May 10, 2011 – BioLumix customer satisfaction Survey:

Customer SurveyAt BioLumix customer satisfaction is our #1 priority! We are in the “service” business and customer satisfaction is essential to not only our growth but, our survival. We strive every day to meet and exceed our customers’ expectations. During the past year we have doubled our customer base. As with most companies that enjoy this type of fast pasted growth there is always the chance for service to slide. We needed to measure whether we are still holding true to our #1 priority; so, we recently conducted a ‘Customer Satisfaction Survey’ to measure our development.

It was gratifying to learn that all our customers said that they would recommend the BioLumix system to their vendors, suppliers and customers! - Ruth Eden, President, BioLumix, Inc.

February 2011

Water DropRecently a new assay for the detection of Heterotrophic bacteria in water was developed for the Biolumix system. The assay was validated by testing 50 samples of multiple types of water that were tested by the BioLumix system side-by-side with the plate count method.

2012 PDA Annual Meeting

2012 Annual PDA Meeting

This meeting will bring together experts from academia, industry and regulatory agencies from around the world to discuss current practices and opportunities in emerging biopharmaceutical manufacturing. This year’s meeting will be focusing on science and technology innovation as well as optimized performance, offering extensive formal and informal networking opportunities and providing a forum to contribute to and influence the advancement of science and regulation in the pharmaceutical industry. A special focus will be given to manufacturing innovations and new technologies, as well as regulatory perspectives on biopharmaceuticals. Use of innovation and new technologies helps to ensure success of new processes.

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The Future of Innovation Coming to Engredea in 2012 with the Innovative BioLumix System

Supply Side West logoEncompassing the world of ingredients, Engredea brings together the community of leading suppliers and manufacturers to source new ingredients, packaging, technologies, equipment, and services.Engredea cultivates innovation for tomorrow’s best-selling products across food/ beverage, dietary supplement and nutricosmetic categories by offering hundreds of exhibits, formulation demos, networking events and education opportunities for the industry. In 2011 Engredea featured more than 3,400 booths, with over 58,000 people attending the event.

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Wednesday, March 7th and Thursday, March 8th, 2012 Anaheim, CA

Engredea LogoNutracon is a key for companies in the health and nutrition industry. This premier conference is geared specifically for the ingredient and technology innovations, helping companies develop new science-supported supplements, functional foods, beverages and nutricosmetics sectors. This year BioLumix will be exhibiting as a part of Nutracon, due to overwhelmingly positive feedback from our customers and contacts. The revolutionary BioLumix system can streamline your microbiology testing and yield rapid results saving time, labor and money.

Who Needs Environmental Monitoring and Process Water Testing?

Introduction

Controlling manufacturing environmental conditions is not only a regulatory requirement but also part of protecting and producing a quality product. Environmental monitoring (EM) of manufacturing facilities provides assurance that the environment is both adequately controlled and in compliance. There is substantial evidence establishing a direct relationship between the level of environmental control and the final quality of the product.

EM serves a critical role in product safety by ensuring that the environment in maintained properly. Swabs are often used for sampling irregular or hard-to-reach surfaces and critical surfaces where contact plates are not practical. In addition, cleaning hold-time studies are often performed using swabs. In general, the purpose of a Microbial EM Program is to: provide crucial information on the quality of the work 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 fulfilled; prevent the risk of contamination of the product; ensure there are environmental controls in the production areas; and provide a profile of the microbial cleanliness of the manufacturing environment.

Current Methodology

Most EM is done by plate counting of colonies which is both simple and inexpensive. However, plate counting methods are slow requiring two to seven days to complete, thereby causing a delay in the detection of contamination, which can increase product loss, plant downtime and result in expensive clean up. The delay in obtaining results impacts reaction to contamination issues and can make investigations very difficult. For example, the rooms in question typically have been cleaned numerous times, so re- sampling results are almost always meaningless and determining the root cause of the contamination is difficult. Since real-time response is not possible, batches are jeopardized.

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.

Available RMM Methods


Methods are available to measure total particles in the air, including Total Organic Carbon (TOC), and ATP (Adenosine Tri-phosphate). 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 (Carrick et. al. 2001 and Easter 2010). Therefore, these results do not measure viable organisms in the environment or on production lines. The standard plating methodologies can take several days. Rapid microbiological methods (RMM) can provide rapid and efficient solutions over traditional plating methodologies. Therefore, both manufacturers and regulators are motivated to develop initiatives and help in the implementation of rapid testing methods (FDA 2004).

On June 8th the conference on Contamination Control ( http://www.pdamidwest.org/) the data from the validation of BioLumix growth based system for EM and water testing will be presented. The BioLumix Optical System is based upon the detection of microorganisms due to color or fluorescence changes caused by the growth and metabolic activity of microorganism in the test vials.

Study Design: 10×10 cm surface coupons made out of 5 various materials (Stainless Steel, Aluminum Alloy, High Density Polyethylene, Silicone Rubber, and Perspex, Plexiglas) were inoculated with different organisms (Bacillus spizizenii var subtilis ; Escherichia coli; Pseudomonas aeruginosa; Staphylococcus aureus; Citrobacter freundii; Candida albicans; and A. brasiliensis formerly Aspergillis niger). The coupons were then swabbed and testing using three assays: (i) Total aerobic count; (ii) Yeast and Molds and (iii) Gram Negative Bile Tolerant Bacteria.

In total, 550 coupons were tested, 290 coupons were inoculated above the specified levels while 260 coupons had counts below the specified levels. There was very good correlation between the BioLumix results and the plate count results, with an overall agreement for samples above spec of 97.2%. None of the 260 un-inoculated coupons detected in the BioLumix system or had plate counts above the specified level. Consequently there was 100% agreement between the two methods. The overall agreement between the two methods was 98.5%.

Total Aerobic Count: A total of 129 swabs were analyzed using the BioLumix TAC vial and the standard plate count method with TSA. All the swabs with count above specified level signaled as being above the specified level in the vials. Five marginal samples detected in the vials and had counts just below the specified level. The agreement between the methods was 96.1%.

