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Quality
QA Approvals
Primasil has the following quality assurance and cleanroom approvals:
- ISO9001:2000 Certified Company
- ISO 13485:2003 Certified
- ISO 14644-1:1999 ISO Class 7 Cleanroom
Platinum-cured products under the "Medisil" brand which can meet or exceed the following globally recognised quality standards:
- ISO 10993
- FDA CFR177.2600
- US Pharmacopoeia Class VI
- European Pharmacopoeia 3.1.9