Medical devices - Pharmaceutical Packaging and Delivery Systems

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

Medical devices - Pharmaceutical Packaging and Delivery Systems

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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 1663, USP 1664: E&L Studies of Pharmaceutical Packaging and Delivery Systems

Pharmaceutical products and medicine are stored in packaging as soon as they are produced and remain there until they are used by patients.

 

Storage

Medicine/pharmaceutical products can be stored in packaging from hours to months depending on the type of packaging or delivery system. Therefore, it is important to consider the contact time of the applied packaging/delivery system and the medicine of current interest when testing the compatibility between packaging and medicine.

Packaging, containers, and delivery systems for medicine/pharmaceutical products must be suited for storing pharmaceutical products, and they must not affect the products. The material from which the packaging, container, or delivery system is made must be compatible with the stored medicine to ensure that no unwanted chemical substances migrate from the packaging or the delivery system to the medicine. Examples of packaging or delivery systems for pharmaceutical products include the temporary packaging and delivery systems from the production phase as well as the final packaging that reaches the patients.

 

Storage in Delivery Systems

In some cases, medicine is transferred to a delivery system. Under certain circumstances, the substance is dosed to the user over time, and therefore the substance may be stored in the delivery system for a long time. Examples of delivery systems include prefilled syringes, infusion bags, inhalers, insulin pens, and dispensers for eye drops.

 

Compatibility Testing

The two standards USP <1663> and USP <1664> are used to assess the compatibility of the pharmaceutical packaging or delivery system. The standards deal with studies of extractables and leachables (often abbreviated E&L) for packaging/containers and delivery systems for medicine/pharmaceutical products.

 

Stability Testing

When packaging is used for medicine, it is important to test whether the packaging affects the stability of the medicine. For further information on stability testing, please refer to:

How can Danish Technological Institute help you?

Danish Technological Institute has methods and equipment at its disposal to, e.g., investigate:

  • Strategy and planning of tests
  • E&L studies for extractables and leachables in connection with pharmaceutical packaging or delivery systems according to USP 1663 and USP 1664
  • Compatibility between material and medicine
  • Emission of particles
  • Stability testing