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