To lay down a procedure for operation and cleaning of Auto Sliding Door Sterilizer.
1.0 OBJECTIVE:
To lay down a procedure for operation and cleaning of Auto Sliding Door Sterilizer.
2.0 SCOPE:
This procedure is applicable to operation & cleaning of Auto Sliding Door Sterilizer in Microbiology laboratory.
3.0 RESPONSIBILITY:
Microbiologist: To perform the operation as per SOP.
Head - Quality Control: To ensure the compliance of the SOP.
4.0 PROCEDURE:
4.1 General cleaning:
4.1.1 Clean the equipment with a cloth dipped in disinfectant solution.
4.1.2 Frequency :Every Cycle before Operation.
4.1.3 Record the cleaning in “Equipment Cleaning Register ‘’
4.1.4 TECHNICAL DATA :
SIZE : 600W x 600H x 600D
VOLUME : 216 Liter
MODEL : PSSD222AS (V)
OPERATION : Automatic with Manual Override
DOOR : Double vertical sliding door
WORKING PRESSURE : Chamber: 1.2Kg/cm2
Jacket: 1.2Kg/cm2
HYDRAULIC TEST PRESSURE Chamber: 3 Kg/cm2
Jacket 3 Kg/cm2
CHAMBER WORKING TEMPRATURE : 121Degree C
MATERIAL OF CONSTRUCTION : Contactable Part - SS 316L
Non-Contactable Part - SS 304
INSULATION : SS 304 Riveted cladding with Glass Wool
CONTROL SYSTEM : PLC Make: Mitsubishi
MMI E 100
10 Cycle memory
Analog input for Temperature & Pressure
Parameter setting – only Numeric
Password Protection for Parameter setting
Level 1 Password - ####
Level 2 Password - ####
Level 3 Password - ####
Level 1 for operator settable
3 Level
Parameter (Date, Time & Printer)
Level 2 for editing cycle parameter
Level 3 for OEM parameter Setting
4.1.5 Cycle Operation: GENERAL OPERATING INSTRUCTIONS:
4.1.5.1 Check following steps before start up.
4.1.5.2 Sufficient water supply is available for seal water of vacuum Ensure pump.
4.1.5.3 Ensure sufficient Feed water supply is available for Electric Boiler
4.1.5.4 Ensure Compressed Air supply is available at appropriate utility location.
4.1.5.5 Ensure air pressure of 6.00 kg/cm2
4.1.5.6 Switch ON the main provided on panel board
4.1.5.7 Loading of Product.
4.1.5.8 Close the door. Refer door-closing operation for details.
4.1.5.9 Check Chart Recorder is in position ON & Chart paper is properly loaded.
4.1.5.10 Check all the set parameters in PLC for required cycle.
4.1.5.11 For sterilization of Media filed in glass container, special sealing breathing cap to be used these is required because when the vacuum created in chamber then cap should be open by internal air pressure of component.
4.1.6 Boiler Operation:
4.1.6.1 System is equipped with boiler for supply of steam during heating period & sterilization period.
4.1.6.2 Switch ON panel Board
4.1.6.3 ?Open Boiler Air Vent valve (BV1) to remove air from boiler so feed water can easily fill in boiler.
4.1.6.4 ?As soon as water level goes above lower level of boiler, steam will generate in boiler through the heater.
4.1.6.5 As heater is ON pressure will be create inside the boiler
4.1.7 DOOR OPERATION (AUTO)
4.1.7.1 Door Closing Operation:
4.1.7.1.1 First confirm that gasket is set properly inside the groove.
4.1.7.1.2 If you want to close Non-Sterile side door, then press, Door 1 Close Push Button provided on Main Panel. Now Door 1 Closing Valve will get ON & door will get Closed
4.1.7.2 Door Opening Operation:
4.1.7.2.1 For opening Non-Sterile side door press Door 1 Open Push Button provided on Main Panel Board. Now, Door 1 Gasket Sealing Valve will get OFF, Vacuum Pump will start & Door 1 Gasket Vacuum Valve will get ON. Due to creation of vacuum behind gasket, it will be sucked back in the groove. When sufficient vacuum is created behind the gasket (sensed by gasket vacuum switch), PLC will get input from Door 1 Gasket Vacuum Switch. As soon as PLC will receive input of Gasket Vacuum Switch. Now Door 1
4.1.7.2.2 Open Valve will become ON & door will start opening. At this time PLC will display message “DOOR 1 OPEN”. When door will get open, it will be for opening sterile side door press Door 2 Open Push Button (Provided on isolation sheet of sterile side) & then release the button. If door is to be opened after completion of cycle.
