Procedure for Particulate Matter Testing in Liquids

1) Purpose

The purpose of this SOP is to outline the procedure for testing particulate matter in liquid samples used in pharmaceutical manufacturing to ensure product quality and safety.

2) Scope

This SOP applies to all liquid formulations produced within the manufacturing facility that require particulate matter testing.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting particulate matter 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 particulate matter testing equipment (e.g., light obscuration particle counter) according to manufacturer’s instructions.
    4.1.2 Calibrate the equipment using certified standard particles of known sizes.
    4.1.3 Ensure the testing area is clean and free from contaminants.

4.2 Particulate Matter Testing Procedure:
    4.2.1 Take a representative sample of the liquid formulation for testing.
    4.2.2 Introduce the sample into the particle counter and initiate the testing process.
    4.2.3 Allow the particle counter to analyze the sample and record the particulate matter count and size distribution.
    4.2.4 Repeat the measurement if necessary to ensure accuracy and consistency of results.

4.3 Calculation and Interpretation:
    4.3.1 Compare the measured particulate matter count and size distribution against acceptance