Yeast and Molds: A total of 85 coupons were analyzed using the BioLumix YM vial and the standard plate count method with SDA (Sabouraud Dextrose Agar W/ Chloramphenicol). All the swabs with count above specified level signaled as being above the specified level in the vials. A few coupons with count very close to the specified level (e. g. 50-80 cfu/swab for a specified level of < 50 cfu/swab) did detect in the vials. One coupon that had a count of 40 cfu/swab, while technically found to be below the specified level, was a very marginal result being so close to the specified level of 50 cfu/swab, did detect in the vial. The agreement between the two methods was 98.8%.

Gram Negative Bile Tolerant Bacteria: A total of 75 coupons were analyzed using the BioLumix ENT vial and the standard plate count method with VRBGA (Violet Red Bile Glucose Agar). One swab with a marginal count of 310 cfu/swab did not detect in the vial. A few coupons with count very close to the specified level (e. g.300-400 cfu/swab for a specified level of < 300 cfu/swab) did detect in the vials. One coupon that had a count of 190 cfu/swab did detect in the vial. The agreement between the two methods was 97.3%.

Conclusion: The BioLumix system was validated as an alternative to the plate count method for EM. The study involved a total of 550 surface coupons representing five diverse types of surface material. These five surfaces represent those encountered in manufacturing, including metal, plastics and rubber. Some of the coupons were inoculated with bacteria or 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.

The advantages offered by the BioLumix system include: automation of results, great speed to results, paperless EM, direct detection of viable microorganisms, detection of multiple types of organisms, increased operation efficiency and consequently an improvement in product quality, reduction in costs, and both enhanced reporting and ability to track trends.

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. 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.

The BioLumix system is capable of testing water for heterotrophic bacteria, coliforms, E. coli, and Pseudomonas. For levels of < 1 cfu/ml the water can be inserted directly into the vial. To test for levels such as < 1/100 ml the water is filtered and then the filter is added directly to the vial.

Water study summary: Ninety- two water samples were analyzed with two specified levels (10 cfu/ ml and 100 cfu/ml). Sixty samples were below the specified level by both methods while 28 samples were above the specified level by both methods. Four samples were below the specified level by the BioLumix method, but above by the plate count method. All these samples had very low counts (1-3 colonies on the plate). There was 96.9% agreement between the two methods.

BioLumix advantage for water testing: Final results were seen in the BioLumix system roughly 13 hours earlier than the plate count method using Standard Methods Agar. The BioLumix method can detect organisms at a level of < 1 cfu/mL of water. The BioLumix system is faster, less labor-intensive, and more sensitive than the plate count method.

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

PDA Midwest Chapter- June 8, 2012 – All Day Contamination Control Event (http:// www.pdamidwest.org/)

United States Pharmacopeia XXI (1985) Chapter <1231> Water for Pharmaceutical Purposes. The National Formulary. Rockville, MD, The United States Pharmaceopeial Convention.

Rapid Microbiological Testing of E. coli with the BioLumix Vial

Escherichia coli are Gram negative rod-shaped organisms found naturally in the lower intestines of warm blooded organisms. Most serotypes of this organism are relatively harmless, making up a small percentage of bacterial colonization in the gut. These serotypes prevent the establishment of pathogenic strains.

E. coli is one of the most common bacteria found in the gut of animals. This includes humans. There are other animal species that contain this organism in the gut including reptiles and fish. E. coli colonizes the gut and can cause infection in the urinary tract and brain stem (meningitis) as well as intestinal diseases referred to as gastroenteritis. There are five classes of E. coli that produce disease. The most serious disease is the Enterohemorrhagic (EHEC) class. These organisms can cause diarrhea distinct from some others (including Shigella) in that there is copious bloody discharge and no fever. The life threatening situation is its toxic effects on the kidneys (hemolytic uremia).

Why Test for the Presence of E. coli?

E. coli is often used as indicator organisms to test the effectiveness of effluent disinfection in a wastewater treatment plant, on animal products as well as in nutraceutical and pharmaceutical products. While these organisms are generally harmless, they do live under the same conditions that human pathogens live. Since we cannot test for every pathogen, we test for easily detectable indicator organisms. The assumption is that if we kill the indicator organisms then we most likely kill the pathogens during effluent disinfection. E. coli has reemerged as an indicator, partly facilitated by the introduction of newer methods that can rapidly identify E. coli.

Current Methodology

The current methodology can take anywhere from 3-7 days and includes multiple broths, agars,
transfers and temperatures. Different methodologies are utilized by the various industries. Below
are some examples:

Nutraceutical and Dietary supplements: The protocol described in USP <2022> requires
absence of the organisms in 10 grams of product. A 1:10 dilution of product is made into TSB or
another enrichment medium. This mixture is incubated for 24 to 48 hours at 30°C to 35°C, and
then 1.0 mL is transferred to 10 mL of MacConkey broth. This mixture is incubated for 24 to
48 hours at 42°C to 44°C. A loop from the MacConkey broth is transferred to MacConkey agar
and the plate is incubated for 18 to 24 hours at 30°C to 35°C. If typical colonies appear, these
colonies are then transferred to Levine Eosin Methylene Blue agar and incubated 24 to 48 hours
at 30°C to 35°C. If none of the colonies exhibit green metallic sheen under reflected light or if
none of the colonies exhibit a blue-black appearance under transmitted light, the sample meets
the requirement for the absence of Escherichia coli. Because results can sometimes be misread
due to interpretation of plates, identification may be run on the sample(s) adding another 2-3
days of testing.

Pharmaceutical: The protocol described in USP <62> again requires the absence of E. coli in
10 grams of product. A 1:10 dilution is made and incubated for 18 to 24 hours at 30°C to 35°C.
From this mixture, 1.0 mL is transferred to 100 mL of MacConkey broth and incubated 24 to 48
hours at 42°C to 44°C. A loop is transferred to MacConkey agar and this plate is incubated 18 to
72 hours at 30°C to 35°C. Growth of typical colonies indicates the presence of E. coli which is
confirmed with an identification test.

