Medical devices - Plastic components in the Pharmaceutical Industry

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kemisk karakterisering af medicinsk produkt, hvor der testes for afsmitning og generelt tilstedeværelse af uønskede, forurenende stoffer.

Medical devices - Plastic components in the Pharmaceutical Industry

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01. Chemical tests of medical devices02. Biocompatibility of medical devices03. ISO 18562: Evaluation of breathing gas pathways04. ISO 10993-7: Ethylene oxide sterilization residuals05. Combination products06. Pharmaceutical Packaging and Delivery Systems07. Plastic components in the Pharmaceutical Industry08. Stability of reagents for in vitro diagnostic (IVD)

USP <665>: Plastic components and systems used to manufacture pharmaceutical and biopharmaceutical products

USP <665> governs plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances.

The objective is to ensure that the materials and systems are suited for their intended use and do not negatively influence the quality, safety, or efficiency of the pharmaceutical product.

 

Investigation of plastic components and systems – Studies according to USP <665>

Studies and assessments must be carried out according to USP <665> to assess if plastic components and systems that encounter drugs during manufacturing meet the impending requirements and are suited for the intended application. The assessments are essential to guarantee patient safety and product reliability.

The studies are carried out according to USP <665> with reference to USP <1665>, USP, <1663>, and USP <1664>:
 

  • USP <665> describes which test parameters should be considered when testing plastic components and systems that encounter drugs during manufacturing.
  • USP <1665> provides recommendations and strategies for risk assessment, test methods, and acceptable limits for impurities in pharmaceutical products to ensure patient safety.
  • USP <665> and USP <1665> have guidelines for carrying out risk-based assessments.
  • USP <1663> and USP <1664> deal with studies of extractable studies and leachables for packaging and delivery systems (often abbreviated E&L,” Extractables and Leachables”). Therefore, it is essential to consider these USP methods when testing plastic components and systems that encounter drugs during manufacturing for the pharmaceutical industry.

 

Important dates

The date of implementation has been postponed several times. To allow time for implementation, the official effective date has been extended to 1 May 2026. After that date, the requirements of USP <665> will be mandatory for the pharmaceutical industry.

 

How can Danish Technological Institute help you?

Danish Technological Institute can assist with the relevant studies of plastic components and systems that encounter drugs during manufacturing to ensure compliance with USP <665> and <1665>. We offer:

  • Testing services regarding strategy and planning of studies.
  • Testing services regarding test set-ups for the studies according to USP <665>, including USP <1665>, USP <1663>, and USP <1665>.
  • Studies of extractable substances and leachables (E&L:” Extractables and Leachables”).

 

USP: United States Pharmacopeia

United States Pharmacopeia (USP) prepares and publishes guidelines and standards. Please note that USPs in some cases are regarded as statutory requirements. However, USP is not a regulatory authority, and the USPs are not formal regulatory documents.