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.