Friday, December 17, 2010

Preparation Of Settle Plates

1.0              OBJECTIVE:

The objective of this SOP is:
1.1               To lay down a procedure for preparation of  plates that can be used as settling plates and in various microbiological analysis.

2.0              RESPONSIBILITY:

2.1               The Microbiologist shall be:
2.1.1          Responsible for preparation of settle plates , their pre incubation and related documentation. 

3.0              ACCOUNTABILITY:

Executive - Quality Control

4.0                PROCEDURE:


4.1                Media with the content of agar can be used for the preparation of settle plates like.
i)                    Soyabean Casein Digest Agar (SCDA) - For enumerating Bacteria and  Fungi ( required for Environmental monitoring and Microbial limit tests.)

ii)                   Sabarauds Dextrose Agar ( SDA ) – For estimation of fungi.( Required for Microbial limit tests. )

4.2                Prepare media as per SOP
4.3                Follow the gowning procedure and enter the M.L.T Room by following SOP.
4.4                Clean the LAF with 70% I.P.A and wait till drying .
4.5                Switch on LAF and UV lamp 15 min. before pouring the plates.
4.6                Open the containers containing sterile petri-dishes (That are previously sterilized by  Autoclaving ) and place on the working surface table of L.A.F.
4.7                Open the containers containing sterile petri-dishes and place them on the working table of LAF.
4.8                Take out the cotton plug of conical flask containing agar medium .
4.9                Sterilize the mouth of the conical flask by flaming it and start pouring about 20-25 ml of medium to each petri-dish  quickly .
4.10            Cover the plates and keep under LAF , till they are solidified.
4.11            After getting solidified, preincubate the plates to the incubator at 30-35°C for 48 hrs to check any accidental contamination.
4.12            Check each and every plate under colony counter before exposure to the environment for monitoring.
4.13            Record the activity in  Media preparation record.
 REFERENCES : 
MCA Orange Guideline 1997.

Operation And Cleaning Of Laminar Bench

1.0       OBJECTIVE

            To lay down a procedure for operation and cleaning of Laminar bench.

2.0        RESPONSIBILTY

            Microbiologist/Executive.

3.0        ACCOUNTABILITY
                                                                       
Executive

4.0        PROCEDURE
4.1      Introduction :
4.1.1     Laminar  flow clean air work station is device which  provides  a total  sweep  of a confined area because the entire body  of  air moves  with  uniform velocity along parallel  lines,  originating through a HEPA filter occupying one entire side of the  confined area.  Therefore, it bathes the entire area with very clean  air, sweeping away contaminants. Laminar-flow provide  well-controlled work areas only if proper precautions are observed.

4.2         Working :
4.2.1          Enter the sterility testing room/aseptic zone with proper gowning procedure.

4.2.2          Clean the LAF with IPA 70% solution daily before operation and after day's working.

4.2.3          Check the electric connection before starting the work.

4.2.4          Note the manometer reading. It should be zero if required set at 'zero'.

4.2.5     Switch ON the LAF unit and also the lights
4.2.6          Check the manometer reading (It should be between 10-15min.)

4.2.7          Switch ON the L.A.F. 1/2 hr. before sterility testing /aseptic operation.

4.2.9     The Pre-filter should be cleaned every 3 months

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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