Hello Shivani,
The basic materials "banned" from cleanrooms (really regardless of class) are things like food, drink, cardboard, make-up, or really anything which can introduce particles routinely into the cleanroom. Refrigerators are allowed, but what you should do is clean the unit down in the Ante Chamber room (gowning room), before introducing into the cleanroom. As an example, when materials are brought into the cleanroom through say a pass-through, the outside container would be wiped down or even the inside all wiped down to reduce any external foreign particles from being introduced into the cleanroom. When we had to bring equipment or tools into the cleanroom these were all wiped down/cleaned prior to entry to ensure there was no external particles which could come off in the cleanroom.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 01-Sep-2021 05:41
From: Shivani Chawda
Subject: ISO 8 clean room requirements
Respected Professionals,
Will you please guide me regarding the banned material list in ISO 8 production area for a medical device company basically dealing with dental aligners, is refrigerator allowed ? please clarify.
Thanks in advance for taking out the time.
Regards
Shivani
------------------------------
Shivani Chawda
Quality Assurance Executive
------------------------------