Procedure for Assembling Equipment for Ointment Manufacturing
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | EQ-022 |
| 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 systematic process for assembling equipment used in ointment manufacturing. Proper assembly ensures that equipment functions optimally, maintains GMP compliance, and prevents cross-contamination.
2. Scope
This SOP applies to all personnel responsible for assembling equipment such as mixing tanks, homogenizers, heating vessels, and filling machines in the ointment manufacturing area.
3. Responsibilities
- Production Supervisor: Ensures that all equipment is assembled correctly before manufacturing starts.
- Maintenance Engineer: Assembles and verifies proper functioning of equipment.
- Quality Assurance (QA) Officer: Conducts final inspection and approves equipment readiness.
- Operators: Assist in assembling equipment components and ensure adherence to cleaning procedures.
4. Accountability
The Production and Engineering Managers are accountable for ensuring that all equipment is assembled correctly, documented, and verified as per GMP standards.
5. Procedure
5.1 Pre-Assembly Checks
- Ensure that all equipment components are clean, dry, and free from residues.
- Verify that all required tools and gaskets are available for assembly.
- Check the equipment calibration status and ensure it is up to date.
5.2 Assembling Mixing Tanks
- Position the mixing tank in its designated location.
- Attach
the mixing blades securely and ensure they rotate freely.
Connect the required hoses and valves for material transfer.
Tighten all clamps and seals to prevent leaks.
5.3 Assembling Homogenizer
- Install the homogenizer shaft and impellers as per manufacturer guidelines.
- Ensure the homogenization chamber is securely locked in place.
- Check motor alignment and lubrication.
- Verify that safety interlocks are functional.
5.4 Assembling Heating and Melting Vessels
- Attach the heating elements and temperature sensors.
- Connect the steam or electrical supply for heating.
- Check for leaks in heating coils and temperature control systems.
5.5 Assembling Filling Machine
- Install filling nozzles and secure them firmly.
- Calibrate filling volume settings as per batch requirements.
- Check the movement of piston pumps or peristaltic pumps.
- Test the conveyor system and ensure smooth movement.
5.6 Equipment Verification
- Conduct a dry run to check the functionality of each component.
- Verify that all safety interlocks and emergency stops are working.
- QA personnel must perform a final inspection and approve the assembly.
5.7 Documentation and Approval
- Record all assembly steps in the Equipment Assembly Log.
- Obtain QA approval before starting manufacturing.
- Label assembled equipment as “Ready for Use.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Equipment Assembly Log (Annexure-1)
- Equipment Verification Checklist (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Manuals
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Assembly Log
| Date | Equipment Name | Component Installed | Assembled By | Verified By |
|---|---|---|---|---|
| 01/02/2025 | Mixing Tank | Blades and Hoses | John Doe | QA Officer |
| 02/02/2025 | Filling Machine | Nozzles and Piston Pumps | Jane Smith | QA Officer |
Annexure-2: Equipment Verification Checklist
| Equipment Name | Component Checked | Status (✔/✖) | Verified By |
|---|---|---|---|
| Mixing Tank | Blade Alignment | ✔ | QA Officer |
| Homogenizer | Motor Function | ✔ | QA Officer |
| Filling Machine | Nozzle Calibration | ✔ | QA Officer |
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 |