Meissner Filtration Sudamerica - Productos
Productos
•Microbiological Services MTS microbiologists are experts in sterile filtration, mycoplasma removal, and virus removal. Fully equipped MTS laboratories perform microbial-challenge studies on customer products, under worst-case processing conditions, using bioburden-specific organisms or standard challenge organisms. •Microbial Retention Studies MTS generally performs filter retention studies on pharmaceutical product, under extended processing conditions. This includes protocol development, viability and inhibition testing, and the challenge using either standard challenge microorganisms or bioburden-specific organisms. •Compatibility Screening A critical analysis of potential interactions between filter components and the pharmaceutical product is performed to ensure that the filter experiences no adverse effects in the pharmaceutical product. •Extractables Testing A gravimetric non-volatile residue (NVR) determination is made for the filter and pharmaceutical product; additional GCD-MS analysis is performed on the extract. •Product-based Integrity Testing Integrity test values are established from testing conducted with actual product; test values are based on the customer's preferred test methodology, including bubble point, diffusion, or pressure hold and are carefully established and documented. •Additional GMP Documentation Upon request, MTS can supply information on materials of construction, challenge protocols, performance data, sterilization protocols, and integrity test values using the customer's preferred method. •Filter Quality Certification Program All pharmaceutical filters are shipped with certificates of quality with release data. This helps customers meet FDA or other agency documentation requirements, facilitates incoming materials handling, and minimizes the need for testing by customers. •Filtration Process Reviews MTS staff can visit customers on-site to perform technical reviews, document and analyze system performance, and help ensure regulatory compliance.
•SteriLUX® PVDF Filter Cartridge •EverLUX® PES Filter Cartridge •STyLUX® PES Filter Cartridge •Steridyne® PVDF Filter Cartridge •Chemdyne® Polypropylene Filter Cartridge •Ultradyne® PTFE Filter Cartridge •Protec® Glass Microfiber Filter Cartridge •ALpHA® Polypropylene Microfiber Filter Cartridge •ALpHA® BW1 Polypropylene Microfiber Filter Cartridge •Vangard® Polypropylene Microfiber Filter Cartridge •Duraclear® Polypropylene Microfiber Filter Cartridge •DeltaMax® Polypropylene Depth Filter Cartridge •DeltaDepth® Polypropylene Depth Filter Cartridge