SOP for washing, siliconization and sterilization of Rubber stopper.

• Objective:
• To lay down a procedure for washing, siliconization, sterilization and drying of Rubber stopper.
• Scope:
• This SOP is applicable for washing, siliconization, sterilization and drying of Rubber stopper.

• Responsibility:
• Production Officers/ Executive shall be responsible for follow the procedure mentioned in this SOP.
• Accountability:
• Production Head shall be accountable for the compliance of SOP.
• Abbreviations
• MMI : Man Machine Interface
• PLC : Programmable Logic Controller
• WFI : Water For Injection

• Procedure
• Controlled area operation
• Take out the decartoned rubber stopper from decartoning room.
• Transfer the rubber stopper to equipment washing and Sterilization room.
• Switch ‘ON’ the Laminar Air Flow unit atleast 30 min. before starting the operation and ensure that the differential pressure reading is within limits.
• Remove the poly bags under LAF unit and discard the poly bags.
• Load the rubber stopper in rubber plug kage on the trolley.
• Switch ON the machine with the key.
• Ensure that autoclave chamber is dry and temperature is ambient.
• Check the cleaning of chamber and all around the machine.
• Check and ensure that the filter provided on the water and air lines are clean. If not found clean, clean them before starting the operation.
• Check the availability of soft water, purified water and water for injection, pure steam, plant steam and compressed air.
• Check the pressure of compressed air should not be less then 6.0 kg/cm²

• Open the valve of plant steam supply line and ensure that the pressure of plant steam supplied to the autoclave in the pressure gauge is not less than 1.2 kg/cm².
• Open the valve on pure steam supply line and ensure that the pressure of pure steam supplied to the autoclave in the pressure gauge is not less than 1.2 kg/cm².
• Open the valve on purified water supply line and ensure that the pressure of purified water supplied to the autoclave in the pressure gauge is not less than 2.0 kg/cm².
• Open the valve on water for injection supply line and ensure that the pressure of water for injection supplied to the autoclave in the pressure gauge is not less than 2.0 kg/cm².
• Open the valve on process air supply line and ensure that the pressure of process air supply to the autoclave in the pressure gauge is Not Less Than 4.0 kg/cm².
• Take the line clearance as per SOP before start of operation.
• Load the rubber stopper trolley on the autoclave chamber.
• Press the “door close switch” to close the door.
• Check the pressure of following mentioned below on front of the panel :-
• Jacket Pressure  : 0.0 Kg/cm²
• Sterile side gasket : 3.0 Kg/cm²
• Non sterile gasket : 3.0 Kg/cm²
• Chamber pressure  : 0.0 Kg/ cm²

• Check and verify the standard parameter of washing and sterilization of rubber Stopper on man machine interface (MMI) for cycle no.5 as per mentioned below:
• Set Parameter :    

S.No	Parameters	Set value in cycle
1	(Wash – I)
	Machine Wash	2 min
	Detergent In	1 Min
	Fluidization	8 min
	Stabilization	10 min
	DM water over flow	5 min
	Drain	10 min
	Machine Wash	3 min
	Drain	5 min
	No of RPTS.	1 Nos.
2	(WASH – II)
	Fluidization	5 min
	Stabilization	6 min
	Drain	5 min.
	DM water over flow	5 min
	Machine Wash	3 min
	Drain	0 min
	No of RPTS.	1 Nos.
3	(WASH – III)
	Delay before drain	5 min
	Drain	5 min
	Machine Wash	3 min
	Drain	10 min
	No of RPTS.	1 Nos.
4	(SILICONISATION)
	Silicon in	2 min
	Silicon Soaking	10 min
	Drain	10 min
	Machine Wash	3 min
	Drain	10 min
	No of RPTS.	1 Nos
5	(STERILIZATION)
	Pre vacuum	– 0.500 Bar
	Pre pressure	0.500 Bar
	No of pre pulses	3 NOS
	Heat Up 1	110.0°C
	Heat Up 2	115.0°C
	Heat Up 3	118.0°C
	Heat Up Hold 1	5 min.
	Heat Up Hold 2	5 min.
	Heat Up Hold 3	3 min.
	Heat Up Band	0.4
	Sterilization Hold temperature	122°C
	Sterilization Hold time	25 min.
	Temperature control Band	0.2ºc
	Overshoot temperature	124.0°C
	Sterilization Stop temperature	120.9°C
	Sterilization reset temperature	120.5°C
	Post vacuum level	– 0.700 Bar
	Post vacuum Hold Time	15 min
	Post Pressure	– 0.100 Bar
	Number of post pulses	3 Nos.
	Exhaust  ON Time	5 Sec
	Exhaust OFF Time	55 Sec
	Process End Pressure	– 0.050 Bar
	Chamber water temperature	80.0 °C
	Basket Drive ON Time	10 sec
	Basket Drive OFF Time	50 Sec

• Press “start” on main menu display.
• Press “Select Process” to select the cycle.
• Press “Print Para” to take print of the set parameter of cycle.
• Take 1.0 litre teepol solution in detergent port and 3.0 litre silicon emulsion in silicon Port.

• Press “starts process” to start the selected Bung Process cycle .
• The Wash – I process starts and chamber rubber stopper is washed with purified water and detergent then after drain the washed detergent water.

• Then wash – II process starts and rubber stopper is only washed with fresh purified water and drain the wash water.
• After completion of wash – II PLC gives the alarm for sampling of purified water. Then withdraw the 100 ml sample in a beaker and inspect the purified water visually against the black and white background for visible particulate matter.
• Record the observation in Batch Production Record.
• Incase visible contamination of particulate matter is observed in the sample, Again repeat the wash – II cycle of that washed lot of rubber stopper and again check the sample of washed rubber stoppers as described above.
• If the repeat sample also fails, investigation shall be carried out to find out the assignable cause. The washing procedure shall be re-validated.
• The wash – III process rubber stopper is washed with water for injection. After washing with water for injection rubber stopper siliconised with silicone emulsion for proper lubrication.
• Rubber stopper is sterilized at temperature 122ºC and chamber pressure 1.10 Bar.
• On completion of the sterilization according to the set parameter, indicator of “process end” will glow on sterile side door and the process will stop, displaying the message ‘Process End’ on MMI.
• On Completion of the cycle, check the cycle graph against the Master chart for Rubber Stopper load, for Temperature and time during the sterilization hold.
• If the graph does not match the master chart the cycle will be considered invalid. Don’t unload the Rubber stoppers in the aseptic Area. Repeat the sterilization cycle. Inform the deviation to the Quality Assurance Department. Carry out the further processing as per the suggestions from the quality assurance.
• After completion of cycle aseptic personnel unload the sterilized rubber stopper as per SOP.
• Record the Operation in the equipment log book and get it checked by production officer/supervisor.

• Forms and Records (Annexures)
• Not Applicable
• Distribution
• Master copy –  Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control
• History
  

  Date	Revision Number	Reason for Revision
  –	00	New SOP

 

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