Identifying the Clean Room Requirements for a Medical Device in US and EU

[Arati]

Identifying the clean room requirements for a medical device in US and EU

I need help in identifying the clean room requirements for medical device assembly and storage in US and EU based on the medical device classification in US and EU.
For example if our product is class II in US and class 2b in EU what are the clean room standards. How will I identify the requirements for clean room. I have done my round of searching was not able to find a exact requirement or guidelines which says for this classification of medical device it should have this clean room standards.

Please help

 

[MIREGMGR]

The guideline that you seek does not exist. There is no requirement for a specific class of cleanroom for a specific medical device class or code. The requirement instead is that the production environment must be controlled such that your medical devices are (within US FDA jurisdiction) safe and effective. (This differs slightly for EC rules, but the concept is the same.)

For devices that are provided sterile, the cleanroom requirement is determined by you based on your requirements to achieve product and process validation, and in particular from your sterilization validation and biocompatibility requirement. You must do whatever is required so that your devices are assuredly biocompatible per standard and sterile to the required probability, on a consistent basis.

 

[ANDY-QA]

It is necessary of low class sterile medical device manufacturer (disposable) to operate in clean-room environment?

What is the guidelines for effective and save environment monitoring & control?

 

[Ronen E]

It is necessary of low class sterile medical device manufacturer (disposable) to operate in clean-room environment?

What is the guidelines for effective and save environment monitoring & control?

Hello ANDY-QA and welcome to the Cove

I suggest that you carefully read MIREGMGR's post above, it answers your questions in a general way. In short - if you can consistently guarantee appropriate cleanliness and sterility without a clean room then you are allowed to do it.

You can use the QSR/cGMP regulations (US 21 CFR part 820) as your guideline for establishing and controlling an appropriate production environment. If you go down the clean room path, ISO 14644 series is relevant as well.

Good luck,
Ronen.