Update of the USP Requirements for Packaging Materials made of Plastics
![Data Integrity Master Class with full-day pre-course session Raw Data](files/eca/userImages/training.img/Z-ECA-Raw-Data-Data-Integrity-Masterclass.jpg)
Recommendation
27-30 August 2024
Copenhagen, Denmark
including 8 Interactive Workshops
In the Pharmacopoeial Forum 40(5) the USP published several proposals on the revision of the General Chapters on packaging materials made of plastics.
In the future, the following general chapters are planned:
- Plastic packaging systems and their material of construction < 661 >
- Plastic material of construction < 661.1 >
- Plastic packaging systems for pharmaceutical use < 661.2 >
- Evaluation of plastic packaging systems and their material of construction with respect to their user safety impact < 1661 >
Packaging materials made of plastic are comprised of homologous polymers with different molecular weights and contain additives such as antioxidants, plasticizers, pigments and other components.
The General Chapter of < 661.1 > will cover the tests which demonstrate that a material can be viewed as well characterized. These include:
- Identity
- Biocompatibility (Biological reactivity)
- General physicochemical properties
- Additives
- Extractable metals
For all further information on the General chapters in the revision process, please see the USP Website of the Pharmacopeial Forum (PF).
Source: USP
Related GMP News
23.07.2024New Ph. Eur. Chapter on Elemental Impurities in Plastic Materials
17.07.2024USP Proposal for Elastomeric Packaging Components
10.07.2024USP Proposal for Metallic Packaging Systems
05.06.2024Requirements for Sterile Packaging Material
14.03.2024New USP Chapter on Cured Silicone Components
07.12.2023First Electronic Product Information (ePI) for Human Medicines