SOP on Operation, Calibration, Cleaning and Maintenance of M Air T Air Sampler

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1.0 Objective:

To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of M Air T Air Sampler

2.0 Scope:

This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of M Air T Air Sampler of pharmaceutical formulation plant.

3.0 Responsibility:

Microbiologist or above of Microbiology Laboratory: Preparation of SOP.

Head – Microbiology section / Nominee: Checking of the SOP.

4.0 Accountability:

Head – Quality Control / Nominee: Compliance of SOP.

5.0 Abbreviations:

SOP    : Standard operating procedure

No.      : Number

QC      : Quality Control

QA       : Quality Assurance

EOC    : End of Cycle

IPA      : Isopropyl Alcohol

6.0 Procedure:

Make: Millipore, Model: M Air T

6.1 Pre Requisites

6.1.1 Sterilize and carry all accessories to the area to be monitored.

6.1.2 The M Air T mainly consists of M Air T apparatus, micro perforated sieves, tripod, and battery charger.

6.1.3 Unlock and remove the micro perforated sieve from the tester.

6.1.3 Remove the cover from the sieve and place the sieve in butter, paper and sterilize in an autoclave.

6.1.4 Take the required number of pre-sterilized (filled with Soyabean Casein Digest agar) agar medium cassettes wrapped in double sleeve packing.

6.1.5 Disinfect the outer surfaces of wrappings with disinfectant in use. Enter into the aseptic area following aseptic area entry and exit SOP of the concerned block.

6.1.6 Place the cassette in the air sampler under an LAF.

6.2 Switching the Sampler ON

6.2.1 Push the ON / OFF Button

6.2.2 After pressing the ON / OFF button the previously selected air sample volume retained in the memory appears on the display.

6.2.3 Press the START / DELAY button twice, so that the display flashes the remaining volume of air to be sampled in the decreasing order.

6.2.4 At the end of the process the display indicates EOC (End of Cycle).

6.2.5 Ensure that the sampling volume is 1000 liters per location.

6.3 Adjusting the Volume to be processed

6.3.1 Push the liters button.

6.3.2 The previously selected volume appears on the screen.

6.3.3 To access other preset volumes press the liters button once.

6.3.4 The preset volume ranges from 25 L, 50 L, 100 L, 250 L, 500 L, 750 L and 1000   Liters.

6.3.5 Press the Liters Key down until the display indicates 1000.

6.3.6 Start the sampling by pressing the START / DELAY button twice.

6.4 Adjusting the Timer to select DELAY Time:

6.4.1 To change the time setting, hold the START / DELAY button.

6.4.2 The display shows previously selected value and starts to count down time.

6.4.3 Time can be changed in increments of 5 minutes up to 1 hr.

6.4.4 To start the count down press down the START / DELAY button again.

6.4.5 To stop press the ON / OFF button.

6.5 Sampling of Air

6.5.1 Unlock and remove the micro perforated sieve from the Tester.

6.5.2 Remove the cover from the sieve.

6.5.3 Sanitize the external surface of the Tester with the filtered 70% IPA.

6.5.4 Position the wings of the cassette into the recessed area of tester head.

6.5.5 Retain the cassette position by holding on its wings.

6.5.6 Remove the lid of the cassette and place it on the bench.

6.5.7 Lock the micro perforated sieve into position.

6.5.8 Press the ON / OFF button.

6.5.9 Perform the air sampling at workbench level.

6.5.10 When the display indicates EOC, unlock the sieve remove it and put the lid back on the cassette.

6.5.11 To remove the cassette from the Tester head, lift the cassette while firmly holding the edge.

6.5.12 Label the location code, Date of Exposure, Media lot number and Date of Media Preparation on plate.

6.5.13 Bring the cassettes to the microbiology lab and incubate.

6.6 Precautions to avoid false positive/negative results

6.6.1 Do not use oxidizing agents such as hydrogen peroxide or per acetic acid.

6.6.2 Avoid spraying liquids into the tester.

6.6.3 Do not autoclave or flame the entire tester.

6.6.4 The stainless steel micro perforated sieve can be autoclaved without its cover.

6.6.5 Do not open the tester head.

6.6.6 Do not perform any activity over the sampler while it is sampling.

6.6.7 Incubate the cassette in inverted position to avoid dehydration of the media.

6.7 Calibration

6.7.1 Calibration shall be done by outside party once in a year.

6.8 Cleaning

6.8.1 The sieve plates and the outer body of the M Air T sampler should be cleaned before and after taking sample with the help of lint free cloth soaked in 70% I.P.A.

5.9 Maintenance

6.9.1 Charge the sampler batteries overnight after taking around 35 samples.

6.9.2 Batteries should be replaced as soon as they get too old.

6.9.3 The micro-perforated sieve should be cleaned with mild detergent, decontaminated with 70% IPA or autoclaved.

6.9.4 Avoid spraying liquids into the tester.

6.9.5 Tester head should not be opened.

7.0 List of Annexure / Formats:

7.1 Not applicable

8.0 References (if any).

8.1 M Air T Sampler Manual

9.0 Distribution

9.1   Master Copy                                     : Documentation Cell (Quality Assurance)

9.2   Controlled Copies                            : Quality Assurance, Microbiology-QC

10.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

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