VALIDATION

Our validation team is available for planning and executing the following validation processes.

 

Packaging tests

  • Visual inspection, ASTM F1886
  • Seal strength, DIN EN 868-5 or ASTM F88/F88M
  • Dye penetration test, ASTM F1929, ASTM F3039
  • Burst test, ASTM F1140
  • Investigation of the microbiological barrier property, DIN EN 58953-6 

                                                              

Packaging validations

  • Packaging tests, DIN EN ISO 11607-1,2,3 EN 868-5, ASTM F1140, ASTM F88/F88M, ASTM F1929
  • Accelerated ageing, ASTM F1980
  • Real-time ageing according to internal standard

 

Cleaning validations

  • Investigation of bioburden, ISO 11737-1, USP [61]
  • Investigation of particle reduction, USP [788]
  • Investigation for cytotoxic substances, ISO 10993-5
  • Investigation for endotoxins, USP [85]
  • Investigation for organic and inorganic residues
  • Biocompatibility, ISO 10993-1

 

Sterilization validations, DIN EN ISO 11137 parts 1,2,3 (gamma)

Sterilization validations, ISO 11135 (EO)

 

Transport simulations and transport tests

  • ISTA 2a, ASTM D4169 D C3, DC 13, ISTA 3a, with pre-conditioning according to ASTM D4332
  • Drop test, ASTM D5276
  • Vibration test, ASTM D999 A, ASTM D4728
  • Compression test, ASTM D4169+D 642
  • Shock pulse, ASTM D6344
  • Vacuum test, ASTM D6653

 

Accelerated ageing, ASTM F1980

Real-time ageing according to internal standard

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