4.1.7.2.3 Leak Test Cycle: This cycle is used to check Vacuum leak tightness of sterilizer chamber.
4.1.7.2.4 Gravity Cycle: This Cycle is generally recommended for products that are to be Sterilized in open containers.
4.1.7.2.5 Garment &Component cycle:
This cycle is generally recommended for sterilization of SS Vessels, Garments etc.
4.1.7.2.6 Bowic and Dick Test Cycle:
This cycle is generally used as test cycle for successful air removal through chamber & Load.
4.1.8 HOW TO SET PRINTER
4.1.8.1 Please do following procedure to see settings of Printer.
4.1.8.2 ?Keep Printer Off. Keep FONT button of printer pressed & then switch ON printer.
4.1.8.3 ?Now printer will print Table. After completion of printing,
4.1.8.4 ?Press LF/FF button of printer & printer will print current settings.
4.1.8.5 ?After completion of printing, Confirm above settings on printer as per PLC make. (Don’t tear off paper keep it as it is on printer & don’t disturb page setting also)
4.1.8.6 ?If printer setting is not as per list given then follow procedure to set printer as per printout.
4.1.9 DISPLAY OF MITSUBISHI PLC
4.1.9.1 START UP & PARAMETER SETTINGS
When all faults are clear (like air pressure low, RTD fail) & both doors are closed &
Pressure equal to room pressure. Display will show as per following.
4.1.9.2 INITIAL CONDITION SCREEN
4.1.9.2.1 F1 key (START): Press F1 key to display start up screen.
4.1.9.2.2 ?F2 key: (ESC)
4.1.9.2.3 ?F3 key (EDIT): To edit program parameter & display password screen.
4.1.9.2.4 ?F4 key (ACK): alarm Acknowledge
4.1.9.2.5 ?You can enter directly prog. No. from this screen when cursor is on prog no. Press NUM key & prog no. then press enter. F1 F2 F3 F4
4.1.9.3 PASSWARD SCREEN
To change the parameters press F3 key. Display will ask for password.
Press NUM key & at the same time enter the password (4 digit)
Release the NUM key & press ??key.
4.1.9.4 SELECT CYCLE SCREEN After entering the password, display will show
4.1.9.4.1 Press F4 (OK)
4.1.9.4.2 Press down arrow (?) key to select cycle parameter, change the parameter with the elp of NUM key and numbers then press enter)
4.1.9.4.3 With the help of (?) key, scroll down at the end.
4.1.9.4.4 Press F3 key to save the parameter.
4.1.9.4.5 Screen will show ‘return >’
4.1.9.4.6 Press ?and_??key to return to the initial screen.
4.1.9.5 INITIAL CONDITION SCREEN
Now to view or change the INPUT/OUT PUT, Press F2 key two times.
This screen will be display as below.
4.1.9.6 I/O STATUS SCREEN:
In this screen you can view the status of all the Input/Output.
Press F3 key is used to go to the operator settable parameter screen.
4.1.9.7 OPERATOR SETTABLE PARAMETER SCREEN:
If you want to change parameter date, time &print ON/OFF status, press F1.Screen for will ask Password.
4.1.9.7.1 Press NUM key at the same time enter the password with help of numbers.
4.1.9.7.2 Release NUM key & press ??to confirm the password. In this screen by pressing down arrow key you can change the date time & printer on/off status.
4.1.9.7.3 •?Key F1: This key is used to login at the specified level.
4.1.9.7.4 •?Key F2: This key is used to logout.
4.1.9.7.5 •?Key F4: This key is used to go to the OEM parameter screen when login to the level 3.
