| Operation and Qualification Of Steam Sterilizer |
1.0 OBJECTIVE To lay down a Procedure for cleaning, operation and qualification of Steam sterilizer in microbiology. 2.0 SCOPE This procedure is applicable for cleaning, operation and qualification of Steam sterilizer in the Quality Control Department of Microbiology Area. 3.0 RESPONSIBILITY 3.1 Lab Assistant/Officer/Executive 3.1.1 Microbiology personnel shall responsible to follow the procedure of operation of steam sterilizer in microbiology laboratory as per SOP. 3.1.2 Microbiology personnel shall responsible for cleaning of steam sterilizer before the operation of steam sterilizer. 3.1.3 Microbiology personnel responsible for discarding the analyzed media after observation of result. 3.2 Head of Department/Designee 3.2.1 Review the SOP as per the current pharmacopeia. 3.2.2 Ensure that training shall be provided each concern person of the laboratory. 3.3 Head of Quality Assurance/Designee 3.3.1 Approve the SOP as per the requirement. 3.3.2 Verify that training shall be provided to each concern person 4.0 ACCOUNTABILITY • Department Head 5.0 PROCEDURE 5.1 Definition: It is a device that uses steam with vacuum to sterilize the objects. It initiates mechanical air removal from within the chamber utilizing a vacuum system followed by steam injection. 5.2 Operation 5.2.1 Visually observe all the utilities such as compressed air, purified water and are connected and work properly as the requirements, check the cleaning status of equipment pressure of compressed air should be 6-7 Bar. 5.2.2 Affix chemical indicator strip on each article to sterilized. 5.2.3 Turn on all electrical supply/connection. In addition to this turn UPS supply. 5.2.4 Keep main supply switch in ON position. Put control switch in ON position. 5.2.5 Check the status of an emergency button. It should be in OFF condition. 5.2.6 Check indicators (Door precondition, Door open and door close control On) are in right condition and they are glowing, if glowing then immediately inform to the maintenance department. 5.2.7 Open the door from non-sterile side (loading side) by pressing door open button. Prepare the required accessories and media in their respective volume of conical flasks/bottles/tubes. 5.2.8 Label each pack of laboratory glassware’s accessories, garments and media container with a strip of chemical indicator tape. 5.2.9 Place chemical indicator near to drain point for every cycle except Vacuum leak test and Bowie-Dick test. 5.2.10 Close the door by pressing “DOOR CLOSE” button. 5.2.11 Ensure that the NST (Non-sterile) door of the autoclave is closed by observing its pressure gauge. Pressure should be not less than 2.5kg/cm2. 5.2.12 Press “CONTROL ON” button. Switch “ON” the heater after completion of vacuum leak test. 5.2.13 After starting Heater Steam pressure should NLT 1kg/cm2 then start further autoclave cycle. 5.2.14 After completion of standard and HPHV cycle unload the material from unloading side in cooling zone area. 5.2.15 Sterilized items can be used within 24hrs. or as per validated time period. If not used, then perform cleaning and re-sterilization. 5.2.16 In case of power failure during the running cycle, do not unload the media/materials/Accessories in sterile area. Discard the media content in the cycle, newly prepare media and again start new sterilization cycle. In case of accessories cycle, start new sterilization cycle with same accessories /material. 5.3 Operating of programmable logical controller (PLC) 5.3.1 Go to MAIN MENU: Total four options will be display follows: Login Logout Manual mode Auto mode 5.3.2 At the time of autoclave operation firstly open the main switch. Than open the boiler heater and chamber steam. When the pressure of boiler heater reaches 1.5kg than turn off the heater 5.3.3 Open the HMI screen and select the auto mode, then select the desired cycle which has to be start for autoclave operation. Download the cycle and check all the parameter than start the cycle. 5.3.4 In the PLC system have auto/manual mode, which is used for opening of autoclave door. The manual function used for operation of autoclave, when any malfunctioning observed in auto mode operation. 