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Is there a standard / rules pertaining to eating in medical device manufacturing area?


Quite Involved in Discussions
Our company is interested in knowing if there are any rules / standards around eating not being allowed in the manufacturing area of medical products? While the rule is in place that it is forbidden, we were hoping to link it with a specific set of known rules.

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
6.4 Work environment and contamination control
6.4.1 Work environment
The organization shall document the requirements for the work environment needed to achieve
conformity to product requirements.
If the conditions for the work environment can have an adverse effect on product quality, the
organization shall document the requirements for the work environment and the procedures to monitor
and control the work environment.
The organization shall:
a) document requirements for health, cleanliness and clothing of personnel if contact between such
personnel and the product or work environment could affect medical device safety or performance;
b) ensure that all personnel who are required to work temporarily under special environmental
conditions within the work environment are competent or supervised by a competent person.

Al Rosen

Staff member
Super Moderator
Sec. 820.70 Production and process controls.
(e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
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