- /
- Standard / USP-671
USP <671>
USP <671>
USP <671> Containers Performance Testing is a well-known standard for testing the protection provided by pharmaceutical packaging systems. The requirement of the standard is based on the ability to resist the flow of moisture and other factors, which could change the quality, stability, and shelf life of the pharmaceutical product. The packaging of medicines is an integral part of maintaining their integrity during storage, transport, and distribution. USP <671> offers testing methods that will determine if a container offers a suitable barrier to the product contained in the container. Presto Stantest provides cutting-edge testing solutions to pharmaceutical manufacturers, helping them evaluate the performance of the packaging materials based on USP <671> requirements.
Significance
Many pharmaceutical products are sensitive to moisture because moisture can change the chemical composition of the product, the potency of the product, and its effectiveness. USP <671> assists the manufacturer in assessing the moisture protection properties of packaging materials and container closure systems. The test data is used to determine packaging, for quality control processes, and for regulatory compliance. Packaging manufacturers can minimize risk for product degradation by identifying packaging systems that can lead to high moisture transmission and ensure the quality of the medicine throughout shelf life. Regular testing can also enhance consumer trust in pharmaceutical packaging. Scope The US Pharmacopoeia (USP) guideline <671> concerns performance tests of containers used for pharmaceutical products and is centered on moisture permeation. This standard applies to bottles, containers, blister packs, and other types of packaging systems for the drug product. It provides methods for evaluating the moisture barrier in terms of its performance under a range of conditions. The approach offers the industry a standardized way of comparing the effectiveness of packaging and to validate the suitability of the container for use in medicine.