1.0 Purpose

To define the procedure for the preparation of disinfectant solutions used in pharmaceutical/biotechnology facilities for cleaning and sanitization purposes.

2.0 Scope

This SOP applies to all personnel involved in the preparation, dilution, and labeling of disinfectant solutions in the facility.

3.0 Responsibility

• QA Department: To approve the SOP and monitor compliance.
• Production/Engineering/Housekeeping Personnel: To prepare, label, and use disinfectant solutions as per SOP.
• QC Department: To perform efficacy testing of disinfectants, where required.

4.0 Definitions

• Disinfectant: A chemical substance used to reduce or eliminate microorganisms on surfaces.
• Working Solution: Diluted disinfectant solution prepared from concentrated stock, ready for use.

5.0 Materials and Equipment

• Disinfectant concentrate (e.g., IPA, Sodium Hypochlorite, Hydrogen Peroxide, Quaternary Ammonium Compounds, etc.)
• Purified water / WFI (as applicable)
• Clean container (sterile where required)
• Measuring cylinder / volumetric flask
• Labels and markers
• PPE (gloves, mask, goggles, lab coat)

6.0 Procedure

6.1 Preparation

1. Verify the disinfectant concentrate label and expiry date.
2. Wear appropriate PPE before handling chemicals.
3. Use only clean, dry, and labeled containers for solution preparation.

6.2 Dilution

1. Calculate the required volume and concentration of the disinfectant solution.
2. Measure the disinfectant concentrate using a clean measuring cylinder.
3. Add the disinfectant concentrate slowly into the required volume of purified water/WFI with continuous mixing.
4. Mix thoroughly to ensure homogeneity of solution.

6.3 Labeling

Each prepared solution must be labeled with:

• Name of disinfectant
• Concentration of solution
• Date of preparation
• Expiry date (based on stability/validation data)
• Prepared by / Checked by signatures

6.4 Storage

1. Store prepared solutions in closed, clean containers.
2. Protect from direct sunlight and heat.
3. Use the solution within its validated in-use shelf life.

7.0 Precautions

• Always prepare disinfectants in a well-ventilated area.
• Avoid contact with skin and eyes.
• Do not mix different disinfectants unless validated.

8.0 Documentation

• Record details of preparation in the Disinfectant Preparation Logbook.
• Retain records as per document retention policy.

9.0 References

• WHO Guidelines for Disinfection
• USP, EP, and relevant regulatory guidelines
• Manufacturer’s instructions

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