5.3.5 Process about button, used for abort of any unnecessary cycle. 5.3.6 Process start button, used when operation performed in manual mode. 5.3.7 The hooter alarm button beep indicate that any malfunctioning happened during operation of system. 5.3.8 The emergency button used to stop the autoclave during any emergency condition. 5.3.9 The option chamber vacuum and chamber vent used for the removal of vacuum from the cycle after completion of HPHV. This option used after turn off the button from manual mode to auto mode. 5.3.10 Vacuum pump option provides fast removal of Vacuum after completion of cycle of HPHV. 5.3.11 The boiler feed pump and boiler heater used for generating steam for the operation of autoclave. 5.3.12 The NST door open/NST door close indicates the opening and closing of autoclave door. 5.3.13 Jacket steam in and jacket steam exhaust used for supplying steam into the jacket when autoclave is operating in manual mode. 5.3.14 Chamber steam and chamber exhaust button used during operation of autoclave in manual mode to supply or exhaust steam from the autoclave. 5.3.15 The chamber condensate option used to remove condensate of vapor from the chamber when operating in manual mode. 5.3.16 Login 5.3.16.1 Press the login button the system will ask the enter user ID and password. The system has unique user ID and password for both operator and admin for operation of autoclave. 5.3.16.2 The operator shall enter their user ID and password and start the cycle for operating of autoclave and admin shall review the cycle parameter and have rights of creating/deleting the user for operating of cycle. 5.3.16.3 Give command of PLC through strip chart for graphical presentation of temperature and pressure by pressing the start button for graphical representation of autoclave cycle. 5.3.17 Operation of cycle 5.3.16.4 After login the system in auto made the HMI show the following. 5.3.16.4.1 Check the parameter of respective cycle before pushing the start buttons, after checking parameter give command to the PLC by selecting “START PROCESS” 5.3.16.4.2 Now gradually steam will be generated by stream generator and the quantity of steam will get accumulated in the autoclave chamber and this will result increase in the temperature and pressure. 5.3.16.4.3 In HPHV process there is pre-vacuum and post vacuum pulses for dry articles. 5.3.16.4.4 In standard cycle there is no Vaccum pulse and this standard cycle is used for articles which do not required drying. 5.3.16.4.5 In leak test cycle there is a vacuum phase to check the chamber leakage. 5.3.16.4.6 At the end of the cycle autoclave will exhaust automatically and there will message display as “PROCESS END ACK” indicating process end. Press it so that unloading door will be acknowledged for systematic opening. For firstly removal of Vaccum in HPHV cycle start the chamber vacuum and chamber vent function while change the mode from auto to manual mode. 5.3.16.4.7 After process end acknowledgment when temperature get down the 90°cc, open the sterile side door by pressing ST door (sterile door). To read this sop click here SOP for Physical Monitoring Of Microbiology Laboratory. 5.3.18 Load pattern for autoclave cycle. After select the auto mode following cycle observed and their properties are following. 5.3.18.1 Vacuum leak Test (VLT): 5.3.18.1.1 Perform the vacuum leak test as the first cycle of the day before any other cycle in the autoclave in cold condition 5.3.18.1.2 Set the following parameter for the Vacuum leak test. Vaccum -0.700 bar. Vaccum stabilization delay 5 minutes Vacuum hold time 10 minutes Acceptable leakage 0.013 bar Process end pressure -0.080 bar 5.3.18.2 Bowie-Dick test 5.3.18.2.1 Bowie- Dick test should be performed once in a week. 5.3.18.2.2 Place the bowie-dick test kit the center of autoclave and operate the cycle as per above mention steps by selecting “Bowie-Dick test” 5.3.18.2.3 The bowie-dick test pack indictor should be uniform color change as per mentioned in bowie-dick test kit. Pre-vacuum -0.600 bar Pre-pressure 0.500 bar Number of pre-pulses 3 No’s Heat Up control band 0.5°c Small valve set points 120.0°c Sterilization hold temperature 121.4°c Sterilization hold time 10 minutes Temperature control band 0.2°c Sterilization overshoot 124.0°c Sterilization stop 120.9°c Sterilization reset 120.5°c Process end pressure 0.030 bar. 5.3.18.3 HPHV cycle 5.3.18.3.1 The HPHV cycle shall be operate after completion of vacuum leak test; place the load as per defined protocol. 