is the process by which it is experimentally established that the performance characteristics of the method meet the requirements for the intended application, in comparison to the traditional method.  Traditional plate methods for microbiological testing require long time to results, highly trained microbiologists, is labor intensive, and creates a bottleneck for product release.  Rapid microbiological methods (RMMs) offer a high degree of automation, significant reduction in time to results, reduced staff training, faster product release, and improved process control.

<1227> Validation of Microbial Recovery from Pharmacopeial Articles – This chapter
provides guidelines for the validation of methods for the estimation of the number of viable microorganisms, for the detection of indicators or objectionable microorganisms, for the validation of microbiological methods used in antimicrobial effectiveness testing, and for the sterility testing of Pharmacopeial articles. It is generally understood that if a product possesses antimicrobial properties because of the presence of a specific preservative or because of its formulation, this antimicrobial property must be neutralized to recover viable microorganisms. This neutralization may be achieved by the use of a specific neutralizer, by dilution, by a combination of washing and dilution, or by any combination of these methods.

<1231> Water for Pharmaceutical Purposes – According to USP <1231>, although there are no absolute microbial standards for water (other than water intended to be sterile), the cGMP regulations require the establishment of appropriate specifications. The specification must take into account the intended use of the water; i.e., water used to formulate a product should contain no organisms capable of growing in the product. Action or alert limits should be established based upon validation data and must be set low enough to signal significant changes from normal operating conditions.

BioLumix Rapid Microbiology Methods offer innovative new testing solutions that are designed specifically for the challenges of the pharmaceutical industry, including a multitude of microbial tests for raw materials, in-process and finished products, as well as, the capacity to perform environmental and water testing. This simplifies, expedites, and reduces the cost of performing microbiological assays.

The BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products” has been accepted by the US Food and Drug Administration (FDA). The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs.  The DMF can be referenced by drug manufacturers, reducing FDA review times and accelerating the regulatory approval process for use of the BioLumix System. In addition, Over the Counter (OTC) products can be tested in conjunction with the BioLumix Validation Package.

 For more information, click here and here.

Microbiology in Social Media

Web-related information about microbiology is plentiful. There are a variety of social media resources available to a microbiologist, from scientific information, to   opportunities to benchmark practices, obtain training opportunities, and to keep current with the latest news and developments in virtually any area of interest .All it takes is a little research and an open mind.

Available Information Sources

microbiology newsNews and Company Sites

In recent years, there have been more and more websites dedicated to microbiology on the Internet. There are also sites dedicated to providing news, as well as, websites dedicated to providing microbiology supplies.

A few examples of major sites containing information and news related specifically to microbiology are:

American Society for Microbiology

ScienceDaily – Microbiology News

The Scientist

The Independent

microbiology newsBioLumix News and Information:

The BioLumix website is updated frequently with information about the technology, new development and current events.  Click on the icon to connect to BioLumix website

Blogs

Blogs can be viewed as online journals that are created by individuals, groups, or companies.  Blogs has exploded in recent years due to the ease of blogging and the multitude of hosting services available.   The growth of the blogosphere has become so pervasive that some question the viability of print magazines.

Many blogs, of interest to a microbiologist, are published frequently and may well serve to replace printed publications in terms of timely information. Below are a few examples:

Small Things Considered

Microbiology Network Blog

Pharmaceutical Microbiology

The RMM Blog

MicrobiologyBytes

microbiology blogBioLumix Blog:

BioLumix posts bi-weekly blogs on a variety of topics in rapid microbiology, about regulations, and about the BioLumix technology. To stay current on our new developments click on the icon to connect to BioLumix blog.

microbiology emailE Mail discussion Groups

Email discussion groups are created to encourage discussion around a unifying topic.  Users subscribe to the group. The basic mechanism is to have a central Email address to which all mails are sent.  If a subscriber has a question or comment it is sent by Email to that address.  The email is then resent to all of the participants.  If one (or more) participant wishes to comment on the Email, that reply is then sent to the central address for redistribution and the cycle repeats.

The Email discussion group is the oldest form of social media participation. There are two Email discussion groups of use to the microbiologist – the PMFList and the PSDGList.   Both focus on Pharmaceutical production and validation.

Social Channels

microbiology linkedinLinkedIn:

LinkedIn is a business-oriented social network and it provides a variety of opportunities to connect with other microbiologists and join discussions. LinkedIn also supports the formation of interest groups, and many people use the groups on LinkedIn as a kind of think tank or open brainstorming session.  Others use it to disseminate information.   It is an essential business resource of information, LinkedIn can help you stay up-to-date with industry trends and share information with others who do similar work to you.  Many companies have a company page on LinkedIn.

Examples of relevant discussion groups:

Rapid Microbiology Testing and Methods

Rapid Microbiology

Microbiology Professionals

Food Microbiology- HACCP

Pharmaceutical Microbiology

BioLumix on LinkedIn:

BioLumix at LinkedinBioLumix has a company page on LinkedIn that contains relevant information about the products as well as corporate news. To view our LinkedIn page click on the icon. BioLumix Linked In page:

 

BioLumix linkedin group

BioLumix also sponsors the discussion group Rapid Microbiology Testing and Methods.  To join the group and read the content of this informative group click on the icon. Rapid Microbiology Testing and Methods

BioLumix on facebook
Facebook:

BioLumix at facebookFacebook defines social media today and is more of a pure social media, than it is used for personal purposes. However, in recent years it started serving also in the promotion of companies and services.  Many companies have Company Pages that can promote their service or products with information and special offers.

BioLumix on Facebook: To view the BioLumix Facebook page click on the icon.

BioLumix at TwitterTwitter:

Twitter is a messaging service that allows users to post short (140 character) “Tweets” to their followers.  Its main use is not in science, but it can offer a good way to rapidly disseminate information.   Many Companies and organizations are using this service to get information out quickly and to direct people to web-based information sources. The very brevity of the tweet format can encourage concise expression of ideas and concepts.

A few examples:

MicrobeWorld

Microbiologybites

SfaMicrobiology

MicrobiologyNet

BioLumix at TwitterBioLumix on Twitter:

To view the BioLumix Twitter page click on the icon.

Google +

Google Plus was established in the beginning of 2013 and is currently the second largest social network in the world.  It was launched by Google, in order to evolve the way we relate to one another, and how we communicate with the world. At the moment its presence in the microbiology world is limited, but with the Google power behind it is expected to be a major source of information in the near future. Some companies have Google+ pages.

BioLumix at Google+BioLumix on Google+:

To view the BioLumix Google+ page click on the icon.

BioLumix at YouTubeYouTube:

YouTube is a video sharing service. Video provides an excellent opportunity to explain and teach scientific concepts.  In the current impatient, busy world, many people would prefer to watch a video instead of trying to digest massive pieces of written information. Since more consumers are spending time online instead of watching TV, the popularity of watching videos online is growing exponentially.

A few examples are:

Microbiology video library

Microbeworld Video

BioLumix at YouTubeBioLumix on YouTube:

BioLumix has posted many videos on-line explaining the technology and dealing with a variety of topics of interest to microbiologist. To view the BioLumix YouTube videos click on the icon.

Usage Survey

A year ago Scott Sutton and the Microbiology Network conducted a survey of the use of social media by microbiologists in a few regulated industries.  There has been a significant increase in the use of social media by scientists and microbiologists as these sources provide an opportunities to keep current with the latest in news and developments in virtually any area of interest to the microbiologist.

Social Media Survey ResultsThis survey was conducted online, with a group that is part of an internet email group. It must therefore be assumed that the respondents are more technologically sophisticated than is the norm, and had familiarity with social media on its side.

The survey looked at two main questions – What social media are being used and what is it used for?

As shown in the figure, LinkedIn was the most popular social media used by microbiologists, followed by Facebook.  The main reason for using the social media was for personal interest, followed by Benchmarking.  This survey also shows that once a technology matures (for example the PMFList and the PSDGList Email discussion groups) participation becomes enthusiastic.

Conclusions

The internet and social media offer a wealth of information and capabilities to the microbiologist; it seems as if more microbiologists can take advantage of the opportunities presented.  BioLumix participates in many of the forms of social media and offers a wealth of information to microbiologists

Water testing- Heterotrophic bacteria, coliforms and E. coli- Why and how to test

Water Quality

Water QualityWater is used in a variety of different industries as well as products within various industries, including Nutraceutical and Dietary Supplement, Pharmaceutical, cosmetics, toiletry industries.  Water can be used as a product ingredient, for example, to create the capsules that contain the supplement.  In the manufacture of the capsules many companies use their own water to create and encapsulate their products.   Water is also used for the cleaning of certain equipment and contact surfaces.

