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Reference project

Cleanroom qualification
for producers of blood glucose meters

A client extends its clean room production facilities for developing and producing sterile components of blood glucose meters. Following the establishment of the new production facilities, the production systems and plants must be requalified.

EXCO is assigned with qualifying the clean rooms (ceilings, floors, walls) and the interior ventilation system (including the sluice control).

Implementation
  • defining a qualifying strategy
  • creating requirements' specifications
  • identifying GMP relevant plant components and quality relevant issues
  • creating functional specifications and risk asessment as well as defining measures to minimize risks by FMEA
  • setting up qualification plans and reports according to the V-modell
    • Design Qualification (DQ)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
  • Überwachung und Koordination der Qualifizierungsmaßnahmen und -aktivitäten

We planned and executed the qualification measures for the clean room. Thus, our partner was able to concentrate fully on developing its new medical device and securing production quality.

Rolf Ziese, project leader, EXCO GmbH
Kunden

Hersteller Medizinprodukte und Diagnostikgeräte, Deutschland

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