Procedure for Clarity and Opalescence Testing of Liquids

1) Purpose

The purpose of this SOP is to outline the procedure for evaluating the clarity and opalescence of liquid samples used in pharmaceutical manufacturing to ensure visual quality and compliance.

2) Scope

This SOP applies to all liquid formulations produced within the manufacturing facility that require clarity and opalescence testing.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting clarity and opalescence testing and ensuring compliance with this SOP.
Production Department: Responsible for providing liquid samples and maintaining process parameters.

4) Procedure

4.1 Equipment Preparation:
    4.1.1 Set up the testing area with a suitable light source and viewing apparatus.
    4.1.2 Ensure the test vessels (e.g., clear glass containers) are clean and free from residues.
    4.1.3 Allow the liquid samples to equilibrate to room temperature before testing.

4.2 Clarity Testing Procedure:
    4.2.1 Pour the liquid sample into a clear glass container.
    4.2.2 Visually inspect the container against a white background under diffused lighting conditions.
    4.2.3 Record observations regarding the presence of any visible particles, haze, or cloudiness.

4.3 Opalescence Testing Procedure:
    4.3.1 Place the liquid sample in front of a light source and observe for any milkiness or opalescence.
    4.3.2 Compare the sample against a reference standard or acceptance criteria for opalescence.
    4.3.3 Record observations regarding the intensity and nature of opalescence.

4.4 Interpretation:
    4.4.1 Evaluate the clarity and opalescence of the liquid sample based on predefined acceptance criteria.
    4.4.2 Classify the sample as acceptable or not based on visual inspection results.

4.5 Acceptance Criteria:
    4.5.1 The liquid sample is considered clear if it exhibits no visible particles and minimal haze.
    4.5.2 Opalescence should not exceed predefined limits or should match the reference standard.

4.6 Documentation:
    4.6.1 Record all clarity and opalescence test results, observations, and any deviations from expected visual quality in the Clarity and Opalescence Testing Record.
    4.6.2 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Clarity and Opalescence Testing Record
Sampling Plan Document

7) Reference, if any

USP General Chapter <788> – Particulate Matter in Injections
Pharmacopeial standards for Clarity and Opalescence testing

8) SOP Version

Version 1.0