According to USP 1231, although there are no absolute microbial standards for water (other than water intended to be sterile), the CGMP regulations require the establishment of appropriate specifications. The specification must take into account the intended use of the water; i.e., water used to formulate a product should contain no organisms capable of growing in the product. Action or alert limits should be established based upon validation data and must be set low enough to signal significant changes from normal operating conditions.

Control of the microbiological quality of water is important for many of its uses. All packaged forms of water are required to be sterile because some of their intended uses require this for health and safety reasons. The needed microbial specification for a given bulk water depends upon its use. Some applications may require even more careful microbial control to avoid the proliferation of microorganisms ubiquitous to water during the purification, storage, and distribution.

To ensure adherence to certain minimal microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. Environmental Protection Agency (EPA) or the drinking water regulations of the European Union or Japan, or the WHO drinking water guidelines. Microbiological requirements of drinking water ensure the absence of coliforms, which, if determined to be of fecal origin, may indicate the potential presence of other potentially pathogenic microorganisms and viruses of fecal origin. Meeting these microbiological requirements does not rule out the presence of other microorganisms, which could be considered undesirable if found in a drug substance or formulated product.

USP<1115> deals with bioburden of non-sterile drug substances and products, and the chapter states that the biggest manufacturing risk is water as an ingredient.  Process water is the single most important risk factor contributing to the contamination of nonsterile products.  The purified waters that are used in manufacturing are deionized and do not contain chlorine that helps control microbial growth.  Purified water is capable of supporting growth of gram negative rod shaped bacteria and many different molds.

Water TestingThe FDA also covers a wide range of different types of water that can be used for pharmaceutical uses and describes different sources for water contamination.  The FDA even states that microbial contamination of oral liquids and topical drug products are a significant problem that is usually caused by contaminated water.  Due to the potential health risks involved with the use of contaminated water, particular attention should be paid to the deionized (DI) water systems, especially at smaller manufacturers.

Chlorinated water may be appropriate for early stage cleaning and sanitization activities, but the uses are risky and should only be used on a case by case basis.  Microbial enumeration is an integral component of a water monitoring system to assess the microbial quality of the water.  Some systems use both high-nutrient (PCA) and low-nutrient (R2A) media to allow the isolation of both heterotrophic organisms and slower growing oligotrophic bacteria.

Water testing is also important when dealing with well water, tap water and even bottled water.  The EPA uses coliform as an indicator of possible fecal contamination.  Coliforms naturally found in the environment, and are usually non-pathogenic, but their presence may indicate fecal coliforms.

The Rapid Automated BioLumix System

BioLumix SystemBioLumix automated; all-in-one microbial testing system is an ideal system for in plant water testing.  The system is fast, simple and cost-effective.  A novel optical system sensing color and fluorescence in ready-to-use vials provides faster results, labor savings, automation, and connectivity. The BioLumix system is capable of testing water for heterotrophic bacteria, total aerobic bacteria, E. coli, coliforms, fecal coliforms and yeast and molds. Using the BioLumix system will quickly determine the microbial quality of the water.

Heterotrophic Vial: This vial can detect organisms requiring low-nutrient media (similar to (R2A) to allow the isolation of both heterotrophic organisms and slower growing oligotrophic bacteria. In a study, over 50 samples of multiple different water types were tested by the BioLumix method and the plate count method side-by-side.  The BioLumix vials were directly inoculated with 0.1 mL of the water sample, or a 1.0 mL of a 1:100 dilution, and a few samples were inoculated with heterotrophic bacteria.  The samples were monitored in the BioLumix instrument for 35 hours.  The results showed that the BioLumix system was roughly 13 hours faster than the plate count method using Stand Methods Agar.  These particular samples were tested at specified levels <10 cfu/ml and <100cfu/ml, but the BioLumix method can detect organisms at levels of <1 cfu/ml of water.

Bottled water for human consumption also needs to be tested for coliforms, which are indicators of possible contamination. The FDA requires either MPN or membrane filtration to check 100 ml of water for any contamination. The MPN method which requires at least nine tubes to perform the test and up to 96 hours of testing; while BioLumix can do the same analysis using just one vial in less than quarter of the time.  The filter method can also be applied using the BioLumix system by filtering the 100ml onto a membrane filter and placing the filter directly into the vial.

What are the advantages of the BioLumix system?

The system serves, as a platform to perform all required assays- using the BioLumix system will allow the users to test for coliforms, heterotrophic bacteria, E. coli and Yeast/Mold. The system can be used for water testing as well as for testing raw materials, in process and finished products.

Saving time- The BioLumix system can save time when testing water for Heterotrophic bacteria instead of taking three days using traditional plates, the BioLumix system will give the same results in 35 hours.

Economical cost of assays: Instead of running an MPN assay, which will require up to 5 days of testing as well as 9 tubes of LTB and up to 9 tubes of EC Media to wait for confirmation of a positive fecal coliform, the BioLumix system requires less than 24 hours and a single vial.

References:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072925.htm -Water for Pharmaceutical Use

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm  Enumeration of Escherichia coli and the Coliform Bacteria

USP <1115> Bioburden Control of Nonsterile Drug Substances and Products

USP <1231> Water Treatment Systems For Industrial & Commercial Use.

TIPS FOR SUCCESSFUL ENVIRONMENTAL MONITORING

Putting together an environmental monitoring plan requires a thoughtful, scientific approach establishing and considering the risks of contamination from each location along the manufacturing process.
environment monitor
WHY MONITOR THE ENVIRONMENT?

Environmental monitoring (EM) is a basic requirement across many regulated industries such as food, cosmetics, Nutraceutical, dietary supplements, and pharmaceuticals. It measures the degree of maintaining environmental control and, therefore, the safety of the manufactured products. Maintaining environmental control can prevent product contamination.

The FDA evaluates the environment of manufacturing facilities against the regulatory code, and the potential of the product allowing for growth of organisms. They expect manufacturers to be in control of the environmental conditions in their facility. There is evidence that a relationship exists between the level of environmental control and the final quality of the product. In product safety, the EM program serves a critical role that the environment is under appropriate control.

In manufacturing facilities, there is a need to demonstrate that production equipment is sufficiently clean thereby the next production lots are not contaminated from the material of the previous lot.

An effective sampling plan needs to be established, the purpose of a microbial EM program is to:
• Provide crucial information on the quality of the work process environment during manufacturing
• Prevent future microbial contamination by detecting and reacting to adverse trends
• Prevent the release of a potentially contaminated batch if the appropriate standards are not met
• Prevent the risk of contamination of the product
• Ensure there are environmental controls in the production areas
• Provide a profile of of the microbial cleanliness of the manufacturing environment.

SITE SELECTION FOR DATA COLLECTION

The site’s selection for data collection should show the effectiveness of cleaning. Such as:
• Site where the product is exposed to people and equipment
• Critical sites that can change product integrity if compromised
• Areas and processes steps where microbial contamination must not happen, such as the final filling of the product into its containers.

In establishing an EM plan, the number and location for sampling sites should be established. When choosing the sampling sites, there needs to be a good representation of risk-based sites where the environment can affect the product quality. Examples of such location include areas that are difficult to clean, or areas close to critical operations.

For sterile products, the manufacturer needs to keep the bioburden of the pre-sterilization as low as possible. There is a need to monitor the air, water, personnel, and surfaces as they all can contribute to the bioburden.
For non-sterile, low bioburden products, there are two main reasons for monitoring the environment:
1. To keep product bioburden under control
2. To know if the environmental isolates could contain objectionable organisms.

Other important questions to consider include:
? What is the antimicrobial effectiveness of the product?
? Will the product promote microbial growth?
? If so, which organisms can grow and get around the inhibitors build into the products?

ESTABLISH A BASELINE

Before initiating an EM program, it is recommended to get a baseline of total aerobic count, Yeast and mold count, perhaps coliform or Enterobacteriaceae, and in some instances lack of objectionable organisms on surfaces and the air. Establishing a baseline also allows for assessments of the types of organisms present, and helps in developing a scientifically sound disinfection program to address chemical kill and physical removal of such contaminants. The data subsequently collected during microbiological performance qualification, and routine monitoring helps to validate the efficacy of disinfection and cleaning procedures.