Food Testing: The food industry follows Bacteriological Analytical Manual (BAM). In most
cases, the Most Probable Number (MPN) method is utilized. This is labor intensive, multi-
step assay consists of presumptive (in LST tubes), confirmed (in BGLB tubes), and completed
phases (in EC tubes). In the assay, serial dilutions of a sample are inoculated into broth media.
Analysts score the number of gas positive (fermentation of lactose) tubes, from which the other 2
phases of the assay are performed and then uses the combinations of positive results to consult a
statistical table. From this table, the analyst is able to estimate the number of organisms present.
The 3-tube MPN test is used for testing most foods. The 5-tube MPN is used for water, shellfish
and shellfish harvest water testing, and there is also a 10-tube MPN method that is used to test
bottled water or samples that are not expected to be highly contaminated. Positive EC tubes
must be transferred to L-EMB agar and if typical colonies are observed, they must be further
identified.

The BioLumix E. coli Vial

The E. coli vial, or EC vial, is a membrane vial that is monitor by the fluorescent
signal in the instrument. The membrane separates the incubation zone from the
reading zone. If E. coli is present, it utilizes MUG (4-Methylumbelliferyl-3-D-
Glucuronide) through an enzymatic reaction to create fluorescence.
A 1:10 dilution is made in TSB or a similar growth medium and this mixture is
incubated for 18-24 hours at 35°C. From the TSB dilution, 0.1 mL is added to an
EC vial containing the MUG supplement and then tested in the BioLumix instrument. The EC
assay runs for 18 hours in the instrument. An
example of E. coli curves is shown in the graph. If
detection occurs, a confirmation test is performed.
From the time the sample is prepared to the time
the confirmation is complete, the EC test takes
only 2 days, saving valuable time.

The BioLumix assay is much simpler to perform, requiring less labor and disposables as any to
the standard method. It is faster (completed in 30 hours), accurate, automated, and it eliminates
any product interference due to the two zone vial.

References:

USP <2021> MICROBIAL ENUMERATION TESTS—NUTRITIONAL AND DIETARY
SUPPLEMENTS
USP <2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED
MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS
USP <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTSFOR SPECIFIED MICROORGANISMS
Peter Feng, Stephen D. Weagant, Michael A. Grant, 2002. Bacteriological AnalyticalManual BAM). Chapter 4: Enumeration of Escherichia coli and the Coliform Bacteria

Why New Rapid Automated Methods Are Desired?

Newer microbiological methods can improve company’s quality of testing and result in significant financial savings.  Such methods can reduce cycle times resulting in a leaner and more responsive supply chain.  At every point where microbial testing is done (raw materials, work-in-progress, or finished products) batches may be held in quarantine for up to seven days before they are pronounced ready to move to the next stage.  Waiting for microbial results can tie up working capital and results in storage expenses and a delay in supplying products to the market.  The faster results can identify a contamination and enable implementation of corrective action, and cost savings.  Consequently, an increasing number of pharmaceutical companies are becoming interested in adopting RMM’s.  By utilizing rapid methods for microbiology, manufacturers can dramatically slash the amount of time products must be held for microbiology testing and drive new efficiencies with less capital tied up in finished goods inventory, and reduced warehouse space requirements.

FDA’s Support and Encouragement of New Technologies

Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER stated that “FDA actively encourages use of new technologies including rapid microbiology methods” (RMM).  During the 2007 PDA 2nd Annual Global Conference on Pharmaceutical Microbiology, Dr. Brenda Uratani, consumer safety officer for the CDER, described the benefits of using rapid methods in microbiology.  Drs. David Hussong and Robert Mello (New Drug Microbiology Staff at CDER) published a paper and stated the following: “New microbiology methods can offer advantages of speed and precision for solving microbiological problems associated with materials or environmental influences.  Neither Corporate economics nor regulatory attitudes should be a barrier to the use of new testing technologies or different measurement parameters.  In fact, if we are to increase our understanding of quality-based products and processes, then quality by design principles and risk analysis methods must be extended to the development of new microbiological technologies. This approach will drive process engineering to yield real, measurable gains in microbiological product quality assurance.”

Dr. Bryan Riley, New Drug Microbiology Staff at CDER, published a paper describing the opportunities for RMM’s within the pharmaceutical industry, “The use of rapid microbiology methods by the pharmaceutical industry should offer many advantages. Receiving microbiology test results sooner will provide for better control and understanding of the manufacturing process via faster feedback”.  He continued stating that “There are many exciting potential uses for rapid microbiology methods in the pharmaceutical manufacturing process, and industry should not feel that FDA will be a hindrance to the appropriate use of these methods.”

BioLumix Meeting with FDA

BioLumix met with FDA’s Center for Drug Evaluation and Research (CDER) personnel to present its new technology, answer questions and demonstrate how the BioLumix rapid, automated microbiology can be used in the Pharmaceutical industry.  The technology was warmly received by the CDER and BioLumix is encouraged by its ability to submit a Drug Master File (DMF). This will help to simplify and speed up the regulatory review process for companies adopting its technology.

The DMF is a technical document that contains support data for specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.  The DMF can be used to streamline the validation of the BioLumix system, saving companies that wish to adopt the technology time and money.  For over the counter drugs the documents can serve as the basis for the validation package.

Everything is New at SupplySide Marketplace 2012!

New venue…new location…Stop by and see what’s new at BioLumix – booth #542 at the SupplySide Marketplace, Javits Center New York City on May 9th & 10th. The BioLumixsystem is the most advanced microbiological testing system of its kind. A demo of theBioLumix system will be available during the tradeshow.

Do you need Validated, Simplified Rapid Microbiology Testing? The state-of-the-art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP, with over 200 instruments performing assays daily. All of BioLumix customers’ audits by FDA and NSF passed their inspection while using the BioLumix System.

Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist’s job isa lot easier, with the same accurate results inless than half the time.

What is the BioLumix System? Test vials areincubated and the assay are monitored every 6 minutes. Each Instrument is capable of simultaneously running 32 test vials at one temperature. The modular structure of the BioLumix System enables flexible growth as needed; up to 1,024 samples can be tested simultaneously with up to 32 instruments connected to a single PC. There is random access to all instrument vial positions at any time. Therefore,no batching is required.

The Biolumix System is designed to accelerate product release with a simplified, automated approach.This yields fast, accurate results while reducing costs. No more waiting days for completed assays. The BioLumix System brings automated microbiological testing in house with most assay results achieved over night, and an Automated Certificate of Analysis within 48 hours for all USP assays. It is simple enough to be operated by no-microbiologists, providing accurate data of raw materials, environmental samples, and finished products.

What would you like to save? Time, money, labor? BioLumix does it all. The BioLumix system is both simple and cost-effective, with its streamlined testing design and single platform testing. The system is designed to accelerate product release using a modified simple methodology. It saves time to results,labor for microbiological testing and money due to its cost effectiveness. In many cases, return oninvestment is takes less than 6 months.

What would you like to test? Tablets, capsules, oils, liquids and powders are easily analyzed andresults are obtained quickly and with real time communication. The simple sample preparation allowstesting for raw materials, in-process product, finished goods, processing water and environmenta ltesting. All of which have been Validated by us, according to USP methodology, so you don’t have to. Infact, we are so excited about our system that we ask your company to send us samples and we will testthem for free so you can see the results!

What Assays would you like to test?

•••••••••

Total Aerobic Microbial Count Total Combined Mold and Yeast Count Enterobacterial Count (Bile-Tolerant Gram Negative Bacteria) ColiformE. coli Pseudomonas aeruginosa Staphylococcus aureus Salmonella Probiotic

Would you like No Product Interference?

The vial design is separated into two zones: the incubation zone where the sample is present, and the detection zone where the readings take place.Therefore, the system prevents any product Interference.

The BioLumix Advantage is:

•••••••••••••

Simplified testing procedures – can be operated by non microbiologists Ready to us vials-shorter sample preparationVial design prevents product interference Real-time communication for immediate action Early warning of contaminated samples An automated Certificate of Analysis within 48 hours including all organisms required by USP Validation package against USP methodology including IQ, OQ and PQ Allows for cost effective internalization of microbiological assays 21 CFR part 11 compliant with audit trail and login/ log out Centralized test data automatically stored and protected Cost reduction of microbiological assays Automation and connectivity – faster product release Allows internalization of microbiological testing
Come See Us at Booth #542!

BioLumix Staphylococcus aureus Vial Assay

Organism of Interest

Staphylococcus aureus is a major pathogen of concern in infectious disease. This organism group may include drug resistant S. aureus, often defined as methicillin resistant Staphylococcus aureus (MRSA). S. aureus is also an objectionable organism for the dietary supplement and nutraceutical industries.

Backgroud

Wikipedia’s description is as follows: S. aureus can cause a range of illnesses fromminor skin infections, such as pimples, impetigo, boils (furuncles), cellulitis folliculitis,carbuncles, scalded skin syndrome, and abscesses, to life-threatening diseases suchas pneumonia, meningitis, osteomyelitis, endocarditis, toxic shock syndrome (TSS),bacteremia, and sepsis. It is implicated in skin, soft tissue, respiratory, bone, joint,endovascular and wound infections. It is still one of the five most common causes ofnosocomial infections, often causing postsurgical wound infections. Each year, some 500,000 patients in American hospitals contract a staphylococcal infection.

Methicillin-resistant S. aureus, abbreviated MRSA and often pronounced “mer-sa” (in North America), is one of a number of greatly-feared strainsof S. aureus which have become resistant to most antibiotics. MRSA strains are most often found associated with institutions such as hospitals, but are becoming increasingly prevalent in community-acquired infections. Arecent study by the Translational Genomics Research Institute showed that nearly half (47%) of the meat and poultry in U.S. grocery stores were contaminated with S. aureus, withmore than half (52%) of those bacteria resistant to antibiotics.

Current Methodology for S. aureus

Nutraceutical and Dietary Supplement Products: USP <1222> describes the methodrequired to test for the absence of S. aureus (typically in 10 grams) in nutraceutical and dietary supplement products. The method involves mixing of the sample in TSB and pre-incubating the TSB containing product at 30 to 35 degrees for 18 to 24 hours. Followed by streaking a loopful from TSB onto the surface of one or more of the following media:Vogel–Johnson Agar Medium (VJ Agar), Mannitol–Salt–Agar Medium (MS-Agar),and Baird-Parker Agar Medium (BP Agar). If no plates contain colonies having the characteristics described, the test specimen meets the requirement for the absence of Staphylococcus aureus. If characteristic colonies are present, a coagulase test is performed.

Pharmaceutical Products: USP <62> describes a similar method to test for the absence of S. aureus. After the pre-incubation in TSB, Mannitol–Salt–Agar Medium isused for plating.

Food Testing: FDA Bacteriological Analytical Manual (BAM) describes several methods for testing of S. aureus in foods. Methods used to detect and enumerate S. aureus maybe dependent for testing of foods and on the past history of the test material. Processed foods may contain relatively small numbers of debilitated viable cells, whose presence must be demonstrated by appropriate means. Finding food contaminated with S. aureusmay lead to legal action against the party or parties responsible for a contaminated food product. For S. aureus specified levels > 100 cfu/g of S. aureus plating on Baird-Parker agar is recommended. The method involves spreading 1.0 ml on 3 plates and looking for typical colonies. At least 20 colonies must be present on the lowest dilution for reliable results. Typical colonies need to be tested for coagulase. The most probable number (MPN) method is recommended for products in which small numbers of S.aureus are expected to be low and in foods expected to contain a large population of competing species. MPN can be performed in TSB containing 10% NaCl and 1% sodium pyruvate. From each tube showing growth (turbidity) a loopful is transferred to a plate of Baird-Parker medium.

