AQF Medical’s manufacturing and packaging environment are of utmost importance to our customers. Our ISO Class 8 cleanrooms are fully integrated into our quality control system and all components are fabricated in strictly controlled, monitored and certified cleanrooms. We recognise components for the medical and pharmaceutical industries require the highest levels of cleanliness at all stages of production to meet stringent hygienic standards, and the need for germ and contaminant free components is ever increasing.
ISO 13485 requires manufacturers to have formal written policies regarding control on documents and records, internal auditing procedures, controls for non-conformance, corrective and preventative actions, process and design controls, record retention, and accountability and traceability.
Components for the medical, pharmaceutical and biotechnology industries require the highest levels of cleanliness at all steps of production to meet stringent hygienic standards. The need for germ and contaminant free components and environments is ever increasing. The conditions of AQF Medical’s manufacturing and packaging environment are of utmost importance to us, and our cleanrooms are fully integrated into our quality control process. Our cleanrooms maintain a low level of particles by the use of a sealed environment with constantly filtered air at a higher pressure than the surrounding areas.
- Multiple ISO Class 8 Cleanroom facilities
- Customer specific manufacturing cells
- Sub assembly and contract packaging capabilities
In addition we also ensure that our team members are fully trained on all procedures including:
- Proper attire and dressing anteroom
- Controlled use of, and entry into, controlled areas
- Cleaning of the room and production equipment per written procedure