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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