Preparation of Cleaning and Sanitizing Solution in Manufacturing Area

In this post Standard Operating Procedure Preparation of Cleaning and Sanitizing Solution in Manufacturing Area in Pharmaceuticals is describe.

1.0 OBJECTIVE:

1.1 To lay down the procedure for preparation of cleaning and sanitizing solution in manufacturing area.

2.0 SCOPE:

2.1 This procedure is applicable to preparation of cleaning and sanitizing solution in manufacturing area.

3.0 RESPONSIBILITY:

3.1 Housekeeping personnel, Officer, Executive – Production Department

3.2 Manager – Production Department

4.0 DEFINITION(S):

4.1 NA

5.0 PROCEDURE:

5.1 Safety Precautions

5.1.1 Use proper safety apparel such as gowns, rubber hand gloves and safety goggles during preparation and use.

5.2 Cleaning and Disinfectant solutions:

2.5 %v/v Dettol

0.1 %v/v Teepol / 0.1 %v/v SU120

2.5 %v/v Savlon

70% v/v Iso-Propyl Alcohol (IPA)

0.4 % w/v sodium hydroxide

2 % Sodium lauryl Sulphate Solution

5.2.1 Preparation of disinfectant and cleaning solution:

Solution No. – I: 2.5 % Dettol (For 1 Liter)

Take 25 ml of Dettol and make-up to 1000 ml with Purified water. Mix well and use within a day.

Note: Destroy the remaining (unused) quantity of solution by pouring in drain point at the end of the working day.

Solution No. – II: 0.1% Teepol / 0.1% SU120 (For 10 Liters)

Take 10 ml of teepol /SU120 and make-up to 10 liters with purified water. Mix well and use within a day.

Note: Destroy the remaining (unused) quantity of solution by pouring in drain point at the end of the working day.

Solution No.-III: 2.5% Savlon (For 1 Liter)

Take 25 ml of Savlon and make-up to 1000 ml purified water. Mix well and use within a day.

Note: Destroy the remaining (unused) quantity of solution by pouring in drain point at the end of the working day.

Solution No.-IV: 70% v/v IPA

Considering the density of IPA 0.783 M/V, calculate the volume of IPA as per the weight of IPA dispensed.

D=M/V, V=M/D (Example: D=0.783, M=10 kg (dispensed quantity of IPA) V=10/0.783, V= 12.771 liters And calculate the total volume of disinfectant solution by multiplying the volume of IPA with factor 100 and the dividing it by 70 (i.e. 70%).

Total Volume of disinfectant (T) = VX100/70

Total Volume of disinfectant (T) = 12.771 X100 / 70 =18.244 liters

Now calculate the volume of purified water to be added (i.e. 30% v/v of IPA solution) by subtracting the Total Volume of disinfectant (T) by volume of IPA (V).

Quantity of water (W) = T – V

Quantity of water (W) = 18.244 – 12.771 =5.473 liters. D=density, M= Mass (weight) of IPA dispensed, V=Volume

Note: Pour the remaining (unused) quantity of solution by diluting with excess quantity of Purified water (i.e. 170 mg of IPA / Kg of water) drain point at the end of the working day of weekend or from the week of preparation of 70 % v/v IPA soln .

Solution No.-V: 0.4 % Sodium hydroxide (NAOH) (For 1 Litre)

Take 4 gm of NAOH and make-up to 1000 ml with Purified water. Mix well and use within a day.

Note: Destroy the remaining (unused) quantity of solution by pouring in drain point at the end of the cleaning activity.

Solution No. VI: 2 % Sodium lauryl sulphate solution (SLS Solution – For 1 Litre):Take 20 g Sodium Lauryl Sulphate and dissolve in 1 liter of purified water in the soap holding

tank. Fill the required soap solution (2% w/v Sodium Lauryl Sulphate (For 1 liter 2% Sodium Lauryl

Sulphate,Always prefer destruction of 2.5 % Disinfectant solution after destruction of 0.1 %Teepol / SU120

Solution / SLS Solution and 70% v/v IPA Solution.

5.2.2 Calculation of IPA before drain:

- 170 mg of IPA/Kg of water.

- or 50 gm of IPA/294 Kg of water.

- or 100 gm of IPA/588 Kg of water.

5.2.3 Maintain record in ‘Cleaning and Sanitization Solution Preparation Register’ as per Annexure

-I, “Cleaning and Sanitization solution utilization record.

6.0 ABBREVIATION(S):

6.1 IPA : Iso-Propyl Alcohol

6.2 ml : Milliliters