Standard Operating Procedure for Use of Surfactants in Lyophilized Products

1) Purpose

This SOP outlines the procedures for incorporating surfactants into lyophilized products to enhance solubility and stability during the lyophilization process and reconstitution.

2) Scope

This SOP applies to all personnel involved in the preparation of lyophilized formulations that require the use of surfactants, including formulation scientists and operators.

3) Responsibilities

• Formulation Scientists: Responsible for selecting the appropriate surfactant for the formulation.
• Operators: Responsible for incorporating the surfactant according to the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the surfactant addition and maintaining records.

4) Procedure

4.1 Selection of Surfactants

4.1.1 Criteria for Selection

• 4.1.1.1 The surfactant should be compatible with the formulation and should not interfere with the active ingredient’s stability or efficacy.
• 4.1.1.2 Commonly used surfactants include polysorbates (Tween 80, Tween 20) and poloxamers (Pluronic F68).

4.2 Incorporation of Surfactants

4.2.1 Weighing and Addition

• 4.2.1.1 Weigh the surfactant according to the formulation requirements in the BMR.
• 4.2.1.2 Add the surfactant slowly into the formulation solution while stirring to avoid foaming and ensure uniform distribution.

4.2.2 Mixing and Homogenization

• 4.2.2.1 Stir the solution using a mechanical stirrer until the surfactant is fully dissolved and evenly distributed in the solution.
• 4.2.2.2 Homogenize the mixture if required to ensure uniformity at the molecular level.

4.3 Documentation

All steps involving surfactant addition, including weights and batch numbers, must be documented in the Surfactant Addition Logbook and verified by QA.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Surfactant Addition Logbook

7) References

• Pharmacopoeial guidelines on the use of surfactants in pharmaceutical formulations

8) SOP Version

Version 1.0

Annexure

Surfactant Addition Logbook Template

  

    
Date
    
Surfactant Name
    
Batch No.
    
Quantity
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Surfactant Name
    
Batch Number
    
Quantity (grams)
    
Operator Name
    
QA Initials