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Packaging Validation & International Compliance

LPT Packaging Validation

LIFE PACKAGING TECHNOLOGY LLC is a single resource for your packaging validation needs.

Lifesciences industries—medical devices, pharmaceuticals, and biotechnology—are experiencing explosive growth. Global demographics continue to accelerate the market and advances in technology are happening every day.

Manufacturers want to simplify their packaging validations. Speed to market is a priority, without sacrificing quality.

Take a hard look at the cost of validating your packaging “in-house.” LPT can deliver a complete packaging system validation fully compliant with FDA, EU, and ISO regulations.

Our packaging validation objective is to design and develop packaging systems, unique to each customer, yet universal to meet the requirements of each specific regulatory agency.

Our Validation Services include . . .

  • 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

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