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SOP on Preparation of Cleaning and Sanitizing Solution in Manufacturing Area

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Procedure for Preparation of Cleaning and Sanitizing Solution in Manufacturing Area. Cleaning is important in the pharmaceutical area to keep the product safe from harmful microorganisms.

Preparation of Cleaning and Sanitizing Solution in Manufacturing Area

1.0 Objective: The aim of this procedure is to establish guidelines for the proper preparation of cleaning and sanitizing solutions in the manufacturing area.

2.0 Scope: This procedure pertains to the preparation of cleaning and sanitizing solutions within the manufacturing area.

3.0 Responsibility:
Housekeeping Personnel
Officer, Executive – Production Department
Manager – Production Department

4.0 Definitions:
Not Applicable (NA)

5.0 Procedure:
5.1 Safety Precautions:
5.1.1 During the preparation and use, ensure proper safety attire such as gowns, rubber hand gloves, and safety goggles are worn.
5.1.2 While diluting, add a disinfectant to the water.

5.2 Cleaning and Disinfectant Solutions:
The following solutions are used for cleaning and disinfection production area:

Solution No. – I: 2.5% v/v Dettol (For 1 Liter)
Take 25 ml of Dettol and dilute with purified water to make 1000 ml. Mix well and use within a day.
Solution No. – II: 0.1% v/v Teepol (For 10 Liters)
Take 10 ml of Teepol and dilute with purified water to make 10 liters. Mix well and use within a day.
Solution No. – III: 2.5% v/v Savlon (For 1 Liter)
Take 25 ml of Savlon and dilute with purified water to make 1000 ml. Mix well and use within a day.
Solution No. – IV: 70% w/w Iso-Propyl Alcohol (IPA)
Take 0.70 kg of IPA and dilute with purified water to make 1.00 kg. Use within a week.
5.2.2 Record Keeping:
Maintain a record in the ‘Cleaning and Sanitization Solution Preparation Register’ as outlined in Annexure –I.

6.0 Abbreviations:
IPA: Iso-Propyl Alcohol
Kg: Kilograms
ml: Milliliters
v/v: Volume by Volume
w/w: Weight by Weight
SOP: Standard Operating Procedure

7.0 References:
Not Applicable (NA)

8.0 Annexures:
ANNEXURE –I: Cleaning and Sanitization Solution Preparation Record

DateSolution No.Disinfectant UsedQuantity UsedPrepared ByChecked By
IDettol25 ml
IITeepol10 ml
IIISavlon25 ml
IVIPA0.70 kg

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