ATS-SOI-5731 Page: 1 of 5 Approval Block Prepared by: Signature Date Margaret Crouse 18 JUN 2014 Reviewed by: Signature Date Brian Flynn 18 JUN 2014 Approved by: Signature Date Kristal Jewell 18 JUN 2014 1. Purpose This document provides instruction for the utilization of the Tuttnauer 2340M autoclave. 2. Scope This document shall be followed by all personnel operating the Tuttnauer 2340 autoclave. 3. References 3.1 Operation and Maintenance Manual for the Tabletop s, Tuttnauer Cat. No. MAN205-0007000EN Rev. Q 3.2 ATS Safety Manual and Material Safety Data Sheet (MSDS) Archive Binder 3.3 ATS SOP 740.00 Rev (A) Standard Operating Procedure: Attest Biological Monitoring System 4. Equipment and Materials 4.1 Tuttnauer 2340M 4.2 Tuttnauer log 4.3 Distilled water 4.4 Sterilization pouches
ATS-SOI-5731 Page: 2 of 5 4.5 Biohazard bags 4.6 tape 4.7 Heat safe gloves 4.8 Safety glasses 5. Safety Refer to ATS Safety Manual and Operation and Maintenance Manual for the Tabletop s for safe operation of electrical equipment, and for safety information. 6. Responsibility 6.1. It is the responsibility of the President to assure that this document remains current. 6.2. It is the responsibility of the President, or any trained technician designee, to provide documented training in the utilization of this device. 6.3. It is the responsibility of the President to assure the general maintenance of this device is performed in a timely manner. 6.4. It is the responsibility of the individual(s) operating this equipment to follow the procedures specified by this document. 7. Preliminary Considerations 7.1 Collect all equipment necessary to conduct the desired operation. 7.2 Exposed media and contaminated waste is to be autoclaved before disposal. Noncontaminated waste is to be disposed of weekly (decontamination not required).
ATS-SOI-5731 Page: 3 of 5 8. Operation 8.1 Check the water reservoir. Ensure that the drain valve is closed and the Multi-purpose valve is in the O for off position. The multipurpose valve is the bottom dial on the front of the autoclave. Remove the gray water reservoir cover from the top of the autoclave. Check the water level by reading the dipstick. If the water level is below the MIN mark add distilled water to bring the water level above MIN. 8.2 Move the ON / OFF rocker switch, located on the front panel, to the ON position. The green Power Light will turn on, indicating that power is ready to be supplied to the Heating Elements. 8.3 Turn the red tracking needle on the pressure gauge counterclockwise to 0 psi. The tracking needle will indicate the highest pressure reached during the cycle. 8.4 Open the front door of the autoclave by turning the handle counter-clockwise and set the Multi-purpose valve knob to the FILL WATER position. When the water reaches the indentation mark at the front of the autoclave, set the multi-purpose valve knob to the STERILIZE position. 8.5 Prepare the Load-Use secondary containment for all items being autoclaved such as biohazard bags or autoclave safe bins. Place biohazard bags in autoclave trays. Place a piece of autoclave tape on each Biohazard bag. If autoclaving a bottle, place a piece of autoclave tape on the bottle. Place SMA heads or other equipment to be sterilized into sterilization pouches. Include Attest Biological Indicators as described in SOP ATS 740.00. 8.6 Load the autoclave and close the door by turning the handle clockwise until it is hand-tight. 8.7 Turn the Thermostat knob to the desired sterilization temperature. The standard cycle at ATS is 273 F or 134 C. See the manual for recommended cycle parameters. The autoclave run is not considered a success unless the Attest Biological Indicators have
ATS-SOI-5731 Page: 4 of 5 passed. 8.8 Set the Timer to the desired sterilization cycle time. At ATS this is 60 minutes. This ensures enough time for the autoclave to warm up if it was off and still do a proper sterilization. The Heat Light will come on, indicating that power is being supplied to the Heating Elements and remain on until the correct sterilization pressure is achieved. Once the correct pressure is reached the Heat Light will cycle on and off, indicating that the Heating Elements are turning on and off to maintain the correct sterilization pressure. When the Timer reaches 0 min, the Heating Elements are turned off and a buzzer will sound indicating that the sterilization cycle is complete. 8.9 Once the Timer has reached 0 min, turn the Multi-purpose valve knob promptly to the Exhaust / Dry position. This will allow the steam and leftover water to return to the reservoir. When the white needle on the pressure gauge has reached 0 psi, the door can be opened. **WARNING: Sterilizer and trays will be hot after cycle is run. Always wear protective gloves and safety glasses. 8.10 If drying is required for sterilization pouches and the pressure has dropped below 10 psi before turning the Multi-purpose valve to Exhaust / Dry position, leave the unit in the STERILIZE position and reset the timer for 10 minutes. When the timer reaches 0 min, the pressure should be above 10 psi. Now the Multi-purpose valve can be turned to Exhaust / Dry position. This will ensure that all the water has been returned to the reservoir. When the white needle on the pressure gauge has reached 0 psi, the door can be opened. **NOTE: The sooner the Multi-purpose valve is turned to Exh / Dry at the end of the sterilization cycle, the more effective and efficient will be the drying cycle. 8.11 Wearing safety glasses and using protective gloves, remove the load from the autoclave. Place the load on top of the autoclave with a protective glove on top. This signals to others that the load is hot. Do not block the water reservoir cover. Steam may be released from this cover during autoclaving.
ATS-SOI-5731 Page: 5 of 5 8.12 Verify that the autoclave tape has turned black or that the steam indicator strip on the sterilization pouch has turned gray/black. This indicates exposure to sterilization temperatures. 8.13 Fill out Tuttnauer Log including results of Attest Biological Indicators. 8.14 Do not dispose of waste until Attest Biological Indicators have passed. Consult SOP ATS 740.00 for more details. 8.15 Once the Attest Biological Indicator is negative, mark out the Biohazard logo on the Biohazard bags using a black marker, tape or tie the bag closed, and dispose in the trash. Items sterilized in pouches should remain in the sterilization pouch until use. 9. Maintenance 9.1 Once per week, clean the air jet. A dirty air jet is the number one cause of failed spore tests. While the autoclave is running, remove the water reservoir cover. Clean the air jet by manipulating the air trap wire back and forth ten times. Record on Tuttnauer Log. For more information see the Operation and Maintenance Manual. 9.2 Once per month, clean the safety valve. Follow instructions in the Operation and Maintenance Manual. Record safety valve cycle in Tuttnauer Log. 9.3 For other maintenance and troubleshooting see Operation and Maintenance Manual.