Update of the USP Requirements for Packaging Materials made of Plastics

Recommendation

7/8 February 2023
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

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