Standard Operating Procedure for Cleaning of Equipment Used for Granules

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the cleaning of equipment used in the manufacturing of granules in the pharmaceutical industry to prevent cross-contamination and ensure product quality.

2) Scope

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

3) Responsibilities

Production Operators: Responsible for cleaning equipment after use as per the SOP.
Quality Assurance: Responsible for verifying the effectiveness of cleaning procedures.
Engineering Department: Responsible for maintenance and calibration of cleaning equipment.

4) Procedure

1. Pre-Cleaning Preparation:
   1. Notify relevant departments about equipment cleaning.
   2. Obtain cleaning materials and equipment specified in the cleaning SOP.
2. Dismantling and Disassembly:
   1. Follow procedures to dismantle equipment components as per the equipment manual.
   2. Ensure all parts are safely removed for cleaning.
3. Cleaning Process:
   1. Pre-rinse the equipment with water or solvent to remove visible residues.
   2. Apply cleaning agents as specified, ensuring complete coverage of all surfaces.
   3. Scrub or wipe surfaces as necessary to remove contaminants.
4. Rinsing:
   1. Rinse thoroughly with water or solvent to remove cleaning agents and residues.
   2. Ensure all rinsing steps are documented.
5. Drying:
   1. Air dry or use validated drying equipment to ensure complete drying of equipment.
   2. Verify dryness visually or using appropriate methods.
6. Reassembly:
   1. Reassemble equipment components following assembly procedures.
   2. Ensure correct placement and alignment of parts.
7. Inspection and Verification:
   1. Inspect equipment visually for cleanliness and integrity.
   2. Perform swab or rinse sampling for verification if required.
8. Documentation:
   1. Complete cleaning records including equipment identification, cleaning agents used, and personnel involved.
   2. Ensure all documentation is accurate and signed by authorized personnel.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Cleaning SOP, Cleaning Validation Protocol (if applicable)

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines and equipment manufacturer’s instructions.

8) SOP Version

Version 1.0