Validation Guide For ErtelAlsop Pharmaceutical Grade Filter Paper

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.

General Information
ErtelAlsop has signed an exclusive agreement with Ahlstrom, of Mt. Holly Springs, Pennsylvania, to serve as their exclusive distributor of pharmaceutical grade filter paper.

This guide was developed to provide information on the methods used to qualify filter paper used in pharmaceutical applications. Included are the filter paper characteristics and the test methods used to qualify the product.

The filter paper grades designated for use in pharmaceutical processing and addressed in this Validation Guide are Grades 6095P, 6392P, 6492P, 7133P, 7265P, 7362P, 7762P, 8393P and 9363P. To ensure consistency, these grades are manufactured in accordance to predetermined controlled methods and product specifications outlined by an ISO 9001 Quality Management System. Each lot of material manufactured is tested against predetermined lot release criteria.

These grades are manufactured with raw material comprised of virgin fibers and reverse osmosis process water. Neither remanufactured nor recycled material is used in these grades.

The following sections outline product descriptions, data sheets and test data from independent laboratory testing. The products are designated on the test reports as FC7P with resin and FC7P without resin. FC7P with resin refers to Grades 7133P, 7265P, 7762P, 9363P and FC7P without resin refers to Grades 6095P, 6392P, 6492P and 8393P.