S.O.P NO :-
Issue No. :- 02
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Page :- 1 of 1
OBJECTIVE :-
Nutreint media which are generally prepared fresh are obtained in the form of dehydrated
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.
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 on
hot 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 No
and 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.
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Q.A.Executive
FREQUENCY OF OPERATION :-
For every batch of media as required.
NO OF ATTACHMENT:-
One
RETENTION OF RECORDS :-
5 Years.
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.
This website Guide for pharmacy students pharmacy colleges and pharmacists pharmaceutical companies in health care
Standard operating procedure SOP for microbiology and aseptic techniques
Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing