Sterilization of Cartridge Filter

                                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 121^oC 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