Standard Operating Procedure for Cleaning of Equipment Used for Transdermal Patches

1) Purpose

The purpose of this SOP is to outline the procedures for cleaning equipment used in the manufacturing of transdermal patches to ensure compliance with GMP standards and to prevent contamination.

2) Scope

This SOP applies to all equipment used in the manufacturing of transdermal patches within the facility, including production and packaging equipment.

3) Responsibilities

The Production Department is responsible for cleaning the equipment according to this SOP. The Quality Assurance (QA) Department ensures compliance through routine audits and inspections.

4) Procedure

4.1 Cleaning Schedule

• 4.1.1 Clean equipment after each production batch or as specified in the equipment cleaning schedule.
• 4.1.2 Perform routine cleaning at the end of each shift or day.
• 4.1.3 Conduct deep cleaning and sanitization at regular intervals as specified (e.g., weekly, monthly).

4.2 Preparation for Cleaning

• 4.2.1 Turn off and unplug the equipment before cleaning.
• 4.2.2 Disassemble removable parts according to the manufacturer’s instructions.
• 4.2.3 Wear appropriate personal protective equipment (PPE) such as gloves, masks, and aprons.

4.3 Cleaning Process

• 4.3.1 Surface Cleaning:
  • 4.3.1.1 Remove any visible residue or product from the equipment surfaces using a clean, dry cloth.
  • 4.3.1.2 Apply an approved cleaning agent to a cloth or sponge and wipe down all surfaces.
  • 4.3.1.3 Rinse surfaces with clean water to remove any cleaning agent residues.
  • 4.3.1.4 Dry surfaces with a clean, lint-free cloth.
• 4.3.2 Parts Cleaning:
  • 4.3.2.1 Soak removable parts in a solution of approved cleaning agent.
  • 4.3.2.2 Scrub parts with a brush to remove any residues.
  • 4.3.2.3 Rinse parts thoroughly with clean water.
  • 4.3.2.4 Dry parts completely before reassembling.

4.4 Sanitization

• 4.4.1 Apply an approved sanitizing agent to the equipment surfaces and parts after cleaning.
• 4.4.2 Allow the sanitizing agent to remain in contact for the specified dwell time.
• 4.4.3 Rinse with clean water if required and dry the equipment.

4.5 Reassembly and Inspection

• 4.5.1 Reassemble the equipment according to the manufacturer’s instructions.
• 4.5.2 Inspect the equipment to ensure it is clean, dry, and free from any cleaning agent residues.

4.6 Documentation

• 4.6.1 Record all cleaning activities in the equipment cleaning logbook, including date, time, and personnel involved.
• 4.6.2 Document the cleaning agents and sanitizers used, including their concentrations and batch numbers.
• 4.6.3 Maintain records of routine and deep cleaning schedules.

5) Abbreviations, if any

GMP: Good Manufacturing Practice
PPE: Personal Protective Equipment
QA: Quality Assurance

6) Documents, if any

Equipment Cleaning Logbook
Cleaning and Sanitizing Agents Records

7) Reference, if any

FDA Guidance for Industry: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
EU GMP Annex 15: Qualification and Validation

8) SOP Version

Version 1.0