SOP of Operation, Calibration, Cleaning and Maintenance of M Air T Isolator Air Sampler
Objective
To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of M Air T Isolator Air Sampler.
Scope
This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of M Air T Isolator Air Sampler of (Pharmaceutical Company Name).
Responsibility
Microbiologist or above of Microbiology Laboratory.
Head – Microbiology section / Nominee.
Accountability
Head – Quality Control / Nominee.
Abbreviations and Definitions
SOP : Standard operating procedure
No. : Number
QC : Quality Control
QA : Quality Assurance
Procedure
Make: Millipore, Model: M air T Isolator
Operation of M Air T Isolator System:
Accessories:
M Air T Isolator pump
M Air T Sampling Head, with sieve
M Air T Tri-Clover
Tripod
Cone
Reducer
M Air T Cassettes
Clamp and silicon seals for Tri-Clover
Silicon tube
Opticap Filter
Setting Parameters
Press PARAM
Enter the sample volume ‘1000Liters’ by using alphanumerical key on control keypad. For deleting the value use
Press ENTER
Enter the delay time ‘0’ by using alphanumerical key on control keypad. For
Deleting the value use key.
Press ENTER
Enter the number of cycles ‘1’ by using alphanumerical key on control keypad. For
deleting the value use key.
Enter the location name by using alphanumerical key on control keypad. One key is having 3 or 4 alphabetic and one number. For alphabetic press and hold for few seconds. The alphabet will change from first alphabet to second, second alphabet to third, third to fourth, fourth to number and then number to again first alphabet, like that it will keep on rotating. After appearing the required alphabet or number immediately remove the finger from the keypad. For deleting the value use
Enter the name of the person by using alphanumerical key on control keypad. One key is having 3 or 4 alphabetic and one number. For alphabetic press and hold for few seconds the alphabet will change from first alphabet to second, second alphabet to third, third to fourth, fourth to number and then number to again first alphabet, like that it will keep on rotating. After appearing the required alphabet or number immediately remove the finger from the keypad. For deleting the value use
Enter the media lot number (cassette) by using alphanumerical key on control keypad. One key is having 3 or 4 alphabetic and one number. For alphabetic press and hold for few seconds the alphabet will change from first alphabet to second, second alphabet to third, third to fourth, fourth to number and then number to again first alphabet, like that it will keep on rotating. After appearing the required alphabet or number immediately remove the finger from the keypad. For deleting the value use
The following parameters appear on LCD Display.
For sampling press the start key to start the cycle.
The following parameters appear on LCD Display while sampling
When sampling is completed the display shows
When printing is completed the display shows
The screen then returns to the main menu and the displays shows
Sampling procedure
Install the sampling head on the tripod
Connect the M Air T tripod to the pump INLET using the silicone tube.
Connect the opticap filter to the pump OUTLET to avoid any risk of particle contamination.
Note: Install the Opticap with the arrow pointing in the direction of airflow.
Clamp the sieve, cone and reducer (cone set).
Remove the cover of the sieve. Loosen and remove the sieve from the analyzer by twisting it counterclockwise.
Grasp the cassette wings and place it on the sampling head.
Lock the cassette into place.
Remove the cover and place it on a work surface with the inside facing down.
Place the sieve over the cassette and lock it into position.
Now insert the sampling point Polyurethane tube into the reducer.
Start the sampling by pressing start key on the control keypad.
After sampling loosen and remove the sieve from the analyzer by twisting it counter clockwise.
Loosen and remove the sieve from the sampling head by twisting it counter clockwise.
Close the plate with cover and remove from the sampling head.
Label the plate as location name, date of sampling and sampled by (initial).
Follow the same procedure for remaining locations.
Cleaning
The sieve plates and the sampling head of the M Air T isolator air sampler should be cleaned before and after taking sample with the help of lint free cloth soaked in 70% I.P.A.
Clean the surface of the M Air T isolator air sampler with a lint free cloth dipped in the disinfectant solution before and after each operation.
Maintained the record in Annexure No. (Format No.).
For use under a flow hood, autoclave the sampling head and sieve.
Calibration
Calibration of the instrument should be performed once in a year by external party.
Maintenance
Avoid spraying liquids into the tester.
Tester head should not be opened.
Operate the pump only after installing all the accessories.
Forms and Records (Annexures)
M Air T Isolator Air Sampler Record
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
History:
| Date | Revision Number | Reason for Revision |
| 00 | NEW SOP |
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