Active Air Sampler SOP Operation and Cleaning : Complete Guide

An Active Air Sampler SOP is used in pharmaceutical microbiology laboratories to monitor viable microorganisms present in the surrounding air. Proper operation, cleaning, and handling of the instrument are essential to obtain reliable environmental monitoring results and prevent cross-contamination between sampling locations.

This SOP describes the step-by-step procedure for operating and cleaning the Active Air Sampler, including preparation of the instrument, media plate handling, air sampling, post-sampling activities, incubation, cleaning, and important safety precautions.

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Objective for Active Air Sampler SOP

To establish a standardized procedure for the proper operation, cleaning, and handling of the Active Air Sampler used for viable air monitoring in the Microbiology Laboratory.

The procedure is intended to ensure that air samples are collected consistently, the sampling equipment is handled appropriately, and the possibility of contamination during sampling and cleaning is minimized.

Scope

This SOP applies to the operation and cleaning of the Active Air Sampler used for environmental monitoring in the Microbiology Laboratory.

It covers:

Preparation of the active air sampler before use
Placement and handling of microbiological media plates
Collection of air samples
Handling of sampled plates
Incubation of exposed plates
Recording and reporting of microbial counts
Cleaning and storage of the air sampler
Safety precautions during operation and cleaning

Responsibility

Designation	Responsibility
Officer / Executive – Microbiology Department	Responsible for operating, cleaning, handling, and storing the Active Air Sampler in accordance with this SOP. The analyst shall ensure that sampling is performed at the approved locations and that all observations and results are properly recorded.
Head / Designee – Quality Control Department	Responsible for ensuring that this SOP is implemented and followed. The Department Head/Designee shall ensure that personnel are appropriately trained and that deviations or abnormal observations are addressed through the applicable quality system.

Procedure for Active Air Sampler

Pre-Operation Checks

Before starting the air sampling activity, verify the following:

Ensure that the Active Air Sampler is sufficiently charged and ready for operation.
Check the external condition of the instrument for any visible damage, dirt, or abnormality.
Verify that the instrument is within its applicable calibration or qualification status.
Ensure that the sampling head and plate holder are clean.
Confirm that the required microbiological media plates are available and properly identified.
Carry the instrument carefully to the approved sampling location.
Perform the sampling activity in accordance with the approved environmental monitoring schedule and sampling plan.

Operation of Active Air Sampler

Preparation of the Sampling Head

Remove the sampling head carefully from the instrument.
Clean the external surfaces of the sampling head using a suitable lint-free cloth moistened with 70% IPA.
Allow the surface to dry appropriately before placing the microbiological media plate.
Place the approved and pre-incubated culture media plate on the plate holder.
Ensure that the plate is correctly positioned and securely seated.

Placement of Media Plate

Remove the lid of the media plate immediately before starting sampling.
Minimize the exposure time of the uncovered plate before commencement of sampling.
Carefully place the sampling head over the media plate.
Ensure that the sampling head is correctly positioned and does not disturb the agar surface.
Avoid touching the agar surface or other critical portions of the media plate.

Air Sampling

Switch ON the instrument using the power button.
Set the required sampling volume/time according to the approved environmental monitoring procedure and instrument configuration.
For the established operating condition, set the sampling period to 10 minutes, corresponding to approximately 1000 litres of air, where this operating condition is supported by the instrument’s validated flow rate.
Start the sampling cycle using the designated start control.
Do not move or disturb the instrument during sampling.
Allow the instrument to complete the programmed sampling cycle.
The instrument shall stop automatically at the end of the programmed cycle, where the automatic-stop function is available.
After completion, carefully remove or open the sampling head as applicable to the instrument design.
Immediately replace the lid on the exposed media plate.
Avoid unnecessary exposure of the sampled plate to the surrounding environment.

Sampling at Additional Locations

Clean the sampling head and plate holder with 70% IPA before proceeding to the next sampling location.
Allow the cleaned surfaces to dry as appropriate.
Repeat the sampling procedure for each designated location.
Use a separate appropriately identified media plate for each sampling location.
Record the required details, such as sampling location, date, sampling time, plate identification, sampling volume, and analyst initials/signature, in the applicable environmental monitoring record.

