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