STANDARD OPERATING PROCEDURE FOR VALIDATION FOR EFFECTIVENESS OF DISINFECTANT

1.0 OBJECTIVE

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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