4.1.9.7.6 Press down arrow key, you will find OEM parameters.
4.1.9.7.7 To change the OEM parameter, enter the password & value to be change as per described earlier.
4.1.9.7.8 Now scroll down at the bottom of the screen with the help of down arrow (?) .
Screen will show display
4.1.9.7.9 Press ? then ??key, it will go to the operator settable parameter screen.
4.1.9.7.10 Again scroll down at the bottom of the screen with the help of down arrow (?) .
4.1.9.7.11 Screen will show display ‘return >’
4.1.9.7.12 Press ? then ??key, it will go to the I/O status screen.
4.1.9.7.13 Now scroll down at the bottom of the screen with the help of down arrow (?)
4.1.9.7.14 Screen will show display ‘return >’.
4.1.9.7.15 Press ? then ??key, it will go to the start up screen.
4.1.9.8 STARTUP SCREEN
4.1.9.8.1 Key-F2 (YES) to start particular cycle.
4.1.9.8.2 Key-F3 (NO) returns to initial condition screen.
4.1.9.9 FAULT CONDITION: In initial condition or when cycle is ON If any faults like RTD fail or air pressure low, emergency stop generates then message will be display on the screen. When fault is cleared it will display automatically on the screen.
4.1.9.10 CYCLES CONTINUE SCREEN: If any fault generate during cycle ON condition, it will be display on the screen. When the fault is cleared screen will display
• To continue the cycle, press F2 key (YES).
• To abort the cycle, press F3 (NO).
•?If machine is in vacuum or in pressurize condition, it will return to the initial condition (pressure equal to room pressure & Temp. equal to room door open
4.1.9.11 DISPLAY SCREEN:
4.1.9.12 Leak Test Cycle:
SET PARAMETER
L.T. VAC: 532mm Hg
L.T. TIME: 15 Min
DR OPEN TEMP: 90°C (Not more than 100 C)
PRESS F3 TO SAVE
RETURN>
When cycle is started Vacuum Pump will start, & Vacuum valve will ON. Message on PLC display will be “LEAK TEST VACUUM ON” Now vacuum will be created within the chamber. When vacuum will reach at set level, Vacuum valve will OFF & Vacuum Pump will stop. Message on PLC display will be “LEAK TEST VAC HOLD”. This vacuum hold time will remain for set value. After completion of hold period, Vacuum break Valve will ON & message at this time on PLC display will be “RELEASE VACUUM”. (PLC will not count first 5 minutes for calculation of leak rate calculation. It will count next 10 minutes of leak test hold & total vacuum leak during this 10 minutes period for calculation) This Valve will remain open till chamber comes to atmospheric pressure. If during vacuum hold leak rate is more than 1 mm of Hg/min. then message displayed will be “LEAK TESTFAIL” with leak rate. If leak rate is less than 1 mm of Hg/min. Then message displayed will be “LEAK TEST OK” along with leak rate. “CYCLE OVER” will be displayed on PLC Display.
4.1.9.13 GRAVITY CYCLE :
SET PARAMETER:
NO OF PULSE: 0 Nos
INI. VAC. VAL: 0.00 Kg/cm2
INI. VAC. TIME: 0 Min
PRHEATING TEMP: 85° C (More than 60C)
PR.HEAT TIME: 0 Min
STERILIZ TEMP: 121.2°C (More than 105 C)
STERILIZ TIME: 20 Min
FINAL VAC VAL: 0.00 Kg/cm2
FINAL VAC TIME: 0 MINCOO
L PULSE: 2 Nos
DR OPEN TEMP: 95°C (Not more than 100 C)
PRINT INTERVAL: 1 Min
PRESS F3 TO SAVE
RETURN>
4.1.9.14 INITIAL PULSATION:.
Pulsation includes initial vacuum, initial vacuum hold, preheating & preheating hold.
NOTE:
If Vacuum Pump & Vacuum valve and Steam to jacket valve switches are provided separately, then during switching ON, first switch ON Vacuum Pump & after approx. 45 seconds, switch ON Vacuum valve switch. During switching OFF, first switch OFF Vacuum valve & then immediately switch OFF Vacuum Pump.
