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Not quite tight? Testing sterile packages

Dye Penetration Test
Dye Penetration Test

Compliance with stringent requirements is required of medical products that have to be sterilised. The design and development process for a medical product and its packaging is often a difficult task. Manufacturers have to guarantee that their product is efficient, safe and effective in the hands of the final consumer. Appropriate test methods are need to provide proof of this.

We perform tests on the basis of internationally recognised and standardised test methods such as the ASTM standards D and F. All test methods are based on the requirements of DIN ISO 11607-1:2009.

  • Shipment simulation, e.g. in accordance ASTM D 4169, ISTA 2A
  • Real-time ageing and accelerated ageing test according to ASTM F1980
  • Dye penetrant testing according to ASTM F1929
  • Seal strength tests according to ASTM F88, EN 868-5, -7
  • Burst test ASTM F2054 / ASTM F1140
  • Creep test according to ASTM F1140

Our detailed test report documents the tests and indicates possible weaknesses. This permits timely elimination of potentially hazardous faults.

Accreditation
The competence of our test laboratories has been confirmed by accreditation bodies:
Contact
Dipl.-Ing. (FH) Karolina Behrens

Dipl.-Ing. (FH) Karolina Behrens

behrens(at)bfsv(dot)de
Phone +49 40 42875-6033