BioLumix to Exhibit its Rapid Automated Microbiology System for Pharmaceutical Testing

BioLumix will be exhibiting at the PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology held at the Marriott Bethesda North Hotel & Conference Center October 17th and 18th. Please come by the BioLumix exhibit (booth #19) and see how we are innovating and streamlining microbial testing for the Pharmaceutical Industry.  Our Rapid Microbiological Method (RMM) will simplify and accelerate the testing process with all assays completed on a single platform.  The automated BioLumix System provides real-time communication for immediate action; most completed assay results in 12-18 hrs – Yeast and Mold within 48 hrs.

A poster entitled: “Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count“  describing the scientific data behind the BioLumix technology and its validation is being presented.  The poster will show a technology overview and validation case studies for the BioLumix System, the new RMM technology that is capable of simultaneously detecting microbial growth, providing an estimation of viable cell counts, and identifying the presence of specific microorganisms, using a novel and automated growth-based format is presented. The case studies demonstrate the ability of the technology to detect total aerobic microorganisms, total yeast and molds, and the presence of E. coli, Staphylococcus, Pseudomonas, Salmonella, as well as additional microorganisms.  The data shown in the study indicates that the BioLumix system can be used as a RMM with comparable results to USP <61>.   The method has good specificity in detecting target organisms and excluding non-target flora.  The detection limit for the BioLumix system equals or is slightly better that the limit for the plate count method. High precision or repeatability was obtained for all three assays tested.  The system is capable of performing multiple assays in a streamlined protocol

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).  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.”

The FDA has accepted the BioLumix Drug Master File (DMF):  The DMF is helpful for all Pharmaceutical companies producing prescription drugs.  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.

The current validation package will allow OTC users to utilize the system immediately, since during the system installation all validation elements will be completed by our trainers and your microbiologists.

Fast Return on Investment

Streamlining your microbial testing with our reliable, easy-to-use system will save you time and money.   In most cases a very quick return on investment can be proved.  We invite you to contact us and inquire about our Return on Investment calculation.  We have shown in many cases the BioLumix System will pay for itself within the first 6 months of ownership. 

Hear What Our Customers Are Saying

Don’t just take our word for it, talk to our customers.  We have recently conducted a customer survey and are proud to share we have 100% customer satisfaction and that all of our customers would recommend the BioLumix.  Unanimously, our customers agree – the main features of the BioLumix system are:  Speed to results, simplicity of use, accuracy and clarity of data presentation. You are free to contact our customers to discuss their first hand experience.

Free Product Trial

Give us your most difficult samples and we will test them for free.  We will provide you with a detailed report which includes a side-by-side comparison to USP methodology along with a sample of the BioLumix 48 hour automated Certificate of Analysis.  The data generated is strictly confidential and is only used to help validate the system for your company should you decide to purchase.

Come to our booth #19 and speak to an expert or contact us directly (734-984-3100) to learn more about the exciting new developments at BioLumix; such as:  our space, time, labor and material saving technology, 48hr Certificate of Analysis, as well as our environmental monitoring and water testing solutions.

We look forward to working with you and earning another satisfied customer!

BioLumix to Submit DMF to FDA for its Rapid Microbiology Method in Pharma

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.

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.”

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.