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.
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
| Date | Solution No. | Disinfectant Used | Quantity Used | Prepared By | Checked By |
|---|---|---|---|---|---|
| — | I | Dettol | 25 ml | — | — |
| — | II | Teepol | 10 ml | — | — |
| — | III | Savlon | 25 ml | — | — |
| — | IV | IPA | 0.70 kg | — | — |