1.0 Purpose

1.1 This procedure defines the requirements for preparing disinfectant solutions used to clean and disinfect the clean room areas, equipment, and facilities at the appropriate use concentrations.

2.0 Scope

2.1 This SOP applies to the preparation of the following disinfectant solutions for use at this pharmaceutical site:

– 0.1% Teepol solution

– 70% Isopropyl Alcohol (IPA)

– 2.5% Lysol solution

– 2.5% Cetrimide solution

– 2.5% Aldecol-H (Ultracid) solution

– 3.0% Chlorhexynol solution

– 2.5% Benzicide-V solution

– 2.5% Gramicide solution

3.0 Responsibilities

3.1 Operator: Technical Assistant or Executive responsible for executing the procedure as described.

3.2 Reviewer: Executive, Manager, or designated personnel responsible for reviewing documented activities against the SOP to ensure compliance.

3.3 Approver: Head of Department or relevant authority responsible for approving the SOP and to ensure the compliance.

4.0 Precautions

4.1 Personnel must wear appropriate personal protective equipment including goggles, gloves, and protective gowns when handling concentrated disinfectants.

4.2 Preparation must be done in an area with adequate ventilation to avoid buildup of chemical fumes.

4.3 Solutions must be properly labeled with contents, concentration, date prepared, and expiration date.

4.4 Disinfectant solutions must be stored separately from other materials in a dedicated area away from direct heat/sunlight.

6.0 Procedure

6.1 Preparation of 0.1% Teepol Solution

6.1.1 In a graduated cylinder, measure out 10 mL of the concentrated Teepol solution.

6.1.2 Transfer the 10 mL to a clean labeled 10-liter plastic container.

6.1.3 Using purified water, dilute to the 10 liter mark on the container.

6.1.4 Mix thoroughly using a clean stir bar on the magnetic stir plate for 5 minutes.

6.1.5 Label the container “0.1% Teepol Solution”, date, lot number, and expiry date.

6.2 Preparation of 70% IPA Solution

6.2.1 Obtain a clean labeled 25 liter plastic container.

6.2.2 From the approved raw material source, measure out 17.5 liters of 100% IPA into the container using a graduated cylinder.

6.2.3 Add 7.5 liters of purified water to the IPA to make 25 liters total volume.

6.2.4 Mix thoroughly using a clean stir bar for 10 minutes.

6.2.5 Filter the solution through a 0.2-micron sterilizing filter into a separate clean, labeled container.

6.2.6 Label as “70% IPA Solution”, date, lot, and expiry.

6.3 Preparation of 2.5% Lysol Solution

6.3.1 Measure 250 mL of concentrated Lysol solution into a graduated cylinder.

6.3.2 Transfer to a 25 liter plastic container.

6.3.3 Add 24.75 liters of purified water to make 25 liter total volume.

6.3.4 Mix thoroughly using a stir bar for 10 minutes.

6.3.5 Label the container “2.5% Lysol Solution”, date, lot, expiry.

6.4 Preparation of 2.5% Cetrimide Solution

6.4.1 Measure 250 mL of concentrated Cetrimide solution into a graduated cylinder.

6.4.2 Transfer to a 25 liter plastic container.

6.4.3 Add 24.75 liters of purified water to make 25 liter total volume.

6.4.4 Mix thoroughly using a stir bar for 10 minutes.

6.4.5 Label the container “2.5% Cetrimide Solution”, date, lot, expiry.

6.5 Preparation of 2.5% Aldecol-H (Ultracid) Solution

6.5.1 Measure 250 mL of Aldecol-H concentrate into a graduated cylinder.

6.5.2 Transfer to a 25 liter plastic container.

6.5.3 Add 24.75 liters of purified water and mix well with stir bar for 10 minutes.

6.5.4 Label the container “2.5% Aldecol-H Solution”, date, lot, expiry.

6.6 Preparation of 3.0% Chlorhexynol Solution

6.6.1 Measure 300 mL of concentrated Chlorhexynol solution into a cylinder.

6.6.2 Transfer to a 25 liter plastic container.

6.6.3 Add 24.7 liters purified water and mix thoroughly with stir bar for 10 min.

6.6.4 Label “3.0% Chlorhexynol Solution”, date, lot, expiry.

6.7 Preparation of 2.5% Benzicide-V Solution

6.7.1 Measure 250 mL of Benzicide-V concentrate into a graduated cylinder.

6.7.2 Transfer to a 25 liter plastic container.

6.7.3 Add 24.75 liters purified water and mix well with stir bar for 10 minutes.

6.7.4 Label “2.5% Benzicide-V Solution”, date, lot, expiry.

6.8 Preparation of 2.5% Gramicide Solution

6.8.1 Measure 250 mL of concentrated Gramicide solution into a cylinder.

6.8.2 Transfer to a 25 liter plastic container.

6.8.3 Add 24.75 liters purified water and mix thoroughly with stir bar for 10 min.

6.8.4 Label “2.5% Gramicide Solution”, date, lot, expiry.

7.0 Labeling and Storage

7.1 All prepared disinfectant solution containers must be clearly labeled with:

– Solution name and concentration

– Date prepared

– Lot number or unique identifier

– Expiration date

– Initials of preparing person

7.2 Prepared solutions must be stored in the designated disinfectant storage area, separated from other materials.

7.3 Storage area must be cool, dry, and away from direct heat or sunlight.

7.4 Solutions may be stored for up to 15 days from preparation date or up to the validated period.

 

Author:  Bhavana Tatineni

Qualification: MSc Microbiology