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.
- Quality control testing and FAT/SAT testing of all Isolators
- Filter Integrity
- Leak Rate
- Mechanical & Electrical Inspection
- Functional and Alarm Testing
- Pressure & Airflow Testing
- 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
- 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