The BioLumix Methodology

Pre-Incubation step Objectionable organisms including S. aureus may be present in very low numbers andmay also be “damaged”. Recovery of these organisms may require growth enrichmentin simple broth media prior to testing in selective media. Enrichment in a media suchas Trypticase soy broth (TSB) is often used as the first step in testing for the presenceor absence of S aureus. In testing of dietary supplement and pharmaceutical samples,enrichment occurs for approximately 18-20 hours. This step is similar to the procedure recommended by USP <1222> and USP <62>. After the pre-incubation in TSB a small amount (0.1 ml, typically) is transferred into the selective media BioLumix STA Vial and inserted into the instrument for 22 hours.

BioLumix Staph Vial Selectivity
The BioLumix STA vial utilizes a combination of inhibitors. These inhibitors target both unrelated organisms such as gram negatives and unrelated gram positives. Theuse of specific carbon sources (Mannitol) to selectively permit growth of primarily only staphylococcal species is also used. In addition, high salt concentrations also inhibitnon-S. aureus organisms including gram negatives and other gram positives. The goal is to slow or inhibit growth of these unrelated organisms including the inhibition of aclosely related organism Staphylococcus epidermidis in this BioLumix media vial.
Growth in the BioLumix STA Vial
A representative BioLumix STA Vial showing growth of S. aureus is shown in the accompanying Figure. The presence of S. aureus causes a detection time (DT) in thecurve (shown as a blue triangle). The figure also includes an un-related organism (Ecoli) tested under the same growth conditions in the BioLumix STA Vial.
Assay Endpoint
If there is no growth and no DT the sample is negative and does notcontain S. aureus. Growth in the
BioLumix STA Vial presumes the presence of S aureus. Confirmationusing a secondary test such ascoagulase is required to verify the presence of S aureus. The coagulase test can be performed directly from the vial.

Organism of Interest

Staphylococcus aureus is a major pathogen of concern in infectious disease. This organism group may include drug resistant S. aureus, often defined as methicillin resistant Staphylococcus aureus (MRSA). S. aureus is also an objectionable organism for the dietary supplement and nutraceutical industries.

Backgroud

Wikipedia’s description is as follows: S. aureus can cause a range of illnesses fromminor skin infections, such as pimples, impetigo, boils (furuncles), cellulitis folliculitis,carbuncles, scalded skin syndrome, and abscesses, to life-threatening diseases suchas pneumonia, meningitis, osteomyelitis, endocarditis, toxic shock syndrome (TSS),bacteremia, and sepsis. It is implicated in skin, soft tissue, respiratory, bone, joint,endovascular and wound infections. It is still one of the five most common causes ofnosocomial infections, often causing postsurgical wound infections. Each year, some 500,000 patients in American hospitals contract a staphylococcal infection.

Methicillin-resistant S. aureus, abbreviated MRSA and often pronounced “mer-sa” (in North America), is one of a number of greatly-feared strainsof S. aureus which have become resistant to most antibiotics. MRSA strains are most often found associated with institutions such as hospitals, but are becoming increasingly prevalent in community-acquired infections. Arecent study by the Translational Genomics Research Institute showed that nearly half (47%) of the meat and poultry in U.S. grocery stores were contaminated with S. aureus, withmore than half (52%) of those bacteria resistant to antibiotics.

Current Methodology for S. aureus

Nutraceutical and Dietary Supplement Products: USP <1222> describes the methodrequired to test for the absence of S. aureus (typically in 10 grams) in nutraceutical and dietary supplement products. The method involves mixing of the sample in TSB and pre-incubating the TSB containing product at 30 to 35 degrees for 18 to 24 hours. Followed by streaking a loopful from TSB onto the surface of one or more of the following media:Vogel–Johnson Agar Medium (VJ Agar), Mannitol–Salt–Agar Medium (MS-Agar),and Baird-Parker Agar Medium (BP Agar). If no plates contain colonies having the characteristics described, the test specimen meets the requirement for the absence of Staphylococcus aureus. If characteristic colonies are present, a coagulase test is performed.

Pharmaceutical Products: USP <62> describes a similar method to test for the absence of S. aureus. After the pre-incubation in TSB, Mannitol–Salt–Agar Medium isused for plating.

Food Testing: FDA Bacteriological Analytical Manual (BAM) describes several methods for testing of S. aureus in foods. Methods used to detect and enumerate S. aureus maybe dependent for testing of foods and on the past history of the test material. Processed foods may contain relatively small numbers of debilitated viable cells, whose presence must be demonstrated by appropriate means. Finding food contaminated with S. aureusmay lead to legal action against the party or parties responsible for a contaminated food product. For S. aureus specified levels > 100 cfu/g of S. aureus plating on Baird-Parker agar is recommended. The method involves spreading 1.0 ml on 3 plates and looking for typical colonies. At least 20 colonies must be present on the lowest dilution for reliable results. Typical colonies need to be tested for coagulase. The most probable number (MPN) method is recommended for products in which small numbers of S.aureus are expected to be low and in foods expected to contain a large population of competing species. MPN can be performed in TSB containing 10% NaCl and 1% sodium pyruvate. From each tube showing growth (turbidity) a loopful is transferred to a plate of Baird-Parker medium.

The BioLumix Methodology

Pre-Incubation step Objectionable organisms including S. aureus may be present in very low numbers andmay also be “damaged”. Recovery of these organisms may require growth enrichmentin simple broth media prior to testing in selective media. Enrichment in a media suchas Trypticase soy broth (TSB) is often used as the first step in testing for the presenceor absence of S aureus. In testing of dietary supplement and pharmaceutical samples,enrichment occurs for approximately 18-20 hours. This step is similar to the procedure recommended by USP <1222> and USP <62>. After the pre-incubation in TSB a small amount (0.1 ml, typically) is transferred into the selective media BioLumix STA Vial and inserted into the instrument for 22 hours.

