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Validation Guide For ErtelAlsop Pharmaceutical Grade Micro Media Depth Filters

Source: ErtelAlsop

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White Paper: Validation Guide For ErtelAlsop Pharmaceutical Grade Micro Media Depth Filters

Validation may generally be defined as, "Establishing documented evidence which provides a high degree of assurance that all specific processes used in the manufacture of a drug product will consistently produce a product meeting its pre-determined specifications and quality attributes". (quote from PDA/FDA Joint Conference on Sterilization Process Validation.) By extension, those elements, such as filters, used in the process must also meet these criteria, that is, they must consistently meet pre-determined specifications and quality attributes. Further, there must be corroborating documentation.

ErtelAlsop filters are manufactured to predetermined finished product specifications. The quality control procedures for release of filter media call for 100% testing of finished lots, i.e., samples of media from each lot manufactured are tested. Selected samples of media from each lot are tested for relative flow and retention characteristics.

It should be noted that no re-manufacturing is allowed for production of pharmaceutical grade filters. Thus, a more stringent control of raw materials is required for these products.

The purpose of this guide is to provide corroborating information about ErtelAlsop's depth filter media used in pharmaceutical processing. The information was derived from tests performed by an independent, outside testing laboratory and includes tests for pyrogenicity, extractables, acute systemic toxicity, and intracutaneous toxicity, per current federal regulations.

Table of Contents
Section I includes general information about pharmaceutical grade depth filters manufactured by ErtelAlsop.

Section II includes Specification Sheets for each individual pharmaceutical grade filter pad.

Section III comprises test data from the independent testing laboratory for grades M-70P and M-90P. These are representative of all twenty-seven pharmaceutical grades since each grade is manufactured from similar materials.

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White Paper: Validation Guide For ErtelAlsop Pharmaceutical Grade Micro Media Depth Filters