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