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Sterilization need

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Guest user Created:   Apr 28, 2023 Last commented:   Apr 28, 2023

Sterilization need

I have a question concerning sterilisation and whether it is required in our specific medical device area that we aim to work in. We will be making topical application products such as cream, gels or balms for eczema, acne, scalp issues, etc. The product itself won’t be sterile, but I was wondering if there was any other sterilisation process to be implemented, like equipment, packaging, etc.

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 28, 2023

No, these products do not need to be sterile, nor the packaging material. What you can take into account is to make the production space a clean room area to ensure that the area for production is completely clean and safe for the product.

More about clean room standards you can find here: https://www.iso.org/standard/53394.html

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Apr 27, 2023

Apr 28, 2023