Standard Operating Procedure for Compounder
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Compounder used in the pharmaceutical manufacturing of otic dosage forms to ensure consistent mixing and blending of materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Compounder in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Compounder as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of mixing and blending.
Maintenance Personnel: Responsible for maintaining the Compounder in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Compounder for cleanliness and integrity before use.
4.1.1.2 Ensure all mixing chambers, blades, and seals are clean and in good condition.
4.1.1.3 Verify that all safety guards and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Compounder and surrounding area.
4.1.2.2 Check and prepare all raw materials and components required for compounding.
4.1.2.3 Ensure utilities (power, water, etc.) are connected and operational.
4.2 Operation
4.2.1.1 Power on the Compounder and set parameters as per batch requirements.
4.2.1.2 Load materials into the mixing chamber as per the formulation.
4.2.1.3 Start the mixing process and monitor for uniform blending of materials.
4.2.2 Monitoring
4.2.2.1 Monitor mixing time, speed, and temperature during the compounding process.
4.2.2.2 Adjust parameters as necessary to achieve desired blend uniformity.
4.2.2.3 Record all critical parameters and observations during the compounding process.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the compounding process and transfer compounded material to designated containers.
4.3.1.2 Clean and sanitize the Compounder and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the Compounder.
4.3.2 Maintenance
4.3.2.1 Clean mixing chambers and blades thoroughly after each use.
4.3.2.2 Perform routine maintenance on seals, bearings, and motor components.
4.3.2.3 Document all maintenance activities and keep maintenance records updated.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Maintenance records
Batch records for each compounding process
Calibration records for temperature and speed controls
7) Reference, if any
Manufacturer’s manual for the Compounder
Pharmacopeial guidelines for pharmaceutical compounding processes
8) SOP Version
Version 1.0