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From past experience with a dental manufacturer, items like this were not required to be manufactured in a clean room. These are not implanted into tissue, they just come in contact with intact tissue. Most manufacturing was done in a 100,000 clean space and did not require being made in our ISO 8 space.
Do you know where the clean room requirement came from? Are you producing sterile aligners? In my experience, items such as dental brackets were not required to be produced in a clean space nor sterilized.
Original Message:
Sent: 03-Sep-2021 05:47
From: Shivani Chawda
Subject: Dental aligners
Hello everyone,
Can anyone from the medical device background give me insight about the finishing of the dental aligners will it be done in the clean room area with hepa filters? As we have notice that the filter is getting chocked, can we show finishing area as non clean room area only with suction pump (to remove the dust) and air conditioning? and can we only show lazer and the disinfection only in the clean room area as part of GMP and ISO 8?
Regards
Shivani
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Shivani Chawda
Quality Assurance Executive
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