SOP of Autoclave
This Document describes (Standard Operating procedure) SOP of Autoclave cum Bung processor
SOP of Autoclave cum Bung processor
I. Purpose & Scope:
- The Purpose of this SOP is to lay down the procedure for operating and cleaning procedure of Autoclave cum Bung processor
- This procedure is applicable to production Department personnel for operating and cleaning procedure of Autoclave cum Bung processor
II. Responsibilities:
• All production personnel shall be responsible to follow and implement this SOP of Autoclave.
III . Introduction and Procedural Part :
- PROCEDURE:
- Inputs required:
- Utility supplies of WFI, PW, soft water, Plant steam, Pure steam and Compressed air
- Inputs required:
- Teepol
- SS scoop
- Rubber stopper
- SS trolley
- Silicon oil
- Container
- Perforated S.S. rubber stoppers cages.
- Cleaned & prepared items for sterilization.
- Measuring cylinder.
- Strip chart and papers for printer.
- Bowie-dick paper.
- Sterilization indicator.
- Clean lint free mop.
- Nylon brush.
- 70% v/v IPA.
- Operation:
- Check cleanliness of area and equipment.
- Take line clearance as per standard operating procedure.
- Check that differential pressure reading is within limit.
- Switch ‘ON’ the main power supply.
- Turn the control switch to ON position.
- Check that strip chart recorder is functioning properly.
- Check availabilities of required utilities of WFI, PW, soft water, Plant steam, pure steam and compressed air.
- Open all utility valves and check Compressed air pressure is not less than 3.0 kg/cm2
- Filters used in the utility line are as follows:
Compressed Air: 0.2 micron.
Vacuum break: 0.2 micron.
Re-circulation water: 5 micron.
- Open by pass valve of plant steam and pure steam line by rotating down to remove the line condensate and close it.
- Check sterilized material has been unloaded from the equipment in aseptic area.
- Check sterile side door is closed before starting operation.
- Check printer is connected and functioning properly.
- Check strip chart is functioning properly.
- Feed the paper into printer and strip chart recorder.
- Ensure pre-condition indicator glows on control panel.
- Record operation details.
- Vacuum leak test (AUTO MODE):
- Switch On the main power supply
- Keep emergency Switch is Release condition.
- Turn the CONTROL ON switch is ON.
- Open non aseptic side door by pressing with the help of door Open push button. Check that chamber is empty and close the door by pressing door closed push button.
- PLC displays
Date Time
MACHINE FABRIK
Pressed main menu in MMI
- Set Parameter
- Start up
- Process data
- Batch data
- Edit password
- Alarm history
- Then in the MMI main menu Entry the batch data detail as per below :
Sterilizer No. —————– Load 1
Batch No. ——————– ABC
Operator code ————— XYZ
Quantity———————-As per validation document
- Press start up, PLC displays select process.
- Vacuum Leak Test displays in PLC.
- Check parameters are set as stated below:
Vacuum : – 0.750 bar
Delay before hold: 3 Minutes.
Vacuum hold time: 10 Minutes.
Acceptable Leakage: 0.013 Bar
Process end pressure: -0.03 bar.
- Pressed the print parameter in PLC display
- Check the parameters.
- Pressed the start the process in PLC display.
- After completion of cycle PLC displays leakage in bar.
- After completion hold time vacuum breaks as 0.2m filtered air is purged into the chamber from aseptic side and as pressure reaches – 0.03 bar process end light glows.
- After completion Result is show Leak test pass.
- After cycle completed Pressed the ACK signal in the PLC display and open the door with the help of Push open door button.
- If pressure drop is more than 0.013 bar, inform maintenance department for rectification.
- Frequency: Before starting the process or any load.
- Bowie & Dick process (AUTO MODE):
- Switch On the main power supply.
- Keep emergency Switch is Release condition.
- Turn the CONTROL ON switch is ON.
- Open door of non aseptic side by pressing with the help of door Open push button.
- Affix Bowie & Dick pack in the chamber near the drain port.
- Closed the door by pressing door closed push button.
- PLC displays:
Date Time
MACHINE FABRIK
Pressed main menu in MMI
- Set Parameter
- Start up
- Process data
- Batch data
- Edit password
- Alarm history
Than in the MMI main menu Entry the batch data detail as per below
Sterilizer No: —————–1234
Batch No.:——————– XYZ
Operator code —————ABC
Quantity———————– As per requirement
- Press start up, PLC displays select process.
