Standard Operating Procedure for Filtration of Bulk Solutions Before Lyophilization

1) Purpose

This SOP outlines the steps required to filter bulk solutions prior to lyophilization to ensure sterility and removal of particulates, ensuring product quality and consistency.

2) Scope

This SOP applies to all personnel responsible for filtering bulk solutions, including production operators and QA staff in lyophilized product manufacturing.

3) Responsibilities

• Operators: Responsible for performing the filtration process according to the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the filtration process and ensuring all documentation is accurate.

4) Procedure

4.1 Equipment Preparation

• 4.1.1 Ensure the filtration system (e.g., sterile filters, filter housing) is cleaned and sterilized prior to use.
• 4.1.2 Set up the filtration unit and ensure all connections are secure and free of leaks.

4.2 Filtration Process

4.2.1 Solution Transfer

• 4.2.1.1 Transfer the bulk solution to be filtered into the filtration unit’s input container.
• 4.2.1.2 Ensure the solution is gently stirred to prevent any settling of particulates.

4.2.2 Filtration

• 4.2.2.1 Pass the solution through the sterile filtration system using a pressure pump or vacuum, as specified in the BMR.
• 4.2.2.2 Monitor the filtration speed and pressure to ensure consistency throughout the process.

4.3 Post-Filtration Steps

4.3.1 Filtration Check

• 4.3.1.1 Verify that the solution is clear and free of visible particles after filtration.

4.3.2 Documentation

• 4.3.2.1 Document the filtration pressure, speed, and duration in the Filtration Logbook.

5) Abbreviations

• BMR: Batch Manufacturing Record

6) Documents

• Filtration Logbook

7) References

• Pharmacopoeial guidelines on sterile filtration (e.g., USP, EP)

8) SOP Version

Version 1.0

Annexure

Filtration Logbook Template

  

    
Date
    
Batch No.
    
Filtration Pressure
    
Filtration Speed
    
Operator Initials
    
QA Verification
  
  

    
DD/MM/YYYY
    
Batch Number
    
Pressure (psi/bar)
    
Speed (L/hr)
    
Operator Name
    
QA Initials