USP 661-1 and USP 661-2 laboratory analysis
As an industrial manufacturer, you wish to perform analyses in accordance with USP 661-1 and USP 661-2.
What tests are recommended by USP 661-1 and 661-2?
The USP establishes standards (including USP 661) to ensure that polymeric materials that come into contact with medicines or medical devices do not impact human health. This standard applies to HDPE, LDPE, PP, PET, PETG, etc.
Packaging regulations 💊
USP 661-1 aims to verify the components of plastic materials.
USP 661-2 aims to verify packaging and interactions with the drug.
Steps:
- Verify the polymer: composition test, identification test, physical and chemical tests, compatibility tests
- Verify the finished packaging; absence of extractables, material resistance
- Document the entire process to ensure regulatory compliance
our technical resources
USP 661 in a few words
USP 661 is a United States Pharmacopeia (USP) standard for plastic packaging used in the pharmaceutical industry. It is a specific chapter in the USP standards that provides guidelines and criteria for packaging materials used in drugs and pharmaceuticals. It aims to ensure that polymer materials have no impact on human health.
In 2016, USP expanded Chapter 661 testing standards to further support packaging safety; these new chapters are USP (661.1) and USP (661.2). These chapters will come into force on December 1, 2025, but early adoption is permitted and encouraged.
USP 661.1 : Plastics Materials of Construction
The aim of this section is to evaluate the plastic materials used in pharmaceutical packaging.
USP 661.2 : Plastic Packaging Systems for Pharmaceutical Use
The aim of this section is to test complete packaging systems for their interaction with drugs.
The FILAB laboratory supports you in your analyses in accordance with USP 661-1 and USP 661-2.
Why perform analyses according to USP 661-1 and USP 661-2?
To enable marketing, all elements in direct contact with the medicine or medical device are subject to strict regulations. Indeed, administration devices and primary packaging must not interact with or degrade the medicine.
The support of an analytical laboratory such as FILAB provides reliable results for assessing the compliance and performance of packaging and administration devices, in accordance with defined specifications and regulatory standards.
The main objectives of the standard
- Patient safety: limiting exposure to potentially harmful substances.
- Product efficacy: ensuring that packaging does not alter the properties of medicines.
- Regulatory compliance: meeting international requirements for globally distributed products.
The FILAB laboratory provides the following services :
Chemical characterization of your packaging materials and their properties
Analysis of extractables and leachables
Internal or external surface analysis
Physicochemical tests (defined according to the type of medicinal product and the type of plastic)
Melting point or glass transition point
Analysis of an unknown particle and comparison with packaging or delivery material
Study of the device's physical properties: thickness, porosity, etc.
Analysis of hazardous substances
Analysis of additives purity
