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Saturday, May 8, 2010

STANDARD OPERATING PROCEDURE Title: Environmental Monitoring Of Microbiology Lab

Purpose:
To describe the methods and standards and methods for the environmental monitoring of sterility testing suite
2.0 Responsibility:
• QC Manager
• Microbiologist
1. Materials:
• Tryptic soy Agar (SAD)
• Sterile cotton swabs.
• Sterile phosphate buffer pH 7.2 in screw caped tubes (flask)
• Sterile S.S tube stand.
• LFH

3.0 Procedure:

A: SETTLE PLATES EXPOSURE.
Expose one settle plate each for one hour at the following locations I sterility testing room.
Near the entrance (inside)
On table top
With in the laminar flow hood for the entire duration of the test o monitor the air during test. The plate is exposing between the analyst and the test apparatus.
(Frequency: daily on the day of test if his area is not operative then twice a week to monitor the area condition.
B: SURFACE SWAB TEST.
I Frequency once a fortnight
II Test sites
Testing room two sites on the floor and two sites on the wall and two sites on LFH bench

Change Room
Two sites each on the floor and walls.



III Method:
1. Unwrap the swabs.
2. Take out the forceps
3. Loosen the screw Capsule of tube containing phosphate buffer pH: 7.2 placed in the tube stand.
4. Wet the swab in phosphate buffer pH 7.2 and drain excess liquid.
5. Swab an area of 2.5 x 2.5 inches square on the walls, floor and LFH buffer pH 7.2 Label with site tested and date.
6. Test all the sites in similar manner
7. When completed proceed for the testing of the swab.

C: INCUBATION:
Incubate all tests at 30C for 72 hours and up to 5 days

D: CORRECTIVE ACTION:

When action levels are exceeded the following steps are to be followed.
Stop testing
Do extra mopping with 5% phenol
Fumigate the area with formalin

E: ALERT AND ACTION LEVEL

The following limits are the guide line to assess the environment.

1. Swab Test Alert Action
A Laminar flow bench 2 CFU/ test 2 tests exceed alert on the same day or 10 CFU per test
B Floor & Walls 50% of plates with growth 25 CFU / plate
2. SETTLE PLATES
A Outside LFH 8 CFU / Plate 3 consecutive tests over alert level or 40 CFU/Plate
B Inside LFH 1 CFU/ Plate 3 consecutive tests over alert level or 6 CFU/Plate

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