Quality

ProSys Quality Management System

ProSys operates the certified quality management system ISO 9001:2015, ensuring quality and consistency through all stages of design, manufacturing, and testing of products.

  1. Quality control testing and FAT/SAT testing of all Isolators
    • Filter Integrity
    • Leak Rate
    • Mechanical & Electrical Inspection
    • Functional and Alarm Testing
    • Pressure & Airflow Testing
  2. Design Qualification – approved drawings, design specification documents, traceability matrix and quality plan
    • Compliance to European Directives – ATEX 2014/34/EU Machinery 2006/42/EC PED 2014/68/EU
    • Risk Assessments
    • Technical Files
  3. Containment testing to ISPE guidelines and EN 689
    • Testing to 1ng/M3 containment performance target
    • Surrogates available include sodium naproxen, mannitol and lactose
    • IOM samplers or closed faced cassettes available for testing

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