PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology brings together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that the Pharmaceutical industry faces on a daily basis. This comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.
During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies, providing invaluable sessions dedicated to pharmaceutical microbiology, and a venue to network with fellow microbiologists, experts in all areas of pharmaceutical microbiology, key vendors of microbiology testing equipment & supplies, and regulatory/compliance professionals. Visit the BioLumix booth (#13) to learn about the most advanced rapid microbiological testing system.
BioLumix Offers Microbial Testing Solutions for the Pharmaceutical Industry BioLumix Rapid Microbiological Method is capable of performing testing equivalent to both USP <61>and <62> simultaneously on a single platform. The novel automated growth-based system simultaneously detects microbial growth, provides an estimation of viable cell counts, and identifies the presence of specified micro-organisms.
The automated, all-in-one microbial testing system is extremely easy to operate. The system is both simple and cost-effective, revolutionizing your current testing methodology. This novel optical system senses color and fluorescence changes in ready-to-use vials provides faster results, labor savings, automation, and connectivity. The streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product and raw materials release.
By encompassing both USP types of testing, the BioLumix is a complete screening solution making the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money.
DMF Submission and Validation The BioLumix Drug Master File (DMF) is on file with FDA. The BioLumix System is fully validatable! During the system installation we will generate the IQ (Installation Qualification), OQ (Operation Qualification), and will help you to complete the PQ (Performance Qualification) portion of the validation, leaving you with a complete validation package against USP <61> and <62>.
The BioLumix Advantage Quality Assurance with a Competitive Advantage – The Automated BioLumix System will accelerate your microbiological testing resulting in faster product release and decreased costs. The streamlined testing design reduces labor, time and supplies. The BioLumix software is 21 CFR Part 11 compliant with log-in, log-ofut and audit trail. It presents real-time communication for immediate action of contaminated samples and a 48 hour Certificate of Analysis for completed samples, as well as other customizable reports. Testing is non-destructive, allowing for further identification of organisms where needed. BioLumix offers a comprehensive range of microbiological tests for raw materials, in-process and finished products as well as processing water and environmental testing. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference.
BioLumix customer service is second to none, with the ability to offer customer support from anywhere in the world. With the BioLumix system, one can depend on receiving the most superior level of service, support and compliance with FDA regulations.
Please take the opportunity to speak with an expert about how the BioLumix System can help lower your testing costs. We invite you to visit our website at www.myBioLumix.com or send us your most difficult samples for testing. We at BioLumix truly believe we will make your company more efficient and add profit to your bottom line.