A) Put Vacuum Pump and / or Vacuum valve and Steam to jacket valve switch to ON position.
B) Watch chamber pressure gauge, when vacuum in the gauge reaches to required level,
- Switch OFF Vacuum Pump and / or Vacuum valve switches & start counting vacuum hold period.
C) After vacuum hold time is over,
- Put Steam In Chamber Valve switch to ON position.
D) Watch chamber pressure gauge.
- When pressure reaches to zero i.e. room pressure, put Venting Valve & Condensate Valve switches to ON position.
E) Watch chart recorder indication.
- When required preheating temperature is reached, switch OFF Steam to chamber Valve & Venting Valve switch.
F) Wait for Preheating Hold period. If during hold period, temperature drops below preheating temperature, again switch ON Steam to chamber Valve, Steam to jacket valve & Venting Valve switch. After reaching temperature switch them OFF again.
G) After completion of Preheating Hold period,
- Switch OFF Condensate Valve switch If there is another pulse again repeat steps A to G.
I) After completion of pulses
- Go to next phase.
4.1.9.15 STERILIZATION:
A) Watch chamber pressure gauge, when pointer reaches to zero (i.e.roompressure)
- Put Venting Valve switch & Condensate Valve switch to ON position.
B) Watch indication of chart recorder, when temperature on chart recorder reaches to 100°C,
- Switch OFF Venting Valve switch.
C) Watch temperature on chart recorder. When temperature is below 4 °C than required sterile temperature,
- Switch ON & switch OFF Steam to chamber Valve switch so that temperature will Slowly reach to required Sterile Hold temperature.
D) When temperature reaches to required sterile temperature, start counting Sterile Hold time.
- During Sterile Hold time, switch ON & OFF Steam to chamber Valve switch to Maintain the Sterile temperature.
E) When sterile hold time is over,
- Put Steam in Chamber Valve switch, & Condensate Valve switch to OFF position.
4.1.9.16 SLOW EXHAUST:
4.1.9.16.1 After completion of sterilization hold period, stop the steam supply to the chamber.
4.1.9.16.2 There is pressure in the chamber. To release this pressure slowly, Condensate Valve will get ON.
4.1.9.16.3 Message displayed on PLC will be “SLOW EXHAUST”. If pressure is not reach within watch dog timer display will show “PRESSURE RELEASE PROBL” along with buzzer.
4.1.9.16.4 After reaching to room pressure, Condensate Valve will OFF & PLC will wait for door open temperature. If during this phase pressure increse more than room pressure vent valve will ON & if pressure goes below than room pressure vacuum break valve will ON.
4.1.9.16.5 When set temperature reaches, message “CYCLE OVER" will be displayed on PLC. (This cooling is natural cooling)
4.1.9.17 COOLING PULSES:
4.1.9.17.1 Vacuum Pump will start & Vacuum valve will ON. Message displayed on PLC display will be “COOLING VAC ON”. Vacuum will be created inside the chamber. This vacuum value is settable & can be set during OEM parameterization. When this value is reached, Vacuum valve will get OFF & Vacuum pump will stop. If cooling vacuum level not reach within watch dog timer display will show “COOLING VAC PROBLEM” along with buzzer. Vacuum break Valve will ON to release the vacuum.
4.1.9.17.2 During this process chamber temperature will be reduced. When chamber pressure will reach to atmospheric pressure, OFF vacuum break valve. PLC will check if Door Open Temperature is reached or not. If Door Open Temperature is reached, PLC will skip further pulses & give message “CYCLE OVER” along with F0 value.
4.1.9.17.3 If temperature is problem & set pulses are greater than one then above operation is
repeated until set pulses are completed or Door Open Temperature is reached. If set pulses are completed & still Door Open Temperature is problem, then message displayed on PLC “WAIT DOOR OPEN TEMP”. If during this phase pressure increase more than room pressure vent valve will ON & if pressure goes below than room pressure vacuum break valve will ON. When Door open temperature is reached message displayed will be “CYCLE OVER” along with F0 value.
When cycle is over, opposite side door i.e. not the last closed door can be opened by door opening procedure described earlier.