CHOOSE SUITABLE METHOD FOR EM

method for monitoring - swabsMost EM is done by plate counting of colonies on agar media, which is simple and inexpensive. However, plate count methods are slow, requiring two to seven days to complete, thereby causing a delay in the detection of contamination, which can lead to an increase in product loss, plant downtime and expensive cleanup. Delays can cause increasing inventory holding cost. The delay in obtaining results impacts reaction to contamination issues and can make investigations very difficult. The plate count methodology is also labor-intensive and requires manual data entry and documentation. Such documentation is prone to human errors and compliance issues.
Methods are available to measure total particles in the air, including Total Organic Carbon (TOC), and Adenosine Tri-phosphate (ATP).These methods are very fast to perform but do not correlate well with total bacterial count or any specific group of organisms, and do not measure viable organisms (Carricket al., 2001; Easter, 2010). Therefore, these results do not measure viable organisms in the environment or on production lines.

WHY BIOLUMIX

why BioLumixThe BioLumix system is useful for rapid and simple monitoring of the manufacturing environment. A large validation study was performed (Eden and Brideau 2012) to show that is correlates well with the plate count method. The BioLumix system was validated as an alternative to the plate count method for EM. The study involved 549 surface coupons representing five diverse types of material. These five surfaces represent those encountered in manufacturing, including metal, plastics and rubber. Some of the coupons were inoculated with bacteria, yeast, or mold. There was 100% agreement between BioLumix assay and the plate count assay for the 260 coupons that were determined to be below the specified level by the plate count method. There was an overall agreement of 97.2%between the two methods when swabs containing counts above the specified level were used. In general, discrepancies in swab results between the BioLumix vial method and the traditional plate count method reflected marginal samples that were very close to the specified testing level, and thus were variable.

REFERENCES

Carrick, K, Barney M, Navarro, A. and Ryder D. (2001). The Comparison of Four Bioluminometers and Their Swab Kits for Instant Hygiene Monitoring and Detection of Microorganisms in the Brewery. J. Institute of Brewing 107, 32-37
Easter M. (2010) A comparison of commercial ATP hygiene monitoring systems. Next Generation Food issue 9, 2010.
Eden, R. and Brideau, R. (2012). Validation of a Rapid System for Environmental Monitoring and Water Testing. In Environmental Monitoring Volume 6, Jeanne Moldenhauer, Ed

The versatility of the BioLumix System – One system for all your microbial needs.

Why go to an automated system?

There has been a growing awareness over the years that utilizing the current methodology for determining microbial contamination is not cost effective due to the slow turnaround.  Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM’s) can speed up significantly the time to results from 7-10 days to 15-48 hours.  An automated detection system provides contamination information earlier than the conventional method, products can be released faster, manufacturing at risk is minimized, and investigations can be conducted and concluded closer to the time of the actual contamination.  The obvious benefit of an automated system is the quicker release of finished products, where the shorter ‘time to result’ may generate considerable cost savings. Some of the other advantages of RMM can include greater accuracy, better sensitivity, increased sample throughput, and automated data capture allowing easier data handling and paperless laboratory.

Why You Should Invest in the BioLumix System?

BioLumix SystemTime is money.  For a nominal investment in automation, the BioLumix Rapid Microbiology System will save valuable days in the QC process: optimize operations; increase throughput; and directly impact company profitability!  The BioLumix system allows for all of your microbiology needs to be met with one automated system.  It can be used to test Raw, In-process, and Finished Materials along with environmental and water samples.  The BioLumix system allows the user to test as frequently and as broadly as desired without significant cost or delays. The results are increased capacity along with cost reduction, improvement of logistics, and overall better efficiencies! With shorter sample preparation time and automated data entry, data archiving, report generation, and product release, the BioLumix system simplifies and automates your laboratory procedures. Tests can be also be performed by non-microbiologists, providing significant savings in laboratory labor.

Advantages of the BioLumix System

1)      All assays performed on a single system.  This allows laboratories to purchase one system but offer and perform many different tests, thus eliminating the problem of finding space for multiple systems in the lab and training personnel on multiple instruments.

a)      Microbial results can be generated in 24-48 hours in assays such as Total Aerobic Count, Yeast and Mold, Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa while utilizing one system.  The system is unaffected by product interference and delivers accurate results. BioLumix is dedicated to producing affordable and easily performable assays that laboratories of all sizes can integrate into their daily work flow and yearly budget.

b)      BioLumix has improved the way microbiology can be performed in the cosmetic, toiletry and pharmaceutical industries.BioLumix has improved the way microbiology can be performed in the cosmetic, toiletry and pharmaceutical industries.  BioLumix offers the first automated PET and Microbial Limits system on a single platform, without any product interference! Preservative Efficacy Testing or Challenge Testing (USP<51>), Microbial Enumeration Testing (USP<61>), and Testing for Specified Microorganisms (USP<62>) can be easily performed without the hassle of preparing and counting multiple plates that would be expected using the standard methodology yielding faster results and being more cost effective.

c)      Environmental Monitoring.  In manufacturing facilities there is a need to demonstrate that the production equipment and environment are sufficiently clean so that the next production lot will not be contaminated by the material from the previous lot, removing the potential of cross contamination. One needs to prove with high degree of certainty that the cleaning process was effective. To do so an effective sampling plan needs to be established.  The BioLumix system can be utilized for rapid and simple monitoring of the manufacturing environment.

d)    Water Testing. Water is widely used as a raw material, ingredient, and a solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients and intermediates.Water Testing As such, all water purification systems must be monitored regularly to verify the quality of the water produced. Monitoring of water for microbiological quality may include testing for total heterotrophic plate count, coliforms/E. coli, or by checking for the presence of other organisms suspected to be present in a water sample. The relevant standards relating to pharmaceutical grade water are USP <1231> Water for Pharmaceutical purposes.

2)      Scarcity of skilled personnel: Microbiology laboratories face major challenges such as the growing scarcity of skilled laboratory workers and the burden of the ever-increasing workload.  The BioLumix system requires limited training to successfully set up the tests.  The system is fully automated including archiving of data, data maintenance and report generation, and it can be used to create a paperless laboratory.

3)      In house testing allows a laboratory to be more cost effective.  Increased turnaround time may be one of the most appealing features of an automated system.  Contamination can be caught quicker and actions can be taken immediately so that products can be released faster into the marketplace.

4)      The Validated BioLumix System.  Since June 25, 2010, all dietary supplement manufacturers have been required to comply with the Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP’s) according to the guidance outlined in USP chapters <2021>, <2022>, and <2023>.  The BioLumix system has software that is 21 CFR Part 111 compliant and BioLumix generates a customized validation book for each of its customers that include:

a)      Installation qualification (IQ):  Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed; and documentation of instrument calibration.

b)     Operational qualification (OQ):  Verifying that the equipment is properly installed calibrated and is operational.  It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.

c)      Performance qualification (PQ): is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.

 

 

References:

1)       United States Pharmacopeia Chapter  <51> Antimicrobial Effectiveness Testing

2)       United States Pharmacopeia Chapter  <61> Microbiological Examination of Nonsterile Products:  Microbial Enumeration Tests

3)       United States Pharmacopeia Chapter  <62> Microbiological Examination of Nonsterile Products:  Tests for Specified Microorganisms

4)       United States Pharmacopeia Chapter <1231> Water for Pharmaceutical Purpose

5)       United States Pharmacopeia Chapter <2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements

6)       United States Pharmacopeia Chapter <2022> Microbial Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements

7)       United States Pharmacopeia Chapter <2023> Microbial Attributes of Non-Sterile Nutritional and Dietary Supplements

8)       United States Pharmacopeia Chapter <1223> Validation of Alternative Microbiological Methods

PRESERVATIVE EFFICACY TESTING: GUIDELINES TO AN AUTOMATED SIMPLIFIED TESTING SYSTEM

Introduction

The ultimate purpose of the Preservative Efficacy Test (PET) is to determine the effectiveness of the preservative(s) present in a cosmetic, toiletry, or pharmaceutical product.  USP Chapter <51> ANTIMICROBIAL EFFECTIVENESS TESTING describes the type of products to be tested (categories), the specified microorganisms to be used for testing, and the inoculum and log reduction amounts required per category of product.  The product to be tested is inoculated with a high number of bacteria, yeast, and mold, and the reduction in the initial inoculum amount is calculated over a 28 day period.

Current Methodology

Until now, the only way to perform PET was by the plate count method.  Typically, a product is inoculated with a high number of organisms (usually 105 - 107), and after 7, 14, 21, and 28 days, samples of that inoculated product are tested to determine the log reduction that occurred to the organisms when subjected to the preservative system.  Because it is not known how effective the preservative system is, serial dilutions have to be plated to determine the number of organisms remaining in one gram of product.  As a result every organism require a number of plates, dilution bottles and tips as shown in figure 1.

