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Microbiology

Microbiological analysis

 

  • Microbiological analyzes according to the PharmEU.
  • Sterility testing
  • Media check /-fill growth test
  • Bioindicators (incl spores)
  • Water analysis (AP, WFI, drinking water)
  • Environmental monitoring
  • Legionella tests
  • Endotoxin tests
  • Germ identifications (API system, 16s, Maldi-TOF)
  • House flora determinations

 

Chemical analysis

 

  • TOC
  • Determinations of antibiotic levels
  • Pharmaceutical substances on request

 

Accredited testing and inspection body for the following procedures

 

  • Testing/inspection body for drinking water heating systems on Legionella acc. ÖNORM B 5019
  • microbiological parameters acc. bath hygiene regulations…
  • Water testing

 

Questions from requirements of GMP routine

 

  • Basics of disinfection and sterilization
  • Aspects of aseptic filling
  • Environmental/room hygiene

 

Assessment, training, and advice

 

  • GMP (EU and USA), GLP (EU and USA), ISO 9000, EN 17025 and other quality standards

 

Hygiene advice and monitoring

 

  • Air, work surfaces, devices, water
  • Hospitals…

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