- Bowie & Dick test displays in PLC.
- Check parameters are set as stated below
Pre vacuum : 0.550 Bar
Pre pressure : 0.500 Bar
No. of Pre Pulses : 3 Nos.
Heat UP1 : 110°C
Heat UP1 Hold : 5 Min.
Heat UP2 : 115° C
Heat UP2 Hold : 3 Min.
Heat UP3 : 119° C
Heat UP3 Hold : 2 Min.
Heat UP Control band : 0.2°c
Small valve SP : 120° C
Ster Hold Temp. : 121.4° C
Ster Hold Time : 10 Min.
Temp. Control band : 0.2°c
Ster Overshoot : 124.0 ° C
Ster Stop : 120.9 ° C
Ster Reset : 120.5 ° C
Process End Pressure : 0.030 Bar
- Pressed the print parameter in PLC display
- Check the parameters as per SOP.
- Pressed the start the process in PLC display
- After cycle completed Pressed the ACK signal in the PLC display and open the door with the help of Push open door button.
- Open door of non aseptic side by pressing with the help of DOOR OPEN push button
- Collect Bowie & Dick pack & print out along with the strip chart and attach it.
- High Pressure High Vacuum Cycle (HPHV) (AUTO MODE):
- This process is applicable to sterilize components, garments, and accessories for aseptic area processing.
- Switch On the main power supply.
- Keep emergency Switch is Release condition.
- Turn the CONTROL ON switch is ON.
- Open door of non aseptic side by pressing with the help of door Open push button and load materials.
- Closed the door by pressing door closed push button.
- PLC displays:
Date Time
MACHINE FABRIK
Pressed main menu in MMI
- Set Parameter
- Start up
- Process data
- Batch data
- Edit password
- Alarm history
Than in the MMI main menu Entry the batch data detail as per below
Sterilizer No. —————–1234
Batch No. ——————– XYZ
Operator code —————ABC
Quantity———————– As per requirement
- Press start up, PLC displays select process.
- HPHV Process displays in PLC.
- Check set parameters are as stated below
Pre vacuum : -0.550 Bar
Pre pressure : 0.500 Bar
No. of Pre Pulses : 3 Nos.
Heat UP1 :110° C
Heat UP1 Hold : 5 Min.
Heat UP2 :115° C
Heat UP2 Hold : 3 Min.
Heat UP3 : 119.0° C
Heat UP3 Hold : 2 Min.
Heat UP Control band : 0.2°c
Small valve SP : 120.0° C
Ster. Hold Temp. : 121.4° C
Ster. Hold Time : 30 Min.
Temp. Control band : 0.2° C
Ster. Overshoot : 124.0 ° C
Ster. Stop : 120.9 ° C
Ster. Reset : 120.5 ° C
Post Vac. Start Press : 0.200 Bar
Post Vacuum : -0.500 Bar
Post Vacuum Hold : 10 Min.
Post Pressure : -0.100 Bar
No. of Post Pulses : 2 Nos.
Process End Pressure : 0.030 Bar
- Pressed the print parameter in PLC display
- Check the parameters as per SOP.
- Checked Batch detail record.
- Pressed the start the process in PLC display
- After cycle completed Pressed the ACK signal in the PLC display.
- After completion of process vacuum breaks automatically by 0.2 m filtered air from aseptic area.
- Inform aseptic area operator to unload material in aseptic area.
- Cycle for standard process (AUTOMODE):
- PLC displays
Date Time
MACHINE FABRIC
- Press start up, PLC displays select process.
- Standard Process displays in PLC.
- check set parameters are as stated below
Sterilization temperature : 121.8 ° C
Pre vacuum : -0.550 Bar
Pre pressure : 0.500 Bar
No. of Pre Pulses : 3 Nos.
Heat UP1 :110° C
Heat UP1 Hold : 5 Min.
Heat UP2 :115.0° C
Heat UP2 Hold : 3 Min.
Heat UP3 : 119.0° C
Heat UP3 Hold : 2 Min.