Advantages of BioLumix Simplified Automated System

The main advantages the customer gains using BioLumix are savings on time, labor, and materialsPreservative Efficacy Test

The BioLumix assay (Figure 2) takes about 75% less hands-on labor as compared to the standard plate count method, and the simplicity of the BioLumix method is unparalleled.  Ease of use, less materials (as seen in comparing Fig1 to Fig2), and less dilution reduces the chance of error.  After inoculation of product with pure cultures, the BioLumix method allows the operator to perform testing in 4 easy steps:

  1. Weigh 1.0 gram of inoculated product to a sterile sample bag.
  2. Add 9.0 mL neutralizing broth and allow to sit for up to 45 minutes.
  3. Add 1.0 mL to the BioLumix vial.
  4. Enter the vial into the BioLumix Instrument and begin the automated testing.

Pre-programmed calibration curves as shown in Figure 3 are used to generate the colony forming unit count per gram of product based on the detection time of the curve.  This eliminates tedious counting of multiple plates and interpretation of results when working with thick or waxy products, or products containing materials that may resemble bacterial or yeast colonies.  The BioLumix method also saves time in obtaining results.  For each day of sampling, BioLumix reduces the time-to-results for bacteria from 48 hours to 24 hours and from 5-7 days for yeasts and mold to 48 hours.  The BioLumix system uses a single vial to replace a number of plates, dilution bottles and pipet tips, thereby reducing disposable costs.calibration curves

Example of Results Obtained

The example, show the results of PET obtained with eye drops with and without benzalkonium chloride.  The results obtained by both the BioLumix system (BL) and the plate count methodology are shown in the two table below.

results obtained by both the BioLumix system (BL) and the plate count methodology

results obtained by both the BioLumix system (BL) and the plate count methodologyThe data by both methods shows that in the product with the inhibitor benzalkonium chloride (Table1) after 7 days all bacteria are reduced by more than 5 log cycles, as are the counts of Candida. It took 14 days for Aspergillus to be reduced by 5 log cycles.

When the product did not contain benzalkonium chloride (Table 2) and as a result was not properly preserved, only P. aeruginosa was reduced by 5 logs after 7 days. E. coli took 14 days to reduce the numbers by 5 logs. The other organism had a very slow reduction over time.  The counts of Aspergillus were reduced by less that 2 log cycles.  The results show that the two methods yield very similar results.

Many other products were tested with the BioLumix PET methodology including scrubs, creams, lotions, Shampoos, hand and facial cleansers to name a few, and equivalency with the plate count methodology and reproducibility of results was demonstrated for all products.

The BioLumix system allows the operator to save time, materials, and money by drastically cutting hands-on labor and time-to-results.  If offers labor reduction by 75-80% of the labor required for the Petri dish method, with much less disposable used, faster time to results and good correlation with current methodology.  It allows for the creation of a paperless laboratory.  The system automation provides automated data achieving, and automated reporting including log reduction calculations.

PDA’s 8th Annual Global Conference on Pharmaceutical Microbiology

October 21-24, 2013 | Bethesda North Marriott Hotel | Bethesda, Maryland; Exhibition: October 21-22

PDA’s 8th Annual Global Conference on Pharmaceutical Microbiology brings together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that the Pharmaceutical industry faces on a daily basis. During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies, providing invaluable sessions dedicated to pharmaceutical microbiology.  Visit the BioLumix booth (#13) to learn about the most advanced rapid microbiological testing system.

advanced rapid microbiological testing system
Rapid Automated USP <61> and <62> on a single Platform
BioLumix Rapid Microbiological System is capable of performing testing equivalent to both USP <61>and <62> simultaneously on a single platform. The novel automated growth-based system simultaneously detects microbial growth, provides an estimation of viable cell counts, and identifies the presence of specified micro-organisms. By encompassing both USP types of testing, the BioLumix is a complete screening solution making the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money. BioLumix has a DMF on file with the FDA, and the system is easy to validate due to growth based format using traditional USP media.

Adding Speed and Automation to Microbiological Testing – The Automated BioLumix System will accelerate your microbiological testing resulting in faster product release and decreased costs. The streamlined testing design reduces labor, time and supplies. The BioLumix software is 21 CFR Part 11 compliant with log-in, log-out and audit trail. The BioLumix Rapid Microbiology System can save multiple days versus current USP testing methods, and dramatically impact key profit drivers, such as elimination of idle time with raw materials, work in progress, and finished goods. The time saved has a direct impact on many operational profits drivers. . . and is The reason over 400 BioLumix Systems are actively being used by many manufacturers.

Here are just a few of the many benefits of the BioLumix System:

  •  Simplified, automated microbiology testing
  •   Paperless laboratory
  •   60% savings in labor
  •   Real-time continuous support for reviewing microbiology assays.

We welcome all of our customers to stop by and say hello!  If you are not yet a customer, we welcome the opportunity to work with you.  Our jobs center on satisfying our customers and providing unparalleled support.  We would be happy to give you a demonstration of the system including testing your samples for free.  After all, we wouldn’t want to sell you a product that doesn’t work for you.  Still not convinced?  We would be more than happy to provide you a long list of customer referrals.

The Pharmaceutical Industry is Growing; the BioLumix System Can Help Your Lab Grow With it

According to the United States National Institute of Health, there are nearly 140,000 clinical studies currently underway involving potential pharmaceutical products. Pharma is a huge industry, and companies both big and small are investing roughly $50 billion a year to get their products to market.Pharmaceutical Microbiological Testing This fervor spans some 200 countries, and with all this in mind it is no wonder that research has increased by an average of 28% each year since 2000. Still, whenever there are huge sums of money involved, people and companies can be enticed to hastily release their products, and this potential for microbial contamination in pharmaceutical products can have serious and far-reaching repercussions. The goal of the BioLumix Microbiological Testing System is to promote an expedient, automated, and efficient laboratory environment, allowing companies to increase their bottom line and ensuring that only safe products make it to the shelves.

Pharmaceutical microbiology is essential to the quality control process of any drug or supplement. Companies can spend immeasurable sums of time and money during this stage, and current plate count methods are incapable of providing labs with an avenue for advancement. BioLumix Rapid Microbiology Methods offer innovative new testing solutions that are designed specifically for the challenges of the pharmaceutical industry, including a multitude of microbial tests for raw materials, in-process and finished products, as well as the capacity to perform environmental testing. This simplifies, expedites, and reduces the cost of performing microbiological assays.

Biolumix Microbiology SystemThe key to the BioLumix System is its use of patented two-zone vials to monitor changes in a broth medium. At the top of each vial, an incubation zone allows a microbiologist to insert samples for testing, and at the bottom, a reading zone is utilized for the automated monitoring of up to 32 specimens by a single unit. Changes in color or fluorescence, which may be a sign of microbial growth, are expressed as light intensity units, which are detected by the systems optical sensor and recorded in its computer. Sample volumes of up to 2 ml can be used in each vial. Additionally, each vial slot features a dual-color Light Emitting Diode (LED) and a fluorescent tube that covers the full spectrum of colors and ultraviolet light. These two-zone vials eliminate the masking of the optical pathway by the products microbial turbidity, and because changes in color and fluorescence are monitored in the reading zone, results cannot be influenced by the sample or any of the microorganisms.

A few of the applications of the BioLumix System include total counts, yeast and mold, Bile tolerant gram negatives, and objectionable organisms. Results are easy to interpret and can be automatically transmitted to other locations, such as a company warehouse, to rapidly ship safe products. Perhaps one of the most convenient aspects of the BioLumix System is the fact that it can be easily operated non-microbiologists. This lessens the amount of tedious work for skilled lab-technicians, and allows them to shift their focus to higher value tasks.

In short, the BioLumix System allows pharmaceutical companies to perform as many tests as are needed to maintain a safe and beneficial product, without sacrificing time or money. Instead, for a one-time investment in BioLumix rapid microbiological method technology, your lab will be able to expedite its quality control process and decrease its overhead, allowing your company to expand in the growing market.  The BioLumix rapid microbiology system will allow for increase capacity, logistical improvements and better efficiencies.

