SOP For Cleaning, Operation & Calibration of Volumetric Air Sampler
by
OBJECTIVE
To lay down the procedure for the operation of the Volumetric Air Sampler.
SCOPE
This SOP is applicable to the operation of a volumetric air sampler in the Microbiology department.
RESPONSIBILITY
Microbiology Personnel shall be responsible for the operation of the volumetric air sampler and maintaining its records.
Executive Microbiology or above who is trained and well versed with the procedure shall be responsible for ensuring that the same procedure is carried out correctly and checking the documents for completeness of the content.
Head – Microbiology/ Designee shall be responsible for the compliance of the procedure.
ACCOUNTABILITY
Head – Microbiology/ Designee shall be accountable for the proper implementation of the SOP.
DEFINITIONS
Air Sampler: A Device used to sample a measured amount of air in a specified time to quantitate the particulate or microbiological status of air in a controlled environment. The air sampling system works on the principle of isokinetic sampling drawing a defined volume of air.
PROCEDURE
Equipment Details:
S. No.
Equipment Name
Equipment ID
Model
Instrument Make
01
Air Sampler
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Sampling Flow: 100 L/min
Sampling Port Flow Rate: 0.38 m/s
Pre-requisites before air sampling:
Make sure that the area to be sampled is clean before performing air sampling.
Ensure proper gowning before entering the area for air sampling.
Always use freshly prepared routine disinfectant for cleaning of volumetric air sampler and ensure proper cleaning of the instrument parts.
Before starting the operation, ensure that DP, RH, and temperature should be under limit.
Check the electrical cables, never use a damaged or worn instrument.
Ensure that the charger is disconnected.
Reagents & Equipments:
Disinfectants for cleaning (Ultrabasil Plus, Imagard Biquat, Imagard IG PRO)
Disinfectant for fogging (Imagard HD)
0.2 µ filtered 70 % sterile IPA.
SCDA plates
Volumetric Air Sampler
Incubators.
Sample collection tools:
The volumetric air sampler battery must be charged for at least 4 hours before use.
Check the same with the indicator lamp on Sampler display panel.
The sampling plate is of 90 mm diameter disposable media plate or glass petri plate duly prepared as per the respective SOP.
Operation of Volumetric Air Sampler:
Press ON/OFF switch to power on the volumetric air sampler, LCD screen appears which consists of function keys on the front panel:
V1.1 : Software Version
O : Operating Staff Number
L : Sampling Location Number
D : Petri dish Number
T : Date and Time
Press the “ENTER” button, then press ” ” key to navigate when the number is highlighted, then by pressing ” ” key, adjust the operating staff number, sampling locations, petri dish number, time, date, pre-set sample volume (liters) and other parameters successively.
Press the “ENTER” button to confirm the adjustments.
Sample volume can be pre-set as 1000L, 500L, 600L, then press “S1”, “S2″, S3” is corresponding to 1000L, 500L, 600L.
To set the delay time, long press “MENU” button along with ON/OFF button, the screen shows the delay mode.
Press ” ” to navigate and set the delay time (“0040”, delay time – time after which the volumetric air sampler shall start aspirating the air).
Again press “ENTER” to fix the delay time.
After the delay time is over the screen displays a sample volume of air to be drawn and “0000” indicates the no. of liters of air being drawn, which will slowly increase and stop after completely drawing the programmed air volume.
If the instrument has a residual liquid of disinfectant, do not place it in a petri-dish.
Press the button S1 or S2, the air sampler will run at pre-set sample volume.
The pump starts sucking in air, when it reaches the set volume, the pump stops.
When the sampling is completed, lift the top and midsection from the base and close the petri dish with its lid.
Remove the petri dish from the sampler and put the midsection and top back to the base.
Seal the petri dish and put the medium in the incubator for cultivating.
To search the historical data, in the state of the main interface, press “MENU” button to search the data.
Press ” ” button to search for data.
Air sampling using FKC – 1B Air Sampler:
Wrap the aspirating head with micro-perforated sieves in an aluminum foil and sterilize in an autoclave at 121.5 °C for 30 minutes.
Take the required number of pre-sterilized agar medium plates in S.S. container.
Disinfect the outer surfaces of S.S. container with 0.2 µ filtered 70 % sterile IPA.
Enter into the sampling locations area by following the area’s entry and exit procedure.
Place the volumetric air sampler at the pre-defined approved locations mentioned in the sampling plan.
Press the ON/OFF switch to power ON the volumetric air sampler and wait for few minutes for the system to initialize and get ready for the sampling.
Check the screen for Volume, Date and Time display, Battery status, Mode, Site, Unit ID, User ID before starting the volumetric air sampler.
Sanitize the petriplate housing head by spraying 0.2 µ filtered 70 % sterile IPA and run the air sampler for 30 seconds.
Aseptically, take out the pre-incubated Soybean Casein Digest Agar plate from S.S. container, place it in the petriplate housing head and remove the lid of petriplate.
Aseptically place the sterile aspirating head and fix it.
Select the volume of air to be sampled/ aspirated, and enter date & time, sampling location ID, and operator ID, as per the procedure in section: Operation of air sampler.
After entering the data, press ENTER to run the volumetric air sampler.
The screen shall display the number of volumes of air being aspirated and after completion of aspirating, the volumetric air sampler shall give a beep.
Remove the aspirating head aseptically and place the lid on the Petri plate.
The plate shall be removed by lifting the plate while firmly holding the edge.
Transfer the Petri plate to S.S. container and transfer to the microbiology Lab for incubation as per the SOP.
After incubation, count the no. of colonies developed on the plate.
Record the usage details in the Annexure-I.
Cleaning:
Clean the aspirating head, petri dish and sampling head cover with 0.2 µ filtered 70 % sterile IPA before and after every operation.
Clean the mid section and inner surfaces of the components with disinfectant.
Calibration:
Frequency: 1 year ± 1 month
Calibration of the volumetric air sampler is to be performed by supplier’s service Engineer.
Maintenance:
In case of any discrepancy affix “UNDER MAINTENANCE” tag with sign and date & inform Engineering & Maintenance Department for rectification.
ABBREVIATIONS
SOP : Standard Operating Procedure
MB : Microbiology
VAS : Volumetric Air Sampler
DP : Differential Pressure
RH : Relative Humidity
SCDA : Soyabean Casein Digest Agar
mm : Millimeter
kPa : KiloPascal
LCD : Liquid Crystal Display
SS : Stainless Steel
IPA : Iso Propyl Alcohol
L : Liter
CFU : Colony Forming Units
REFERENCES
Operation Manual
ANNEXURES
Annexure-I : SOP/MBXX-YYY Volumetric Air Sampler Usage Logbook
DISTRIBUTION DETAILS
SOP shall be distributed to Quality Assurance and Microbiology Department.
REVISION HISTORY
SOP Version No.
Change Control No.
Reason For Revision
Effective Date
CC-XX-YY
VOLUMETRIC AIR SAMPLER USAGE LOGBOOK
Make: ______________________ Instrument ID No.: __________________
