Standard Operating Procedure for Jacketed Mixing Vessel
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Jacketed Mixing Vessel used in the pharmaceutical manufacturing of otic dosage forms to ensure efficient mixing and temperature control.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Jacketed Mixing Vessel in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Jacketed Mixing Vessel as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of mixing and temperature control.
Maintenance Personnel: Responsible for maintaining the Jacketed Mixing Vessel in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Jacketed Mixing Vessel for cleanliness and integrity before use.
4.1.1.2 Check jacket for leaks and ensure all connections are secure.
4.1.1.3 Verify that temperature control devices are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Jacketed Mixing Vessel and surrounding area.
4.1.2.2 Check and prepare all materials and ingredients required for mixing.
4.1.2.3 Ensure that utilities (steam, cooling water, etc.) are connected and ready for operation.
4.2 Operation
4.2.1 Mixing Process
4.2.1.1 Power on the Jacketed Mixing Vessel and set temperature controls as per batch requirements.
4.2.1.2 Load materials into the vessel as per the formulation.
4.2.1.3 Initiate mixing process and monitor for uniformity and consistency.
4.2.2 Temperature Control
4.2.2.1 Monitor and adjust jacket temperature to maintain desired process temperature.
4.2.2.2 Record temperature readings and control settings at regular intervals.
4.2.2.3 Ensure that product temperature remains within specified limits throughout the mixing process.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the mixing process and transfer mixture to designated containers or further processing steps.
4.3.1.2 Clean and sanitize the Jacketed Mixing Vessel and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the vessel.
4.3.2 Maintenance
4.3.2.1 Inspect and clean mixing blades and vessel interior after each use.
4.3.2.2 Perform preventive maintenance on temperature control devices and jacket.
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 mixing process
Calibration records for temperature control devices
7) Reference, if any
Manufacturer’s manual for the Jacketed Mixing Vessel
Pharmacopeial guidelines for pharmaceutical mixing processes
8) SOP Version
Version 1.0