Recently Dr. Miller presented a web seminar about a case study of the implementation of the BioLumix system.  To listen to this seminar click on the link http://cnpg.comparenetworks.com/144579-Implementation-of-New-RMM-BioLumix-Case-Study/

BioLumix System Saves Valuable Time in Yeast and Mold Testing

Rapid Microbiology Yeast and Mold TestingIf you are a microbiologist, or work in close relation with a laboratory, you probably already know that yeast and mold testing is one of the longest quality control processes. Both the plate count and the membrane filtration techniques used by many microbiology labs often take between 5-7 days to complete, and this ends up costing you and your organization valuable time and money in the mean time. The BioLumix rapid microbiology system is based on cutting edge knowledge of the microbial metabolic process, and is the most versatile method around when it comes to the expedient detection of microorganisms. For the nominal cost of our automated testing systems, your company could shave several days off of their production and distribution time, and secure a catalyst that will increase profits for years to come.

Yeasts and molds constitute a large and diverse group of microscopic foodborne fungi, totaling several hundred different species. One of the main reasons that these organisms are so successful in attacking foods and cosmetics is their versatility, having very broad temperature (5-60 ?C) and acid/alkaline (pH 2-pH 9+) requirements for growth. This means yeast and mold are capable of invading crops, such as those producing grains, nuts, beans, and fruits both before harvesting and during storage, and can also make their way into our processed food. In many cases Yeasts and molds are not immediately visible, however these fungi can cause varying degrees of deterioration and decomposition in products, with the manufacturer only discovering their presence when it’s too late.

Several different kinds of molds and yeasts can be hazardous to humans and animals due to their ability to produce toxic metabolites called mycotoxins. These metabolites are stable compounds, and the performed toxins are usually not destroyed during food processing, or even when cooking at home. Other yeasts and molds can also cause allergic reactions or infections, especially in immunocompromised demographics, such as the elderly, the young, the debilitated, or those undergoing antibiotic and chemotherapy treatment. To make matters worse, yeasts and molds often cause products to spoil after they have left the processing facility, posing potentially a health hazards and product quality issues to the consumers. For this reason, a wide range of industries require that companies test their products for yeast and mold before they go on sale. In a nutshell, the quicker you can produce and quality test products, the quicker you can get your inventory to market, and the more profitable you will be.

This value proposition is the premise upon which our rapid microbiological testing system was founded. The BioLumix system is committed to simplifying, expediting, and reducing the cost of performing microbiological assays so that companies can bolster production with a fraction of their current working capital. Our ready to use vials are capable of detecting yeast and mold in 48 hours, saving 3-5 days when compared to plate count and membrane filtration techniques and keeping more money in your pocket.

optical technology for yeast and mold testingThe keys to our systems celerity are its patented CO­­­2 sensors and optical technology, which continuously monitor growth media in each vial. Because yeasts and molds are obligate aerobes, they must take in oxygen and release Carbon Dioxide (CO­­­2) in order to grow. This cellular respiration is part of the Krebs cycle, and is used by all aerobic organisms to generate energy. When the sensor detects the presence of CO­­­2 it is a sign that microbial growth is present. The optical sensor simultaneously takes readings of the vials at 6 minutes intervals, detecting changes in color, and allowing for rapid detection of growth. Results are easy to interpret and can be automatically transmitted via a multitude of communication channels to its needed location, such as a warehouse or production facility to expedite shipping of a safe product. Our fully automated system can also be operated by a non-microbiologist, reducing labor by up to 60%, and allowing skilled scientists to spend their time in the lab more efficaciously. With less tedious work, microbiologists can turn their attention to higher value tasks, such as interpretation of data and product safety analysis, making your lab far more efficient.

With the BioLumix rapid microbiology system, labs can revolutionize the way that one conducts their quality control process. Our platform makes production times shorter, products safer, and recalls less frequent and far less costly. Adding value and increasing lab productivity with BioLumix will allow your organization to thrive, and will put you in a position to be successful for years to come.  

Pharmaceutical Microbiology

Pharmaceutical Microbiology

BioLumix offers innovative microbiological testing solutions designed specifically for the Pharmaceutical industry. We offer a comprehensive range of microbiological tests for raw materials, in process and finished products as well as environmental testing. We’re always available to answer any inquiries regarding the system specifications, installation, validation, performance, benefits and cost savings. If you would like to speak with one of our experienced microbiologists or engineers, please contact us directly: (734) 365-7500

We are committed to delivering high value products, with a real technological difference, to satisfy our customer’s needs and help improve their quality assurance. We’re always available to answer any inquiries regarding the system specifications, installation, validation, performance, benefits and cost savings. If you would like to speak with one of our experienced microbiologists or engineers, please contact us directly: (734) 365-7500

 

3928 Varsity Dr.
Ann Arbor, MI 48108

Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com

http://www.mybiolumix.com/
https://plus.google.com/1065126081990…

BioLumix RMM platform featured in Latest Edition of NutraCos Journal

Introduction

The BioLumix platforms Rapid Microbiological Method (RMM) was recently featured in NutraCos journal for its ability to offer a multitude of unprecedented advantages to companies, as well as its versatility across various industries. NutraCos is an international journal that features articles on everything from nutraceuticals and probiotics, to regulations and policy.1 Given the rapidity of technological advancement, and the complex structural nature of the cosmetic, OTC and nutraceutical industries, many companies and individuals utilize NutraCos as a way to stay current with the latest developments throughout the world. In the journals January/April 2013 edition, our President, Dr. Ruth Eden, and Senior Research Microbiologist, Roger Brideau, explain the technology, as well as the benefits of the BioLumix automated microbial testing system to an international audience.2

 

Why Use Rapid Microbiological Methods?
Rapid microbiological methods are technologies that allow their users to get microbiological test results faster compared to traditional USP methodologies, which use plates and require a minimum of two to seven days in order to achieve complete results.  The BioLumix system can report results within hours, and all final results are available within 48 hours. This can dramatically impact key profit drivers by eliminating the wait for microbial results that can tie up working capital and often results in storage expenses and delays in supplying products to the market. Essentially, inventory stays on the floor instead of going out the door to the customer/patient population.  A shortening of the length of the manufacturing cycle means less required working capital investments, and simplifies rapid microbiology.

RMM Using BIOLUMIX
The systems three components consist of a modular instrument, disposable vials, and a 21 CFR Part 11 compliant computerized software package, the latter of which provides the user with an audit trail, operator identification, a data management system, and multiple customizable report formats. This process functions by continually monitoring the changes of a broth medium in which target organisms grow. The BioLumix system uses a CO2 sensor at the top of each disposable vial to detect released CO2, which is produced by all microorganisms, as well as reagents at the bottom of each vial, which measure changes in color/fluorescence of the broth medium by way of light intensity units in response to microbial metabolism.

 

The BioLumix system is extremely versatile and is capable of performing most microbiological assays tests, such as those for microbial content (microbial enumeration of total counts and yeast and molds), objectionable organisms, suitability testing and preservative efficacy testing.

A suitability test, to show usage of an adequate neutralizer inactivates the preservative in the product being tested. This demonstrates that if organisms are in fact present they will be able to grow and be detected. The suitability test can be performed very simply and quickly with the BioLumix system.

Testing of any cosmetic, pharmaceutical or personal care product should include a survey for contamination often referred to as testing for Microbial Content, which uses assays designed to measure the growth of bacteria, yeasts and molds to flag products for the presence of contaminants.3, 4 For most cosmeceutical products, regulations state that total aerobic count should be <100 cfu/g, and that yeast and mold counts should be <10 cfu/g. The workflow of the testing of a personal care sample for the presence of microbial contamination is very simple and requires a fraction of the time and labor needed to perform the same tests using the USP methodology.  Each product can also be assayed specifically for the detection of E coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Salmonella species.

Upon determination that a product has been properly neutralized and has very low levels of contamination, the user can conduct a Preservative Efficacy Test (PET), sometimes referred to as the Antimicrobial Efficacy Tests. This test is required for all cosmetic and personal care products in the United States and follows the guidelines set forth by USP 51.5 Briefly put, the product must be challenged within individual containers, each going through this process separately using one of the five required organisms, which include ATCC established strains of E. coli, S. aureus, P. auruginosa, C. albicans, and A. brasiliensis. The PET assay measures the reduction of a high inoculum (106-107 cfu/g) in the presence of a product containing preservative over 28 days, which also tests the ability of the preservative to prevent a rebound of an organism (regrowth). After these tests the BioLumix software produces a certificate of analysis with a succinct report of the microbiological properties of each product for use at your convenience. This equates to proactive detection of contaminated products, and ensures that minimal resources are spent on production and subsequent recall of said products if they are found to be contaminated.

Conclusion

The BioLumix Rapid Microbiology System can save multiple days of time to reach the assay endpoint versus traditional plate methods.  This time saving could dramatically impact key profit drivers, such as elimination of idle time with raw materials, work in progress, and speed to finished goods. Faster detection of microbial contamination also results in faster corrective action in the event that material is above the targeted specification level. Earlier awareness of contamination problems in production runs can result in less production of defective final finished goods. By significantly decreasing the manufacturing cycle, one can lower their required working capital investment.

