USP 1664 Pharmaceutical Packaging Test

EUROLAB laboratory provides testing and compliance service within the scope of USP 1664 standard. This standard provides a framework for the design, rationale and implementation of assessments of drug product leaks derived from pharmaceutical packaging and distribution systems.

Because leaks can potentially affect drug product efficacy, safety, and quality, a scientifically sound leak assessment is important for manufacturers and their various suppliers, primarily as a means of determining suitability for use in pharmaceutical packaging/distribution systems.

In addition, such a potential leak assessment can provide an understanding of leaky sources and how to assess and manage leaks during the drug development and manufacturing processes. This section establishes the critical dimensions of a leak assessment and discusses the practical and technical aspects of each dimension. This section does not establish specific analytical methods or leak specifications and acceptance criteria for any particular dosage form or packaging system or drug product combination; nor does it describe every situation where a leak assessment is required.

A general discussion of pharmaceutical product leaks is not likely to anticipate and cover all situations that may occur in the pharmaceutical industry where a leak assessment may be required. Designing an individual leak assessment is a process that balances sound science, prudent resource allocation, and effective risk management with an emphasis on patient safety and product quality.

Achieving this balance is the responsibility and obligation of the pharmaceutical product manufacturer and assumes that applicable legal and regulatory requirements are taken into account. The principles and best proven practices outlined in this general section represent a consensus interpretation of sound science and are therefore predictable and applicable to any situation where a leak assessment is required for pharmaceutical application.

EUROLAB assists manufacturers with USP 1664 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.