SOP for Preparation of Freeze-Dried Antibiotics

Standard Operating Procedure for Preparation of Freeze-Dried Antibiotics

1) Purpose

This SOP outlines the procedure for preparing antibiotics for freeze-drying (lyophilization), ensuring product sterility and stability throughout the process and during storage.

2) Scope

This SOP applies to all personnel involved in the preparation of freeze-dried antibiotic formulations, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for designing the antibiotic formulation suitable for freeze-drying.
Operators: Responsible for preparing the antibiotic solution as per the Batch Manufacturing Record (BMR).
QA: Responsible for verifying the freeze-drying process and ensuring accurate documentation.

4) Procedure

4.1 Preparation of Antibiotic Solution

4.1.1 Equipment Setup

4.1.1.1 Ensure that all equipment (e.g., mixers, filtration systems) is cleaned, sanitized, and calibrated before use.
4.1.1.2 Prepare sterile containers for the antibiotic solution and maintain aseptic conditions during preparation.

4.1.2 Solution Preparation

4.1.2.1 Weigh the required antibiotic and excipients using a calibrated balance according to the BMR.
4.1.2.2 Dissolve the antibiotic in a suitable buffer or solvent (e.g., saline, WFI) and stir until fully dissolved.

4.2 Filtration and Lyophilization

4.2.1 Filtration

4.2.1.1 Filter the solution using a sterile 0.22-micron filter to remove particulates and ensure sterility.

4.2.2 Filling and Lyophilization

4.2.2.1 Fill sterile vials with the filtered antibiotic solution and freeze at -80°C before transferring to the

lyophilizer.

4.2.2.2 Perform lyophilization as per the parameters outlined in the BMR, ensuring proper monitoring of temperature and pressure.

4.3 Documentation

All steps, including weighing, solution preparation, filtration, filling, and lyophilization, must be recorded in the Freeze-Dried Antibiotics Logbook and verified by QA.

5) Abbreviations

BMR: Batch Manufacturing Record
WFI: Water for Injection

6) Documents

Freeze-Dried Antibiotics Logbook

7) References

Pharmacopoeial guidelines for freeze-drying of antibiotics

8) SOP Version

Version 1.0

Annexure

Freeze-Dried Antibiotics Logbook Template


  
    Date
    Antibiotic Name
    Batch No.
    Volume Filled
    Lyophilization Parameters
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Antibiotic Name
    Batch Number
    Volume in mL
    Parameters (Temp, Pressure)
    Operator Name
    QA Initials