The BioLumix instrument is a straightforward and easy to use system that allows for rapid and accurate results.  The system is fully automated including data archiving, data maintenance, and report generation. It is paperless and efficient; saving on disposables, time and space. In short, BioLumix streamlines microbiological testing, delivering a simpler, faster, and automated solution saving your company significant time, labor and money.

To read the whole article complete with direct comparison tables and figures, visit our scientific presentations page. (http://www.mybiolumix.com/scientific-presentations/)

 

References

  1. Lee, C. “NutraCos,” Vitafoods Europe. London, UK: Informa Exhibitions, 2013.
  2. Mori, F. L. “NutraCos,” Via M. Donati 6. Milano, Italy: B5 s.r.l., 2013.
  3. United States Pharmacopeia, Chapter <61>, 2009.
  4. United States Pharmacopeia, Chapter <62>, 2009.
  5. Moser, C.L.; Meyer B.K. AAPS PharmSciTech. 2009, 12 (1), 222-6

Case Study of a New Growth-Based Rapid Microbiological Method that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count

Published In “Encyclopedia of Rapid Microbiological Methods”, vol 4. Editor Michael Miller 2013, PDA Bethesda, MD. DHI Publishing River Grove. IL.

 

Chapter  Highlights

The BioLumix Rapid Microbiological System is capable of performing testing with a similar outcome to USP <61> (USP, 2009a) and <62> (USP, 2009b) simultane­ously on a single platform faster than the conventional USP methodology. The automated growth-based system detects microbial growth, provides an estimation of viable cell counts (total aerobic count, yeast and mold, bile tolerant Gram-negatives), and identifies the absence of specified groups of microorganisms. The novel BioLumix Optical System using ready-to-use vials provides faster results, labor savings, automation, and connectivity. The streamlined testing design and rapid results lead to reduced material-holding time for faster product and raw materials release. The BioLumix System is capable of analyzing tablets, capsules, powder, liquid and viscous material without any product interference. BioLumix offers a comprehensive range of micro­biological tests for raw materials, in-process and finished products, as well as process water. Environmental monitoring (e.g., detecting micro-organisms on surfaces) is also performed easily by inserting the swab directly into the assay vial. Early warning of contaminated samples, as well as sample release informa­tion, could be automatically communicated through your intranet, significantly improving your company’s efficiencies. The software is 21 CFR Part 11 compliant and a Drug Master File (DMF) is on file with the FDA.

Industry Needs

Effective microbiological monitoring of pharmaceutical manufacturing processes is a necessary step to meet industry standards of product quality.  From a microbiology perspective, the industry should apply Quality Risk Management (QRM) principles in order to design a process to prevent contamination of product while investigating ways that correct contamination events.  QRM is an important part of science-based decisions that are essential for the quality management of pharmaceutical manufacturing.

Similarly, the FDA’s cGMPs for the 21st Century: A Risk-Based Approach, states “that using a scientific framework to find ways of mitigating risk while facilitating continuous improvement and innovation in pharmaceutical manufacturing, is a key public health objective, and that a new risk-based pharmaceutical quality assessment system will encourage the development of new technologies, such as Process Analytical Technology (PAT), to facilitate continuous manufacturing improvements via implementation of an effective quality system”.

In 2003 the FDA introduced the PAT initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” PAT is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT should reduce cycle time thus reducing the wastes of waiting and excess inventory already identified by lean manufacturing.

BioLumix Can Help Meet Industry Needs

Standard microbiological methods require up to seven days to complete.  At every point where microbial testing is carried out (raw materials, work-in-progress, or finished products) batches may be held in quarantine before they are pronounced ready to move to the next product stage.  Waiting for microbial results can tie up working capital and often results in storage expenses and delays in supplying products to the market. Essentially, inventory stays on the floor instead of going out the door to the customer and/or patient population.

The BioLumix Instrument is an example of a new generation Rapid Microbiological Method (RMM).  The BioLumix System is based upon detection of changes in color or fluores­cence due to microbial metabolism in liquid medium within a novel two-zone test vial. An optical sensor monitors these changes within the vial’s reading zone, which is physically separated from the incubation zone. This two-zone approach prevents masking of the optical pathway by product or microbial turbidity and, therefore, eliminates product interference.

The BioLumix System can be used to perform testing for total aerobic count, yeast and molds, and Gram-negative bile-tolerant bacteria as described in USP <61> (USP, 2009a).  The system can also detect objectionable organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella according to USP <62> (USP, 2009b). Each of these assays can be simultaneously performed using the same instrumentation. The sensitivity of the BioLumix System is a single viable cell per sample vial; when a single cell replicates to a specific detection threshold level, a positive response is recorded (detection time (DT)). The threshold level is ~100,000 cells/mL for bacteria and ~10,000 cells/mL for both yeast and molds. BioLumix uses the dilute-to-spec protocol, which requires diluting the sample to product release specifications or in-process action levels. If growth is detected, the sample fails; if there is no detection, the sample passes (i.e., the counts are below the specification limit).

 

Summary of Data from the Chapter

  1. Side by side growth comparison to USP<61> was shown for Total Aerobic Counts, Yeast & Molds, and for Gram Negative Bile-Tolerant organisms.
  2. Specificity using Inclusivity and Exclusivity testing was demonstrated for the BioLumix system.
  3. The Limit of Detection was demonstrated using target organisms.
  4. Robustness of the system was demonstrated using the following parameters:  effect of instrument temperature, effect of sample size, and effect of media volume in BioLumix vials.
  5. Ruggedness of the system was demonstrated using the following parameters:  effect of the analyst, effect of reagent lots, and effect of different instruments.

 

References

  1. United States Pharmacopeia (USP) (2009a), Chapter <61>, Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, The National Formulary, Rockville, MD, The United States Pharmaceopeial Convention.
  2. United States Pharmacopeia (USP) (2009b), Chapter <62>, Microbiological  Examination of Nonsterile Products: Tests for Specified Microorganisms, The national Formulary, Rockville, MD, The United States Pharmaceo­peial Convention.

BioLumix Exhibits at 2013 PDA Annual Meeting in Orlando, FL

This year’s Annual PDA Meeting –will be held in sunny Orlando at The Peabody Hotel, April 15-17th.  This meeting focuses mainly on present-day manufacturing, challenges in the industry, and those we will face in the future.  The meeting is separated into three tracks so each attendee may pick and choose different areas to learn more about.  Additionally, several planned networking and social activities will bring all kinds of professionals together to ask questions, learn and get to know one another.

FDA Approval - Drug Master FileAttendees will have an opportunity to visit the BioLumix booth – # 404.  The BioLumix System is a rapid, automated microbiological method that is the only system capable of concurrently testing both USP <61> and <62>.  The system provides a single platform for testing raw materials, in-process, finished product, environmental swabbing and processing water.  BioLumix provides a complete screening solution with real-time communication for early warning of contaminated samples (in hours rather than days), results for bacteria in 12-24 hours and Yeast & Mold in less than 48 hours.  Once all testing is complete, an automated Certificate of Analysis is available and can be printed via the printer or connected to a LIMS system.

The BioLumix system, as described in the “Encyclopedia of Microbiological Methods Volume 4” edited by Dr. Michael Miller’s, in Chapter 7, simultaneously detects microbial growth, provides an estimation of viable cell counts and identifies the presence of specified microorganisms.  Additionally, BioLumix has contributed Chapter 14 of “Environmental Monitoring,” edited by Jeanne Moldenhauer, “Validation of a Rapid System for Environmental Monitoring and Water Testing.”  Both books will be available to review at the BioLumix booth #404.

By encompassing both USP chapters (61 and 62), the BioLumix is the all-in-one microbial testing solution for companies looking to save significant time, labor and resources.  The system will bring automation to the current microbial testing! The system is based on optical sensors that detect color of fluorescent changes in ready to use carbon dioxide sensing vials.  These vials eliminate the need to make, prepare and QC traditional media.

BioLumix has a DMF (Drug Master File) on file with the FDA for prescription pharmaceuticals.  For OTC (Over the Counter) products, the system is fully Validatable.  BioLumix installers will generate the IQ (Installation Qualification) and OQ (Operation Qualification) on-site during the 2 ½ day training session.  We will also work with your team to complete the side-by-side testing portion of the PQ (Performance Qualification), leaving your company with a complete Validation package.

