Soleris and BioLumix – when to use which system

By Joseph Heinzelmann

As the need for rapid microbiological testing in various industries continues to grow, Neogen’s recent acquisition of BioLumix helps provide new resources to an already successful rapid microbiological testing product. Specifically in the nutraceutical, dietary supplement, cosmetic and pharmaceutical markets, the BioLumix system serves customers with a system supported by validation datasets, ready to use microbial tests, and Neogen’s excellent customer service. In fact, the value of the system from the perspective of some of our customer’s can be found in their testimonials and feedback. Along with great customer service, some of the key aspects that customers are able to take advantage of include 48-hour certificate of analysis and ready to use assays.

Upon reviewing both the BioLumix system and Soleris, it is apparent that both of these systems offer advantages over other methods and products. These include:

  • Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours
  • Automation and connectivity allows faster product release
  • Streamlined testing increases laboratory efficiencies
  • Paperless laboratory: centralized test data automatically stored and protected
  • Ready to use test vials
  • Excellent customer support

The differences lie in the application and validation information supporting both systems. For example, the BioLumix system has submitted a DMF to help aid companies on technical and regulatory information on approvals for prescription drugs. The BioLumix system has an established protocol for preservative efficacy testing, adhering to USP Chapter <51>. Neogen also has the capability to provide services on the BioLumix system, such as suitability testing, USP Chapter <61>.  The BioLumix system comes with uniquely designed validation books for nutraceutical and dietary supplements, cosmetics and toiletry, and for over the counter medication.

Similarly, the Soleris system has been for various food matrices. For
example Soleris has been validated for use in aseptically packed UHT products, dressings and sauces, and many other matrices as supported by the AOAC approvals. Because of the focus over the last few years of Soleris in food matrices, Neogen has developed various tests and applications specifically for food. For example, the 48 hours direct lactic acid vial for dressings and sauces, the orange serum broth vial for low pH and beverage applications, and the alicyclobacillus vial for beverages.

Validation strategies for both systems also varied because of market requirements. For example, in the food industry, companies seeking certain SQF level certifications require an AOAC approval on all methods used. Meaning that food testing validations were done according to the outlines and recommendations provided by AOAC International.

In addition, Neogen’s industry leading customer and technical service are now supported by the microbiological excellence of the staff from BioLumix. Both systems come with packages and programs for installation qualification, operational qualification and performance qualification. Furthermore, both systems have packages available to maintain the system through preventative maintenance programs.

Which system is right for you? It depends on the type of products manufactured, and the requirements. Neogen would be happy to help you understand the advantages of both systems and provide more information that can help you make the correct decision. You can contact Neogen by calling 800-234-5333 or emailing foodsafety@neogen.com.

 

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