Partial listing of our validation services
- Complete package design, specification and prototyping for package validation objectives and clinical and/or commercial release
- Full engineering compliance services to ISO 11607, parts 1 and 2 for “Packaging for Terminally Sterilized Medical Devices”—including complete sterile barrier system validation
- Equipment selection and development of packaging equipment installation, operation and performance protocols and reports
- Production of packaging components for package validation work
- Pre-validation, feasibility testing for design verification
- Package test methods recommendation(e.g. ASTM, ISTA) and coordination for outsourced packaging laboratory testing
- Package validation plan consultation and development, including sample size and statistical rationale
- Thermal Packaging Systems Validations to Custom Profile or Industry Standards, such as ISTA 7E
- Sustainable Package Design Validation to ISO Standards and EU Packaging Waste Directive