ISO-11607 Packaging for Terminally Sterilized Medical Devices
ISO 11607 Packaging Process Validation for Terminally Sterilized Medical Devices Overview Part 1 vs. Part 2 How to Validate What Changed Pitfalls FAQs Last updated: November 2025 (ISO 11607-1/-2 current through Amd 1:2023) Updated for 2025. ISO 11607 defines how your sterile barrier system is designed, sealed, tested, and proven—from first article through shelf life. […]
Price Guarantee
Price Guarantee LSO At Medical Package Testing we are so confident about our prices that we guarantee them! If you find a quoted price for your project which is less than our quoted price, we guarantee to meet the lower price by 5%. How to Claim your Guarantee: Send us your quote for review and […]
Medical Secondary Packaging
Medical Secondary Packaging LSO The best way to determine the style and features that will best protect and enhance your product is to work with an experienced packaging engineer or carton designer. A poor fit between the carton and the inner package/product will often result in damage, the cost of which usually exceeds any cost […]
Medical Primary Packaging
Medical Primary Packaging LSO Primary Packaging is the first-level of medical product packaging which contains the actual product. The best way to determine the style and features that will best protect and enhance your product is to work with an experienced packaging engineer or carton designer. A poor fit between the product and the packaging […]
Package Design
Package Design LSO LSO has a commitment of excellence to the Medical Device Industry. One of the most critical aspects of your product is the package that transports it to your clinical destinations. Our primary objective is to have your medical device arrive safely and intact at its final destination. One of LSO’s core competencies […]
Environmental Conditioning
Environmental Conditioning LSO Environmental conditioning testing validates the resilience of medical device packaging under real-world conditions such as temperature fluctuations, humidity, and pressure changes. By predicting longevity, verifying sterility, and reducing risks, this testing ensures your packaging meets ISO 11607 standards and FDA regulations. Trust Life Science Outsourcing to deliver precise testing, protect product integrity, […]
Distribution Simulation Testing
Distribution Simulation Testing LSO What is distribution simulation for medical device packaging? There are numerous environmental and physical conditions that medical packages and products will encounter when traveling from point of manufacture to the sterilization facility, distribution center, health care facility, or other final destination. Distribution simulation testing evaluates packaging ability to withstand such conditions […]
Real Time Aging
Real Time Aging LSO Real-Time Aging programs provide the best data to determine shelf life and the effects of aging on materials. The test is conducted by placing the test item on a shelf and allowing it to be exposed to typical storage conditions. Doing this will establish the items accurate expiration date. However this […]
Package Validation Testing
Package Validation Testing LSO Medical device manufacturers are called upon to obtain approval on each individual medical device package. According to the ISO 11607 standard, the manufacturer must ensure the product and package system conjoin to create a complete product which performs efficiently, safely, and effectively in the hands of the user. Package Validation Testing […]
Accelerated Aging
Accelerated Aging LSO Accelerated Aging is an artificial procedure for establishing the lifespan or shelf life of a product in an expedited manner. Data obtained from the study is based on conditions that simulate the effects of aging on the materials. A product can be released to market based upon successful Accelerated Aging test results […]