Climet Particlemonitoring Sop Generic 566y15
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PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
1.0
PURPOSE 1.1
2.0
SCOPE 2.1
3.0
None
RESPONSIBILITIES 5.1
6.0
None
DEFINITIONS 4.1
5.0
This SOP includes the procedure for operation and routine maintenance of the CLiMET® CI-450 Laser Particle Counter.
REFERENCES 3.1
4.0
This procedure describes the operation and routine maintenance of the CLiMET® CI-450 Laser Particle Counter.
It is the responsibility of the person/s operating and performing routine maintenance on the CLiMET® CI-450 Laser Particle Counter to adhere to this SOP.
PROCEDURE/PROCESSES 6.1
Sample Volume 6.1.1 Turn the particle counter on by pressing “POWER” button. 6.1.2 From the Main Menu, press “SET UP”. 6.1.3 Press the “VOLUME” key at the top of the menu area. The sample volume entry screen will appear.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
6.1.4 Press the “CUBIC METER” key, and then press “1”. 6.1.5 Press the enter key to return to the main setup screen. 6.2
Display 6.2.1 From the main setup screen press the “MORE” key. Select “0.5 µm” and “5.0 µm” by pressing those keys. The keys will turn green. 6.2.2 Press “SET DATE” key. The entry screen will appear. Enter the date by month/day/year. Then press “ENTER”. 6.2.3 Select the “D/M/Y” key. It will turn green. 6.2.4 Press “SET TIME” key. The entry screen will appear. Enter the time by XX:XX (hour : minute). This is the 24 hours display of time (no AM/PM). Then Press “ENTER”. 6.2.5 Press “EXIT” key to come back to main setup screen.
6.3
Initial Delay 6.3.1 From main setup screen press the “INITIAL DELAY” key. The initial delay entry screen will appear. 6.3.2 Enter 30 for 30 seconds delay, then press “ENTER”. 6.3.3 Press the enter key to return to the main setup screen.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.4
Number of Samples 6.4.1 To set the CI-450 to take a fixed number of samples: 6.4.1.1
Press the “STOP AFTER N” key from the sample group. It will turn green.
6.4.1.2
Press the “NUMBER ‘N’” key and enter the desired number of samples (a minimum of 1 sample of 1 m3 of air will be sampled).
6.4.2 To set the particle counter to take continuous samples, one sample after another, until the “STOP” key is pressed:
6.5
6.4.2.1
From the main setup screen, press the “NUMBER ‘N’” key. Press the “INF” key.
6.4.2.2
Press the “ENTER” key.
Auto-average 6.5.1 Press the “PRINT AVERAGES AFTER N” key. The key will turn green. 6.5.2 The number of samples to be averaged is determined by the number of samples entered.
6.6
Total mode 6.6.1 From the main setup screen, press “TOTAL”. The “TOTAL” key will turn green. 6.6.2 Press “COUNTS”. The “COUNTS” key will turn green.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.7
End of sample printouts 6.7.1 From the main setup screen, press the “PRINT END OF SAMPLE” key. It will enable when the key is green.
6.8
Press “SAVE SETTING” to save the setting, and press “EXIT” to exit the main setup screen.
6.9
Sampling 6.9.1 From the main menu, press “PAPER FEED” to feed the paper up. 6.9.2 Attach a 0.2 µm filter into the probe tubing. Connect the tubing into the inlet. The probe should be vertical to the sampling surface. Press “START” to purge the particle counter for 1 cycle (1 cubic meter).
Deleted: probe
Note: Run the purge cycle (Zero Count) only when sample taken is in an ISO class 5 room. 6.9.2.1
The “Zero Count” must have a zero count on both 0.5 µm and 5.0 µm.
6.9.2.2
If any counts are obtained, repeat the purge cycle until a zero count is obtained.
6.9.3 After purge cycle is completed, remove the filter. 6.9.4 Press “START” to run the particle counter. The printing result will automatically print out at the end of sampling.
Deleted: purge cycle
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
6.10
Security 6.10.1 Level 4: allows free access to all menus and functions. 6.10.2 Level 3: prevents entry into the set up screen. 6.10.3 Level 2: prevents entry into the set up and load settings screens. This level allows access to the report menu screens. 6.10.4 Level 1: prevents entry into the set up, load settings, and report menu screens.