Heat UP Control band : 0.2° C
Small valve SP : 120° C
Ster. Hold Temp. : 121.4° C
Ster. Hold Time : 30 Min.
Temp. Control band : 0.2° C
Ster. Overshoot : 124.0 ° C
Ster. Stop : 120.9 ° C
Ster. Reset : 120.5 ° C
Process End Pressure : 0.030 Bar
- Pressed the print parameter in PLC display
- Check the parameters as per SOP.
- Checked Batch detail record
- Pressed the start the process in PLC display
- After cycle completed Pressed the ACK signal in the PLC display.
- Inform aseptic area operator to unload material in aseptic area.
- Bung processing cycle ( AUTO MODE):
- Check the cleanliness of Rubber plug drum.
- Open the bolt from top to open the basket.
- Loading rubber stoppers in the Drum using SS scoop and close the basket by tightening the bolt.
- Switch On the main power supply
- Keep emergency Switch is Release condition
- Turn the CONTROL ON switch is ON.
- Open door of non aseptic side by pressing with the help of door Open push button and loading the drum.
- Closed the door by pressing door closed push button.
- Take 10 ml of Teepol in a measuring cylinder and make up the volume to 1 liter with WFI.
- Pour the solution in to the detergent port.
- Take 20 ml of silicon oil in measuring cylinder and make up the volume to 1 liter with WFI.
NOTE: Take 20 ml silicon oil for 10,000 to 50,000 rubber stoppers and 30 ml for more than 50,000 rubber stoppers.
- PLC displays
Date Time
MACHINE FABRIC
Pressed main menu in MMI
- i) Set Parameter
- ii) Start up
iii) Process data
- iv) Batch data
- v) Edit password
- vi) Alarm history
Than in the MMI main menu Entry the batch data detail as per below
Sterilizer No. —————–1234
Batch No. ——————– XYZ
Operator code ————ABC
Quantity——————- As per requirement
- Press start up, PLC displays select process.
- Bung Processors displays in PLC.
- Check parameters of Bung processors cycle.
WASH -1:
Machine wash : 3 min
Detergent in : 1 min
Detergent flushing : 1 min.
Fluidization : 10 min.
Stabilization : 5 min.
Purified Water over flow : 5 min
Drain : 3 min
Machine wash : 3 min.
Drain : 5 min
Number of repeat : 1 Nos.
WASH -2:
Fluidization : 10 min
Stabilization : 5 min
Purified water over flow : 5 min
Drain : 3 min
Machine Wash : 3 min
Drain : 5 min
Number of repeat : 1 Nos.
WASH -3:
Water for injection : 15 min
Stabilization : 10 Min.
Drain : 3 min
Machine Wash : 3 min
Drain : 5 min
Number of repeat : 1Nos.
SILICONIZATION:
Silicon in : 1 min
Water for injection : 10 min
Silicon Flushing : 1 min
Silicon Soaking : 10 min
Drain : 3 min
Machine Wash : 3 min
Drain : 5 min
Number of repeat : 1 Nos.
STERILIZATION of rubber stoppers:
Pre-vacuum : -0.550 bar
Pre-pressure : 0.500 bar
Number of pre pulses : 03 Nos.
Heat UP1 : 110° C
Heat UP1 Hold : 5 Min.
Heat UP2 : 115.0° C
Heat UP2 Hold : 3 Min.
Heat UP3 : 119.0° C
Heat UP3 Hold : 2 Min.
Heat UP Control band : 0.2° C
Small valve SP : 120° C
Ster. Hold Temp. : 121.4° C
Ster. Hold Time : 30 Min.
Temp. Control band : 0.2°C
Ster. Overshoot : 124.0 ° C
Ster. Stop : 120.9 ° C
Ster. Reset : 120.5 ° C
Post Vac. Start Press : 0.200 Bar
Post Vacuum : – 0.500 Bar
Post Vacuum Hold : 10 Min.
Post Pressure : -0.100 Bar
No. of Post Pulses : 2 Nos.
Process End Pressure : 0.030 Bar
- Pressed the print parameter in PLC display
- Check the parameters as per SOP.
- Checked Batch detail record.
- Pressed the start the process in PLC display.
- After cycle completed Pressed the ACK signal in the PLC display
- Inform aseptic area operator to open door of aseptic area and unload material.
