Standard Operating Procedure for pH Testing of Gels
1) Purpose
The purpose of this SOP is to outline procedures for pH testing of gels in the pharmaceutical industry to ensure product quality and consistency.
2) Scope
This SOP applies to all personnel involved in pH testing of gels within the pharmaceutical production facility.
3) Responsibilities
Quality Control (QC) Supervisor: Oversee pH testing procedures as per this SOP.
QC Analysts: Perform pH tests and record results accurately.
Production Operators: Provide gel samples and support as required for pH testing.
4) Procedure
4.1 Equipment Setup
4.1.1 Verify and calibrate the pH meter according to manufacturer instructions.
4.1.2 Prepare fresh pH buffers of known pH values (e.g., pH 4, 7, and 10) for calibration.
4.2 Sample Preparation
4.2.1 Allow gel samples to equilibrate to room temperature before testing.
4.2.2 Mix samples gently to ensure homogeneity without introducing air bubbles.
4.3 pH Measurement
4.3.1 Rinse the pH electrode with distilled water and blot dry between measurements.
4.3.2 Immerse the pH electrode into the gel sample and allow the reading to stabilize.
4.3.3 Record pH readings once stabilized and repeat measurements as necessary for accuracy.
4.4 Calibration of pH Meter
4.4.1 Calibrate the pH meter using the prepared pH buffers before each testing session.
4.4.2 Verify calibration with fresh buffers and adjust if necessary to maintain accuracy.
4.5 Data Analysis and Acceptance Criteria
4.5.1 Compare pH measurements against predefined acceptance criteria or specifications.
4.5.2 Identify and document any deviations from specified pH limits.
4.6 Cleaning and Maintenance
4.6.1 Clean the pH meter electrode with distilled water and store it properly after each use.
4.6.2 Perform regular maintenance and calibration of the pH meter as per schedule.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– pH Test Reports
– Calibration Certificates
– Equipment Cleaning and Maintenance Logs
– SOP for pH Testing
7) Reference, if any
– USP <791> pH
– Pharmacopoeial guidelines for pH testing of pharmaceuticals
– Manufacturer’s instructions for pH meter operation and calibration
8) SOP Version
Version 1.0