Millstone Medical remains highly active in the standards and regulatory committees that drive the ever-changing requirements for package validation. We act as a key resource to our customer’s internal teams throughout the product life cycle.
Process and medical packaging design validation from equipment selection and aging studies through final packaging design verification.
- Comprehensive package integrity testing including Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ):
- Sealing Validations
- Distribution Testing
- Accelerated Aging
- Cleaning Validation
- Sterilization Validation (Ethylene oxide (EtO) and Gamma)
- Label Design and Production
- Process Failure Mode Effects Analysis (PFMEA) Development