- Loading and unloading of chamber:
- Move and align the trolley with carriage or material to railings of the chamber.
- Move and attach them to the safety lock of machine.
- Push the trolley on railings of chamber into the chamber.
- After completion of process open the door.
- Move and align the trolley with carriage or material to railings of the chamber.
- Move and attach them to the safety lock of machine.
- Pull the trolley on railings of chamber out of chamber.
- Cleaning:
- Check that chamber temperature is not more than 30 OC to 40 OC and aseptic area side door is closed.
- Check that chamber is empty.
- Clean externally the equipment including filter housing and acrylic cover of electrical panel board with a dry lint free mop.
- Open non-sterile door by pressing with the help of door Open push button.
- Mop entire surface of chamber including side pocket drains trolley rails, air purging section, and inner section of doors, trolley and locking rods from aseptic side end to non aseptic side end using a lint free mop.
- Cleaning recorded in Annexure I- Bung Processor log.
(F/APPL/PI/013/01-02)
- Frequency: Before starting the process.
- Filter integrity test frequency– 01 year
- Preventive and breakdown maintenance:
- Carryout preventive maintenance as per preventive maintenance schedule, SOP No. APPL/EN/045
- In case of any breakdown stop the activity and inform to engineering department by raising maintenance job requisition, format No. – F/APPL/EN/067/01-01.
- After rectification clean area and machine properly and start the activity.
5.12 Validated load details:
| Cycle | Cycle details | Type of load | Load details | Minimum load | Maximum load |
| Vacuum leak test (VLT) | Vacuum holds for 10 min at
-750 bars |
NA | NA | NA | NA |
| Bowie dicks test | 121.40C for
15 min |
NA | Bowie Dick Kit | NA | NA |
| High Pressure High Vacuum Cycle (HPHV) |
Sterilization at 121.40C for 30 min. | Garments | Head gear, Suit and booties | 08 pairs | 16 pairs |
| Filter Assembly | 01 Nos. | 01 Nos. | |||
| Filling machine parts and accessories | Head gear, Suit and booties, | 08 pairs | 16 pairs | ||
| Powder filling hopper | 01 nos | 01 nos | |||
| Rubber plug hopper | 01 nos | 01 nos | |||
| Port wheel | 01 nos | 01 nos | |||
| Port wheel guard | 01 nos | 02 nos | |||
| Teflon plate | 02 nos | 04 nos | |||
| SS blade | 01 nos | 02 nos | |||
| SS plate | 01 nos | 04 nos | |||
| Piston | 20 nos | 40 nos | |||
| Piston box | 01 nos | 01 nos | |||
| Scoop | 01 nos | 03 nos | |||
| Forceps (12 inch) | 06 nos | 12 nos | |||
| Spatula (06 inch) | 05 nos | 10 nos | |||
| Rubber stopper chute | 01 nos | 1 nos | |||
| Piston lock | 14 nos | 14 nos | |||
| S.S. Container | 02 nos | 06 nos | |||
| Blue Lint Free mops | 02 nos. | 06 nos. | |||
| Filter Assembly | 01 nos | 01 nos | |||
| Filtration tank | 01 nos | 01 nos | |||
| Spanners | Nil | 01 nos | |||
| M/c nut bolts | Nil | 15 nos | |||
| Silicon tubes
(3ft, 5ft) |
01 nos | 02 nos | |||
| Bung process | Bung washing, sterilization and vacuum drying | Rubber bungs | Rubber bungs | 10,000
nos |
60,000
nos |
ANNEXURE-I
Autoclave cum Bung processor usage Record
Page No : 1 of 1
| Sr. No. | Date | Activity | Time | Done
By |
Checked By | |
| Start | End | |||||
ANNEXURE-II
Autoclave cum Bung processor operation Record
Page No : 1 of 1
| Date | |||
| Product Name | |||
| Batch No. | |||
| Type of Cycle | |||
| Cycle No | |||
| Description of Load: | |||
| Description of Material | Quantity | ||
|
|
|
|
|
| Cycle Start Time | |||
| Cycle End Time | |||
| Sterilization Start time | |||
| Sterilization End Time | |||
| Unloading Time | |||
| Unloaded By | |||
| Done By | |||
| Checked By | |||
| Remark | |||