6.11
Changing Paper 6.11.1 Turn the unit on. Remove the printer paper compartment cover in the upper right corner of the rear by unscrewing the two thumbscrews by hand. 6.11.2 Cut or tear any remaining paper near the compartment, and then hold down the paper advance key to remove old paper still in the printer. 6.11.3 Hold the new roll of paper in the palm of your hand so that the end of the paper extends from the bottom of the roll out to your fingertips. 6.11.4 Use your fingertips to insert the end of the paper into the printer mechanism located at the upper rear of the compartment. 6.11.5 Insert the paper behind the visible horizontal lip. The printer will automatically sense and draw the paper through the mechanism.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.11.6 If the paper does not feed through after the paper advance stops running, pull the paper back out, and cut a fresh edge on the end of the paper. Make sure that the paper is straight rather than curled so that it does not curl in front of the lip. 6.12
Calibration 6.12.1 The CLiMET® CI-450 Laser Particle Counter should be calibrated annually by external qualified service.
6.13
Cleaning 6.13.1 Cleaning will be performed when placing the CI-450 in a control area. 6.13.2 Turn the unit off and remove the power cord. 6.13.3 Cap the inlet or attach a sample probe to the inlet to prevent from entering the inlet.
fluid
6.13.4 Cover the electrical connectors on the rear with the caps provided. 6.13.5 Wipe the surface of the unit with disinfectants. Do not allow the disinfectant to saturate the printer mechanism. 6.14
Storage 6.14.1 If the CLiMET® CI-450 is to be stored for three months or longer without use, the battery should be disconnected. 6.14.1.1 Open the battery access door at the rear of the unit. Locate the battery connector and disconnect it from the battery by separating the connector.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.14.1.2 It is adequate to store the disconnected battery in the unit. 6.14.1.3 Reconnect the battery again before use. Make sure that the battery wires are not pinched against the metal edges of the enclosure. The battery typically lasts 6 months to a year. Failure to hold a charge for more than two hours is an indication that the battery is failing and should be replaced. 7.0
ATTACHMENTS 7.1
8.0 DCR #
None
REVISION HISTORY Revision 00
Effective Date
Reason New Doc
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
Approved: Nicole C. Canto, PSC Validation Engineer
date
Kevin Hines, Sr. Project Manager
date
Approved:
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
1.0
PURPOSE 1.1
2.0
SCOPE 2.1
3.0
None
RESPONSIBILITIES 5.1
6.0
None
DEFINITIONS 4.1
5.0
This SOP includes the procedure for operation and routine maintenance of the CLiMET® CI-450 Laser Particle Counter.
REFERENCES 3.1
4.0
This procedure describes the operation and routine maintenance of the CLiMET® CI-450 Laser Particle Counter.
It is the responsibility of the person/s operating and performing routine maintenance on the CLiMET® CI-450 Laser Particle Counter to adhere to this SOP.
PROCEDURE/PROCESSES 6.1
Sample Volume 6.1.1 Turn the particle counter on by pressing “POWER” button. 6.1.2 From the Main Menu, press “SET UP”. 6.1.3 Press the “VOLUME” key at the top of the menu area. The sample volume entry screen will appear.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
6.1.4 Press the “CUBIC METER” key, and then press “1”. 6.1.5 Press the enter key to return to the main setup screen. 6.2
Display 6.2.1 From the main setup screen press the “MORE” key. Select “0.5 µm” and “5.0 µm” by pressing those keys. The keys will turn green. 6.2.2 Press “SET DATE” key. The entry screen will appear. Enter the date by month/day/year. Then press “ENTER”. 6.2.3 Select the “D/M/Y” key. It will turn green. 6.2.4 Press “SET TIME” key. The entry screen will appear. Enter the time by XX:XX (hour : minute). This is the 24 hours display of time (no AM/PM). Then Press “ENTER”. 6.2.5 Press “EXIT” key to come back to main setup screen.
6.3
Initial Delay 6.3.1 From main setup screen press the “INITIAL DELAY” key. The initial delay entry screen will appear. 6.3.2 Enter 30 for 30 seconds delay, then press “ENTER”. 6.3.3 Press the enter key to return to the main setup screen.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.4
Number of Samples 6.4.1 To set the CI-450 to take a fixed number of samples: 6.4.1.1
Press the “STOP AFTER N” key from the sample group. It will turn green.
6.4.1.2
Press the “NUMBER ‘N’” key and enter the desired number of samples (a minimum of 1 sample of 1 m3 of air will be sampled).
6.4.2 To set the particle counter to take continuous samples, one sample after another, until the “STOP” key is pressed:
6.5
6.4.2.1
From the main setup screen, press the “NUMBER ‘N’” key. Press the “INF” key.
