USP 661-1 and USP 661-2 laboratory analysis
En tant qu'industriel vous souhaitez réaliser des analyses selon l'USP 661-1 et USP 661-2
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 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.
FILAB can assist you with your analysis in accordance with USP 661-1 and USP 661-2
Why perform USP 661-1 and USP 661-2 analysis ?
To allow marketing, all elements in direct contact with the drug or medical device are subject to strict regulations. Administration devices and primary packaging must not interact with or degrade the drug.
The support of an analytical laboratory such as FILAB enables us to provide viable results for assessing the conformity and performance of packaging and administration devices, according to defined specifications and regulatory standards.
What tests are recommended by USP 661-1 and 661-2?
The USP sets standards (including USP 661) to ensure that polymeric materials coming into contact with drugs or medical devices have no impact on human health. This standard applies to HDPE, LDPE, PP, PET, PETG …
The tests described here include:
The FILAB laboratory provides the following services :
Chemical characterization of your packaging materials and their properties
Analyse des extractibles et relargables
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
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