Standard Operating Procedure for Cleaning of Equipment Used for Creams
1) Purpose
The purpose of this SOP is to outline the procedures for the cleaning of equipment used in the manufacturing of creams in a pharmaceutical facility to prevent cross-contamination and ensure product quality.
2) Scope
This SOP applies to all personnel involved in the cleaning of equipment used for creams within the pharmaceutical production facility. It covers procedures for cleaning, disinfection, and inspection of equipment.
3) Responsibilities
It is the responsibility of the production and cleaning validation teams to follow this SOP accurately. The production supervisor is responsible for scheduling equipment cleaning, while the cleaning validation team ensures that cleaning procedures are validated and effective.
4) Procedure
4.1 Pre-Cleaning Preparations
4.1.1 Notify the production supervisor and obtain necessary clearance for equipment cleaning.
4.1.2 Gather all required cleaning materials, including approved cleaning agents, tools, and personal protective equipment (PPE).
4.1.3 Review the equipment cleaning logbook for previous cleaning records and any special instructions.
4.2 Disassembly and Initial Cleaning
4.2.1 Disassemble the equipment following the manufacturer’s instructions and safety guidelines.
4.2.2 Rinse equipment parts with water to remove visible residues and debris.
4.2.3 Clean equipment surfaces using appropriate cleaning agents and tools, ensuring coverage of all surfaces.
4.3 Cleaning Validation
4.3.1 Perform cleaning validation according to the approved protocol to ensure effectiveness of the cleaning procedure.
4.3.2 Collect swab or rinse samples as per the cleaning validation protocol for analysis.
4.3.3 Evaluate cleaning validation results against acceptance criteria to confirm cleanliness.
4.4 Final Rinse and Inspection
4.4.1 Rinse equipment thoroughly with purified water or specified rinsing agent to remove cleaning agents.
4.4.2 Inspect equipment visually for cleanliness, ensuring no residues or contaminants are visible.
4.4.3 Perform final inspection under appropriate lighting conditions and document inspection results.
4.5 Reassembly and Post-Cleaning Verification
4.5.1 Reassemble equipment components following assembly instructions and torque specifications.
4.5.2 Verify proper reassembly and functionality of equipment, conducting checks as per equipment checklist.
4.5.3 Obtain clearance from quality assurance (QA) or QC personnel for equipment use.
4.6 Documentation
4.6.1 Complete the equipment cleaning logbook with details of cleaning activities, including cleaning agents used, cleaning duration, and personnel involved.
4.6.2 Attach cleaning validation reports and inspection records to the equipment cleaning logbook.
4.6.3 File completed documentation in accordance with document retention policies.
5) Abbreviations, if any
PPE: Personal Protective Equipment
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Equipment Cleaning Logbook
Cleaning Validation Reports
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP (United States Pharmacopeia) General Chapter 1072: Disinfectants and Antiseptics
8) SOP Version
Version 1.0
