SOP for Operating Procedure of Double Door Autoclave : Pharmaguideline

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SOP for Operating Procedure of Double Door Autoclave

Standard operating procedure double door autoclave.


To lay down the step by step procedure for operating the Autoclave.


This procedure is applicable for operating the double door autoclave.


3.1 Doing : Lab Asst./Technical Assistant/Executive
3.2 Checking : Technical Assistant/Executive/ Manager


Head of the Department


For Automode
5.1 Switch ‘ON’ the WFl pump to Fill up the WFl in boiler at marked level.
5.2 Switch ‘ON’ the vacuum pump.
5.3 Switch ‘ON’ the mains of control panel.
5.4 The Yellow, Blue, Red lamp will glow up‘ON’.
5.5 If emergency switch is pressed then release it.
5.6 Press control Start.
5.7 Keep the Auto/manual switch on Auto mode.
5.8 ‘ON’ the control Start.
5.9 Upon power supply the display will show the following massage.
Date : Time :
5.10 Press key i.e. ‘Ñ’ located below display
The display show
F1 = Set parameter
F2 = View parameters
F3 = Process Data
F4 = Start/Batch Data
5.11 Press F4 among F1 to F12 switch located on control panel.
5.12 The display will show
F7 = Select process
F8 = START process
F9 = Print set parameters
5.13 To select the cycle. Press F7. So the different cycle displayed one by one. So select the cycle & press Enter i.e. Located below on control panel.
5.14 Press ‘F9’ for printing at every minute.

5.15 Keep the Auto/Manual Button on Manual Mode.
5.16 To open the door-I i.e. non-sterile side ‘ON’ the vacuum Switch & door-I vacuum Switch located on Next portion of control panel Nr. DTC display.
5.17 When the Door-I pressure gauge show O-1. Then ‘ON’ the Door-I open switch.
5.18 Load the material & accessories or media as per specified cycle.
5.19 Switch OFF the vacuum pump switch, door-I vacuum & door-I open switch. Close the door-I by pressing door-I close switch. Then press door-1 and 2 pressure switch.
5.20 The door-I will closed from non sterile side
5.21 Keep the Auto/Manual button on Automode.
5.22 Press F8 to start the process, when pressure reaches at 2kg on boiler tank.
5.23 To change the parameter of cycle press F1.
5.24 The display ask password. Enter 783.
5.25 So display show process
F1 = Vacuum leak test
F2 = Browidic
F3 = Standard
5.26 Press the button of selected cycle i.e. If standard cycle selected press F3, display will show process-3 Std- process.
5.27 Press ‘Ñ’next key. The display will show
Preheating temperature & time.
Again press ‘Ñ’ next the display will show
Standard temperature i.e. 121°C blinking.
Again press ‘Ñ’ next key. The display will show.
Sterhold time blinking & temperature control Band.
Change time temperature parameters with control panel keys 1 to 9 & 0 located on control panel.
5.28 After completion of cycle the alarm will sound.
5.29 Immediately push next ‘Ñ’ key so that the display will show process phase.
5.30 Again press next key
Elap time
Elap Pulse
Leak pale
F-6 alarm
5.31 Push F-6 alarm
5.32 Again press next ‘Ñ’ key. The display will show
F5-F-10 Ackn Alarm.
5.33 Push F-10 to stop Alarm & F5 to return.
5.34 So the display will show process data.
5.35 Allow to come the door-II (sterile side) pressure to (0 to -1)
5.36 Press the switch or the door-II open so that the door-II will open on sterile side.
5.37 Unload the autoclave.
5.38 Press vacuum pump & Door-II Vacuum switch.
5.39 Off the door-II open switch.
5.40 Press door-II close switch.
5.41 To off the autoclave keep Auto/manual button steady.
5.42 Close the Emergency switch.
5.43 Lock the control panel.
5.44 Switch ‘OFF’ the main.
Note : To stop the autoclave for emergency during process push ‘process abbot’ switch.
Procedure for MANUAL MODE :
5.45 Keep AUTOMODE button on ‘MANUAL MODE’

5.46 Switch ‘ON’ the Boiler, Vacuum Door I & Vacuum Pump.
5.47 Press ‘Door- I open’ gauge reading should be below (0 to – 1)
5.48 After loading autoclave switch OFF ‘Door-I open’ & switch ON ‘Door-I close’
5.49 Then switch “OFF” Door-I vacuum switch and switch “ON” “Vacuum”, pressure door-I & pressure door-II switch.
5.50 Whenever the pressure reaches 2.0kg boiler tank ‘switch ON’ ‘JKT steam’ & ‘Chamber steam.’
5.51 Note down the time when temperature reaches on 121°C After completion of cycle ‘switch OFF’ chamber steam & ‘chamber exhaust’
5.52 Whenever pressure goes below ‘O’ and temperature goes below ‘100°C’ ‘switch off’ ‘JKT steam’ and ‘chamber exhaust’ ‘door-I pressure’ & ‘door-II pressure’.
5.53 To open door-II switch ON ‘Door-I pressure’ & ‘door-II open’.
5.54 Unload autoclave on sterile side.
5.55 Switch ‘ON’ door-II close & after completion switch OFF ‘mains’.
Note :- Whenever autoclave operated on Automode the print MODE works & On ‘Manual MODE’
the print MODE will not work So time, temperature are recorded manually.


WFI = Water for Injection
°C = Degree Centigrade
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