ErtelAlsop, the leader in innovation in depth filter equipment and filter media, announces the availability of a new free Validation Guide for ErtelAlsop Pharmaceutical Grade Depth Filters for all of its pharmaceutical grade filter media.

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.

The purpose of this new guide is to provide corroborating information about ErtelAlsop’s depth filter media used in pharmaceutical processing.

The Guide comprises three sections. Section I includes general information about pharmaceutical grade depth filters manufactured by ErtelAlsop.

Section II includes detailed specifications for each individual grade filter medium.

Section III contains important laboratory test data for ErtelAlsop’s pharmaceutical grade filter media. This 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.

ErtelAlsop products include pharmaceutical depth filter media made to strict controls and included in the Drug Master File at the Center For Drug Evaluation and Research of the FDA. Precision die cut media is available for plate and frame and cylindrical filter presses and Zeta-Pak® lenticular filter cartridges. ErtelAlsop also manufactures sanitary design hardware for incorporation of these media.