Cleanroom requirements for surgical apparel

[DrFergal]

Hi everyone. I am new to this website but have visited as a guest on occasion to get access to your valuable knowledge.

We are an EU based legal manufacturer of class I and class Is devices (sterile gowns and theatre consumables). We are looking to move the manufacture of some of our products, namely disposable nonwoven surgical caps and theatre warming jackets (for non-scrubbed staff) from China to the EU. We would outsource the manufacture so I was wondering if cleanrooms would be required for these products under the MDR because it will massively change our strategy for outsourcing the manufacture (standard textiles company vs specific medical device manufacturer).

Masks and sterile gowns/drapes would obviously continue to be manufactured in cleanrooms.

I would appreciate any advice on this? Thanks I’m advance.

As a side note: We are currently in the process of looking for a new regulatory affairs consultant for tech file writing, ISO audits etc. and wondered if there is a way of finding suitable consultants through this forum?

 

[Billy Milly]

Personally, I hope I will never be operated in a theatre where devices from uncontrolled environments are used...
Joking aside, if you can stil fulfill the GSPRs without any controlled environment, this is possible, but in my opinion very unlikely.

There are some good consultants participating on here, see Paid Consulting section for more info or/and PM the persons you see fit based on their input here.

 

[Philip B]

You need to risk assess your products and determine the environment they need to be packed in. Will depend on the products, their intended use, contact with patients (if any), the method of manufacture, whether they are to be terminally sterilised etc etc.