Post-Sampling Handling of Media Plates

After completion of air sampling, ensure that the exposed media plate is properly closed.
Check the plate identification and confirm that it corresponds to the sampling location.
Transfer the sampled plates to the designated microbiological incubation area without unnecessary delay.
Incubate the plates according to the approved microbiological test method and validated site procedure.
Where the established method specifies the two-stage incubation condition, incubate the plates initially at 20–25°C for 3 days, followed by 30–35°C for 2 days.
Examine the plates at the specified observation stages.
Record the observed microbial growth as CFU per 1000 litres of air, where a 1000-litre sample has been collected.
Identify and handle any unusual growth, excessive contamination, or abnormal observation according to the applicable environmental monitoring procedure and deviation/OOS/OOT system.

Important: Incubation temperatures, duration, sampling volume, alert/action limits, and reporting requirements should be based on the site’s approved and validated microbiological method. They should not be changed solely on the basis of this general SOP.

Cleaning of Active Air Sampler

Proper cleaning of the air sampler is important to minimize the risk of contamination being transferred between sampling locations.

Switch OFF the instrument after completion of sampling.
Remove the sampling head and other removable components as permitted by the manufacturer’s instructions.
Clean the sampling head and plate holder gently using a clean, lint-free cloth moistened with 70% IPA.
Clean the external body of the instrument carefully.
Do not spray IPA directly onto the instrument.
Ensure that liquid does not enter the display, switches, charging port, electrical connections, or other openings.
Clean the display only with a clean, dry, lint-free cloth.
Allow the cleaned components to dry before reassembly or storage.
After cleaning, visually inspect the instrument for cleanliness and any signs of damage.
Place the air sampler in its designated protective case.
Store the instrument in the designated location under the conditions specified by the manufacturer or site procedure.

Cleaning Frequency

The Active Air Sampler shall be cleaned:

Before use, where required by the approved sampling procedure.
Between different sampling locations where applicable to prevent cross-contamination.
After completion of the sampling activity.
Whenever visible contamination or dirt is observed.
After maintenance or servicing, where applicable.
At any additional frequency specified in the equipment-specific procedure or manufacturer’s instructions.

Safety and Handling Precautions

Handle the Active Air Sampler carefully to prevent physical damage.
Do not drop, strike, or place excessive pressure on the instrument.
Do not spray IPA directly onto the instrument.
Use a lint-free cloth for cleaning.
Prevent IPA from entering electrical or electronic parts of the equipment.
Do not touch the agar surface of the microbiological media plate.
Minimize the time for which a media plate remains uncovered.
Perform environmental monitoring activities in accordance with the approved laboratory and environmental monitoring procedures.
Where required by the site procedure, perform media handling and related activities under the designated Laminar Air Flow (LAF) or other qualified controlled environment.
Follow applicable laboratory safety requirements while handling disinfectants and microbiological cultures.
Report any instrument malfunction, abnormal noise, display error, physical damage, or other unusual observation to the responsible person.

Acceptance and Reporting of Results

The microbial count obtained from active air sampling shall be recorded in the approved environmental monitoring format.

Results shall be evaluated against the applicable site-approved alert and action limits, which should be established according to the area classification, applicable regulatory requirements, product/process risk, and the site’s environmental monitoring program.

Any result exceeding an established alert or action limit shall be handled according to the approved environmental monitoring, deviation, investigation, and CAPA procedures.

Abbreviations

Abbreviation	Full Form
SOP	Standard Operating Procedure
QA	Quality Assurance
QC	Quality Control
QCM	Quality Control – Microbiology
IPA	Isopropyl Alcohol
LAF	Laminar Air Flow
CFU	Colony Forming Unit
NA	Not Applicable
%	Percentage
°C	Degree Celsius

Change History

Effective Date	Change Control No.	Details of Revision	Reason for Revision
—	—	Initial issue	New SOP

References