Friday, December 17, 2010
Monitoring By Active Air Sampler
1.0 OBJECTIVE :
The objective of this SOP is:
1.1 To lay down a procedure for active air sampling in sterile area.
2.0 RESPONSIBILITY :
2.1 The Quality Assurance Personnel shall be :
2.1.1 Responsible for Sampling.
2.2 The Microbiologist shall be :
2.2.1 Responsible for sampling and interpretation of results.
2.3 Executive - Quality Control shall be :
2.3.1 Responsible for checking and approving the results.
3.0 ACCOUNTABILITY :
Head - Quality Control
4.0 PROCEDURE :
4.1 SAMPLING PROCEDURE :
4.1.1 Prepare media
4.1.2 Prepare settle plates as
4.1.3 Autoclave the mesh of the Air-Sampler by covering it with aluminum foil or hydrophobic paper.
4.1.4 Transfer the sterile media plates to the respective areas in airtight S-S container & transfer materials.
4.1.5 Enter in the respective areas by following the proper entry (gowning) procedure.
4.1.6 Before entering into the area spray the outer portion of the container followed by moping with a lint free cloth with 70% IPA solution.
4.1.7 Open the container in the respective areas and put, date & time at the base of plates.
4.1.8 Open the sterile media plate and place it in the sampler subsequently by placing sterile mesh of the Air-sampler over the media plate.
4.1.9 Sample 1000 liters of air from a single sampling point.
4.1.10 After sampling open the mesh of Air –sampler and take out the agar plate from the sampler.
4.1.11 Cover the plate with lid and put it into the air tight container and bring it to the laboratory and incubate them, in a inverted position, in the incubators at 20-25°C for 72 hrs followed by 30-35°C for 48 hrs and note the observations in format as mentioned in monitoring plan.
4.1.12 Frequency, limits and locations are mentioned in the monitoring plan.
4.1.13 Store the records in documentation room.
4.2 Precautions :
4.1 Before handling of the sterile petri plate and Sampler mesh disinfect the hand gloves with 70% IPA solution.
4.2 Prevent movement around the area during sampling which can cause turbulence in the air.