Sterilization of Different Components And Items
1. Purpose:-
1.1. This
procedure is developed to Sterilize different components & items.
2. Scope:-
2.1.
This method applies for Sterilization of Ampoules,
Vials, Rubber Stopper, Machine parts, Silicon Tubing, Vessels, Filters,
Uniforms and Different Products etc.
3. HSE Statement:-
3.1.
Follow the following instructions to perform the
subjected job in safe manners.
§
Only persons trained and knowledgeable in the
use of a specific piece of equipment.
§
Recommended machinery maintenance or pre
planned maintenance must be conducted.
§
Standard operating procedures are in place for
machinery and equipment use.
§
Report any job related injuries or illnesses,
questions on health and safety, or any unsafe or unhealthy working conditions
to their supervisor.
§
Personal protective equipment necessary for safe
use of the equipment.
4. Responsibilities:-
Ø
Lab
Assistant. is responsible to conduct assigned tasks in safe manners and report
to supervisor in case of any problem.
Ø
Microbiologist
is responsible to carry out the complete process.
5. Materials:-
i.
Autoclave
ii.
SS Trays
6. Definition:-
6.1. Sterilization:
§
Sterilization is the process of killing the
entire viable microorganism.
7. Flow Chart:-
§ N/A
8. Description:-
8.1.
Select the sterilizer (i.e. Autoclave) according to the
type of component or items to be sterilized. Tools having Rubber or Teflon
parts and finished product should be sterilized in steam sterilizer (Autoclave)
& other parts made up of SS Material in Dry Heat Sterilizer (Oven).
8.2. Machine
parts, fitted over each other should be sterilized in same sterilizer to avoid
any size variation due to different temperature treatment, may result in
difficulty during assembling parts.
8.3.
Select sterilization Temperature / time cycle as per
guidelines below:
8.4.
For Autoclave, washed items should be wrapped in
Aluminum Foil, butter paper in perforated S.S. Trays with covers.
8.5. For oven, washed components / items should be
arranged in S.S. Trays with covers for sterilization.
Note: Sterilized Items should be used within 12 hrs
after sterilization.
9. Record:-
§
Sterilization Cycle log
§
Sterilization Load Verification Checklist (Ampoule
Autoclave)
§
Sterilization Load Verification Checklist (PVS)
10.
Reference:-
§
Standard Manufacturing Procedure
11.
Distribution:-
Sr. #
|
Distributed
to
|
Received
(Current)
|
Returned
(Obsolete)
|
01
|
Quality Control Department
|
|
|
02
|
Quality Assurance Department
|
|
|
03
|
Quality Management Department
|
|
|
12.
Revision
History:-
Date Changes
N/A
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