USP 661-1 and 661-2 laboratory analysis

What is USP 661?

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.

And tomorrow ?

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.

FILAB can assist you with your analyses in accordance with USP 661-1 and 661-2

Why perform USP 661-1 and 661-2 analyses ?

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 are the standards laid down 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:

  • Identification and characterization tests by IR and DSC
  • Physicochemical tests (defined according to the type of drug product and the type of plastic).

FILAB can help you with your USP 661 analyses ?

Why choose FILAB for your USP 661 analyses ?

The FILAB laboratory provides pharmaceutical manufacturers with the technical skills and state-of-the-art analytical equipment they need to meet their requirements and offer them the most appropriate services and tailor-made support for their packaging and administration devices.

The FILAB laboratory provides the following services :

  • Accelerated ageing study

  • 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

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thomas ROUSSEAU Scientific and Technical Director
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