US Environmental Protection Agency Office of Pesticide Programs Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD Standard Operating Procedure for Use and Maintenance of Incubated Orbital Shakers SOP Number: EQ-10-03 Date Revised: 09-12-17 ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 1 of 6 SOP Number EQ-10-03 Title Use and Maintenance of Incubated Orbital Shakers Scope This SOP describes the use and maintenance of orbital shakers (Forma model 420). Application Shakers are used to grow microbial cultures under agitated conditions. Approval Date SOP Developer: Print Name: SOP Reviewer Print Name: Quality Assurance Unit Print Name: Branch Chief Print Name: Date SOP issued: Controlled copy number: Date SOP withdrawn: ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 2 of 6 TABLE OF CONTENTS Contents Page Number 1. DEFINITIONS 3 2. HEALTH AND SAFETY 3 3. PERSONNEL QUALIFICATIONS AND TRAINING 3 4. INSTRUMENT CALIBRATION 3 5. SAMPLE HANDLING AND STORAGE 3 6. QUALITY CONTROL 3 7. INTERFERENCES 3 8. NON-CONFORMING DATA 4 9. DATA MANAGEMENT 4 10. CAUTIONS 4 11. SPECIAL APPARATUS AND MATERIALS 4 12. PROCEDURE AND ANALYSIS 4 13. DATA ANALYSIS/CALCULATIONS 6 14. FORMS AND DATA SHEETS 6 15. REFERENCES 6 ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 3 of 6 1. Definitions 1. Additional abbreviations/definitions are provided in the text. 2. RPM = Rotations per minute 3. LCD = Liquid crystal display 4. ISO = International Organization for Standardization 2. Health and Safety Follow procedures specified in SOP MB-01, Laboratory Biosafety. The Study Director and/or lead analyst should consult the Safety Data Sheet for specific hazards associated with products. 3. Personnel Qualifications and Training Refer to SOP ADM-04, OPP Microbiology Laboratory Training. 4. Instrument Calibration 1. Temperature calibration. a. Access the Configuration menu by first pressing the down arrow, then the up arrow, and then the Silence button. b. Press the Temperature button beneath Temp. Use the up and down arrows to increase or decrease the temperature value to match an independent, accurate temperature measuring device. When selected, press the Time, Speed, or Temp button to save the setting. 5. Sample Handling and Storage Ensure all samples are properly covered (e.g., caps, aluminum foil, parafilm). 6. Quality Control 1. Record the temperature of each unit on each working day on the appropriate Temperature Record form (see section 14) when the instrument is in use. 2. The thermometers are point checked annually against an ISO accredited verification thermometer. 7. Interferences 1. If the shaker is operated at a temperature 5-10°C above ambient, the circular vent at the rear of the cabinet must be 1 inch from the wall and the rear vent must be fully opened by turning the Phillips screw clockwise. If the operating temperatures are more than 10°C above ambient, the rear vent must remain closed (fully counterclockwise). 2. Before inserting tubes or flasks, ensure the screws that attach the racks to the platform are tight 3. The lid must be closed to operate the shaker. 4. Do not operate the shaker without a load. ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 4 of 6 8. Non- conforming Data 1. Management of non-conforming data will be consistent with SOP ADM- 07, Non-Conformance Reports. 2. Any deviation from the standard operating procedures will be documented in the record book and investigated. Determine the cause of problems maintaining the target temperature and take the appropriate corrective action. If the problem cannot be determined or corrected, call in a service technician to evaluate the situation and initiate the service on the equipment. 3. For maintenance, service, and troubleshooting refer to sections 3 and 4 of the manual (see section 15). 9. Data Management 1. Data will be archived consistent with SOP ADM-03, Records and Archives. 2. Record the temperature of each shaker promptly, legibly and in indelible ink on the appropriate temperature record form (see section 14). 10. Cautions 1. Do not leave the shaker unattended when starting the unit. Be sure all flasks and test tube racks are firmly seated in the clips and routinely check the security of the flask clip and the platform attachment screws. 2. Shaker #1 is attached to a Knee-well Slide Assembly - make sure the lever catches the latch tab after pushing the slide assembly back in prior to turning on the shaker. 3. The Model 420 Orbital Shaker control system monitors and provides alarms for nine operating parameters (refer to pages 2-5 and 2-6 of the manual, see section 15). 4. For spills inside of the shaker, refer to section 4 of the manual (see section 15) for dismantling the shaker and refer to SOP MB-13, Handling Spills, for the spill control procedures for biohazardous organisms in biosafety levels 1, 2, and 3. 11. Special Apparatus and Materials Forma Orbital Shakers (model 420), serial numbers 131375-1815 (Shaker #1) and 131376-1816 (Shaker #2). 12. Procedure and Analysis 12.1 General Shaker Operation a. Turn on the unit using the main power switch (located on the right side of the unit next to the power cord) and press Start to operate the shaker. Be sure Knee-well Slide Assembly is locked prior to turning on shaker #1. b. When starting, the numbers along the top row of the LCD will differ ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 5 of 6 from the setpoint values shown along the bottom row of the LCD. These numbers will change as the unit begins to operate. c. Record the temperature of each unit when in use (refer to section 13.1 and 13.2 of the manual, see section 15). 12.2 Time Settings a. Hold. With the time set at Hold, the time display in the upper left portion of the screen begins to count upward, showing the total operating hours and minutes. b. Countdown. When the Hold setpoint is changed to countdown, the shaker will operate for the specified period and automatically shut down. The display will show the total time in the setpoint segment and the operating time remaining in the Actual part of the display as the microprocessor counts down to zero. c. Changing from Hold to Countdown. i. Press the button beneath the Time setpoint. Hold will begin to flash. ii. Press either arrow to access the Countdown Time setpoint. The preset time setpoint will begin to flash. iii. Press the up and down arrows to set the desired operating time in five minute increments. iv. When the desired elapsed time is set, press the Time button to return to the Operating Screen. Pressing the Start button will start the shaker and begin the countdown sequence. When 00:00 is reached, the shaker will automatically shut off and the Cycle Complete alarm will sound. 12.3 Speed Settings a. The Actual speed will display zero RPM and will gradually rise as the platform begins its motion. b. Changing the speed. i. Press the button beneath the Speed setpoint. The RPM value will begin to flash. ii. Press the up or down arrows to set the new speed in 1 RPM increments. iii. Press the Speed button again to return to the Operating Screen. 12.4 Temperature Settings a. The temperature, shown in the upper right portion of the LCD, will indicate the actual ambient temperature inside the cabinet and will slowly move toward the setpoint. ------- SOP No. EQ-10-03 Date Revised 09-12-17 Page 6 of 6 b. Changing the temperature setpoint. i. Press the button beneath the temperature setpoint (Temp °C). The temperature value will begin to flash. ii. Press the up or down arrows to set the new temperature in 0.1 °C increments. iii. Press the temperature button again to return to the Operating Screen. 13. Data Analysis/ Calculations None 14. Forms and Data Sheets Test Sheets. Test sheets are stored separately from the SOP under the following file names: Incubated Orbital Shaker Temperature Log EQ-10-03_Fl.docx 15. References Forma Orbital Shaker Operating and Maintenance Manual 7000420 Rev. 7. ------- |