4.2 GARMENT & COMPONENT CYCLE
4.2.1 SET PARAMETER:
NO OF PULSE: 3 Nos
INI. VAC. VAL: - 0.40 Kg/cm2
INI. VAC. TIME: 2 Min
PRHEATING TEMP: 85° C (More than 60C)
PR.HEAT TIME: 2 Min
STERILIZ TEMP: 121°C (More than 105 C)
STERILIZ TIME: 30 Min
FINAL VAC VAL: -0.40 Kg/cm2
FINAL VAC TIME: 2 MIN
DR OPEN TEMP: 90° C (Not more than 100 C)
PRINT INTERVAL: 1 Min
PRESS F3 TO SAVE
RETURN>
4.2.2 INITIAL PULSATION
4.2.2.1 After starting the cycle, PLC will display message “INITIAL VACUUM ON” & this
phase will start, if pulsations are greater than one. (If pulses are zero then directly
“HEATING ON” message will be displayed & Sterilization mode will start) Pulsation includes initial vacuum, vacuum hold, preheating & preheating hold.
4.2.2.2 In this stage Vacuum Pump will start & Vacuum valve and Steam to jacket valve will
get ON and will remain ON, till vacuum in chamber will reach to set value (VACUUM
VALUE). If set vacuum does not reach within watch dog time, then fault "INITIAL
VACUUM PROB" along with buzzer will be displayed on PLC Display and thus
operator will come to know that there is some problem in creating vacuum. Here
operator has to acknowledge the fault by pressing F4 key of PLC Display. Now
operator has to find out the fault & resolve the problem so that process will go
forward
4.2.2.3 When vacuum in chamber is reached up to set value of vacuum, message “INITIAL VACUUM HOLD” will be displayed on PLC Display, and hold timer will start as per settable parameter. When initial vacuum hold is over one pulse completes.
If during initial setting of parameters, pulses are more than 1 then pre heating will start (If pulse = 1 then directly after first vacuum hold, PLC will move towards
STERILIZATION stage). At this stage Steam in Chamber Valve will open.
Condensate Valve & Venting Valve will also open at the room pressure.
4.2.2.4 When set temperature of preheating reaches, preheating hold timer will be started as per settable parameter and essage "PRE HEATING HOLD" will be displayed. Now Steam to chamber Valve, Steam to jacket valve & vent valve will be controlling.
If preheating temperature does not reach within watch dog time, message along with buzzer “PRE HEATING PROBLEM” will inform that there is some problem. Again operator has to acknowledge the problem by pressing acknowledge F4 key & resolve the problem.
4.2.2.5 Now if there is another pulse again these steps will be repeated automatically. After completion of pulses, it will go to STERILIZATION mode.
4.2.2.6 Normally 3 pulses are required but it depends on product & validation procedure. (When chamber pressure more than or equal to the set value then steam to chamber valve will get OFF & vent valve will get ON. When chamber pressure less than or
equal to the set value then steam to chamber valve will get ON & vent valve will get OFF.4.2.2.7 During sterile hold period if chamber pressure higher than settable value timer will stop & chamber pressure lower than settable value timer will start at same point)
4.3 STERILIZATION:
4.3.1 When sterilization mode starts message "HEATING ON" will be displayed. Steam inchamber Valve and Steam to jacket valve will get ON, Venting Valve andCondensate Valve will also get ON at room pressure.
4.3.2 After preheating hol5d temperature will increase sterile PID1 temp. hold up to sterile PID1 settable time. Then temperature increase sterile PID2 temp. hold up to sterile PID2 settable time. Then temperature increase sterile PID3 temp. hold up to sterile PID3 settable time.
4.3.3 When temp. Reaches at 100 deg. C. Venting Valves gets OFF.
4.3.4 When temp. Reaches to set sterilization temperature message "STERILE HOLD" will be displayed on PLC & hold timer will start. PLC will display clock time, temperature, chamber pressure & balance time.
4.3.5 Sterile temperature will be maintained automatically in chamber by PID loop incorporated within software programme.
4.3.6 If sterile temperature does not reach within watch dog timer, buzzer along with message "STERILE TEMP. PROBLEM" will inform about fault. You have to acknowledge the Fault by pressing F4, resolve the fault & process will move further.
