FERTILITY ( GROWTH PROMOTION ) TEST FOR MEDIA.

1.0       OBJECTIVE

To lay down the procedure for fertility ( growth promotion ) test for media.

2.0       RESPONSIBILTY

            Microbiologist./ Q.C Executive

3.0       ACCOUNTABILITY

            Head - Quality Control 

4.0            PROCEDURE

4.1            Prepare media as per SOP No – K/QC/050

4.2            The selection of organisms depends on medium to be subjected to fertility test. 

4.3            Subculture the required organism ( like: - S. aureus, C.albicans, , B. subtilis, C. sporogenes,E.coli , Salmonella and Pseudomonas ) on Nutrient agar slants ( for bacteria ) and Soyabean casein digest agar    ( for fungi ) , one day before, to get 24 hrs old culture.

4.4            Prepare thin suspension and dilute it serially so as to get 10 - 100 cfu/ml  which shall be determined by plate counts.

4.5            Keep the inoculated plates for incubation and serial dilution tubes in the refrigerator.

4.6            After confirmation of the counts, inoculate 1ml of suspension containing 10-100 cfu/ml into the media taken for growth promotion test and incubate them at the required temperatures ( i.e at 30 - 35°C for bacteria  , 20-25°C for fungi ).

4.7            If the growth occurs within three days in case of bacteria and five days in case of fungus the media is found suitable for microbiological testing.

4.8            In case if the medium is not differential as in case of Tetrathionate  broth , the subsequent tests, as per respective General procedure, shall be carried out to demonstrate the fertility of the medium

4.9            Record the details in the format mentioned in Annexure I

4.10      FREQUENCY

Every new batch or lot of dehydrated media.

4.2       MEDIA  STOCK REOCRD

            4.2.1     Take the stock of dehydrated media once in a six month.

            4.2.2     Dehydrated media received from any supplies should be entered as per Annexure no II and similarly                     issued qty and remaining qty should be enter date wise in the mention above annexure.

            4.3       ABBREVIATIONS

Cfu  -  Colony forming unit

Ml -  Milliliter

5.0       REASON FOR REVISION

Change in format

6.0       TRAINING:

Trainer             --          Head – Quality Control

Trainees--        Quality Control Chemists & Assistants 

Period   --          One day

7.0       DISTRIBUTION:

Certified Copy No.   1   :  Head of Department – Quality Control

Original Copy                :  Head – QUALITY ASSURANCE.

8.0       ANNEXURES:

Annexure-I   Format for fertility test of Media

Annexure- II  Media Stock Record.                            

9.0       REFERENCES:         

            USP  25 Page no.-1879

                                                                           ANNEXURE I

FERTILITY (GROWTH PROMOTION) TEST OF MEDIA

REF. SOP NO.:	Revision No.     :  01	Page No.:  1 of 1
	Effective Date:

NAME OF MEDIA		DATE OF PREPARATION
BATCH NO.		STERILI.  TEMP./ TIME
MAKE		STERILIZATION DONE BY
MFG. DATE		ORGANISM USED
EXP. DATE		DATE OF TEST

BRACKETING OF ORGANISM:

NAME OF ORGANISM	SERIAL DILUTIONS
	1 : 10	1 : 100	1 : 1000	1 : 10000	1 : 100000

INCUBATION TEMPERATURE:        Between        to       °C for bacteria 

                                                                        Between        to       °C for fungi

NAME OF ORGANISM	GROWTH OBSERVED
	1 DAY	2 DAY	3 DAY	4 DAY	5 DAY
Observed By

Acceptance criteria: Bacteria must show clear colony forming units / turbidity within  three days.

                               : Fungi must show clear colony forming units / turbidity within five days.

OBSERVATION   : GROWTH OF MICRO-ORGANISMS IN THE FORM OF TURBIDITY /COLONY OBSERVED /             NOT OBSERVED ON THE MEDIA .

RECOMMENDATION: MEDIA IS FOUND SUITABLE  /  NOT SUITABLE FOR PERFORMING MICROBIOLOGICAL TESTING

MICROBIOLOGIST                                                                                 CHECKED BY

SIGN & DATE                                                                                    SIGN & DATE      

                                                                                               

                                                                           ANNEXURE II

MEDIA STOCK RECORD

REF. SOP NO.:	Revision No.     :  01	Page No.:  1 of 1
	Effective Date:

     NAME OF MEDIA : ______________________________________________            CODE NO:__________

Date of Receiving or Issued	Batch No.	Expiry Date	Fertility test status	Quantity received of Issued	Balance Quantity	Issued by

MICROBIOLOGIST                                                                       CHECKED BY

SIGN & DATE                                                                                  SIGN & DATE