Standard Operating Procedure (SOP) for Environmental Monitoring
1.0 Purpose: The purpose of this SOP is to provide guidelines for performing environmental monitoring in a laboratory setting.
2.0 Scope: This SOP applies to all personnel involved in performing environmental monitoring in the laboratory.
3.0 Responsibilities: The laboratory personnel responsible for performing environmental monitoring shall:
- Ensure that the monitoring area is clean and free from any contaminants.
- Follow the procedures outlined in this SOP.
- Document all procedures and results accurately.
4.0 Materials and Equipment:
- Swabs
- Sterile sampling bags
- Sterilization equipment (e.g. autoclave)
- Agar plates
- Incubator
- Sterilized forceps
- Air sampling equipment
5.0 Procedure:
5.1 Preparation of Culture Media:
- Follow the manufacturer’s instructions to prepare the culture media.
- Autoclave the media to sterilize it before use.
- Incubate the media to ensure that it is free from any microbial contamination.
5.2 Surface Sampling:
- Sterilize the workbench or laminar flow hood before use.
- Open a sterile swab package aseptically and moisten the swab with sterile saline.
- Swab a defined area on the surface of interest
(e.g. workbench, walls, equipment, etc.).
Transfer the swab to a sterile sampling bag.
Label the bag with the date, time, location, and sample identification number.
Transport the bag to the laboratory using a suitable container to avoid contamination.
Prepare culture media and perform microbial identification and enumeration on the swab sample using standard procedures.
5.3 Air Sampling:
- Sterilize the air sampling equipment before use.
- Set the sampling rate according to the manufacturer’s instructions.
- Position the sampler in the sampling area and allow it to operate for the appropriate time.
- Turn off the sampler and remove the sampling media.
- Label the media with the date, time, location, and sample identification number.
- Transport the media to the laboratory using a suitable container to avoid contamination.
- Prepare culture media and perform microbial identification and enumeration on the air sample using standard procedures.
5.4 Water Sampling:
- Sterilize the water sampling equipment before use.
- Collect water samples using sterile techniques.
- Label the container with the date, time, location, and sample identification number.
- Transport the container to the laboratory using a suitable container to avoid contamination.
- Prepare culture media and perform microbial identification and enumeration on the water sample using standard procedures.
6.0 Documentation:
- Record all procedures and results in a logbook or other suitable documentation system.
- Include the date, time, location, and the results of the environmental monitoring.
7.0 Safety Precautions:
- Wear appropriate personal protective equipment (PPE) when handling samples or culture media.
- Use caution when handling sharps such as syringes and needles.
8.0 References:
- USP <1116> Microbial Evaluation of Clean Rooms and Other Controlled Environments
- ISO 14644-1 Cleanrooms and associated controlled environments
9.0 Revision History:
- Version 1.0: Initial version.
- Version 2.0: Updated with revised procedures and references.
