Medical devices - Combination products

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

Medical devices - Combination products

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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)

Analysis of combination products

A perfect match is required between equipment and drug for combination products that consist of a drug and medical equipment.

The material of the medical equipment must be compatible with the drug that is used to ensure:

  • that undesirable chemical substances are not extracted from the medical equipment to the drug.
  • that the drug is stable in combination with the medical equipment.

Some examples of combination products are prefilled syringes, infusion bags, inhalers, insulin pens, eye drop dispensers, and other equipment for drug dosing.

The storage time of the drug in the medical equipment can vary from hours to months depending on the type of combination product. Therefore, it is important to consider the contact time between the medical equipment and the drug when testing the compatibility between the material and the drug as well as the stability of the drug that is used.

 

How can Danish Technological Institute help you?

At Danish Technological Institute we have methods and equipment at our disposal for testing:

  • Biocompatibility according to ISO 10993-18
  • Drug stability
  • Material compatibility between the material and drug
  • Particle matters
  • Strategy and planning of tests