MicroVantage ™ MA Series - Pharmaceutical Grade Polyethersulfone, Polypropylene and Nylon Membrane Filter Elements - Shelco Filters - #1

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• • • • • Features Media Definitions Shelco’s new MicroVantage™ pleated membrane cartridges are designed to meet the high standards of the pharmaceutical industry. These cartridges are manufactured to the most stringent production standards making them the new benchmark of the industry. Manufactured in a ISO 9000 environment, each pharmaceutical grade cartridge has its own lot code for traceability and comes with a certificate of quality assurance. Each operation including assembly, testing, cleaning, drying and packaging is done in an appropriately rated and certified clean room. MicroVantage™ MA SERIES – PHARMACEUTICAL GRADE Polyethersulfone, Polypropylene and Nylon Membrane Filter Elements The MicroVantage™ Pharmaceutical Grade Series is available in a wide range of pore sizes Each cartridge is 100% integrity tested All pharmaceutical grade cartridges are validated using modified HIMA protocols at a challenge level of 107 organisms per cm² of filter media. (0.22 ìm challenged with Brevundimonas diminuta) (0.45 Challenged with Serratia marscecens) (0.65 Challenged with Saccharomyces cerevisiae) All materials of construction meet requirements of the FDA Title 21 of The Code of Federal Regulations Cartridges are designed for maximum throughput and particle retention at the lowest pressure drop Polyethersulfone, Nylon and Polypropylene construction offers a wide range of compatibility Each cartridge is validated to pass USP class 6 Toxicology extractable tests, oxidizable substance for plastics, endotoxin level and other quality test. Non-pyrogenic per USP guidelines and using the LAL procedures. Applications • WFI • Aseptic Processing • Serums • Drugs • Biologicals • Chemicals • Tank Ventilation Polyethersulfone cartridges are designed to be used as a sterilizing grade cartridges for the pharmaceutical industry. MicroVantage PES P-Grade cartridges are double layered for 100% bacterial retention and integrity. PES is low protein binding and has excellent flow rates. It is particularly suited for the filtration of vaccines, biologicals and sterile fill application in SVP’s and biological products. It is also well suited for the filtration of products whose constituents, such as preservatives, can absorb to the media. PES NYLON POLY Nylon cartridges are designed to be used as sterilizing grade cartridges for the pharmaceutical industry. The higher quality nylon membrane utilized in these cartridges is optimized for the retention so that it need not be double layered . They see broad service in sterile fill applications in SVP’s and as bio burden management filters in LVP’s. Media and service liquid filtration are other common applications for this cartridge. Polypropylene membrane cartridges are single layered and designed for use in the filtration of aggressive solvents, and as compressed gas and vent filters. Each cartridge is diffusion tested using 60/40 IPA and water. (Hydrophobic membrane) Air flow: 0.1 = (20 SCFM/psid/10 inch cartridge length) 0.2 = (30 SCFM/psid/10 inch cartridge length) • •