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