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Saturday, August 16, 2008

Standard operating procedure SOP for microbiology department

Standard operating procedure SOP for microbiology department for a WHO GMP pharmaceutical manufacturing company.
your company name S.O.P NO :-
Issue No. :- 02
Page :- 1 of 1

TITLE :- MEDIA PREPARATION FOR ROUTINE MICROBIOLOGICAL TESTING

OBJECTIVE :- Nutreint media which are generally prepared fresh are obtained in the form of ehydrated powder and constitute the specific composition as per the microorganism's need for their growth. Generally used media are dehydrated media which can be reconstituted as per the direction of use by the manufacturer of these dehydrated medias.

UNIT OF RESPONSIBILITY :- Q.A Executive , Trained Q.A Assistants.

IMPORTANT POINTS / NOTE / PRECAUTIONS:
1. During preparation of the media see that no spillage takes place while heating onhot plate.
2. The dehydrated media being highly hygroscopic should not be exposed for more time during weighing.
3. Carefully read the instructions given on the label, direction and use. Also note the USE BEFORE ' date and batch No.

PROCEDURE :-
a) Receipt of media from the supplier
After the receipt of media from the supplier the batch No. and the expiry of the manufacturer is entered into the media reciept register along with the challan Noand the date of reciept. This batch no. and the expiry date along with the date of
reciept is reflected in the media preparation record against each media prepared.

b) Preparation:
1) For rehydration, use clean, undamaged glassware and distilled water for the preparation of these media.
2) Place appropriately weighed amount of the medium in a clean dry flask, 2-3 times larger than the final volume of the prepared medium. Add part of the required amount of the distilled water and swirl to dissolve.
3) Gradually add the remaining water from the side of the container.
4) For completely dissolving heat on the hot plate, taking care to avoid excessive heating scorching of the medium.
5) The pH should be adjusted to the value specified and is corrected by adding diluted HCl or sodium hydroxide.
6) Dispense completely dissolved medium as desired and sterilize as directed on the label.Generally sterilization is done at 1210C & 15 lbs pressure for 20 minutes using an autoclave.There are certain media which are not to be autoclaved.
7) The reconstitution and the sterilisation requirement of the media is tabulated in the annexure 1, 2, & 3
8) The media after preparation is used within 96 hours of after preparation.
9) If not used immediately should be stored at temp of 8- 15 deg C.and if not used within 96 hours should be destroyed.

OTHER RELEVANT DETAILS :-
Destruction
The media after use is destroyed as mentioned in the SOP for disposal of micro biological waste. sop number
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Q.A.Executive

FREQUENCY OF OPERATION :- For every batch of media as required. Also see Pharma Process Validation

NO OF ATTACHMENT:-

RETENTION OF RECORDS :- 5 Years.
YOU MAY DOWN LOAD FOLLOWING SOPS HERE

1.MEDIA PREPARATION FOR ROUTINE MICROBIOLOGICAL TESTING
2.CLEANING OF AUTOCLAVE
3.PREPARATION OF LOAD OF AN AUTOCLAVE
4.TECHNIQUE TO BE FOLLOWED IN STERILITY TESTING ROOM
5.BIOBURDEN TESTING OF OINTMENT BY MEMBRANE FILTERATION METHOD.
6.STERILTY TESTING OF STERILE OINTMENTS
7.CLEANING OF ASEPTIC AREA ( STERILITY TESTING ROOM )
8.PARTICLE SIZE OF RAW MATERIAL AND FINISHED PRODUCTS BY THE USE OF
MICROSCOPE
9.FUMIGATION OF ASEPTIC AREA (STERILITY TESTING ROOM)
10.HANDLING AND MAINTAINENCE OF MICROBIAL CULTURES/METHOD OF SUBCULTURING/DESTRUCTION:
11.TO CHECK THE EFFECTIVITY OF DISINFECTANT
12.TEMPERATURE MONITORING OF DIGITAL TEMPERATURE THERMOSTATIC INCUBATORS B.O.D. INCUBATOR AND THERMOSTATIC INCUBATORS
13.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA SETTLE PLATE METHOD

14.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA BY SURFACE SWAB METHOD
15.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA AIR SAMPLING METHOD
15.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA FINGER DAB TESTING

16.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA ( STERILITY TESTING ROOM)
SETTLE PLATE METHOD
17.ENVIRONMENTAL MICROBIAL MONITORING OF NON-ASEPTIC AREA SETTLE PLATE METHOD
18.DISPOSAL OF MICROBIOLOGICAL WASTE MATERIAL
19.IDENTIFICATION OF PATHOGENS IN VESTIBULE AREA OF ASEPTIC AREA
20.GENERAL METHOD FOR CHECKING OF BACTERIOLOGICAL QUALITY OF WATER.
21.VALIDATION FOR DESTRUCTION OF MICROBIAL WASTE USING (AUTOCLAVE)
22.PREPARATION OF DISINFECTANT SOLUTION
23.IDENTIFICATION OF MICROORGANISMS
24.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA
25.ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA
26.MICROBIAL MONITORING OF COMPRESSED AIR.
YOU MAY DOWN LOAD FOLLOWING SOPS HERE
WHO GUIDELINE FOR PHARMA

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