Sterilization of Cartridge Filter
1.
Purpose:-
This procedure is developed to ensure the
sterilization of cartridge filter.
2.
Scope:-
This procedure applies to Sterilization of Cartridge
Filters only by Autoclaving.
3.
HSE
Statement:-
3.1.
Follow the following instructions to operate the equipment
/ machine in safe manners.
3.1.1.
Only persons trained and knowledgeable in the use of a
specific piece of equipment use that equipment.
3.1.2.
All work is performed in accordance with applicable
regulatory requirements.
3.1.3.
Standard operating procedures are in place for
machinery and equipment use.
3.1.4.
Report any job related injuries or illnesses, questions
on health and safety, or any unsafe or unhealthy working conditions to their
supervisor.
3.1.5. Do not remove guards from machinery and equipment
except when necessary for servicing.
3.1.6.
Personal protective equipment necessary for safe use of
the equipment,
4.
Responsibilities:-
4.1.
Assistasnt is
responsible to conduct assigned tasks in a safe manner and report to supervisor
in case of any problem.
4.2.
Microbiologist is
responsible to monitor the subjected process.
4.3.
Microbiologist
is responsible to manage all activities include operator training, record
keeping, proper use of personal protective equipment & other related tasks.
5.
Materials:-
5.1. Material / Equipment Required:-
Autoclave
Cartridge
Filter
Wrapping
Material
6.
Definition:-
6.1. Sterilization:
Sterilization is the process of killing the viable
microorganism.

1.
Description:-
1.1. Wetting of Filter
1.1.1.
Open the vent valve.
1.1.2.
Fill the cartridge filter assembly to wet the cartridge
filter with WFI (and freshly prepared 70 % IPA in case of N2 / air filter)
1.1.3.
Ensure that all the air has been removed by keeping the
vent valves slightly opened for 1st minute of flushing and then close it and
rinse for 3 – 5 minutes (use 3 – 4 liter of wetting solution)
1.1.4.
Drain the liquid by opening the drain valve and by
applying compressed air / N2 at a maximum pressure of 0.5 Bar / 7 PSI.
1.1.5.
When the housing is empty close all the valves, the
filter has been completely wetted.
1.2. Wrapping of Filter
1.2.1.
Open the inlet, outlet and all over valves.
1.2.2.
Wrap the filter with steam permeable autoclave paper or
aluminum foil around them.
1.3. Sterilization
1.3.1.
Sterile the filter & filter assembly by autoclaving
it at maximum temperature of 121oC for 30 minutes.
1.3.2.
Now filter is ready for integrity test.
1.3.3.
Maintain the sterilization record.
1.3.4.
Use the sterilized filter & filter assembly within
12 hrs.
1.4. Precautions
1.4.1.
Before usage flush the filter.
2.
Record:-
2.1.
Sterilization Cycle Log
2.2.
Sterilization Load Verification Checklist
2.3.
Machine log book
3.
Reference:-
3.1.
NA
4.
Distribution:-
Sr. #
|
Distributed
to
|
Received
(Current)
|
Returned
(Obsolete)
|
01
|
Quality Control Department
|
|
|
02
|
Quality Assurance Department
|
|
|
03
|
Quality Management Department
|
|
|
5.
Revision
History:-
Date Changes
N/A