- Clean room Certified to AS 1386 (Class 3500)
- Quality management system certified ISO 13485
Standards
- Validation for the steriliser is ISO 11135
- Current qualification and
validation processes in CPP Process:
- Class 7.3.6 Product Design Validation
- Class 7.5.2 Bag Sealing Machine Validation
- Class 7.5.2.2 ETO Sterilisation Validation
