Medical device package testing and validation for ISO 11607, ASTM, and FDA compliance—seal integrity, aging studies, and transit simulation services.
Medical device packaging plays a critical role in product sterility, safety, and performance. At Life Science Outsourcing (LSO), we provide comprehensive package testing and validation services to ensure compliance with ISO 11607, ASTM, and FDA requirements.
Our in-house testing and validation capabilities help medical device manufacturers validate their sterile barrier systems (SBS), optimize packaging durability, and meet regulatory standards for global market approval.
We conduct rigorous package validation testing to verify that your packaging maintains sterility, integrity, and compliance throughout its lifecycle. Our testing includes:
testing ensures:
Aging studies determine the shelf life and sterility maintenance of medical device packaging. We offer:
We test medical device packaging under extreme temperature, humidity, and environmental conditions to ensure durability and sterility maintenance. Our services include:
For manufacturers seeking faster time-to-market, LSO offers pre-validated sterile barrier packaging that meets ISO 11607 and ASTM standards, eliminating the need for lengthy validation processes.
Bubble emission testing detects microscopic leaks in sterile packaging using ASTM F2096 methods.
Packaging must withstand real-world shipping, handling, and storage conditions. LSO offers:
Dye penetration testing (ASTM F1929) verifies sterile barrier integrity by detecting unsealed areas in flexible packaging.
Ensuring that preservatives maintain effectiveness over time is crucial for liquid-based medical devices. LSO offers:
We evaluate seal strength and opening force to ensure user-friendly, reliable medical packaging. Our testing includes:
Stability testing determines how medical device packaging holds up over time, ensuring compliance with FDA and ISO guidelines. Our services include:
A non-destructive method for assessing packaging defects, seal integrity, and damage. We provide:
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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