BioLumix Staph Vial SelectivityThe BioLumix STA vial utilizes a combination of inhibitors. These inhibitors target both unrelated organisms such as gram negatives and unrelated gram positives. Theuse of specific carbon sources (Mannitol) to selectively permit growth of primarily only staphylococcal species is also used. In addition, high salt concentrations also inhibitnon-S. aureus organisms including gram negatives and other gram positives. The goal is to slow or inhibit growth of these unrelated organisms including the inhibition of aclosely related organism Staphylococcus epidermidis in this BioLumix media vial.Growth in the BioLumix STA VialA representative BioLumix STA Vial showing growth of S. aureus is shown in the accompanying Figure. The presence of S. aureus causes a detection time (DT) in thecurve (shown as a blue triangle). The figure also includes an un-related organism (Ecoli) tested under the same growth conditions in the BioLumix STA Vial.Assay EndpointIf there is no growth and no DT the sample is negative and does notcontain S. aureus. Growth in theBioLumix STA Vial presumes the presence of S aureus. Confirmationusing a secondary test such ascoagulase is required to verify the presence of S aureus. The coagulase test can be performed directly from the vial.

Come and Meet Us at the PDA Annual Meeting

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, providesan estimation of viable cell counts, and identifies thepresence of specified micro-organisms.

Automated, all-in-one microbial testing system isextremely easy to operate. The system is both simple and cost-effective, revolutionizing your current testing methodology. A novel optical system sensing color and fluorescence in ready-to-use vials provides faster results, labor savings, automation,and connectivity. The streamlined testing designand 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 makingthe existing microbial testing simpler, faster, andautomated – saving your company significant time,labor and money.

DMF Submission and Validation

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, OQ, and will help you to complete the PQ 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. BioLumix software is 21 CFR Part 11 compliant withlog in/logout and audit trail. It presents real-time communication for immediate action of contaminatedsamples 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. Weoffer 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.

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 highest degree 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 profitto your bottom line.

Rapid Testing for Gram negative Bacteria- the BioLumix Approach

Gram Negative Bacteria- Cell Wall

Gram negative cell walls are more complex than Gram positive cell walls, both structurally and chemically. Structurally, a Gram negative cell wall contains two layers external to the cytoplasmic membrane. Immediately external to the cytoplasmic membrane is a thin peptidoglycan layer, which accounts for only 5% to 10% of the Gram negative cell wall by weight. External to the peptidoglycan layer is the outer membrane, which is unique to Gram negative bacteria. For Gram negative species, many of the lytic virulence factors such as collagenases, hyaluronidases, proteases, and beta-lactamase are located within the periplasmic space.

The outer layer of the Gram negative bacterial cell wall is made up of lipopolysaccharide and proteins. This outer layer protects a thin layer of peptidoglycan. For the Gram positive bacteria, the outer layer of the cell wall is the peptidoglycan layer and does not contain lipoproteins. Below the outer layer of lipopolysaccharide, there exist layers of periplasmic space and the plasma membrane.

The pathogenic capability of Gram-negative bacteria is often associated with their cell walls, especially, the lipopolysaccharide layer (also known as LPS or endotoxin layer). In humans, LPS can triggers an immune response characterized by cytokine production and immune system activation.

Gram Negative Bacteria- Who are they?

Important gram negative bacteria include: the Enterobacteriaceae family, Pseudomonads, Aeromonas, Plesiomonas, Xahothomonas, Burkholderia, Haemophilus.

The Enterobacteriaceae family contains a number of pathogens including E. coli, Salmonella, Shigella, Klebsiella pneumoniae, Pasteurella, and Yersinia. Pseudomonas aeruginosa is an opportunistic pathogen and can cause urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, etc. Pseudomonas aeruginosa is found in many natural and domestic environments including plants, soils and surface water, especially warm moist environments containing organic material or contaminated by human or animal waste.

Members of the genus Aeromonas and Plesiomonas are involved in human intestinal disease. The species Hemophilus influenzae is a cause of meningitis in children, while Pasteurella. multocida causes cholera in fowl. Burkholderia cepacia, an important pathogen of pulmonary infections in people with cystic fibrosis.

Current methodology

In USP <61-62> the test for Bile-tolerant Gram-negative Bacteria (BTGNB) replaces the “Test for Enterobacteriaceae and Certain Other Gram-Negative Bacteria”. In older USP protocols. USP <62> does require testing for absence of P. aeruginosa and Burkholderia cepacia.

The method usually involves a 1:10 dilution using Soybean–Casein Digest Broth (TSB) as the diluent, and incubation at 20 to 25 C for a time sufficient to resuscitate the bacteria but not sufficient to encourage multiplication of the organisms (usually 2 hours but not more than 5 hours). Thereafter the appropriate amount is sub-cultured on Violet Red Bile Glucose Agar (VRBGA) and incubates at 30 to 35 C for 18 to 24 hours. For the testing of lower numbers of BTGNB, the MPN method can be used. For P. aeruginosa the TSB is pre-incubated for at 30 to 35 C for 18 to 24 hours. Growth is sub-cultured onto a plate of Cetrimide Agar and incubate at 30 to 35 C for 18 to 72 hours

The BioLumix approach

The BioLumix system offers two approaches for the detection of gram negative bacteria:

  1. The Two Vial Approach: An approach similar to the USP procedure where two separate vials are used. One vial detects Bile-tolerant Gram-negative Bacteria and another vial detects P. aeruginosa.
  2. The Single vial approach: An approach where a single vial is used to detect all gram negative bacteria.

A 1:10 dilution of the product is made in TSB. For specified levels of >10 cfu/g, a 1.0 ml sample of this dilution is added to the ENT (Enterobacteriaceae) vial and to a PSE (Pseudomonas) vial. The system automatically monitors the vials and will determine in if the samples are clean or contaminated. When the specified level of absent in 1.0 gram or 10 grams is required, the TSB is pre-incubated overnight as an enrichment step, and then 0.1 ml of the sample is added to the vial.

