Procedure for Maintaining Scraper Blade Mixers

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/044
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 approach for maintaining scraper blade mixers used in ointment production. Proper maintenance ensures efficient mixing, prevents contamination, and extends equipment lifespan.

2. Scope

This SOP applies to all personnel responsible for the operation, cleaning, and maintenance of scraper blade mixers in the manufacturing facility.

3. Responsibilities

• Production Supervisor: Ensures scraper blade mixers are maintained as per schedule.
• Machine Operator: Performs routine checks and identifies maintenance needs.
• Quality Assurance (QA) Personnel: Verifies cleanliness and operational efficiency.
• Engineering Technician: Conducts preventive and corrective maintenance.

4. Accountability

The Production and QA Managers are accountable for ensuring that scraper blade mixer maintenance follows GMP standards and is properly documented.

5. Procedure

5.1 Pre-Use Inspection

• Check that the scraper blade mixer is clean and free of residue.
• Ensure that the blade is securely attached and shows no signs of wear.
• Verify that the mixing vessel is properly aligned with the scraper blade.

5.2 Routine Maintenance

• Lubricate moving parts to prevent friction-related wear.
• Inspect and tighten fasteners to secure the blade.
• Ensure the scraper blade does not have cracks or sharp edges that may contaminate the batch.
• Monitor motor function and check for unusual noises during operation.

5.3 Cleaning After Each Batch

• Disassemble scraper blade components following manufacturer guidelines.
• Wash the blade, mixing vessel, and surrounding areas with an approved cleaning agent.
• Rinse thoroughly with purified water to remove any residues.
• Sanitize all parts and reassemble before the next use.

5.4 Preventive Maintenance Schedule

• Perform deep cleaning and sanitization weekly.
• Conduct blade wear analysis monthly.
• Replace worn-out scraper blades as per the manufacturer’s recommendation.
• Calibrate the scraper blade mixer every six months.

5.5 Handling Equipment Failures

• Stop production immediately if any mechanical issue is detected.
• Document the fault and notify the Engineering department.
• Ensure necessary repairs or replacements are conducted before resuming operation.

5.6 Documentation and Approval

• Record all maintenance activities in the Equipment Maintenance Log.
• QA must review and approve maintenance records.
• Retain maintenance records for audits and inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• RPM – Revolutions Per Minute

7. Documents

• Equipment Maintenance Log (Annexure-1)
• Cleaning and Sanitization Log (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: Equipment Maintenance Log

Date	Machine ID	Maintenance Type	Action Taken	Verified By
01/02/2025	SM-101	Routine Inspection	Lubricated bearings	QA Officer
02/02/2025	SM-102	Blade Replacement	Installed new scraper	QA Officer

Annexure-2: Cleaning and Sanitization Log

Date	Machine ID	Cleaning Agent Used	Sanitization Method	Verified By
01/02/2025	SM-101	Sodium Hypochlorite	Rinsed and Dried	QA Head
02/02/2025	SM-102	Ethyl Alcohol	Wiped and Flushed	QA Head

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