USP 665 analysis laboratory

You would like to carry out a USP 665 analysis of the plastic materials used in your pharmaceutical products

What is USP 665?

The United States Pharmacopeia (USP) has introduced USP 665 as a draft standard for the qualification of plastic systems and materials used in the manufacture of pharmaceutical and biopharmaceutical products. Its aim is to guarantee the safety and efficacy of medicines through the proper qualification of materials in contact with them.

What is the purpose of USP 665?

USP 665

USP 665 aims to provide guidelines for the characterization of plastic materials and systems used in the production, processing and packaging of pharmaceutical products.

In particular, it deals with the assessment of risks associated with potential interactions between plastic materials and pharmaceutical products. Such as the release of extractable and/or leachable substances that could affect product quality or patient safety.

What are the key points raised by USP 665?

In order to guarantee the safety of polymeric materials used in the pharmaceutical industry, USP 665 is developing 2 main axes:

  • In-depth assessment of material safety to prevent contamination of drugs by harmful substances through leaching tests.
  • Physico-chemical tests to verify the properties of materials, ensuring their suitability for the intended pharmaceutical use.

FILAB can help you analyze your products in accordance with USP 665

Why choose FILAB for USP 665 testing ?

The FILAB laboratory has the experience and specific analytical equipment to support pharmaceutical companies in the analysis of plastic materials used in the manufacture of pharmaceutical and biopharmaceutical products in accordance with USP 665, through tailor-made support.

The support of an expert plastics analysis laboratory like FILAB enables us to better understand the strategic challenges and changes in the pharmaceutical sector.

Our technical resources for USP 665 extractables analysis

In order to provide you with reliable analyses and interpretations, FILAB , 665 laboratory, has a complete range of analytical equipment, adapted to your needs. These include

GCMS or LC-MSMS for research
ICP (AES and MS) for the identification and quantification of organic pollution
SEM-EDX microscopy, a truly rapid and versatile diagnostic tool.

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

Anaïs DECAUX Customer Support Manager
Ask for your quote
+33 (0)3 80 52 32 05 Request
a quote