SOP for Operation of Air Sampler

1.0 PURPOSE

To lay down the procedure for operation of Air Samplers.

2.0 SCOPE

It is applicable to Air samplers M Air T units for Routine Air sampling, Isolators and Compressed Air sampling.

3.0 RESPONSIBILITY

Microbiologist.

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Air Sampling by (M Air T)

5.1.1 To switch the Unit on, press the ON/OFF button.
5.1.2 Previously selected air sample volume retained in memory appears on the keypad display.
5.1.3 Push the LITRES button to change the desired volume as preset.
5.1.4 The present volumes are 25 L, 50 L, 100 L, 250 L, 500 L, 750 L, and 1,000 L.

5.2 Adjusting the delay timer (if required).

5.2.1 Hold down the START/DELAY button. The display will show the previously selected value and will start to count down the time (LCD display flashes).
5.2.2 Time can be changed in increments of 5 minutes up to one hour.

5.3 Installing a Cassette and Testing

5.3.1 The Unit works in the upright position or, by using a tripod, in the horizontal or inclined position. For testing above bench level, the Unit may be supported by a commercial tripod or can be used by hand.
5.3.2 The tripod enables the operator to use the Unit in two different positions: horizontally or at 30° from the horizontal position.
5.3.3 Fix the tripod onto the Unit by screwing it into the Unit fixing hole.
5.3.4 Ensure pre-filled media cassettes are at room temperature before starting the test.
5.3.5 Unlock and remove the micro-perforated sieve from the Unit.
5.3.6 Ensure the sieve is autoclaved or sanitized. Autoclave the sieve for 30 minutes at 121°C (see SOP for autoclave operation), and sanitize the external surfaces of the Unit with sterile, 70% IPA for next use.
5.3.7 Position the wings of the media cassette into the recessed area of the Unit head.
5.3.8 Retain the media cassette in position by holding on to its wings. Remove the lid, and place it on the bench internal face down.
5.3.9 Lock the micro-perforated sieve into position.
5.3.10 Press the ON/OFF button. Set the sampling parameters and then quickly press the START/DELAY button twice.
5.3.11 The display will flash then the unit will start.
5.3.12 The keypad display will indicate the countdown of the volume of air that remains to be sampled.
5.3.13 When the display indicates EOC, unlock the sieve, remove it, and put the lid back on the cassette.
5.3.14 To remove the cassette from the Unit head, lift the cassette while firmly holding the edge.
5.3.15 Label and incubate the cassette in the upside down position.

5.4 Precautions

5.4.1 Do not use oxidizing agents such as hydrogen peroxide or peracetic acid when cleaning the unit.
5.4.2 Do not use bleach on the micro-perforated sieves.
5.4.3 Avoid spraying liquids into the Unit.
5.4.4 Do not autoclave or flame the entire Unit. The stainless steel micro-perforated sieve can be autoclaved without its cover.
5.4.5 Do not open the Unit head.
5.4.6 Use specified battery type (Model R 14). Using another type may reduce the number of tests, and the volume of air processed during 5 last sampling cycles will not be guaranteed.
5.4.7 When replacing batteries, their polarity must be strictly respected. Polarity inversion may damage the equipment.
5.4.8 Do not use the charger with non-rechargeable batteries, to avoid damage.

5.5 Isolator and Compressed Air Sampling by (M Air T).

5.5.1 Control Keypad Description.

5.5.1.1  START: starts the action displayed on screen.

5.5.1.2  STOP: stops the action displayed on screen.

5.5.1.3  Deletes characters entered.

5.5.1.4  ENTER: go to next screen.

5.5.1.5  When scrolling through data entry screens (values or text), the cursor flashes after the last character entered.

5.5.1.6  Example.

5.5.1.7  S A M P L I N G V O L U M E ?

5.5.1.8  L I T E R S : 1 0 0 0.

5.5.1.9 Parameters can be changed using the key to delete information.

5.6 Starting the Pump

5.6.1 Turn on the pump using the switch on the back of the pump. After initial startup messages, the pump automatically runs an auto-test. After 5 seconds the following message displays:

M I L L I P O R E M A I R T I S O L

A U T O T E S T O K

5.6.2  The last calibration date appears after 5 seconds:

L A S T C A L I B R A T I O N

D A T E : D D M M  Y Y

5.6.3  After 2 seconds the following screen automatically displays:

V O L U M E S A M P L E D S I N C E

L A S T C A L I B : X X X X X X X L

5.6.4  Then the screen displays the parameters of the last sample taken.

R E A D Y D D M M M Y Y H R : M N

V O L : X X X X L C Y C L E : X

5.7 Checking Parameters or Stopping the Pump During Sampling

5.7.1  To check the parameters during pump operation, press the PARAM key. The   following display

appears:  

S T A R T D E L A Y

M I N : X

L O C A T I O N

X X X X X X X X

O P E R A T O R N A M E

X X X X X X X X X

5.7.2  To stop a sampling run, press the STOP key. The screen displays the following message:

S A M P L I N G A B O R T E D

V O L S A M P L E D : X X X X L

5.7.3  Alternating with this screen:

R E S U M E > E N T E R

A B A N D O N > S T O P

5.7.4  Press ENTER to restart sampling.

5.7.5 Press STOP to stop sampling and return to the main menu.

5.8 USING THE M AIR T CASSETTE

Note: Prefilled ready to use as well as empty sterile soybean-casein digest agar poured preincubated cassettes can be used.
5.8.1 Remove the sieve cover. Loosen and remove the sieve from the analyzer by twisting it anti-clockwise.
5.8.2 Grasp the cassette wings and place it on the sampling head. Lock the cassette into place.
5.8.3 Remove the cassette cover and place it on a work surface with the inside facing down.
5.8.4 Place the sieve over the cassette and lock it into position.
5.8.5 Remove the cassette by grasping the “wings” and lifting it off the sampling head after the sampling is done.

5.9 Installing the M Air T for multisampling at a single port

5.9.1 Connect the “FESTO” tubing to the sample port, the other end of “FESTO “ tubing shall be connected to the pressure reducer.
5.9.2 Connect the outlet of the pressure regulator to the pressure reducer of the M Air T.
5.9.3 Program the number of samples to be taken and delay timer (If required).
5.9.4 Open the valve of the sample port.
5.9.5 Regulate the pressure of the air so that the flow rate is in between 140L to 180L per minute.
5.9.6 Ensure that M Air T media cassette is in place before sampling is started.
5.9.7 Close the media cassettes properly after sampling
5.9.8 Clean the pump with 70 % IPA before taking it to the next sampling location/ port.
5.9.9 For the rest of sampling ports repeat the above-mentioned steps.

5.10 Shutting down the system

5.10.1 Clean the pump thoroughly with 70 % IPA after the sampling is completed.
5.10.2 Close all the inlets before removing the pump.
5.10.3 Cover the head with the lid provided for the purpose.
5.10.4 Shut down the instrument always in the idle mode.
Related: Procedure for Air Sampling in Sterile Pharmaceutical Manufacturing Area

5.11 Precaution

5.11.1 During sampling, the inlet gas flow rate must exceed the vacuum flow rate (136 liters/minute), so that the excess air will be diverted through the evacuation.
5.11.2 Program the desired parameters before starting the testing.
5.11.3 Do not use for microbiological monitoring of compressed Oxygen.
5.11.4 Do not sample gas/ air at pressures above the specified limit of 5 bar (73 psi).

5.12 Calibration

5.12.1 Calibration of the air samplers shall be done once in a year by an external agency.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 L - Litres
6.3 °C - Degree Centigrade
6.4 % - Percentage

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