Friday, December 17, 2010

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
  /   /














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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