Format: Environmental Monitoring In Microbiology Laboratory

Annexure-I

PERSONNEL / ENVIRONMENTAL MONITORING IN MICROBIOLOGY LAB.

AS PER SOP

DATE OF MONITORING		EXPOSURE TIME
ACTIVITY		MONITORED BY
PRODUCT		BATCH NO.
NO. OF PERSONS  IN AREA		OBSERVED ON

PERSONNEL MONITORING BY CONTACT /PLATE METHOD IN MICRO. LAB. ( STERILE AREA )

NAME	ACTIVITY DURING HAND-PRINT TEST	COLONY OBSERVED
		LIMIT < 1 CFU
		Bacteria	Fungi

ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD

GRADE - A CLASS 100  (UNDER LAF)
LIMIT: Bacteria <1 CFU/ Plate. & NIL Fungi.                Frequency – Daily
LOCATION	Positionn	Bacteria	Fungi		LOCATION	Position	Bacteria	Fungi
Sterility Testing	M  6				Sterility Testing	M  7
GRADE – B(a)   CLASS 10,000  (BACKGROUND AREA OF LAF)
LIMIT : Bacteria <5 CFU/ Plate. & NIL Fungi.             Frequency-Daily
LOCATION	Position	Bacteria	Fungi		LOCATION	Position	Bacteria	Fungi
Sterility Testing	M  5				Cool-Zone	M  8
Change Room-IV	M  4
GRADE - A CLASS 100  (UNDER LAF)
LIMIT: Bacteria <1 CFU/ Plate. & NIL Fungi.                Frequency – Once in a week
MLT Room	M  12				BET Room	M  10
GRADE –B   CLASS 10,000
LIMIT : Bacteria <15 CFU/ Plate  & NIL Fungi.           Frequency- Once in a week
LOCATION	Position	Bacteria	Fungi		LOCATION	Position	Bacteria	Fungi
Change Room-1	M 1				Change Room-3	M  3
Change Room-2	M 2				M.L.T. Room	M  11
GRADE -C   CLASS 100000
LIMIT: Bacteria <50 CFU/ Plate. &.NMT-1 Fungi              Frequency- Once in a fourteen days
LOCATION	Position	Bacteria	Fungi		LOCATION	Position	Bacteria	Fungi
Microbiology Room	M  13				B.E.T. Room	M  9

Observation:        Bio-burden found within / out of specified limit

ANNEXURE-II

 

PRESSURE DIFFERENTIAL OF MICROBIOLOGY TESTING LABORATORY

DATE

TIME

STERILE AREA OF MICROBIOLOGY LABORATORY

MICROBIOLOGY LABORATORY

OBS- ERVD BY

CHEC-KED BY

CHANGE ROOM-1

CHANGE  ROOM-I1

CHANGE ROOM-1II

CHANGE ROOM-1V

STERILITY  TESTING

COOL-ZONE

AUTOCLA-VE  ROOM

MICROBIO ROOM

M.L.T. ROOM

B.E.T. ROOM

Op. Range- 1-2 mm of water

Op. Range-  2-4 mm of water

Op. Range- 4-6  mm of water

Op. Range-  6-8  mm of water

Op. Range- 8-10  mm of water

Op. Range- 4-6  mm of water

Op. Range- 2-4  mm of water

Op. Range-  1-2  mm of water

Op. Range-  2-4  mm of water

Op. Range-  2-4   mm of water

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ANNEXURE-III

 

TEMPERATURE AND HUMIDITY MONITORING IN MICROBIOLOGY LABORATORY

DATE

STERILE AREA OF MICROBIOLOGY LABORATORY

MICROBIOLOGY LABORATORY

DONE BY

CHEC -KED BY

CHANGE ROOM-I °C

CHANGE ROOM-I1 °C

CHANGE ROOM-1II °C

CHANGE ROOM-1V °C

STERILITY TESTING °C/Humidity(%)

COOL- ZONE °C

AUTOCLAVE ROOM °C

M.L.T. ROOM °C

B.E.T. ROOM °C

MICROBIO. LAB. °C

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