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About Complying With Global
Medical Device Packaging Requirements
It is not only important for the
Medical Device manufacturer to see that the products are delivered
to the users in safe and sound condition, it is also essential to
see that necessary tests are performed in order to meet with the
regulatory requirements. It is therefore essential to keep in mind
from the initial stage of the product development process.
It is the responsibility of Medical
Device manufacturer to guarantee that the products will be
protected during transportation, and that they comply with health
and safety regulations. Pharmaceutical and medical products have
certain special characteristics (such as their limited shelf
life). For this reason, their requirements for transportation and
commercialization must be aligned with them.
There are international protocols
aimed at guaranteeing safety focus on factors such as the seal
integrity, materials or how the package reacts to the passage of
time - the major once are :
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ISO 11607 Packaging for terminally
sterilized medical devices.
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EN 868 Packaging materials and
systems for medical devices to be sterilized, general requirements
and test methods.
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ASTM D1585 Guide for Integrity
Testing of Porous Medical Packages.
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ASTM F2097 Standard Guide for Design
and Evaluation of Primary Flexible Packaging for Medical Products.
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ASTM F3475-11 Standard Guide for
Biocompatibility Evaluation of Medical Device Packaging Materials.
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BS EN ISO 15378:2017 Primary
packaging materials for medicinal products. Particular
requirements for the application of ISO 9001:2015, with reference
to good manufacturing practice (GMP).
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ISTA 3 packaging and transport
standards are now official standards to be used for FDA approval
on medical devices for the US market.
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ISO 11137, which measures Gamma and
E-beam sterilization.
(Source :
https://www.safeloadtesting.com/latest-innovations-in-medicaldevice-packaging/
).
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