MICROBIOLOGY, STABILITY,RESIDUE AND VALIDATION TESTS

– Microbiological Testing Services :

  • Sterility, Bacterial endotoxin , Bioburden / ISO 11737-2 , USP 41 NF 36(85) , ISO 11737-1

– Antimicrobial activity tests:

  • Bactericidal Activity / TS EN 1276
  • Fungisidal Activity / TS EN 1650

– Accelerated Stability / ASTM F 1980

– E.O residual / ISO 10993-7

– Gamma sterilization dose detection and routine control / ISO 11137-2

– Cleaning and Rinsing Validation

  • Oil-grease analysis / SM 5520-B
  • Detergent residual analysis / ISO 2211
  • TOC and SEM analysis
  • Corrosion test / TS 5172 EN ISO 13402 , TS EN 1618 , BS EN ISO 10555-1

– Packaging Validation Tests (leaking and durableness) / ASTM F 1929 , EN 868-5