Single Vial Approach

The GN (Gram Negative) vial has excellent inclusivity for gram negative organisms and does not detect most of the gram positive bacteria. After the first dilution in TSB, with or without pre-incubation depending on the specified level, 0.1 ml of the TSB is added to a single GN vial. This is a very simple and fast procedure to access the absence or presence of gram negative bacteria. This single vial can replace the two vials listed above with better coverage of gram negative bacteria.

ENT Vial: The Enterobacteriaceae vial monitors a change in color due to a pH shift as Enterobacteriaceae organisms ferment glucose in the presence of selective media. The vial medium selectivity is similar to VRBGA.

PSE Vials: The Pseudomonas vial uses the same CO2 sensor as the BioLumnix Total Aerobic Count vial, but with a selective medium. The vial medium selectivity is similar to Centrimide agar.

GN Vial: The hydrolysis of fluorogenic synthetic substrates by bacterial enzymes causes an increase in fluorescence. A fluorogenic synthetic enzyme substrate containing 4-methylumbelliferon, common to all gram negatives, is used in the presence of selective media that inhibits the growth of gram-positive bacteria. The GN vial detects the presence of all Enterobacteriaceae, Pseudomonas, Burkholderia and many other gram negative bacteria. The curves below show the growth of quadruplicate samples for P. aeruginosa (figure on the right: green, lt. blue, red, and purple) and for E. coli (figure on the left: green, lt. blue, red, and purple). A negative control (Bacillus species) is shown in each figure and is represented along the baseline in dark blue.

Advantages: The results of all these assays are available overnight (24 hours), the system is fully automated including achieving of data, data maintenance and report generation, it can be used to create a paperless laboratory. The system is unaffected by product interference, delivering accurate results with faster product release. These assays are simpler to perform than the standard methods saving time, labor, and money.

References

United States Pharmacopeia (2009) Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. The National Formulary. Rockville, MD, The United States Pharmaceopeial Convention.

United States Pharmacopeia (2009) Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. The National Formulary. Rockville, MD, The United States Pharmaceopeial Convention.

Back to Back: BioLumix Attends Nutracon, Engredea and will be Featured in the Innovation Station during Engredea

Where & When?

March 7th-8th, BioLumix will be attending Nutracon at the Anaheim Hilton hotel for the first time ever in 2012, due to overwhelmingly positive feedback from both our customers and prospective customers about the show. Shortly after the Nutracon show, BioLumix will take its place in Booth #321 for the three day show, Engredea, March 9th – 11th. During this time, BioLumix will be featured at the Innovation Station located within the Engredea show floor.

Are cGMP Regulations Driving Up Your Costs?

Learn how we can save you time and money! Streamline your microbiological testing, reduce cost, increase efficiency and see rapid return on investment with the BioLumix system. BioLumix is fully automated, validated against US methodology, 21 CFR Part 11 Compliant system that allows for Complete microbiology testing results within 24-48 hours, allowing for faster product release time, shorter sample prep time – saving time, money and other resources. BioLumix was chosen as one of the most significant innovations in Engredea 2012-Don’t miss us at the innovation station

Why Visit us at Booth #321?

Be sure to stop by the BioLumix booth (#321) to view a product demo, meet some of our customers to learn the benefits that the system brought to them and inquire about our show special pricing. Examine our numerous product literature and scientific white papers.

The BioLumix System is completely modular, able to handle the microbiological testing needs of both large and small companies. In most cases a Return-On-Investment can be proved within 6 months. We truly believe the BioLumix System will make your company more efficient and add profits to your bottom line! Don’t just take our word for it, speak to our customers directly.

Confirmation Testing of Presumptive Positive Assays Using the BioLumix System

In Microbiology, the initial test result using selective or differential media is called Presumptive Test. Most presumptive tests require confirmation. Confirmation can be accomplished using specific reagents and materials. However, due to the critical importance of testing for pathogens and/or objectionable organisms as contaminants; it may be necessary to perform identification of any organisms isolated from samples. Identification measures microorganisms to the species level.

Initial Testing

For testing of any sample for the presence of microorganisms it is critical to perform a measure of total organism counts (viable organisms). BioLumix provides testing for both Total Aerobic Counts (Bacteria) and for Total Yeast and Mold Counts (Fungi). The BioLumix system in this regard mimics testing for both bacteria and fungi using USP or BAM plate methodology. In these initial tests for total counts there isn’t any discrimination of objectionable organisms from common organisms and common flora. Objectionable organisms for Nutraceutical Samples as an example may include E coli, Staphylococcus aureus, Salmonella or Pseudomonas aeruginosa.

Use of Selective Media

For most samples, it will be necessary to test for at least some objectionable organisms. In order to perform tests for each specific objectionable organism it is necessary to use selective media specifically designed to select for the target organisms. For example, for E coli testing, it is necessary to use selective media that contains both inhibitors that prevent the growth of non-E coli organisms and substrates that can utilized by E coli and not by most other microorganisms. BioLumix make use of such a media, referred to as the EC vial.

Confirmation Test

Unique confirmation tests that can be performed directly from the vials are described for the various objectionable organisms.

E. Coli- Indole Test

For samples that grow and detect in the BioLumix system, a series of Confirmation Tests can be utilized to begin the process of understanding whether the organism(s) are genuine E coli or not. For E coli testing a common initial confirmation test is the Indole Test using the Kovacs reagent. The Indole Test measures the presence of any indole in the growth media as a by-product of tryptophan metabolism by E. coli. Figure 1 depicts a negative (yellow ring) and positive Kovacs Reaction (Red ring) at the top of the media in the test vial.

