SOP for Lyophilization of Blood Products and Plasma Derivatives

Standard Operating Procedure for Lyophilization of Blood Products and Plasma Derivatives

1) Purpose

This SOP outlines the method for the lyophilization of blood products and plasma derivatives to ensure stability during long-term storage and transport.

2) Scope

This SOP applies to personnel involved in the formulation, preparation, and testing of blood products and plasma derivatives for lyophilization, including formulation scientists, operators, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for selecting excipients and stabilizers that protect proteins and other plasma components during freeze-drying.
Operators: Responsible for preparing the blood or plasma product for lyophilization according to the Batch Manufacturing Record (BMR).
QA Personnel: Responsible for verifying product stability, safety, and proper documentation post-lyophilization.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Criteria for Stability

4.1.1.1 Stabilizers such as albumin or sugars (e.g., sucrose) are often added to protect plasma proteins and other components from degradation during lyophilization.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the required stabilizers and plasma products accurately as per the BMR.
4.2.1.2 Dissolve the plasma product in a suitable buffer and stir gently to ensure homogeneity and complete dissolution of stabilizers.

4.2.2 Sterile Filtration and Filling

4.2.2.1 Filter the solution through a sterile 0.22-micron filter to remove particulates.
4.2.2.2 Aseptically fill sterile vials with the filtered

solution, ensuring the correct volume is dispensed according to the BMR.

4.2.2.3 Freeze the vials at -80°C to prepare for lyophilization.

4.3 Lyophilization and Post-Lyophilization Testing

4.3.1 Load the frozen vials into the lyophilizer and follow the freeze-drying cycle as outlined in the BMR.
4.3.2 After lyophilization, reconstitute the plasma or blood product and perform tests to ensure that the plasma components remain intact and bioactive.

4.4 Documentation

Record all preparation, lyophilization, and post-lyophilization steps in the Blood Products Lyophilization Logbook. QA should verify all documentation and testing results.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Blood Products Lyophilization Logbook

7) References

Pharmacopoeial guidelines for the preparation of blood products and plasma derivatives

8) SOP Version

Version 1.0

Annexure

Blood Products Lyophilization Logbook Template


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

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