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https://pharmastate.blog/environment-monitoring-by-settle-plates-in-aseptic-facility/#:~:text=Individual%20settle%20plates%20may%20be%20exposed%20for%20less,hours%2C%20the%20action%20levels%20should%20be%20adjusted%20accordingly.
https://www.pharmaguideline.com/2018/10/why-expose-media-plates-for-4-hours.html
While media plates can be exposed in clean rooms for about half an hour too, most experts, including the EU guideline to good manufacturing practice, claim that the optimum time for media plate exposure is four hours. This time has been determined as the best time according to mathematical calculations of the rate of settling of organisms per the exposed hours.
https://pharmastate.blog/environment-monitoring-by-settle-plates-in-aseptic-facility/
Individual settle plates may be exposed for less than 4 hours. If the settle plates are exposed for less than 4 hours, the action levels should be adjusted accordingly. Action to be taken in the event of a result being on or over the action level:- Exceeding action levels on isolated occasions may not require more action than examination of control systems.
https://www.researchgate.net/post/About_settle_plate_time_in_cleanroom_microbial_monitoring_does_anyone_company_prolong_settle_plate_more_than_4_hour
GMP-WHO or GMP-EU recommends an exposure time of 4 hours for settle plate due to drying of agar.
https://www.ejpps.online/settleplatesandannex1
Finally, back to the humble settle plate, both versions of Annex 1 mention the use of settle plates and both have notes about exposure time. The 2008 text says ‘Individual settle plates may be exposed for less than 4 hours’ (para 18 Note (a)) whereas the 2020 draft states ‘Settle plates should be exposed for the duration of operations and changed as required after 4 hours.
https://cdn.ymaws.com/phss.co.uk/resource/resmgr/Files/Settle_plate_exposure_under_.pdf
Settle plates are typically exposed for periods of up to 4 hours. An exposure time of 4 hours is recommended in the EU Guidelines to Good Manufacturing Practice, although individual settle plates may be exposed for less than 4 hours (and for pharmaceutical operations subject to other regulatory requirements, alternative exposure times may be considered.)
https://www.criver.com/eureka/how-ready-are-your-cleanrooms-for-annex-1-updates
a. 546 Individual settle plates may be exposed for less than 4 hours. Where settle plates are exposed for less than 4 hours the limits in the table should still be used, no recalculation is necessary. Settle plates should be exposed for the duration of critical operations and …
https://www.alpfmedical.info/media-fills/environmental-monitoring-applications-and-limits.html
The E.U. limit of less than 1 cfu per four-hour settle plate also falls into this category. In theory one might expose a plate for longer than four hours to improve the sensitivity of the method but, in practice, four hours is near the outer limit of drying out with consequent loss of growth supportiveness.
https://pharmaceuticalmicrobiologi.blogspot.com/2016/12/passive-air-sammpling.html
Collect all the plates after completion of 4 hrs exposure time. For Exmple less than 4 hours exposures, to be establish the In-house limits, because all guidelines limits given CFU/ 4hours only. After exposure close the lid and incubate the plates inversely. Incubation temperature at 20-25 ° C have been used for 72 hours, next 30-35 ° C for 48 hours.
https://focus-lab.com/usp_1116_and_iso.html
Settle Plates (cfu/90 mm plate/4 hours) Contact Plates (cfu/55 mm plate) Glove Print 5 Fingers (cfu/glove) A > 1 > 1 > 1 > 1. B. 10. 5. 5. 5. C. 100. 50. 25 _ D. 200. 100. 50 _ Regardless, Action and Alert levels should be rational, justified, and continuously reassessed and improving.
https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
settle plates (diameter 90 mm) cfu/4 hours (b) contact plates (diameter 55 mm) cfu/plate glove print 5 fingers cfu/glove A < 1 < 1 < 1 < 1 B 10 5 5 5 C 100 50 25 - D 200 100 50 - Notes (a) These are average values. (b) Individual settle plates may be exposed for less than 4 hours. 20.
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