What are USP standards and what does USP-NF mean?
- The USP-NF is a combination of the United States Pharmacopeia (USP) and the National Formulary (NF) and describes quality standards for medicines, outlines analysis methods, and explains terminologies.
- The USPs were established by law as official benchmarks for quality.
- USP rules are enforced by the FDA and other U.S. agencies.
- There are also quality standards for pharmaceutical packaging in the USP-NF. On the one hand, existing standards are referenced and, on the other hand, test methods with limit values are described.
USP standard – ISO/ASTM reference for pharmacists
For the medical and pharmaceutical industries, ZwickRoell offers a comprehensive product portfolio that takes into account the legal framework and applicable standards and regulations, not only in development and production but also in the packaging of medical and pharmaceutical products.
An excerpt of important application descriptions in the field of medicine and pharmaceuticals according to ISO standards and ASTM standards can be found in our comprehensive web pages on the medical and pharmaceutical industry.
For better orientation for pharmacists, who are not guided as much by normative standards but rather by USP standards, we have provided below an initial comparison of important applications with the corresponding USP chapters in the United States Pharmacopeia. We are committed to expanding and updating this on an ongoing basis.
USP Chapter | Title | ISO Reference | Functional Proficiency Tests |
---|---|---|---|
<1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 7886-1 | Breakaway Force and Glide Force Test Leakage Test |
<1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-4 | Glide Force Test Closure System Liquid Leakage Test Unscrewing Torque of the Tip Cap Pull-Off Force of the Tip Cap |
<1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-6 | Glide Force Test Closure System Liquid Leakage Test Unscrewing Torque of the Tip Cap Pull-Off Force of the Tip Cap |
<1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-8 | Breakaway Force and Glide Force Test Leakage Test Unscrewing Torque of the Tip Cap Pull-off Force of the Tip Cap Residual Seal Force (RSF) Test |
<1382> | Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11608-3 | Glide Force Test Leakage Test |
<1207> | Package Integrity Evaluation—Sterile Products | Residual Seal Force Test (RSF) | |
<382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 7886-1 | Breakaway Force and Glide Force Test |
<382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-4 | Breakaway Force and Glide Force Test Pull-Off Force of the Tip Cap |
<382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11040-8 | Breakaway Force and Glide Force Test Pull-Off Force of the Tip Cap |
<382> | Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery Systems | ISO 11608-3 | Breakaway Force and Glide Force Test Leakage Test |