Modulation Spectroscopy Evaluation via Headspace Gas Ingress by Using Frequency Method Development for Container Closure Integrity

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy

USP39<1207>

PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS

Role of packaging material on Pharmaceutical product stability

AgendaƒGeneral Overview ¾What is packaging? ¾Importance of packaging ¾Functions of packaging ¾Material characteristics
ƒChoosing the Appropriate Primary Pack Suitable polymer/ Blister Packs Containers & Closures
ƒTesting of materials QC test QC Plus Pack integrity
ƒRegulatory US, EU, Pharmacopoeial
ƒCase studies

ASTM2338-09

Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method1

Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

For questions on the content of the guidance, contact CBER’s Office of Compliance and Biologics Quality at 301-827-3031; CDER’s Office of Pharmaceutical Science at 301-796-1228; CDRH’s Office of Device Evaluation at 240-276-3747; or CVM’s Office of New Animal Drug Evaluation at 301-827-6963.

U. S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Veterinary Medicine February 2008