Procedure for Particle Size Reduction in Ointment Manufacturing
| Department | Production/Quality Assurance (QA)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/026 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for reducing the particle size of active pharmaceutical ingredients (APIs) and excipients in ointment manufacturing. Proper particle size reduction enhances uniformity, improves stability, and ensures better product efficacy.
2. Scope
This SOP applies to all personnel involved in the particle size reduction process using mills, homogenizers, or other mechanical size reduction equipment.
3. Responsibilities
- Production Supervisor: Ensures the particle size reduction process follows defined parameters.
- Machine Operator: Operates and monitors the milling or homogenization equipment.
- Quality Assurance (QA) Personnel: Verifies uniformity and compliance with specifications.
- R&D Scientist: Defines particle size requirements for different formulations.
4. Accountability
The Production and QA Managers are accountable for ensuring that particle size reduction is conducted as per GMP guidelines and documented properly.
5. Procedure
5.1 Pre-Processing Checks
- Ensure the milling/homogenization equipment is clean and calibrated.
- Verify that the raw materials are within the required moisture and temperature specifications.
- Confirm the target particle size distribution from the Batch Manufacturing Record (BMR).
5.2 Selection of Size Reduction Method
- Ball Milling:
Used for reducing coarse particles.
Jet Milling: Used for finer particle reduction without heat generation.
High-Shear Homogenization: Used for reducing particle size in liquid formulations.
5.3 Particle Size Reduction Process
- Feed the materials into the milling/homogenization system.
- Set the milling parameters such as speed, pressure, and time as per formulation requirements.
- Monitor the equipment for uniform particle size reduction.
5.4 Sampling and In-Process Quality Control
- Take a sample at predefined intervals.
- Check for particle size distribution using a particle size analyzer.
- Verify that the particle size is within the acceptable range (e.g., 10-50 microns).
5.5 Final Verification
- Inspect for agglomerates or oversized particles.
- Compare results with standard specifications before proceeding to mixing.
5.6 Documentation and Approval
- Record all process parameters in the Particle Size Reduction Log.
- QA must verify and approve the reduced particle batch before further processing.
- Label the processed material as “Ready for Use.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- R&D – Research and Development
- BMR – Batch Manufacturing Record
7. Documents
- Particle Size Reduction Log (Annexure-1)
- In-Process Quality Control Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Particle Size Reduction Log
| Date | Batch Number | Reduction Method | Initial Size (µm) | Final Size (µm) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Jet Milling | 100 | 30 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Ball Milling | 200 | 50 | QA Officer |
Annexure-2: In-Process Quality Control Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Particle Size Distribution | 10-50 µm | 30 µm | Pass |
| 02/02/2025 | SOP/Ointment/002 | Agglomerate Content | <1% | 0.5% | Pass |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |