SOP for Preparation and Usage of Disinfectants

SOP for Preparation and Usage of Disinfectants

1.0 Objective

1.1 To establish a procedure for the preparation, filtration, labeling, storage, and usage of disinfectants in the Microbiology Section to ensure effective environmental control and contamination prevention.

2.0 Scope

2.1 This SOP is applicable to the preparation and use of disinfectants in the Sterility Testing Area, MLT (Microbial Limit Testing) Area, Sub-culture Area, and other areas of the Microbiology Laboratory.

3.0 Responsibility

3.1 Microbiologist or above – Microbiology Laboratory:

• Preparation and filtration of disinfectants.

• Proper labeling, storage, and documentation.

• Ensuring correct usage as per defined applications.

3.2 Head – Microbiology Section / Nominee:

• Review and approval of the SOP.

• Ensuring implementation and compliance.

4.0 Accountability

4.1 Head – Quality Control / Nominee:

• Overall compliance with this SOP.

5.0 Procedure

5.1 General Requirements

5.1.1 Prepare disinfectants as per the concentrations and applications defined in Table–1.

5.1.2 All disinfectants prepared for use in Sterility Testing, MLT, and Sub-culture areas shall be filtered through a sterile 0.2 µm membrane filter into suitable sterile containers.

5.1.3 Preparation and filtration shall be carried out in the MLT area after completion of routine work or when the area is available.

5.1.4 Use Purified Water or Water for Injection (WFI), as applicable, for dilution.

5.2 Collection, Labeling, and Storage

5.2.1 Collect filtered disinfectants in suitable clean containers/bottles.

5.2.2 Label each container with the following details:

• Name of disinfectant

• Date of filtration/preparation

• Preparation number (where applicable)

• Filtered/Prepared by

• Use Before Date

5.2.3 Filtered disinfectants shall be used up to the next day of filtration.

5.2.4 Store prepared disinfectants in designated areas under appropriate conditions.

5.3 Preparation for Routine Use

5.3.1 For routine scheduled disinfection of floors, walls, and surfaces, prepare the required quantity of diluted disinfectant in buckets and use immediately.

5.3.2 For disinfectants used during operational activities, prepare the required dilution and transfer into spray bottles.

5.3.3 Spray bottles shall be labeled with:

• Name

• Date of preparation

• Preparation number

• Prepared by

• Use Before Date

5.3.4 Such diluted disinfectants shall be used up to the next day of preparation.

5.4 Specific Usage Instructions

5.4.1 Use 70% Isopropyl Alcohol (IPA) for cleaning and disinfection of LAF (Laminar Air Flow) workbenches and low bioburden areas.

5.4.2 Use Sterillium as supplied (undiluted) for hand disinfection in Sterility Testing areas.

5.4.3 Use Cidex undiluted by spraying for surface disinfection where specified.

5.4.4 Use the defined volumes of disinfectant concentrate and diluent as per Table–2 for preparation of 1000 mL diluted solution.

5.5 Documentation

5.5.1 Record each preparation of disinfectant in the Dilute Disinfectant Preparation Record (Annexure–01)

Table–1: Disinfectants and Their Applications

Table–2: Composition of Dilute Disinfectants for 1000 mL Preparation

Note: Volume of disinfectant concentrate : Volume of dilute disinfectant as specified above.

6.0 List of Annexures

• Annexure – 01: Dilute Disinfectant Preparation Record

SOP on Container Closure Integrity Testing (CCIT) for Dry Powder for Injection