SOP of Air Sampler

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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