“Standard Operating Procedure for Environmental Air Sampling Using Slit to Agar Air Sampler in Classified Areas”

1.0 Objective

The objective of this SOP is to provide clear and precise instructions on the use of the slit to agar air sampler, ensuring the effective monitoring of environmental air quality in controlled or classified areas. By following this procedure, users can perform air sampling with accuracy and consistency, reducing the risk of errors.

2.0 Scope

This procedure applies to the use of slit to agar air samplers in monitoring viable microbial contamination in classified areas such as clean rooms, pharmaceutical production environments, or sterile manufacturing zones.

3.0 Responsibility

• Operation: The procedure must be carried out by trained personnel such as a Microbiologist, Technical Assistant, or Executive.
• Supervision: An Executive or Manager is responsible for reviewing and ensuring the process is performed as per the SOP.

4.0 Accountability

The Head of the Department is accountable for the overall implementation of this SOP, ensuring it is followed correctly and consistently.

5.0 Procedure

5.1 Instrument Setup and Operation

1. Begin by pressing the “Safety” switch located on the left side of the instrument to ensure safety protocols are engaged.
2. Power on the air sampler by switching the red ON/OFF button located on the control panel.
3. Once powered on, the screen will illuminate with a bright yellow display. You will now be able to set up the instrument for air sampling.
4. To set the volume of air to be sampled, navigate to the option labeled “RST: PST (I)” on the display.
5. Use the arrow (>) key to select the volume adjustment digit, and then press the (+) or (-) key to adjust the volume to your desired value. Once the correct volume is set, press the “ENT” button to confirm.
6. After setting the desired volume, ensure that “PST (2)” is set to zero on the display to indicate a fresh cycle for sampling.

5.2 Preparation for Sampling

1. Sterilize the stainless-steel sampling head lid and the media plate lid by placing them into a stainless-steel perforated box. Subject these items to dry heat sterilization (DHS) at 180°C for a period of 2 hours to ensure all potential contaminants are eliminated.
2. Once sterilization is complete, carefully transport the sterilized box to the designated sampling area. Handle it with care to maintain sterility.
3. Before handling the equipment, sanitize your hands using 70% isopropyl alcohol. Allow the alcohol to dry thoroughly, and don sterilized gloves.
4. Prepare sterile Petri dishes (100mm x 15mm), each containing approximately 25ml of soybean-casein digest agar. Place these dishes in the sampler and cover them with sterile stainless-steel lids to maintain integrity.

5.3 Air Sampling Process

1. To initiate the sampling process, press the black reset button located on the instrument’s control panel. You will see a green light on the “RUN” switch, indicating that the sampling process has begun.
2. The instrument will begin drawing air through the slit to agar mechanism. The digital display will track the volume of air being sampled in real-time.
3. Once the set air volume is sampled, the green light will turn off, and the fan will stop running, indicating that the cycle is complete.
4. Carefully remove the sampling head and replace the Petri dish lid to avoid contamination.
5. Turn off the instrument and ensure it is safely powered down after each use.

5.4 Post-Sampling Procedures

1. Label each sampled Petri dish appropriately with relevant details such as location, time, and date of sampling.
2. Transfer the Petri dishes, along with the sampling head and media plate lid, to a stainless-steel container for safe transport to the microbiological laboratory.
3. In the lab, incubate the Petri dishes at a temperature of 30°C to 35°C for a period of 72 hours. This will allow viable microorganisms to grow, enabling an accurate viable count.

5.5 Cleaning and Preparation for Next Use

1. Prior to performing subsequent air sampling, decontaminate the stainless-steel sampling head and the media plate lid using 70% sterile isopropyl alcohol (IPA). Alternatively, you may opt to use freshly sterilized equipment.
2. If another sample is to be taken immediately, restart the device by pressing the black reset button and repeat the sampling process.
3. Follow the sampling schedule as defined in your environment’s monitoring plan.

6.0 Abbreviations

• DHS: Dry Heat Sterilization
• ml: Milliliter
• SOP: Standard Operating Procedure
• IPA: Isopropyl Alcohol