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Dummy samples
- Dunnage is traditionally defined as “loose wood, matting, or similar material used to keep a cargo in position in a ship’s hold.” In the medical device manufacturing world, however, it’s come to serve as the umbrella term for any dummy samples used in medical package testing and validation.
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What is dunnage in medical package testing?
What is dunnage in medical device manufacturing?
What is dunnage and why is it important?
What are package testing requirements for medical devices?
Dunnage is traditionally defined as “loose wood, matting, or similar material used to keep a cargo in position in a ship’s hold.” In the medical device manufacturing world, however, it’s come to serve as the umbrella term for any dummy samples used in medical package testing and validation.
Package distribution test samples must contain product or representative product (dunnage/simulant) that has been sealed at equipment worse case conditions and sterilized. Expected transit life includes processing, handling, sterilization, transit and warehousing.
Jun 28, 2018 · Package testing requirements. For medical devices, package validation testing is outlined in ISO 11607 and consists of seal integrity (seal strength), material integrity (bubble leak), distribution testing, and package aging. Package aging has the longest lead time.
Package distribution test samples must contain product or representative product (dunnage/simulant) that has been sealed at equipment worse case conditions and sterilized.
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If dunnage is used, specify what it is and how it compares to worst-case samples. Note: Dunnage is a filler made of similar materials to your product. Dunnage is used to take up the space and should have approximately the same density as your packaged product during sterilization validation.
Jan 4, 2016 · The objective of package testing is twofold: first, to ensure the integrity of the sealed package, and second, to ensure that no weaknesses develop during sterilization, normal handling, transportation, and storage.
Mar 20, 2018 · Examples include corrugated boxes, dunnage, or additional packaging inside a sealed tray or pouch that prevents the medical device from damaging the sterile barrier system. For example, while a package design can be tested to ensure it maintains a sterile barrier, the enclosed device must not damage the SBS during shipping and handling.
