formulations manufactured at [Company Name] that require particulate matter testing as part of in-process and finished product quality control.

3. Responsibilities

• QC Analyst: Performs particulate matter testing using validated methods and records the results.
• QC Supervisor: Reviews test reports and verifies calculations.
• QA Officer: Ensures all testing complies with SOP and pharmacopeial limits before batch release.

4. Accountability

The Quality Control Manager is accountable for implementation and compliance with this SOP.

5. Procedure

5.1 Light Obscuration Particle Count Test

1. Use a calibrated light obscuration particle counter as per instrument SOP.
2. Allow the instrument to warm up and perform system suitability using particle standard solution.
3. Rinse the system using particle-free water before starting the analysis.
4. Degas sample solution using ultrasonicator or vacuum filtration to avoid bubble formation.
5. Filter sample if required using a 0.45 µm filter to remove any extraneous particles (if applicable).
6. Analyze at least 10 mL of sample and perform three replicate measurements.
7. Count cumulative particles ≥10 µm and ≥25 µm and report results in particles per container.

5.2 Microscopic Particle Count Test (if applicable)

1. Use a clean glass filter assembly and micropore filter of 0.8 µm pore size.
2. Filter required sample volume (25 mL or 100 mL based on container size).
3. Dry the membrane and place on a clean microscope slide with mounting solution.
4. Scan complete membrane under microscope at 100X and 400X magnification.
5. Count and record the number of particles ≥10 µm and ≥25 µm per field.

5.3 Acceptance Criteria

As per USP <788> and applicable pharmacopeias:

• For small volume injections (≤100 mL): Not more than 6000 particles ≥10 µm/container and 600 particles ≥25 µm/container.
• For large volume injections (>100 mL): Not more than 25 particles/mL ≥10 µm and not more than 3 particles/mL ≥25 µm.

5.4 Documentation

1. Record test data in Particulate Matter Test Log (Annexure-1).
2. Summarize test report in Annexure-2 and include batch release sheet in Annexure-3.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• USP: United States Pharmacopeia
• EP: European Pharmacopoeia
• µm: Micrometer

7. Documents

1. Particulate Matter Test Log – Annexure-1
2. Test Summary Report – Annexure-2
3. Batch Release Sheet – Annexure-3

8. References

• USP <788> Particulate Matter in Injections
• EP 2.9.19 Particulate Contamination
• Indian Pharmacopoeia – Particulate Matter Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QC Manager	Head QA
Department	Quality Control	Quality Control	Quality Assurance

11. Annexures

Annexure-1: Particulate Matter Test Log

Date	Batch No.	Product	Volume Tested	Method	Analyst
18/06/2025	AMP-IV-003	Injection Ampicillin	20 mL	Light Obscuration	Neha Raut

Annexure-2: Test Summary Report

Product	Batch	≥10 µm	≥25 µm	Status	Reviewed By
Injection Meropenem	MERP-007	2,800	150	Complies	Vijay Naik

Annexure-3: Batch Release Sheet

Product	Batch No.	Test Completed	Result	Approved By
Injection Ceftriaxone	CFT-021	Yes	Complies	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Updated for annexures and revised limits	Annual Review	QA Head