Staphylococcus aureus – Coagulase Test

The BioLumix vial for testing for the presence of Staphylococcus aureus contains inhibitors of non-Staphylococcus organisms and substrates, such as mannitol as the sole carbon source used by S aureus. If growth is found in the BioLumix STA vial, the analyst can begin to confirm the presence or absence of S. aureus, directly from the vial, using the classic coagulase tests. The coagulase test that has been used for decades uses a known antisera specific for S. aureus epitopes. When S aureus is present, the antiserum reacts with the specific epitopes and forms a lattice of antibody-antigen, and the material coagulates within hours. Figure 2 illustrates the coagulase positive (upper tube) and negative (lower tube) reaction.

Pseudomonas aeruginosa- Oxidase Test

The BioLumix vial for testing for the presence or absence of Pseudomonas aeruginosa contains inhibitors such as Centrimide to prevent the growth of non-pseudomonads and substrates for use by P. aeruginosa. If growth is found in the BioLumix PSE vial, the analyst can begin to confirm the presence or absence of P. aeruginosa using the classic oxidase test. When P. aeruginosa is present, the oxidase test strip reacts with the centrifuged precipitate material (bacterium) and yields a rapid dark blue reaction. This reaction is based on the presence of certain cytochrome oxidase that are found intracellularly in the P. aeruginosa.Figure 3 illustrates the positive oxidase color test ( + ) from the negative reaction ( – ).

Salmonella- Immunoassay Strip

The BioLumix vial for testing for the presence of Salmonella contains inhibitors of non-salmonella bacteria and substrates utilized by Salmonella. If growth is found in the BioLumix SAL vial; the analyst can begin to confirm the presence of absence of Salmonella using commercially available test kits that typically make use of Immunological reactive endpoints. One such kit is shown in the cartoon (Figure 4) and depicts immuno-reactive bands on a test strip.

Identification

Any negative confirmation assay indicates that the target organism is absent and the result is negative. However, in the rare occasions that the vial shows growth and the confirmation assay is positive, it does not necessarily mean that an objectionable organism is present. In these situations further identification of the growing organism might be required. The growing organism could be isolated on selective or non-selective medium and identified by any appropriate identification system.

Testing Nutraceutical Products in the cGMP Era: Questions and Answers

Questions to Dr. Ruth Eden

With the full implementation of cGMP’s for dietary supplements, what are the changes that you have seen in microbiology testing and inquiries regarding how to comply with the regulations?

The implementation of cGMP for all manufacturers (large and small) of dietary supplements and Nutraceutical products means that all manufacturers must test their products for microbiology quality assurance and generate a Certificate of Analysis for each batch. The products need to be tested in accordance with the methods described in USP <2021> and <2022>. Products need to be tested for Total Aerobic Microbial Count, Total Combined Mold and Yeast, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organisms such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test them internally. Many outside laboratories utilize BAM and AOAC methods that were never validated against the USP methodology for Dietary supplement products.

Any method that is different from the USP methodology (manual or equipment) used for microbiology testing needs to be validated prior to its use. The validation assures equivalency of the new method to the reference method. This means the new technique or device is giving us equivalent results to the USP methodology, the results are reproducible and can be trusted. USP <1223> Validation of Alternative Microbiological Methods describes the tests that need to be conducted.

Some manufactures were slow to implement the new regulations and the new methodology required for dietary supplement product testing. Others adopted methodologies from the food industry, without proper understanding of the difference between these methodologies and the USP methodologies. We get many inquiries from manufacturers that would like to save money, speed up time to microbiological results by internalizing their microbiological testing, while complying with the regulations.

What are some of the key issues surrounding microbiology testing that a manufacturer should consider when determining equipment and personnel needs for their laboratory?

Internal testing of products for microbiology gives the manufacturer much more control over the operation offering faster time to results, faster product release, and is more cost effective. Some manufacturers are hesitant to bring the microbiology testing in house for fear of the complexity of testing, the need for trained microbiologist, etc.

However, manufacturer share some common concerns when considering the internalization of microbiology testing: 1. Am I going to comply with FDA cGMP regulations? 2. How am I going to validate my testing? 3. Do I need to hire a microbiologist to internalize the testing? 4. Will this offer a return on my investment?

Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. The validation package must properly document that the Installation Qualification (IQ) and Operational Qualification (OQ) were completed, to verify that the equipment was properly installed, calibrated and operational and that its performance are qualified. The Performance Qualification includes performance criteria such as: side-by-side comparison to the USP methodology, accuracy and precision, specificity, and range, limits of detection and quantification, along with ruggedness and robustness, reproducibility of the results, false positivity rate and false negative rate. Generating such data requires many resources.

BioLumix brings along a system that is fully validated during the system installation. With a simplified method such as the BioLumix System we can alleviate these fears and provide a simple cost effective method to test products for microbiology.

How does BioLumix plan to meet the changing requirements of dietary supplement manufacturers in implementing more precise, faster and cheaper microbiological testing in their laboratories?

BioLumix has developed a Rapid Microbiological Method that has been validated according to the FDA requirements. The validated BioLumix system is an alternative to the classic USP methodology. It is a streamlined testing system which is far less time consuming and requires less skilled technical personnel to operate. The BioLumix system offers a Certificate of Analysis for all relevant USP assays within just 48 hours. These include the FDA required tests such as total aerobic count, yeast and mold count, Bile-Tolerant-Gram -negative count, and objectionable organisms such as E. coli, S. aureus, and Salmonella. This means quarantine time for microbial testing is cut from 5-6 days to 24-48 hours for finished products, in-process and raw materials and environmental work surfaces.

Our system is fully validated during installation we perform the IQ, OQ and PQ required to fully validate the system in the customer location. We help write the appropriate SOPs, help generate the training records, and do not leave our customers until they are fully compliant.

The BioLumix testing system allows for faster sample preparation plus provides automated real-time communication, fast product release and early warning of contamination via USP microbiological testing. Because the BioLumix system is automated and its software generates the results, it is not necessary to have an employee dedicated solely to running the microbiology quality assurance tests. This makes the BioLumix system a cost-effective way for dietary supplement manufacturers to meet the new FDA cGMP requirements for microbiological testing.