Operation on Bung processor cum steam sterilizer

Operation on Bung processor cum steam sterilizer

Objective:

To lay down a procedure for the operation of the Bung processor cum steam sterilizer.

Scope:

This SOP is applicable for the operation of the Bung processor cum steam sterilizer.

Responsibility:

Production operator/technician – responsible for the Operation of Bung processor cum steam sterilizer.

Production officer / Executive – to ensure that Operation on Bung processor cum steam sterilizer is carried out as per SOP.

Accountability:

The production Head and QA Head shall be accountable for the compliance of SOP.

Abbreviations:

SOP: Standard Operating Procedure

WFI: Water for Injection

MMI: Man-Machine Interface PLC: Programmable Logic controller

Procedure:

Pre-Start-Up:

Check that the Bung processor cum steam sterilizer area and the chamber are visibly clean and no remnants of the previous load are present

Open the valve of the plant steam supply line and ensure that the plant steam pressure supplied to the autoclave in the pressure gauge is not less than 2 kg/cm².

Open the valve on the pure steam supply line and ensure that the pure steam pressure supplied to the autoclave in the pressure gauge is Not Less Than 2 kg/cm².

Open the valve on the purified water supply line and ensure that the purified water pressure supplied to the autoclave in the pressure gauge is Not Less Than 5 kg/cm².

Open the valve on the water for the injection supply line and ensure that the water for injection pressure supplied to the autoclave in the pressure gauge is not less than 5 kg/cm².

Open the valve on the process air supply line and ensure that the process air supply pressure supplied to the autoclave in the pressure gauge is Not Less Than 0 kg/cm².

Open the valve and ensure the incoming Compressed air line is Not Less Than 0 kg/cm².

Cleaning of the Bung processor cum steam sterilizer shall be done every day before starting the machine as per SOP

Automatic operation;

Switch on the electric supply to the control panel by selecting the key switch to the ON position.

Ensure that the aseptic area side door is closed as indicated by the indicator lamp on the control panel towards the cooling zone.

Ensure that the autoclave has passed the vacuum Leak Test performed as per SOP, before starting the sterilization cycle.

Start the process recorder and enter the batch details in the MMI as described below :

• Batch Data
• Sterilizer No:
• Batch No.:
• Operator Code:
• Print Interval:60 sec

Select cycle No. on the control panel of the autoclave as per the respective SOP Nos

Cycle No. – 1 (Load –  Vacuum Leak Test  )

Cycle No. – 2 (Load – Bowie – dick Test)

Cycle No. – 3 (Load – Sterilization of Media )

Cycle No. – 4 (Load – Sterilization of Garments, Sterilization of Powder Filling Machine Parts & liquid-filling machine parts , Sterilization of Miscellaneous components)

Cycle No. – 5 (Load – Washing, siliconization, and sterilization of  Rubber stopper )

Cycle No. – 6 (Load – Sterilization of Cartridge filter)

On completion of the sterilization according to the set parameter, the indicator of “process end” will glow and the process will stop, displaying the message ‘Batch stop’.Check the parameter in the man-machine interface (MMI) as per the Load cycle no. mentioned in the respective SOP for the loaded material.

Start the sterilization cycle by pressing the “START” push button on the control panel, simultaneously the process recorder will start automatically by displaying the message batch start (automatic)

Check the thermograph of the process recorder for the cycle parameter as per the respective sops of the material being sterilized.

On completion of the cycle and the aseptic area, personnel unloads the sterilized material.

Aseptic AREA:

After the completion of the cycle light of ‘process End’ is glow.

Ensure that the Nonsterile side door is close before opening the door of the sterile side.

Press the ‘St Door open’ switch to open the door of the sterile side then the door is open slowly.

Unload the sterilized material and press the ‘ST Door close’ switch to close the sterile side door. The door is closing slowly.

SHUT DOWN:

After completion of the process shut down the machine by key.

Clean the machine as per SOP.

Record the operation and cleaning details in the Equipment log book format and Batch Production Record and get it checked by the production officer/supervisor.

1. Date
2. Load Description
3. Batch No.
4. Operation (From ____To______) Done By & Checked  By)
5. Preventive  Maintenance /Break  Down ( From______To_____)Done By & Checked  By
6. Cleaning (From ____To____ ) Operated By/Checked  By

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy –   Quality Assurance

Controlled copies- Quality Assurance, Production

History:

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