Standard Operating Procedure for Automated Cleaning System
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Automated Cleaning System used in the pharmaceutical manufacturing of otic dosage forms to ensure effective and consistent cleaning of equipment.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Automated Cleaning System in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Automated Cleaning System as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the cleaning effectiveness.
Maintenance Personnel: Responsible for maintaining the Automated Cleaning System in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Automated Cleaning System for cleanliness and integrity before use.
4.1.1.2 Check that all detergent and solvent levels are adequate.
4.1.1.3 Verify that all safety interlocks and sensors are functional.
4.1.2 Preparation
4.1.2.1 Prepare the equipment to be cleaned according to standard procedures.
4.1.2.2 Load the equipment into the cleaning chamber of the Automated Cleaning System.
4.1.2.3 Set up the cleaning parameters on the control panel.
4.2 Operation
4.2.1 Starting the Cleaning Cycle
4.2.1.1 Close the cleaning chamber and start the automated cleaning cycle.
4.2.1.2 Monitor the cleaning process through the control panel.
4.2.1.3 Ensure that all cleaning parameters such as temperature, pressure, and cycle time are maintained.
4.2.2 Cleaning Process
4.2.2.1 Observe the cleaning progress and intervene if necessary.
4.2.2.2 Ensure that the cleaning solution and rinsing cycles are completed as per the SOP.
4.2.2.3 Verify cleanliness visually or using appropriate testing methods.
4.2.3 Post-Cleaning
4.2.3.1 Once the cleaning cycle is complete, open the cleaning chamber and remove the equipment.
4.2.3.2 Inspect the cleaned equipment for cleanliness and residual cleaning agents.
4.2.3.3 Document the cleaning cycle results and any deviations observed.
4.3 Post-operation
4.3.1 Maintenance
4.3.1.1 Clean the Automated Cleaning System after each use.
4.3.1.2 Perform routine maintenance and calibration of the system components.
4.3.1.3 Record all maintenance activities and update maintenance logs.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Cleaning validation records
Maintenance records
Equipment cleaning log
7) Reference, if any
Manufacturer’s manual for the Automated Cleaning System
Pharmacopeial guidelines for cleaning validation in pharmaceutical manufacturing
8) SOP Version
Version 1.0
