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 Orbital Shakers SOP Number: EQ-10-01 Date Revised: 11-03-11 ------- Initiated By: Technical Review: QA Review: Approved By: SOP No. EQ-10-01 Date Revised: 11-03-11 Page 1 of 8 EPA/OPP MICROBIOLOGY LABORATORY ESC, Ft. Meade, MD Standard Operating Procedure for Use and Maintenance of Orbital Shakers SOP Number: EQ-10-01 Date Revised: 11-03-11 Print Name: Print Name: Technical Staff Print Name: QA Officer Print Name: Branch Chief Date: / / Date: / / Date: / / Date: / / Effective Date: / / Controlled Copy No.: Withdrawn By: Date: / / ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 2 of 8 TABLE OF CONTENTS Contents Page Number 1.0 SCOPE AND APPLICATION 3 2.0 DEFINITIONS 3 3.0 HEALTH AND SAFETY 3 4.0 CAUTIONS 3 5.0 INTERFERENCES 3 6.0 PERSONNEL QUALIFICATIONS 4 7.0 SPECIAL APPARATUS AND MATERIALS 4 8.0 INSTRUMENT OR METHOD CALIBRATION 4 9.0 SAMPLE HANDLING AND STORAGE 4 10.0 PROCEDURE AND ANALYSIS 4 11.0 DATA ANALYSIS/CALCULATIONS 6 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 6 13.0 QUALITY CONTROL 6 14.0 NONCONFORMANCE AND CORRECTIVE ACTION 7 15.0 REFERENCES 7 16.0 FORMS AM) DATA SHEETS 7 ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 3 of 8 1.0 SCOPE AND APPLICATION: 1.1 This SOP describes the use and maintenance of orbital shakers (Forma model 420). 2.0 DEFINITIONS: 2.1 Manual = Operating and Maintenance Manual 7000420 Rev. 7 2.2 RPM = Rotations per minute 2.3 LCD = Liquid crystal display 2.4 ISO = International Organization for Standardization 3.0 HEALTH AND SAFETY: 3.1 All manipulations of the test organisms are required to be performed in accordance with biosafety practices stipulated in SOP MB-01, Lab Biosafety. 4.0 CAUTIONS: 4.1 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 check the security of the flask clip and the platform attachment screws monthly. 4.2 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. 4.3 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). 4.4 For spills inside of the shaker, refer to section 4 of the manual 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. 5.0 INTERFERENCES: 5.1 If the shaker is to be 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 ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 4 of 8 temperatures are more than 10°C above ambient, the rear vent must remain closed (fully counterclockwise). 5.2 Before inserting tubes or flasks, make sure the screws that attach the racks to the platform are tight 5.3 The lid must be closed to operate the shaker. 5.4 The shaker should not be operated at the maximum RPM without a load. 6.0 PERSONNEL QUALIFICATIONS: 6.1 Personnel are required to be knowledgeable of the procedures in this SOP. Documentation of training and familiarization with this SOP can be found in the training file for each employee. 7.0 SPECIAL APPARATUS AND MATERIALS: 7.1 Forma Orbital Shakers (model 420), serial numbers 131375-1815 (Shaker #1) and 131376-1816 (Shaker #2). 8.0 INSTRUMENT OR METHOD CALIBRATION: 8.1 Temperature calibration. 8.1.1 Access the Configuration menu by first pressing the down arrow, then the up arrow, and then the Silence button. 8.1.2 Press the Temperature button beneath Temp. Using the up and down arrows, 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. 9.0 SAMPLE HANDLING AND STORAGE: 9.1 Refer to individual study and research protocols for sample handling parameters. 10.0 PROCEDURE AND ANALYSIS: 10.1 General shaker op erati on. 10.1.1 Turn on the unit using the main power switch (located on the right side ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 5 of 8 of the unit) and press Start to operate the shaker. Be sure Knee-well Slide Assembly is locked prior to turning on shaker #1. 10.1.2 When starting, the numbers along the top row of the LCD will differ from the Setpoint values shown along the bottom row of the LCD. These numbers will change as the unit begins to operate. 10.1.3 Record the temperature of each unit when in use (refer to section 13.1 and 13.2 of the manual). 10.2 Time settings. 10.2.1 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. 10.2.2 Countdown. When the Hold setpoint is changed to countdown entering a time value in hours and minutes, the shaker will operate for that 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. 10.2.3 Changing from Hold to Countdown. 10.2.3.1 Press the button beneath the Time setpoint. Hold will begin to flash. 10.2.3.2 Press either arrow to access the Countdown Time setpoint. The preset time setpoint will begin to flash. 10.2.3.3 Press the up and down arrows to set the desired operating time in five minute increments. 10.2.3.4 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. 10.3 Speed settings. ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 6 of 8 10.3.1 The Actual speed will display zero RPM and will gradually rise as the platform begins its motion. 10.3.2 Changing the speed. 10.3.2.1 Press the button beneath the Speed setpoint. The RPM value will begin to flash. 10.3.2.2 Press the up or down arrows to set the new speed in 1 RPM increments. 10.3.2.3 Press the Speed button again to return to the Operating Screen. 10.4 Temperature settings. 10.4.1 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. 10.4.2 Changing the temperature setpoint. 10.4.2.1 Press the button beneath the temperature setpoint (Temp °C). The temperature value will begin to flash. 10.4.2.2 Press the up or down arrows to set the new temperature in 0.1 °C increments. 10.4.2.3 Press the temperature button again to return to the Operating Screen. 11.0 DATA ANALYSIS/CALCULATIONS: None. 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT: 12.1 The temperature of each shaker is to be recorded promptly, legibly and in indelible ink on the appropriate temperature record form. Completed forms are archived on a yearly basis in notebooks kept in secured file cabinets in room D217. Archived data are subject to OPP's official retention schedule contained in SOP ADM-03, Records and Archives 13.0 QUALITY CONTROL: ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 7 of 8 13.1 The temperature of each unit will be recorded once daily each working day (Monday through Friday excluding holidays and days when the ESC is closed for any reason) on the appropriate Temperature Record form (see 16.0) when the instrument is in use. On days when the unit is not in use, the designation "N/A" will be recorded on the Temperature Record form (see 16.0). 13.2 The thermometers are point checked annually against an ISO accredited verification thermometer. A piece of label tape, displaying the correction factor, is placed around the top of the corresponding thermometer. This procedure is described in SOP EQ-02, Calibration of Thermometers. The point check calibration records of thermometers are maintained in a notebook which is archived in room D217. 14.0 NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any deviation from the standard procedures will be documented in the record book and investigated. The reasons for any difficulties achieving and maintaining the target temperature will be determined and the appropriate corrective action will be taken by the laboratory staff. If the problem cannot be determined or corrected, a service technician will be called in to evaluate the situation and to initiate the service on the equipment. 14.2 For maintenance, service, and troubleshooting refer to sections 3 and 4 of the manual. 15.0 REFERENCES: 15.1 Forma Orbital Shaker Operating and Maintenance Manual 7000420 Rev. 7. 16.0 FORMS AND DATA SHEETS: 16.1 Orbital Shaker Temperature Log ------- SOP No. EQ-10-01 Date Revised: 11-03-11 Page 8 of 8 16.1 Orbital Shaker Temperature Log OPP Microbiology Laboratory Laboratory #/Shaker ID: / Thermometer ID/Correction Factor: / °C Dale/I nilials Temperature* Organism Comments** * Corrected temperature recorded. **Include purpose for use and research/study protocol number, if applicable. ------- |