OBJECTIVE :-
The load of the autoclave consists of a Nutrient media, glasswares, gowns
machine parts which needs to be sterilised for the purpose of microbiological use
UNIT OF RESPONSIBILITY : QA Executive and trained QA Assistants
IMPORTANT POINT/ NOTE / PRECAUTIONS :-
1 Ensure that the parts to be sterilised are covered properly for effective sterilization
2 Load the autoclave in such a way to ensure even distribution of the steam in autoclave
3 After the completion of autoclave cycle is over ensure that the steam is released slowly
in order to avoid the back pressure inside the autoclave
4 Ensurer the water level before loading any matrial in the autoclave
PROCEDURE :-
1 The items such as media needs to be prepared as per the directions for use in SOP
2 The media tubes, bottles should be plugged with non absorbant cotton and should be
covered with parchment paper
3 The pertidishes are bundled into the parchment paper
4 The empty bottles are plugged with nonabsorbant cotton and are covered with
parchment paper
5 All the items are then transfered into the autoclaved alongwith the Autoclave indicator
labels after which the autoclave is started
6 Note down the time when autoclave is started
7 Let the pressure and temperature rises to 15lbs pressure & 1210c respectively, and
note the time at which the above parameters are reached
8 Let the unit run for 20 minutes, after complition of sterilisation cycle note down the time and
switch off the autoclave
9 Maintain the record of the load as per attachment Nos
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- QA Executive
FREQUENCY OF OPERATION :- Every load for Sterilization
NO OF ATTACHMENT :- One
RETENTION PERIOD OF RECORDS :- 5 years
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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