Please stop by Booth #404 to speak with a BioLumix expert, view our recent publications, ask questions, get answers and join the growing customer base of BioLumix users! Learn how BioLumix Rapid Microbiology can deliver significant reduction in time to results, reduced staff involvement, leading to faster product release. . . and how these can impact your key “operational profit drivers.” We look forward to earning another satisfied customer.  See you soon at the PDA Annual Meeting!

Microbiological Testing of Enzymes

What are Enzymes?

Enzymes are specialized proteins that accelerate the rates of chemical reactions by lowering the activation energy; the substrates are converted into products.  There are numerous different types of commercially available enzymes such as protease, amylase, cellulose and lipase.

Where are they used?

Many different industries use enzymes in the production of their products.  They range from animal nutrition, brewing industry, food processing, detergents, dairy industry, paper industry, biofuels, contact lens cleaners, photographic industry, carbohydrate processing and biochemicals.  Enzymes are also an integral part of the pharmaceutical and Nutraceutical industry.  In laundry detergents enzymes that degrade proteins causing stains, such as those found in grass stains, red wine and soil can be used.

Lipases are another useful class of enzymes that can be used to dissolve fat stains and clean grease traps or other fat-based cleaning applications.  Nutritional enzymes have risen to prominence during the past several years, driven by customers that would like to improve their digestive health. The biggest category for supplemental enzymes is still human digestion, an area that has become increasingly more important for maintaining optimum health. Supplementation of single enzymes, such as lactose to treat lactose intolerance, is probably the most familiar area of enzyme use. However, general dietary supplementation with a broad range of digestive enzymes is becoming increasingly more common. Supplemental enzymes can also be used to enhance the effect of herbs and botanicals. The active component of herbs and other botanicals can remain trapped within the cell wall matrix or may be in a form that is not easily broken down and absorbed. Select enzymes are added to these products to break open certain bonds to free the bioactive compounds.  The application of enzymes technology to pharmaceutical products is also a growing field.

How do they Work?

Amylases in the detergents can help by aiding in the breakdown of starch stains.  Also in the biofuel industry cellulases are used to break down cellulose into sugars that can be fermented, and then further processed to ethanol.  Trypsin is used in baby food to predigest the food for the babies.   Proteases can also be used in contact lens cleaners to remove proteins on the lens.  The figure below show a schematic diagram of how enzymes work:

Most enzymes require microbiological testing similar to other industrial products.   BioLumix has an easy method to complete this goal.  The versatility of the BioLumix system allows for a wide range of enzymes to be tested for a broad array of microorganisms; such as Total Aerobic Count, E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Lactic Acid Bacteria, Coliforms, Enterobacteriaceae, and Yeast and Molds. Liquid products allow a direct sample to be pipetted directly into the vial, while solid samples require a dilution step first.

The BioLumix Rapid Automated Method:

Enzymes traditionally can be very difficult to test due to their unique properties.  The two most common difficulties when working with enzymes is solubility and pH levels of the product.  When using the BioLumix system, pH is adjusted once the product has first been diluted at 1:10 in TSB or buffer during the preparation before the sample is placed into the vial.  Solubility issues can be solved in a few different ways. One way is by allowing the product to sit in solution and give it time to breakdown, and another way it to warm the product in a water bath or an incubator.

During enzyme testing at BioLumix, on plates the enzyme created a precipitate that looked very similar to colonies, which could lead to difficulties in reading the plate.  The plate needed to be  sub-cultured to determine if it was growth or just the precipitate.  The precipitate did not interfere with the BioLumix vials and provided a clear answer.  Additionally, the results were obtained two days sooner.  An oil based enzyme can also cause difficulties when using traditional plating methods versus the BioLumix system.  In the BioLumix system the oil does not have an effect on the result and can give a definitive answer.  While on plates, the oils can sometimes appear on top of the agar and give the appearance of colonies.

Another less common issue is gas production by the product when it is mixed with a liquid.  If the product is known to release gas the easy solution is to allow the product to off gas before adding it to the appropriate vial.  Then after an hour of being in the liquid, the sample can be stomached or mixed again to release the remaining gas.  While in traditional methods, the gas production can give false positive results in tests with Durham tubes, which would then require additional days to complete.

BioLumix Advantage:

The BioLumix system is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs. The BioLumix offers real-time results of contaminated samples saving hours, possibly days. Completed Total Aerobic Count, Coliform or Enterobacteriaceae results are obtained within 18-22 hours; Yeast and Mold results are obtained within 48 hours; the objectionable organisms can be detected within 24 hours after pre-enrichment. Also these assays are simpler to perform than the standard methods saving time, labor and money. The system is unaffected by product interference, delivering accurate results with faster product release.  When referring to batches of product that will be released days early due to the BioLumix system, which allows the storage and production less time to run and hastens the turnaround time of the product, the overall process of enzyme production will decrease.

Biolumix Automation Drives Profits

BioLumix Automation Drives Profits!

No longer look at micro testing of raw materials and finished products as a “necessary evil” in remaining cGMP compliant.   Rather, with BioLumix Rapid, Automated Microbiology, you can view microbiology product testing as a position of company strength and competitive advantage!

TIME IS MONEY. . .  we have detailed financial models prepared by our current customers that demonstrate the dramatic impact BioLumix is having when you apply Multiple Days Saved to real profit drivers, such as:  

Biolumix System

  •   Savings as a result of early detection of contamination
  •   Lower cost of inventory
  •   Increase capacity of existing factory and lab
  •   Reduce cost of storage
  •   Lower cost of test related overhead
  •   Savings on cost of capital
  •   Potential improvement in account receivables. . .  all of which directly impact profits!

Automation Drives Profits
The enacted cGMP regulations require manufacturers to ensure that products are free of contamination by objectionable organisms, and that appropriate microbiological testing is conducted.

BioLumix Rapid Microbiology offers a high degree of automation, significant reduction in time to results, reduced staff involvement, and faster product release. . .  all which impact key “operational profit drivers,” such as:

  • Savings as a result of early detection of contamination
  • Lower cost of inventory
  • Increase capacity of existing factory and lab
  • Reduce cost of storage
  • Lower cost of test related overhead
  • Savings on cost of capital
  • Potential improvement in account receivables

 

Contact Us TODAY To Learn More About Our FREE DEMO PROGRAM!

PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology

PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology brings together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that the Pharmaceutical industry faces on a daily basis. This comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies, providing invaluable sessions dedicated to pharmaceutical microbiology, and a venue to network with fellow microbiologists, experts in all areas of pharmaceutical microbiology, key vendors of microbiology testing equipment & supplies, and regulatory/compliance professionals. Visit the BioLumix booth (#13) to learn about the most advanced rapid microbiological testing system.

BioLumix Offers Microbial Testing Solutions for the Pharmaceutical Industry BioLumix Rapid Microbiological Method is capable of performing testing equivalent to both USP <61>and <62> simultaneously on a single platform. The novel automated growth-based system simultaneously detects microbial growth, provides an estimation of viable cell counts, and identifies the presence of specified micro-organisms.

The automated, all-in-one microbial testing system is extremely easy to operate. The system is both simple and cost-effective, revolutionizing your current testing methodology. This novel optical system senses color and fluorescence changes in ready-to-use vials provides faster results, labor savings, automation, and connectivity. The streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product and raw materials release.

By encompassing both USP types of testing, the BioLumix is a complete screening solution making the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money.

DMF Submission and Validation The BioLumix Drug Master File (DMF) is on file with FDA. The BioLumix System is fully validatable! During the system installation we will generate the IQ (Installation Qualification), OQ (Operation Qualification), and will help you to complete the PQ (Performance Qualification) portion of the validation, leaving you with a complete validation package against USP <61> and <62>.

The BioLumix Advantage Quality Assurance with a Competitive Advantage – The Automated BioLumix System will accelerate your microbiological testing resulting in faster product release and decreased costs. The streamlined testing design reduces labor, time and supplies. The BioLumix software is 21 CFR Part 11 compliant with log-in, log-ofut and audit trail. It presents real-time communication for immediate action of contaminated samples and a 48 hour Certificate of Analysis for completed samples, as well as other customizable reports. Testing is non-destructive, allowing for further identification of organisms where needed. BioLumix offers a comprehensive range of microbiological tests for raw materials, in-process and finished products as well as processing water and environmental testing. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference.

BioLumix customer service is second to none, with the ability to offer customer support from anywhere in the world. With the BioLumix system, one can depend on receiving the most superior level of service, support and compliance with FDA regulations.

Please take the opportunity to speak with an expert about how the BioLumix System can help lower your testing costs. We invite you to visit our website at www.myBioLumix.com or send us your most difficult samples for testing. We at BioLumix truly believe we will make your company more efficient and add profit to your bottom line.

Pseudomonads and Their Rapid Detection

Description of Pseudomonad Organisms

Pseudomonas bacteria (Pseudomonads) encompass gram negative, motile, non-fermenting rods. This genus is ubiquitous in nature and these organisms can impact a number of environments and patient populations. The Pseudomonads may be found in soil, on plant material, in water, and can be isolated from various tissues and body fluids from mammals. In human health, some of these organisms, primarily Pseudomonas aeruginosa, can be an opportunist pathogen and cause serious health problems. If allowed to reach unsafe levels, this organism may cause several health problems including skin rash and other skin infections, ear infection, urinary tract infection, and in rare instances, pneumonia. Other Pseudomonads, for example, P. stutzeri can be isolated from wounds but are generally not associated with human disease. Many Pseudomonads found in the soil can damage plant materials by causing spoilage.

Who tests for Pseudomonas and why?

Water Testing: Pseudomonas aeruginosa is a bacterium commonly found in purified water systems. Pseudomonas grows in water. It thrives at warm temperatures, which is why it is so often associated with spas. It can also grow in purified water systems.

Pharmaceutical and Cosmetic Products: Analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to September 2006 demonstrated that 48% of recalls were due to contamination by either Burkholderia cepacia, or Pseudomonas spp (Jimenez L. 2007). In cosmetic products, P. aeruginosa was recovered from contaminated mascara material and was identified as the agent responsible for corneal ulcers in the 1970s (Ortho 2009). Pseudomonads can survive and grow in DI water—Contaminated DI water may be the source of microbial contamination if it is used for the final rinse of equipment that has been cleaned and sanitized, and it may be the source of contamination for finished products in these industries.

Dairy and Food: The predominant microorganisms limiting the shelf life of processed fluid milk at 4°C are Pseudomonas spp. these species are able to grow to high numbers during refrigerated storage. Pseudomonas species accounted for79% of the psychotropic isolates that spoiled pasteurized milk (Dogan and Boor 2003). Important characteristics of Pseudomonads include their abilities to grow at low temperatures (3–7?C) and to hydrolyze and use large molecules of proteins and lipids for growth.

Biolumix Offers Two Options for Detecting Pseudomonads

For certain industries it is important to detect Pseudomonas aeruginosa, while for others it is important to detect all Pseudomonas spp, including the closely related Burkholderia cepacia. As a result BioLumix offers two different types of vials: the PSE vial for the detection of P. aeruginosa; and the PSB vial for the detection of all strains of Pseudomonas and for B. cepacia.

Detection of Pseudomonas aeruginosa (PSE Vial)

For the Pharma (OTC), Cosmetic and Nutraceutical Industries the primary cause for concern is the absence or presence of Pseudomonas aeruginosa. P. aeruginosa is common and is able to become an opportunistic pathogen in people and may cause severe disease (Hugh and Gilardi 1974). The ability to detect P. aeruginosa is critical in the non sterile Pharmaceutical products, Cosmetic and Nutraceutical Industries to ensure the product material is safe. BioLumix offers a highly selective media in the form of a test vial (PSE) that primarily only allows for the growth of Pseudomonas aeruginosa organisms. Confirmation of the presence of this organism is accomplished using the simple Oxidase reaction on vial contents. The test sample is merely enriched in TSB (Tryptic Soy Broth) per USP instructions and then tested directly in the BioLumix PSE vial. Other common Pseudomonads and closely related organisms, including B. cepacia and P putida, as examples, are excluded from growth due to the use of antibiotic supplements in the BioLumix PSE vial. P. aeruginosa is typically more antibiotic resistant than other Pseudomonas organisms (Blazevic, DL et al 1973). Figure 1 illustrates the growth curve of Pseudomonas aeruginosa ATCC 9027 in the BioLumix PSE vial.

KEY:Dark Blue Curve- P. aeruginosa Green Curve- Negative Control

Detection of other Pseudomonads (PSB Vial)

For many industries including the dairy industry and manufacturers using water, there is a need to test for all Pseudomonads as they impact these industries economically. Other Pseudomonads may include P. fluorescens, P. putida, and P. stutzeri. Burkholderia cepacia, can also be detected using the BioLumix PSE-B vial. Specific to the use of water in manufacturing: Pseudomonas bacteria can be found naturally in the ground and within drinking water sources such as aquifers. Contamination of either dairy products or water systems by Pseudomonads is something to avoid and early detection of goods using a rapid microbiological detection system such as the BioLumix Instrument System, would offer an advantage to the manufacturer. Figure 2 illustrates the growth of many types of Pseudomonads and Burkholderia cepacia in the BioLumix PSE-B vial.

KEY: Dark Blue Curve- B. cepacia; Green Curve -P aeruginosa; Light Blue Curve – P. putida; and Red Curve– P. fluorescens growth

REFERENCES

Blazevic, DJ, Koecke, M.H., and Mastsen J.M. (1973). Incidence and identification of Pseudomonas fluorescens and Pseudomonas putida in the clinical laboratory. Applied Microbiology 25: (1)

Dogan, B. and Boor, K J. (2003). Genetic diversity and spoilage potentials among Pseudomonas ssp. isolated from fluid milk products and dairy processing plants. Appl. Microbiol.,69: 130-138.

Hugh, R. and Gilardi, G. (1974) In “Manual of Clinical Microbiology” Edited by Spaulding, Lennette, Spaulding and Truant. Chapter 23 Pseudomonas.

Jimenez L.(2007). Microbial diversity in pharmaceutical product recalls and environments. Review. PDA J Pharm Sci Technol. 2007 Sep-Oct;61(5):383-99.

Ortho D. (2009). Insight into Cosmetic Microbiology, Chapter 8 263-267

BioLumix Microbial Limit Vial (MC)

Introduction:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whetheror not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. Thelack of replication might be interpreted as the lack of contamination.

How It Works

The Microbial Limit vial’s sensor detects production of CO2 by microorganisms, based upon the principle that CO2 is a universal metabolite produced by all microorganisms. The disposable vial contains a transparent solid sensor located at the bottom which changes its optical properties whenever CO2 diffuses into it. Only gases can penetrate the sensor; blocking liquids, microorganisms, and particulate matter. Consequently, the optical readings are not masked by the sample. CO2 generated by bacterial metabolism in the liquid medium diffuses into the sensor and interacts with an indicator reagent to provide an indication of the presence of the carbon dioxide.

Applications:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whether or not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. The lack of replication might be interpreted as the lack of contamination.

The first step of the assay is to perform a 1:10 dilution of the product in neutralizing broth such as D/E (Dey/Engley) broth, Letheen Broth, or TAT (Tryptone-Azolectin-Tween) Broth. There after 1.0-0.1 ml of the sample is added to the Microbial Limit vial. The Microbial Limit vial contains the neutralizers that inhibit many common preservatives and this neutralization event helps the customer to correctly measure the presence of contaminating organisms.

Examples of Growth Curves Using the Microbial Limit Vial:

In the curves shown below in the Figure, there is an example of both a positive curve and a negative curve. The bacterium used was Pseudomonas aeruginosa.

The BioLumix Microbial Limit vial was specifically designed to be used in complying with USP. Due to the fact the Microbial Limit vial has both Lecithin and Tween in its media composition helps allow for neutralization of the preservative in the sample to be maintained during the assay for viable organisms. Thus, this vial is useful to the customer that has already determined the amount of neutralizing buffer and its content of neutralizer to be used when the product sample is first prepared in diluent. Together the use of the correct neutralizer and the use of the BioLumix Microbial Limit vial helps ensure an accurate assay for the replicating organisms.

Table 1 summarizes the types of Products that customers test in the BioLumix Microbial Limit vial to measure the presence of organisms.

Summary:

The versatility of the BioLumix Microbial Limit vial includes the ability to support growth of most aerobic bacteria, many yeast and some mold organisms. In most cases YMC vial is used for the detection of yeast and molds. The BioLumix Microbial Limit vial can be used for determination of microbial content (contamination), for use in suitability studies that test whether a product can support growth of microorganisms, and in Preservative Efficacy Studies (PET analysis) that is used for cosmetic products. The BioLumix Microbial Limit vial can also be used by customers whose products include Dietary Supplements and Nutraceutical products for which preservatives (natural or chemical) are also added. Supplement products with natural preservatives also need to be neutralized and tested for their ability to support microbial growth.