SOP for Formulation of Lyophilized Vaccines

Standard Operating Procedure for Formulation of Lyophilized Vaccines

1) Purpose

The purpose of this SOP is to describe the process of formulating vaccines for lyophilization to preserve their potency, safety, and efficacy during storage and transport.

2) Scope

This SOP applies to all personnel involved in the formulation of lyophilized vaccines, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for developing the vaccine formulation, including the selection of stabilizers and cryoprotectants.
Operators: Responsible for following the formulation process as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying the accuracy of the formulation process and ensuring documentation is complete.

4) Procedure

4.1 Preparation of Vaccine Solution

4.1.1 Equipment Setup

4.1.1.1 Ensure that all equipment used for formulation (e.g., mixers, filtration systems) is sanitized and calibrated.
4.1.1.2 Use sterilized containers and maintain aseptic conditions throughout the process.

4.1.2 Vaccine Preparation

4.1.2.1 Weigh the active component (antigen) and excipients as per the formulation instructions.
4.1.2.2 Dissolve the antigen in a sterile solvent (e.g., saline, WFI) and mix gently to avoid denaturation.
4.1.2.3 Add stabilizers and cryoprotectants to protect the vaccine during the lyophilization process.

4.2 Filtration and Filling

4.2.1 Filtration

4.2.1.1 Filter the prepared vaccine solution using a 0.22-micron sterile filter to remove any particulates.

4.2.2 Filling of Vials

4.2.2.1 Fill sterile vials with the filtered solution under aseptic conditions, ensuring each vial contains the correct volume.
4.2.2.2 Seal the vials and prepare them for the lyophilization process.

4.3 Documentation

All steps, including vaccine preparation, filtration, and vial filling, must be recorded in the Vaccine Formulation Logbook, verified by the QA team.

5) Abbreviations

BMR: Batch Manufacturing Record
WFI: Water for Injection

6) Documents

Vaccine Formulation Logbook

7) References

WHO Guidelines for the Safe Production of Vaccines

8) SOP Version

Version 1.0

Annexure

Vaccine Formulation Logbook Template


  
    Date
    Vaccine Name
    Batch No.
    Volume per Vial
    pH
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Vaccine Name
    Batch Number
    Volume (mL)
    pH Value
    Operator Name
    QA Initials

Date	Vaccine Name	Batch No.	Volume per Vial	pH	Operator Initials	QA Verification
DD/MM/YYYY	Vaccine Name	Batch Number	Volume (mL)	pH Value	Operator Name	QA Initials