4.3.7 After Sterile Hold timer is over, Steam in Chamber Valve, & Condensate Valve will close & PLC will move towards next phase.
4.4 FINAL VACUUM:
4.4.1 Message "FINAL VACUUM ON" will be displayed on PLC. Vacuum Pump will start,then some time delay Vacuum valve will open. Steam, condensed water will besucked off & vacuum creation will be started inside the chamber. When set vacuumis reached, Vacuum valve will close & Vacuum Pump will stop. Message "FINALVACUUM HOLD" will be displayed on PLC. This vacuum hold is for drying of product& time should be selected accordingly.
4.4.2 If final Vacuum does not reach with in watch dog timer, buzzer along with message “FINAL VACUUM PROBL”. When final vacuum hold timer is over, Steam to jacket valve get OFF and Vacuum break Valve will open & message displayed on PLC willbe "RELEASE VACUUM". Vacuum will be released & chamber will come to room pressure. If it is not reaching to room pressure within watch dog time buzzer along with message “VAC. RELEASE PROB”. You have to acknowledge the Fault by pressing F4, resolve the fault & process will move further. After reaching to room pressure, Vacuum break valve will close. PLC will check for door open temperature. If door open temperature is reached then "CYCLE OVER” message will come on PLC display along with F0 value.
4.4.3 If door temp. not reach within watch dog time “DOOR OP TEMP.PROB” message will displayed on PLC display you have to acknowledge the Fault by pressing F4, wait for the door open temp.
4.5 BOWIE AND DICK TEST CYCLE:
4.5.1 SET PARAMETER:
NO OF PULSE: 3 Nos
VAL : - 0.40 Kg/cm2
INI. VAC. TIME: 1 Min
PRHEATING TEMP: 85° C (More than 60C)
PR.HEAT TIME: 2 Min
STERILIZ TEMP: 121.1°C (More than 105 C)
STERILIZ TIME: 17 Min
FINAL VAC VAL: -0.40 Kg/cm2
FINAL VAC TIME: 2 Min
DR OPEN TEMP: 95°C (Max 100 C)
PRINT INTERVAL: 1 Min
PRESS F3 TO SAVE
RETURN>
4.5.2 Remove wrapping from the Standard Test Pack of Bowie and Dick test & place the indicator above the nominal geometric centre of the horizontal plane of the usable space & vertical at a distance of between100 and 200 mm above the chamber base.
After closing the door when you start the cycle, it will run standard Garment & Component Cycle.
4.5.3 After completion of cycle “CYCLE OVER” will be displayed on PLC display along with F0 value After completion you have to open the same door which was closed before staring the cycle. Remove test pack & examine the indicator for compliance with the required specifications.
4.6 F0 VALUE CALCULATION:
The F0 value of a sterilization process is the liability of the process expressed in terms of the equivalent time in minutes at a temperature of 121o C delivered by that process to the product in its final container . This value will be printed at the end of the cycle.
From D value / Z value / Total lethal rate in minutes F0 calculation is done as per the formula as under:Where ??t is the time interval between successive temperature measurements.
F0 = ??t (of Lethal rate)
4.7 LOGIC FOR THE F0 VALUE CALCULATION
4.7.1 When the temp. reach up to 100 ° C PLC will start the logic of F0 calculation. In this logic PLC will start reading the lethal rate corresponding to temperature at every 1 min. interval in 1 degree step. This value of lethal rate will be stored & after 1 min. there will be second value which will be added in previous value & the total value will be stored. After 1 min. again there will be new value which is to be added in previous stored total value & new value will be stored. This calculation will be stopped when temp. Is reduced 100 ° C after sterilization. Now cycle is over the last summation or F0 value will be printed.
4.8 Fill the details of each cycle
4.9 Precautions :
Don’t Open both the Doors at a Time.
Sufficient water supply is available for seal water of vacuum Ensure pump.
Ensure sufficient Feed water supply is available for Electric Boiler.
Ensure Compressed Air supply is available at appropriate utility location.
Cleaning, sliding, steriliser, microbiology
