Standard Operating Procedure for Cleaning of Equipment Used for Gels

1) Purpose

The purpose of this SOP is to establish procedures for the cleaning of equipment used in the manufacturing of gels to prevent cross-contamination, ensure product quality, and comply with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the cleaning of equipment used for gel production within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Supervisor: Oversee equipment cleaning procedures as per this SOP.
Production Operators: Perform equipment cleaning and inspection tasks.
Quality Assurance (QA) Personnel: Verify cleaning effectiveness and compliance with procedures.

4) Procedure

4.1 Pre-Cleaning Preparation
4.1.1 Wear appropriate personal protective equipment (PPE) such as gloves and safety goggles.
4.1.2 Notify production and quality personnel of equipment to be cleaned and its status.

4.2 Cleaning Process
4.2.1 Dismantle equipment parts as per the cleaning procedure and SOP.
4.2.2 Remove residual product and contaminants using approved cleaning agents and tools.
4.2.3 Rinse equipment thoroughly with purified water to remove cleaning agents and residues.

4.3 Disinfection
4.3.1 Apply disinfectants as specified in the cleaning SOP to sanitize equipment surfaces.
4.3.2 Ensure adequate contact time for disinfectants as per manufacturer’s recommendations.

4.4 Inspection and Assembly
4.4.1 Inspect cleaned equipment visually for cleanliness and signs of damage or wear.
4.4.2 Reassemble equipment components carefully and according to assembly instructions.

4.5 Verification and Documentation
4.5.1 Perform swab or rinse sampling to verify the effectiveness of cleaning and disinfection.
4.5.2 Document cleaning and disinfection activities, including any deviations or corrective actions.

4.6 Storage and Post-Cleaning Practices
4.6.1 Store cleaned equipment in designated areas to prevent re-contamination.
4.6.2 Follow post-cleaning procedures to maintain equipment integrity and readiness for use.

5) Abbreviations, if any

SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
QA: Quality Assurance

6) Documents, if any

– Equipment Cleaning and Disinfection Records
– Swab/Sample Test Results
– SOP for Equipment Cleaning

7) Reference, if any

– FDA Guidance for Industry: Cleaning Validation
– USP <1072> Disinfectants and Antiseptics
– Manufacturer’s instructions for cleaning agents and disinfectants

8) SOP Version

Version 1.0