MONITORING OF MICROBIAL LOAD

MONITORING OF MICROBIAL LOAD

Objective:

This test is undertaken to verify that the system can provide the required microbiological cleanliness defined in the USP, Microbiological evaluation of clean rooms and other controlled environment(1116) and EU guidance on Good Manufacturing Practice.

Acceptance Criteria:

Less than 100 CFU per cubic meter of air. (By using sampler method).

Less than 80 CFU per 90mm dia settle plate for 4 hours of exposure. By using air settle plate method).

Method:

Microbiological monitoring shall be carried out as per the organization SOP “Microbial Environmental Monitoring”.

Number of sample locations:

Each 10 m²(Approx) of area should have one sampling location.

The number of locations may be seen in the table provided whilst the count locations within each room should be shown on a drawing as an appendix.

Number of sampling locations:

Room No.	Room Description	Floor Area(m²)	No. of sampling locations

Results Tables:

Room No	Room Description	Location no	Air sampler method		Settle plate method		Acceptance criteria met? (Yes/No)	Verified as Acceptable (Sign & date)
			CFU per m³ of air	A R No.	CFU per 90mm dia plate	A R No.

Acceptance Criteria:

Area Classification	Air sample (cfu/m³)	Settle plates(diameter 90mm) cfu/4 hours
Grade C	100	50
Grade D	200	100