To lay down the procedure for validation for effectiveness of the disinfectant.
2.0 SCOPE
This SOP shall be applicable for validation for effectiveness of all disinfectants in the Microbiology Lab.
3.0 RESPONSIBILITY
3.1 Microbiologist 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 Make 0.5%, 1.0%, 1.5%, 2.0%, 2.5% & 5.0% solution of all disinfectant which are used for mopping and spraying of production area and microbiology lab etc.
5.2 1ml 0.5%, 1.0%, 1.5%, 2.0%, 2.5% & 5.0% diluted disinfectant solution shall be take in sterile Petri plate in duplicate mark it.
5.3 Sterile soybean casein digest agar media shall be taken and melted at about 45°C and contaminated media with appr. 100 orgss. of Bacillus subtilis. Staphylococcus aureus etc.
5.4 Contaminated media appr. 15-20ml shall be poured into the above petri plates and rotate for proper spreading and allow to solidify.
5.5 One plate without disinfectant solution shall be prepared for positive control.
5.6 An another plate shall be prepared without disinfectant solution and organism (plain SCDA media) for negative control.
5.7 After solidification plates shall be incubated at 30- 35°C for 48 hrs. for bacteria and further 20 – 25°C for 72 hrs for fungus.
5.8 After 5 days the result shall be observed.
5.9 If growth is not observed in any of the diluted disinfectants means that the concentration is effective for sanitation and cleaning.
6.0 REFERENCES
N.A
7.0 ANNEXURE
N.A
8.0 ABBREVIATIONS :
SOP : Standard Operating Procedure
QCD : Quality Control Department
EQP : Equipment
Dept. : Department
QC : Quality Control
QA : Quality Assurance
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
Lab. : Laboratory
Appr. : Approx
Orgss : Organism
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