5.3.18.3.2 The set parameter of HPHV cycle as follow. Pre-vacuum 0.700 Pre-vacuum hold time 002 min Pre-heat pressure 2min Pre-heat hold time 2 min Pre-pulse number 3 Nos Sterilization temperature 121.0°c Sterilization hold time 30 minutes Critical temperature 120.9°c Exhaust end pressure 0.100 bar Control band 0.5degree Post vacuum level -0.700bar Post vacuum hold time 10 minutes Post vacuum break -0.080 bar Jacket alarm time 60 min. Heat up alarm time 60 min. Print interval time 60 second Post pulse number 01 No’s 5.3.18.4 Standard process (Fast standard cycle) 5.3.18.4.1 Standard Process-I should be operating after the completion of vacuum leak test. This cycle is used for the sterilization of media in bottles/flask/tubes. 5.3.18.4.2 If the quantity if media as cycle was short than the load, then compensate the load volume with dummy purified water/ water for injection in the conical flask or tubes. 5.3.18.4.3 This cycle applicable for operation of agar medium (from 100mL up to 750ml) and liquid medium in 100 ml test tubes and bottles. 5.3.18.4.4 Set the parameter of standard cycle for fast exhaust as follow. Sterilization temperature 121.0°c Sterilization temperature 20 min. Critical temperature 120.9°c Overshoot temperature 124.0°c Process end pressure 0.080 Bar. Control band 0.5°c Jacket alarm time 60 min. Heat-up alarm time 60min. Print interval time 60 second To read this sop Click here SOP for Operation and qualification of Dry heat sterilizer. 5.3.18.5 Standard cycle (slow exhaust cycle) 5.3.18.5.1 Standard process-1 should be operating after the completion of Vaccum leak test. This cycle is used for the sterilization of media in 10 tubes stands. 5.3.18.5.2 If the quantity of media as cycle was short than the load, then compensate the load volume with dummy purified water/water for injection in the tubes. 5.3.18.5.3 This cycle applicable for operation of agar medium (10ml) and liquid medium in test tube and bottle. 5.3.18.5.4 The parameter of standard slow cycle is following. Sterilization temperature 115°c Sterilization hold time 15 Critical temperature 114.9° Over shoot temperature 118.0°c Process end pressure 0.080 Bar Control band 0.5°c Heat-up alarm time 60 min Print interval time 60 second 5.3.19 Shut-down procedure 5.3.19.1 Clean the autoclave before shutdown if there is any spillage in chamber. 5.3.19.2 Switch off “panel button and off the feed water supply and chamber heater. 5.4 Cleaning of steam sterilizer 5.4.1 Clean outer body of the steam sterilizer with 70% IPA using lint free cloth clean the equipment with a lint free cloth with purified water before and after every days of work 5.4.2 Clean the sterilizer external SS surface with dilute detergent followed by wet mop of purified water. 5.4.3 Clean the chamber with lint free cloth soaked with 70% IPA. 5.4.4 Cleaning once a week or whenever required or any spillage is there. 5.4.5 Record the cleaning in format no. XXX “Cleaning Record of Autoclave” To read this sop Click here SOP for Cleaning, Operation and usage of dynamic pass box. 5.5 Acceptance criteria 5.5.1 Vacuum leak Test: the vacuum leak test should not exceed 0.013 bar/min. 5.5.2 Bowie- Dick Test: there should be a uniform color change from purple to black over the entire pattern of the indicator sheet. 5.5.3 HPHV and standard process cycle: The temperature should be within the range of 121.1°c to 124°c and pressure should be 1.04 to 1.24 Bar during the dwell period. 5.6 Qualification: Perform the qualification of the instrument of steam sterilizer once in a year with the help of external party. Qualification shall be done after major breakdown. 5.7 Maintenance 5.7.1 Check all the safety components are in working condition 5.7.2 Check the recording instrument for proper print out. Replace inked ribbons if necessary. 5.7.3 Lubricate the door gasket, replace if hard or creaked. 5.7.4 Check overall pipping and valves connection for leakage. |