6.4.2.2
Press the “ENTER” key.
Auto-average 6.5.1 Press the “PRINT AVERAGES AFTER N” key. The key will turn green. 6.5.2 The number of samples to be averaged is determined by the number of samples entered.
6.6
Total mode 6.6.1 From the main setup screen, press “TOTAL”. The “TOTAL” key will turn green. 6.6.2 Press “COUNTS”. The “COUNTS” key will turn green.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.7
End of sample printouts 6.7.1 From the main setup screen, press the “PRINT END OF SAMPLE” key. It will enable when the key is green.
6.8
Press “SAVE SETTING” to save the setting, and press “EXIT” to exit the main setup screen.
6.9
Sampling 6.9.1 From the main menu, press “PAPER FEED” to feed the paper up. 6.9.2 Attach a 0.2 µm filter into the probe tubing. Connect the tubing into the inlet. The probe should be vertical to the sampling surface. Press “START” to purge the particle counter for 1 cycle (1 cubic meter).
Deleted: probe
Note: Run the purge cycle (Zero Count) only when sample taken is in an ISO class 5 room. 6.9.2.1
The “Zero Count” must have a zero count on both 0.5 µm and 5.0 µm.
6.9.2.2
If any counts are obtained, repeat the purge cycle until a zero count is obtained.
6.9.3 After purge cycle is completed, remove the filter. 6.9.4 Press “START” to run the particle counter. The printing result will automatically print out at the end of sampling.
Deleted: purge cycle
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
6.10
Security 6.10.1 Level 4: allows free access to all menus and functions. 6.10.2 Level 3: prevents entry into the set up screen. 6.10.3 Level 2: prevents entry into the set up and load settings screens. This level allows access to the report menu screens. 6.10.4 Level 1: prevents entry into the set up, load settings, and report menu screens.
6.11
Changing Paper 6.11.1 Turn the unit on. Remove the printer paper compartment cover in the upper right corner of the rear by unscrewing the two thumbscrews by hand. 6.11.2 Cut or tear any remaining paper near the compartment, and then hold down the paper advance key to remove old paper still in the printer. 6.11.3 Hold the new roll of paper in the palm of your hand so that the end of the paper extends from the bottom of the roll out to your fingertips. 6.11.4 Use your fingertips to insert the end of the paper into the printer mechanism located at the upper rear of the compartment. 6.11.5 Insert the paper behind the visible horizontal lip. The printer will automatically sense and draw the paper through the mechanism.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.11.6 If the paper does not feed through after the paper advance stops running, pull the paper back out, and cut a fresh edge on the end of the paper. Make sure that the paper is straight rather than curled so that it does not curl in front of the lip. 6.12
Calibration 6.12.1 The CLiMET® CI-450 Laser Particle Counter should be calibrated annually by external qualified service.
6.13
Cleaning 6.13.1 Cleaning will be performed when placing the CI-450 in a control area. 6.13.2 Turn the unit off and remove the power cord. 6.13.3 Cap the inlet or attach a sample probe to the inlet to prevent from entering the inlet.
fluid
6.13.4 Cover the electrical connectors on the rear with the caps provided. 6.13.5 Wipe the surface of the unit with disinfectants. Do not allow the disinfectant to saturate the printer mechanism. 6.14
Storage 6.14.1 If the CLiMET® CI-450 is to be stored for three months or longer without use, the battery should be disconnected. 6.14.1.1 Open the battery access door at the rear of the unit. Locate the battery connector and disconnect it from the battery by separating the connector.
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Title/Description: Revision No.
6.14.1.2 It is adequate to store the disconnected battery in the unit. 6.14.1.3 Reconnect the battery again before use. Make sure that the battery wires are not pinched against the metal edges of the enclosure. The battery typically lasts 6 months to a year. Failure to hold a charge for more than two hours is an indication that the battery is failing and should be replaced. 7.0
ATTACHMENTS 7.1
8.0 DCR #
None
REVISION HISTORY Revision 00
Effective Date
Reason New Doc
PHARMACEUTICAL SERVICES CORPORATION STANDARD OPERATING PROCEDURE
SOP Number: Title/Description:
Operation and Maintenance of the CLiMET® CI-450 Laser Particle Counter
Revision No.
Approved: Nicole C. Canto, PSC Validation Engineer
date
Kevin Hines, Sr. Project Manager
date
Approved:
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