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How to determine Hygienic Zones

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#1 cassandra0923


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Posted 27 July 2017 - 07:48 PM

Hello Everyone,


I was told by a colleague that in Processing areas less than 20,000 sqft Zone 3 sites are to be treated at Zone 2 sites.  Is this true?  If so, where can I find the documented source?  My Plant Manager wants written confirmation.


Thanks in advance

#2 jenky


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Posted 27 July 2017 - 09:02 PM

I suspect this information is coming from the FDA Investigations Operations Manual.  However, maybe the interpretation is slightly incorrect.  In Chapter 4 (page 135-136), the environmental zones are defined.  The Zone 2 definition makes reference to 20,000 sq. ft. as an example for a larger processing area, but I think some folks have taken this number and tried to make it a hard rule.  It is important to read the full definition for all zones and make the best decision based on your processes and traffic patterns.   


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