In manufacture of heat labile sterile drug products, the final step involves filtration through
sterilizing grade filters. It is the drug manufacturer's responsibility to check whether an …

Pre-use/post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the
last several years. To a large extent, the debate is because of the fact that scientific data …

In recent years, a desire to minimize the risks associated with sterilizing filtration has
prompted much discussion on the need for preuse/post-sterilization integrity testing …

Sterilizing grade filtration has been reliably used for decades and increasingly so, as more
medicinal products are large molecule based, which requires cold sterilization, ie filtration …

Sterilizing grade filtration has been used for decades with reliability and assurance. The
reliability of this particular aseptic processing step increased with filter stability …

The following study was conducted to determine the effect of different preservatives
commonly used in the biopharmaceutical industry on the product-specific bubble point of …

Compounding pharmacies that compound sterile preparations must choose sterile filters that
are approved for human use. They may rely on the filter manufacturer's Certificate of Quality …

Sterile filter validation is an important process in the pharmaceutical, biotechnology, and
healthcare industries to ensure the effectiveness and integrity of sterile filtration systems …

The Parenteral Drug Association published the authoritative summary of best practices in
sterile filtration and validation of sterile filtration in its 1998 TR. Filter validation is an …

Eudralex volume 4, Annex 1, the European Union Good Manufacturing Practice for sterile
products, requires that “The integrity of the sterilised filter should be verified before use”(1) …