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PACKAGING AND MATERIALS IN CONTACT WITH FOOD -
 PACKAGING FOR MEDICAL DEVICES

The packaging and materials in contact with food must be produced throughout the supply chain by applying the Good Manufacturing Practices.
Biochem offers services to verify the characteristics of the packaging, for purposes of compliance with the relevant standards for food or protection and preservation of the product in relation to the contents.
The packaging for medical devices must ensure the maintenance of sterility where the device put on the market after sterilization.
Some categories of tests available are:
Chemical characterization of materials, Leak test, Physico-chemical tests, barrier to microorganisms test, dye penetration test, Leaching test, Accelerated aging, Sterility test.
We can develop specific protocols and validate the methods to be used.
Main Reference legislation: FDA 21CFR, 2010/11/CE, DM 21/03/1973

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* Compliance with DM 21/03/1973
* Compliance with 2010/11/CE requirements
* Compliance with FDA 21CFR monographs
* Compliance with ISO 11607 requirements
* Accelerated aging (ASTM.F1980; ICH)
* Microbial barrier ASTM F1608
* Integrity tests and Standard test method for detecting seal leaks in porous medical packaging; Seal strength
* Sterility Test after Accelerated aging
* Global migration
* Specific migration
* Compliance with EN 14350-2 “Child use and care articles - Drinking equipment - Part 2: Chemical requirements and tests”
* Bisphenol A
* Phthalates and plasticisers content or migration
* Heavy metals detection or migration
* Method validation

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