1. Purpose:-
To ensure use of correct method of
preincubation of Medias used for routine sterility test and
Bioburden test.
2. Scope:-
This procedure applies to Media’s
preparation for sterility & Bioburden test performed for product
test & plant environment
monitoring.
3. HSE
Statement:-
Not Applicable.
4. Responsibilities:-
i)
Manager Quality Control is responsible
to ensure that procedure & formats are followed entirely as approved.
ii)
Microbiologist is responsible to perform the test.
5. Materials:-
5.1 Flask
5.2 Medias
5.3 Hot plate and Stirrer
6. Definitions:-
6.1
Preincubation:-
Incubation prior to some other treatment or process
6.2 Media: -
Media is the nutritive source for the
cultivation of microorganisms. The media usually prepare from protein by acid
or enzymatic digestion. Medias are usually available in dehydrated form. We
have only to mix required measured quantity in distilled water. Follow instructions
for preparation as mentioned on the label of media container.
6.3 Sterilization: -
It is the process of killing or
removing microorganisms. Media is sterilized by autoclaving at
1210C for 15 minutes
at a pressure of 15 PSI.
7.Flow Chart:-
8. Description:-
8.1 Procedure:-
8.1.1 Prepare
and autoclave (if required) the required media as per SOP.
8.1.2 After successful autoclaving, take out media flasks from autoclave,
tighten their screw caps and let them
cool at room temperature.
8.1.3 Allot a
lab number to all media flasks by consulting the file “Preparation &
Preincubation Record”.
Also
record the same lab number of Medias in this file with all other mentioned
relevant data.
8.1.4 In case of
agar media, also record the total number of plates prepared with all other
necessary data.
8.1.5 Place the
media flasks and prepared plates in incubators at their respective optimum
growth
temperatures (e.g. Tryptic soy
broth at 22.50C – 250C, Fluid thioglycollate media and
agar media at 300C– 350C). Incubate broth Medias for 3 –
5 days and agar media for 24 – 48 hours.
8.1.6 Check all
the Medias for any growth or turbidity on daily basis till the end of
preincubation period. If
any growth or turbidity is shown in any media flask or plate remove it
from incubator.
8.1.7 Use only
those media flasks and plates in routine tests which qualify the preincubation
period
successfully.
9. Forms and Records:-
10.1 Sterilization
and Preincubation record of Medias
10.2 Log
of Sterilization Cycle (Autoclave
10. References:-
11.
Distribution:-
This SOP has to be distributed in below mentioned Departments:-
|
Sr. NO
|
Distributed to
|
Received
(Current)
|
Returned
(Obsolete)
|
|
1
|
Quality Control
Department
|
|
|
|
2
|
Quality Management
Department
|
|
|
12.
Revision History:-
Date Changes
N/A