CSZ provides stability testing for the medical and pharmaceutical industry. Testing services meet a variety of test requirements for accelerating aging, shelf life testing, expiration date testing, and more. Services are available to test or store a wide range of products in specific temperature and/or humidity conditions. Applications include, but are not limited to: stability testing, accelerated aging, pharmaceutical, packaging, life science, biomedical storage and research.
Our stability testing services meet a variety of ASTM standards for accelerated aging and FDA stability testing standards for long term, intermediate and accelerated test conditions for drug substances, drug products and packaging. Refer to the list below for a few of the more common test specifications.
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS) and the physical properties of their component packaging materials.
(Source: ASTM F1980 - 07)
Document available on ASTM web site: http://www.astm.org
Stability Testing of New Drug Substances and Products
This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. It does not seek to address the testing for registration in or export to other areas of the world. The guidance exemplifies the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.
(Source: ICH Q1A (R2) November, 2003)
Document available on ICH web site: http://www.ich.org