106745791 Document type: SOP Document code: TB 07-02 INCUBATOR USE AND MAINTENANCE Confidentiality: none TABLE OF CONTENTS 1. PURPOSE...................................................................................................................... 2 2. SCOPE .......................................................................................................................... 2 3. RESPONSIBILITIES ...................................................................................................... 2 4. CROSS-REFERENCES ................................................................................................. 2 5. PROCEDURES .............................................................................................................. 2 5.1. Equipment .................................................................................................................................... 2 5.2. Use of incubator ........................................................................................................................... 2 5.3. Maintenance ................................................................................................................................ 2 5.3.1. Disinfection ............................................................................................................................ 2 5.3.2.Calibration .............................................................................................................................. 3 5.3.3. Servicing ................................................................................................................................ 3 5.3.4. Quality control ....................................................................................................................... 3 6. REFERENCES ............................................................................................................... 4 7. CHANGE HISTORY ....................................................................................................... 4 This SOP template has been developed by FIND for adaption and use in TB laboratories Release date: ddMMMyy Page 1 of 4 106745791 1. PURPOSE This SOP describes the use and maintenance of the incubators in the _______________TB Laboratory. The incubator is used for culture of Mycobacterium tuberculosis by ensuring optimum growth conditions. Optimal operation of the incubator is achieved through proper installation, regular monitoring and maintenance. 2. SCOPE This SOP covers all procedures requiring incubation in the _______________TB Laboratory. 3. RESPONSIBILITIES All staff members working in the _______________TB Laboratory are responsible for the implementation of this operating procedure. All users of this procedure who do not understand it or are unable to carry it out as described are responsible for seeking advice from their supervisor. 4. CROSS-REFERENCES See: Document Matrix_TB 01-01_V1.0.doc Location: Refer to SOPs listed under TB 02 (General Procedures), TB 03 (Specimen Handling) and TB 05 (Culture and Drug Susceptibility Testing) 5. PROCEDURES 5.1. Equipment Incubator with proper electrical isolation, installed according to the user manual. Install incubator in a well-ventilated dry space, on a level surface, away from heat sources 5.2. Use of incubator Keep the door closed to prevent heat loss to the environment. Ensure that rack positions are clearly marked. The incubator should be switched off when not in use. Do not overload. 5.3. Maintenance 5.3.1. Disinfection Every 6 months or in case of spill of infectious material within the incubator. Disconnect the plug from the main socket. Identify adequate volume of available safe space for temporary storage of biohazardous material. Ensure that materials kept in the incubator are clearly marked. Page 2 of 4 106745791 Clean metallic surfaces (racks, floor, walls and doors) with 70% ethanol. Clean materials located in the incubator which may have been contaminated by spill. Connect the incubator to the main power supply and switch on. Relocate incubator contents once the temperature has reached 36°C. Notify staff of the contents of relocation. 5.3.2.Calibration The temperature should be calibrated: Prior to use. After temperature changes have been detected and rectified. Following a power failure. After cleaning of spills. Ensure that the door is closed and that the incubator is switched on. Set the required temperature using the temperature control and leave the incubator to run for 1 hour. Place a thermometer into the centre of the incubator with probe away from the heating element. Take the temperature reading after 30 minutes. If the temperature is not 36°C ± 1°C, adjust the control. Repeat process every 30 minutes until the required temperature is reached. Continue to take readings until two consecutive readings (30 minutes apart) are 36°C ± 1°C. Record readings in the Incubator Calibration form. Use: Incubator Calibration_form.doc Location: The incubator is ready for use at the calibrated temperature. 5.3.3. Servicing Service and repairs should be performed by a qualified service technician. Records on service and repairs should be kept in the “Equipment and Chemical Maintenance” file. Records of the service must be kept in the Equipment Maintenance File Use: Equipment Maintenance File_form.doc Location: 5.3.4. Quality control Record temperature once daily and document in the Incubator Temperature Logbook. Use: Incubator Temperature Logbook _form.xls Location: Page 3 of 4 106745791 6. Perform monthly temperature spot checks by placing thermometers at various positions in the incubator to verify that the internal incubator temperature is constant at 36 1°C. REFERENCES World Health Organization. Maintenance and repair of laboratory, diagnostic imaging and hospital equipment. Geneva: WHO; 1994. World Health Organization. Regional Office for the Eastern Mediterranean. Basics of quality assurance for intermediate and peripheral laboratories. 2nd ed. Cairo; 2002. 7. CHANGE HISTORY New version # / date Old version # / date No. of changes Description of changes Source of change request Page 4 of 4