Standard Operating Procedure for Preparing Lyophilized Formulations for Intravenous Use
1) Purpose
This SOP describes the process of preparing lyophilized formulations intended for intravenous (IV) administration, ensuring sterility, stability, and proper reconstitution characteristics.
2) Scope
This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products designed for intravenous administration.
3) Responsibilities
- Formulation Scientists: Responsible for designing the IV lyophilized formulation and ensuring compatibility with reconstitution solutions.
- Operators: Responsible for preparing the solution according to the Batch Manufacturing Record (BMR).
- QA: Responsible for ensuring sterility, product stability, and proper documentation.
4) Procedure
4.1 Preparation of IV Lyophilized Formulation
4.1.1 Equipment Setup
- 4.1.1.1 Ensure that all equipment (e.g., mixers, sterilization units) is cleaned, sanitized, and calibrated before use.
- 4.1.1.2 Maintain aseptic conditions throughout the preparation process.
4.1.2 Solution Preparation
- 4.1.2.1 Weigh the required active ingredients and excipients using a calibrated balance according to the BMR.
- 4.1.2.2 Dissolve the active ingredients in a suitable solvent (e.g., Water for Injection) and stir until fully dissolved.
4.2 Filtration and Filling
4.2.1 Filtration
- 4.2.1.1 Filter the prepared solution using a sterile 0.22-micron filter to ensure sterility.
4.2.2 Filling and Lyophilization
- 4.2.2.1 Aseptically fill sterile vials with the filtered solution and freeze at -80°C before lyophilization.
- 4.2.2.2 Perform lyophilization according to the cycle parameters outlined in the BMR.
4.3 Reconstitution Testing
- 4.3.1 After lyophilization, test the reconstitution characteristics of the product by adding a suitable diluent (e.g., saline or dextrose solution) and monitoring the dissolution time.
- 4.3.2 Ensure that the solution reconstitutes fully, with no particulates, within the specified time frame.
4.4 Documentation
Record all steps, including solution preparation, filtration, filling, lyophilization parameters, and reconstitution test results, in the IV Lyophilized Formulations Logbook.
5) Abbreviations
- BMR: Batch Manufacturing Record
- WFI: Water for Injection
6) Documents
- IV Lyophilized Formulations Logbook
7) References
- Pharmacopoeial guidelines for IV drug products and reconstitution testing
8) SOP Version
Version 1.0
Annexure
IV Lyophilized Formulations Logbook Template
| Date | Formulation Name | Batch No. | Reconstitution Time | Volume Filled | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Batch Number | Reconstitution Time (minutes) | Volume in mL | Operator Name | QA Initials |