Is there any guideline available for temperature and RH mapping in cleassified areas?
What is the requirement/frequency usually followed for this activity?
Thanks.
They clearly mentioned in ISO-14644-3.In that they had given the procedure how to Map the Temperature and RH and also Frequency.
Regards
Suresh
How do we conduct temperature mapping? do we have to conduct it regularly even without significant changes in the configuration of the room? TIA
Hi,
depending on your local requirements, temperature mappings within a cGxP environment are conducted as follows (see USP recommendation):
1.) Empty warehouse prior to first comissioning
2.) full warehouse in summer season (depending on your location)
3.) full warehouse in winter season (depending on your location)
The fully stocked mapping is repeated if:
1.) you encounter significant deviations during the operation of the warehouse
2.) you carry out a re-racking (change of racking)
3.) you add or remove conditioning units
4.) you respecify the use of the facility with changed tempertaure- and humidity range
Note: the above is common best practice, it is not demanded specifically in any countries regulations as far as I am aware (EU, US). Your regulator will let you know what they see as mandatory. If you are based in Europe make sure you understand EMEA and your local requirements
Hope this helps you.
Regards,
Herbert