To lay down the procedure for environmental monitoring by the settle plate method.
2.0 SCOPE
This SOP shall be applicable for environmental monitoring by the settle plate method in Microbiology Laboratory.
3.0 RESPONSIBILITY
3.1 Microbiologists and above shall be responsible for the preparation and execution of this SOP
3.2 QC & QA Head shall be responsible for the checking and approval of this SOP.
3.3 HOD shall be responsible for the authorization of this SOP.
4.0 ACCOUNTABILITY
Head QC
5.0 PROCEDURE
5.1 Nutrient agar media shall be prepared as per SOP of preparation of media preparation and prepare the settle plates for microbial bioburden evaluation.
5.2 Pre-incubated plates shall be carried aseptically in an SS container to the processing area.
5.3 The details shall be marked on the plate given ahead: (1) Date of exposure (2) Area of exposure, location
5.4 Petri plates shall be exposed at the predefined place and slowly remove the lid of the petri dish without touching the media inside and keep it on the edge of the bottom plate
5.5 All Petri dishes shall be exposed in the respective areas in the same manner.
5.6 Petri dishes shall be exposed for 4 hours or as a validated cycle.
5.7 After exposure, Petri dishes shall be closed slowly without touching the media inside.
5.8 After the completion of the plate exposure time, Petri plates shall be covered & replace back in SS container in an inverted position.
5.9 SS container shall be carried in the microbiology lab and incubate the plates at 20–25ºC for 72 hrs for fungal detection and further transfer the plates at 32.5 ± 2.5ºC for bacterial contamination.
5.10 The colony forming units shall be counted present in each Petri plate with the help of colony counters and record results as per Annexure I.
5.11Observation of exposed plates shall be taken on a daily basis for better communication of the result
5.12 And final observation after 5 days shall be recorded in Annexure I.
5.12.1 Blank Determination: Preserve one agar plate prepared simultaneously but without exposure and incubate it along with other exposed plates at the same temperature and same time. This plate will serve as a blank for comparison.
5.13Positive control: positive control shall be the GPT of sterilized media
5.14 Precautions
5.14.1 The personnel in charge of the cleaning and sanitation shall be use gloves and dress.
5.14.2 Ensure to strictly follow the instructions in the handling of each cleaning solution subject to their functional characteristics.
5.14.3 The whole process of cleaning and sanitation shall be carried out with purified water.
5.14.4 Skin Contact shall be avoided with the sanitation solutions as they are irritating in nature.
6.0 REFERENCES
N.A
7.0 ANNEXURE
|
Annexure No. |
Title of the Annexure |
Format No. |
|
Annexure I |
Environmental Monitoring
Record of Production Area |
F……………………… |
|
Annexure-II |
Environmental Monitoring
Record of Microbiology Area
|
F……………………... |
SOP : Standard Operating Procedure
QCD : Quality Control Department
Dept. : Department
QC : Quality Control
QA : Quality Assurance
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
I.P.A : Iso Propyl Alcohol
END OF DOCUMENT
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the In-vivo Laboratory.
4. List of All SOPs and Documents for Clinical Research
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6. List of All SOPs and Documents for the Animal House Facility
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