USP <1207> Updates Leak Testing Recommendations For Pharmaceutical Companies

By Hemi Sagi

Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures. As a result, container closure integrity testing is an important step in the preparation and transportation of many different products. Unlike other mass produced devices, blood filters, catheters, diagnostic probes, syringes, ventilator tubes and other items must meet strict requirements set by the Food and Drug Administration (FDA).

Last fall the United States Pharmacopeia (USP) released the proposed revisions to general chapter Sterile Product Packaging – Integrity Evaluation <1207> for public comment in the Pharmacopeial Forum. USP <1207> is designed to offer guidance on container closure integrity leak testing methods and qualification.