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 criteria specified in pharmacopeial standards or internal specifications.
4.3.2 Classify particulate matter as viable or non-viable based on size and origin (e.g., intrinsic vs. extrinsic).
4.4 Acceptance Criteria:
4.4.1 The particulate matter count does not exceed the specified limits for the product.
4.4.2 The size distribution of particulate matter meets the defined criteria.
4.5 Documentation:
4.5.1 Record all particulate matter test results, equipment calibration details, and any corrective actions taken in the Particulate Matter Testing Record.
4.5.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Particulate Matter Testing Record
Calibration Record for Particle Counter
Sampling Plan Document
7) Reference, if any
USP General Chapter <788> – Particulate Matter in Injections
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
