Evaluating Pharmaceutical Container Closure Systems

The use of qualitative and quantitative methods can help packaging professionals determine the presence of extractables and leachables.
David E. Albert, NAMSA (Northwood, OH)
The United States Pharmacopeia (USP) and FDA have been and continue to be the driving force behind the safety evaluation of materials and container closure systems in the United States. An important step in such evaluations is characterizing the materials and the chemicals that can migrate or extract from container closure system components to the drug product. Figure 1 shows the various types of chemicals that can migrate from polymeric materials1. Such basic information is critical to understanding the biological safety and suitability of a container. A number of tests can be used to establish initial qualification of the container closure system, and a quality control plan can help ensure compatibility and safety.

Aseptic Processing of Biological Products: Current Regulatory Issues

“Facing the Challenges of Drug Product and Device Development & Manufacturing”
Patricia F. Hughes, Ph.D. Branch Chief (Acting) FDA/CDER/OPQ/OPF/DMA/BIV
WCPB 2016 January 27, 2016 Washington, D.C.

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

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

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