SOP for Preparation of Lyophilized Allergen Extracts

Standard Operating Procedure for Preparation of Lyophilized Allergen Extracts

1) Purpose

This SOP outlines the procedure for the preparation of lyophilized allergen extracts to ensure product stability and retention of allergenic activity during storage and reconstitution.

2) Scope

This SOP applies to formulation scientists, operators, and QA personnel involved in the development, preparation, and quality control of allergen extracts that undergo lyophilization.

3) Responsibilities

Formulation Scientists: Responsible for designing allergen extract formulations that are stable during freeze-drying and compatible with reconstitution requirements.
Operators: Responsible for preparing the allergen extract formulation according to the Batch Manufacturing Record (BMR).
QA Personnel: Responsible for validating the integrity and bioactivity of the lyophilized allergen extracts.

4) Procedure

4.1 Formulation of Allergen Extracts

4.1.1 Selection of Stabilizers

4.1.1.1 Use stabilizers such as trehalose or sucrose to protect allergenic proteins from denaturation during freeze-drying.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Accurately weigh the required allergen extracts and stabilizers as specified in the BMR.
4.2.1.2 Dissolve the allergen extract in a buffer solution and stir gently to ensure homogeneity.

4.2.2 Sterile Filtration and Filling

4.2.2.1 Filter the solution using a sterile 0.22-micron filter to eliminate any particulates.
4.2.2.2 Aseptically fill sterile vials with the filtered solution and freeze the vials at -80°C before lyophilization.

4.3 Lyophilization and Post-Lyophilization Testing

4.3.1

Transfer the vials into the lyophilizer and initiate the freeze-drying cycle as defined in the BMR.

4.3.2 After lyophilization, reconstitute the allergen extract and conduct tests to confirm allergenic activity and stability.

4.4 Documentation

Ensure all steps are documented in the Allergen Extract Lyophilization Logbook, including solution preparation, filtration, lyophilization, and post-lyophilization testing. QA must verify all records for accuracy.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Allergen Extract Lyophilization Logbook

7) References

Pharmacopoeial guidelines for the preparation and testing of allergen extracts in pharmaceutical products.

8) SOP Version

Version 1.1

Annexure

Allergen Extract Lyophilization Logbook Template


  
    Date
    Allergen Name
    Batch No.
    Stabilizer Used
    Reconstitution Results
    Bioactivity Test
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Allergen Name
    Batch Number
    Stabilizer Name
    Pass/Fail
    Pass/Fail
    Operator Name
    QA Initials