Standard Operating Procedure for Preparation of Buffers for Lyophilized Formulations
1) Purpose
This SOP outlines the process for preparing buffers used in lyophilized formulations to ensure proper pH and composition for the stability of active ingredients throughout the lyophilization process.
2) Scope
This SOP applies to all staff involved in buffer preparation, including formulation scientists, production operators, and QA teams in the production of lyophilized products.
3) Responsibilities
- Operators: Responsible for buffer preparation according to the Batch Manufacturing Record (BMR).
- Quality Control (QC): Responsible for pH verification and ensuring buffer quality.
- QA: Responsible for monitoring and verifying all buffer preparation documentation.
4) Procedure
4.1 Buffer Preparation
4.1.1 Equipment Setup
- 4.1.1.1 Calibrate the pH meter before use.
- 4.1.1.2 Ensure that all equipment used for preparation is sanitized and verified as clean.
- 4.1.1.3 Prepare all required materials as outlined in the BMR.
4.1.2 Buffer Component Preparation
- 4.1.2.1 Measure out the required quantities of each component using a calibrated scale.
- 4.1.2.2 Transfer the components into deionized or distilled water, as per the formulation.
- 4.1.2.3 Stir the solution until all components are completely dissolved.
4.1.3 pH Adjustment
- 4.1.3.1 Measure the pH of the buffer using the calibrated pH meter.
- 4.1.3.2 Adjust the pH by adding small amounts of acid or base solutions, as required, to achieve the desired pH.
- 4.1.3.3 Recheck the pH until the specified range is achieved.
4.1.4 Filtration
- 4.1.4.1 Filter the buffer solution using a sterile filtration system to remove any particulate matter.
- 4.1.4.2 Store the buffer in clean, labeled containers, indicating the pH, batch number, and preparation date.
4.2 Documentation
All steps, including buffer component quantities, pH readings, and adjustments, must be documented in the Buffer Preparation Logbook.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QC: Quality Control
- QA: Quality Assurance
6) Documents, if any
- Buffer Preparation Logbook
7) References, if any
- USP Guidelines for Buffer Preparation
8) SOP Version
Version 1.0
Annexure
Buffer Preparation Logbook Template
| Date | Buffer Name | Batch No. | pH | Operator Initials | QC Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Buffer Name | Batch Number | pH Value | Operator Name | QC Initials |