Personal monitoring by contact plate method in sterility testing area.
OBJECTIVE: To lay down a standard operating procedure for personal monitoring by contact plate method in sterility testing area.
SCOPE: This SOP is applicable for personal monitoring by contact plate method in sterility testing area.
RESPONSIBILITY:
Quality control – Executives
Quality control – Officer (microbiologist)
ACCOUNTABILITY: Quality control – Head
ABBREVIATIONS: SCDA: Soya bean Casein digest agar
PROCEDURE
Media preparation:
Prepare the media as per SOP for procurement, receipt, preparation, sterilization and storage of media for microbiological analysis, SOP.
Procedure for preparation of plates: Take the two-layer packed, pre sterilized RODAC (55 mm) plates. Remove the first layer of polythene of RODAC plates. Put in the pass box under U.V light for 30 minutes.
Transfer the plates from pass box to LAF bench.
Keep the media in LAF bench and cool the media to the temperature up to 45 – 50° C to avoid condensation on the petri plate lid.
Remove the second polythene packing of RODAC plate. Arrange the RODAC plates in LAF.
Dispense aseptically, the Soyabean Casein Digest agar, approximately 8 – 10 ml in presterilized RODAC plates. Allow the agar plates to solidify. Preferably wait till 30 mins. to let the sterilized media containing plates solidify.
After agar solidifies remove RODAC plates from the LAF bench.
Incubate the plates in inverted position at 30 – 35°C for 48 hours to ensure that they are free from any contamination before they are used. Mention the date of preparation at the bottom of the plate using a permanent glass marking pen.
Inspect each plate thoroughly for any colony, suspect colony, crack, condensate or dehydration.
If any such plate is observed, record and discard as per SOP for decontamination and disposal procedure used petri plates/ cultures/ biological indicators and slants in microbiological analysis SOP.
Procedure for personal monitoring by contact plate method. (Applicable for Microbiological testing area)
Take the required number of RODAC plates that are pre incubated for 48 hours.
Enter the testing area as per respective SOP for entry and exit procedure.
Take all the sanitized materials from the pass box and keep on the LAF bench.
Mark the Location ID/PM/DD/MM/YY on the inverted side of culture plate and sign the plate. Where Location
ID stands for sample location, PM stands for Personal monitoring, DD stands for date, MM stands for month and YY stands for year.
Microbiologist shall perform personal monitoring in testing area. For gloved hand monitoring should be in grade A and for gown, monitoring should be in grade B.
The lid of the RODAC plate shall be opened, part of the garment shall be pulled away from the body, & the medium shall be gently pressed to the surface of garment in such a way that the entire convex surface of agar shall touch the surface.
After sampling close the lid of contact plate and spray 70% IPA on the sampled location.
After sampling person should leave the area to remove the garments.
For sampling of gloved hands open the lid of the rodac plate and press 5 fingers gently on the agar surface.
Take samples from both the hands-on separate culture plates and mark appropriately with the name of the
sampling location.
After sampling close the lid of the plate and ask the personnel to spray the gloved hands with 70 %, IPA .
Keep one plate from a lot of plates used for sampling unopened as negative control.
Record the details of activity in format.
Incubation: –
Transfer the plates to the incubator at 200C-250C for 72 hours for fungal and at 30ºC-350C for 48 hrs. for Bacterial.
After completion of incubation, take the plates having colonies for count with help of colony counter.
REQUENCY: Monthly planning.