Procedure for Cleaning Utensils Used in Ointment Manufacturing

Department	Production/Quality Assurance (QA)/Engineering
SOP No.	SOP/Ointment/059
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 define a standardized method for cleaning utensils used in ointment manufacturing. Proper cleaning ensures removal of residues, prevents cross-contamination, and maintains compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in cleaning and maintaining utensils such as spatulas, mixing spoons, scrapers, beakers, and other tools used in ointment production.

3. Responsibilities

• Production Supervisor: Ensures that cleaning is performed as per this SOP.
• Machine Operator: Collects utensils and prepares them for cleaning.
• Cleaning Personnel: Performs cleaning, sanitization, and drying of utensils.
• Quality Assurance (QA) Personnel: Inspects and verifies cleaning effectiveness.

4. Accountability

The Production and QA Managers are accountable for ensuring that utensil cleaning follows GMP standards and is properly documented.

5. Procedure

5.1 Pre-Cleaning Preparations

• Ensure that all utensils used in the batch are collected for cleaning.
• Wear appropriate Personal Protective Equipment (PPE), including gloves, masks, and aprons.
• Ensure that all cleaning materials, including detergents and sanitizers, are available.
• Inspect utensils for visible residues before starting the cleaning process.

5.2 Cleaning Process

5.2.1 Initial Rinsing

• Rinse utensils thoroughly with warm purified water to remove loose residues.
• For heavily coated utensils, soak in warm water for 10-15 minutes.

5.2.2 Detergent Cleaning

• Prepare a cleaning solution using an approved detergent.
• Use soft brushes or sponges to scrub utensils, ensuring all surfaces are cleaned.
• Ensure cleaning reaches all crevices and edges of utensils.
• Rinse with purified water to remove detergent residues.

5.2.3 High-Pressure Rinsing

• Use high-pressure purified water to rinse off any remaining detergent traces.
• Repeat the rinsing process until all detergent residues are eliminated.

5.2.4 Final Sanitization

• Prepare a sanitizing solution (e.g., 70% ethanol or peracetic acid solution).
• Immerse utensils in the sanitizing solution for at least 10 minutes.
• Ensure complete coverage of all surfaces.
• Remove utensils and drain excess sanitizer.

5.3 Drying and Storage

• Allow utensils to air dry in a controlled environment.
• Store cleaned utensils in a designated clean storage area.
• Ensure utensils are covered to prevent dust accumulation.

5.4 Post-Cleaning Inspection

• Conduct a visual inspection to ensure no residues remain.
• Perform swab tests for microbial verification.
• Record the results in the Cleaning Log.

5.5 Documentation and Approval

• Log all cleaning activities in the Cleaning Record.
• QA personnel must review and approve the cleaned utensils before reuse.
• Retain cleaning records for audits and compliance verification.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• PPE – Personal Protective Equipment

7. Documents

• Cleaning Log (Annexure-1)
• Cleaning Validation Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Date	Utensil Type	Cleaning Solution Used	Sanitization Agent	Verified By
01/02/2025	Spatula	Detergent Solution	70% Ethanol	QA Officer
02/02/2025	Mixing Spoon	Alkaline Cleaner	Peracetic Acid	QA Officer

Annexure-2: Cleaning Validation Report

Date	Utensil Type	Swab Test Result	Microbial Limits	Final Status	Approved By
01/02/2025	Spatula	Pass	Within Limit	Approved	QA Head
02/02/2025	Mixing Spoon	Pass	Within Limit	Approved	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