PEP Engineered Products and Graver Technologies, LLC are pleased to announce the release of the ZTEC P 0.2 micron Sterilizing Grade filter cartridges, specifically intended for use in the most critical applications within the biopharmaceutical market. The applications include the final filtration of therapeutics, vaccines, serums and cell culture media and diagnostic reagents.
Since many pharmaceutical preparations cannot be terminally heat sterilized, it is necessary to sterilize by means of filtration. The standard for sterility by filtration in these applications is defined as the ability of a filter to remove 107 organisms/cm2 of surface area. This performance data as well as the other required pharmaceutical documentation to support the claims has been included in the Validation Guide that is available upon request.
The new ZTEC P Sterilizing Grade filters utilize a double layer of PES membrane that has been specifically tested against the target organism Brevundimonas diminuta and validated through multiple lot testing to meet the requirements specified in ASTM 838-05 for sterile effluent. Each filter is 100% integrity tested, serialized and comes with Certificate of Conformance in the package.
For more information e-mail us or call 1-519-620-7381.