Standard Operating Procedure for Equipment Cleaning and Sanitization in Otic Manufacturing Unit
1) Purpose
To define the procedure for cleaning and sanitizing equipment used in the manufacturing of Otic (Ear) Dosage Forms to prevent cross-contamination and ensure product quality.
2) Scope
This SOP applies to all equipment and utensils used in the production, packaging, and storage of Otic dosage forms within the manufacturing facility.
3) Responsibilities
Production Operators: Responsible for cleaning equipment after use and preparing it for sanitization.
Cleaning Crew: Responsible for executing cleaning and sanitization procedures according to the schedule.
Quality Assurance (QA) Department: Responsible for monitoring and verifying cleanliness and compliance.
4) Procedure
4.1 Pre-cleaning Preparation
4.1.1 Inspection
4.1.1.1 Inspect equipment for visible residues, labels, and accessories.
4.1.1.2 Remove any product remnants and dismantle equipment components if required.
4.1.2 Initial Cleaning
4.1.2.1 Wash equipment with water and detergent using designated cleaning tools.
4.1.2.2 Rinse thoroughly with purified water to remove detergent residues.
4.2 Sanitization
4.2.1 Preparation of Sanitizing Solution
4.2.1.1 Prepare sanitizing solution as per approved formula and concentration.
4.2.1.2 Use validated methods to ensure effectiveness of sanitizing solution.
4.2.2 Sanitization Procedure
4.2.2.1 Apply sanitizing solution uniformly to all surfaces of the equipment.
4.2.2.2 Allow sufficient contact time as specified in the sanitization procedure.
4.3 Drying and Inspection
4.3.1 Drying
4.3.1.1 Air dry equipment in a designated area to prevent recontamination.
4.3.1.2 Use lint-free cloths for drying if necessary to ensure complete drying.
4.3.2 Inspection
4.3.2.1 Inspect equipment visually for cleanliness and completeness.
4.3.2.2 Perform swab testing or other validation methods as per schedule or when required.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices
6) Documents, if any
Cleaning and sanitization records
Validation reports for sanitizing solutions
Swab testing results
7) Reference, if any
GMP guidelines for equipment cleaning and sanitization in pharmaceutical manufacturing
8) SOP Version
Version 1.0
