Standard Operating Procedure for Using Soxhlet Extractor
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Soxhlet extractor in the pharmaceutical manufacturing of otic dosage forms to ensure efficient extraction of compounds from solid materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of Soxhlet extractors in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Soxhlet extractor as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the efficiency of the extraction process and ensuring compliance with regulatory standards.
Maintenance Personnel: Responsible for maintaining the Soxhlet extractor in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Soxhlet extractor for cleanliness and integrity before use.
4.1.1.2 Ensure that the glassware, heating mantle, and control panel are functional and clean.
4.1.1.3 Check that the solvent supply is sufficient and the connections are secure.
4.1.2 Preparation
4.1.2.1 Clean the glassware with a suitable solvent.
4.1.2.2 Prepare the solid samples for extraction according to the specified protocol.
4.1.2.3 Assemble the Soxhlet apparatus and secure the solid sample in the extraction thimble.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the heating mantle and set the desired temperature for the extraction solvent.
4.2.1.2 Start the extraction process and monitor the solvent reflux through the Soxhlet apparatus.
4.2.1.3 Adjust the temperature if necessary to ensure a steady rate of solvent reflux.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the Soxhlet extractor and solvents.
4.2.2.2 Avoid touching the hot components or inhaling solvent vapors during operation to prevent burns and inhalation hazards.
4.2.2.3 Follow all safety protocols to prevent solvent spills or accidents.
4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the heating mantle and allow the apparatus to cool before disassembly.
4.3.1.2 Remove the solid sample and collected extract, then clean all components with a suitable solvent.
4.3.1.3 Document any deviations in temperature, extraction time, or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the glassware, heating mantle, and control panel with a suitable solvent.
4.3.2.2 Inspect the glassware for any signs of wear or damage and replace them as necessary.
4.3.2.3 Calibrate the temperature settings periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the Soxhlet extractor log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Soxhlet extractor log
Temperature and extraction time records
7) Reference, if any
Manufacturer’s manual for the Soxhlet extractor
Pharmacopeial guidelines for extraction processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0
