Standard Operating Procedure for Using Rotary Evaporator
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the rotary evaporator in the pharmaceutical manufacturing of otic dosage forms to ensure efficient solvent evaporation.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of rotary evaporators in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the rotary evaporator as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the efficiency of the evaporation process and ensuring compliance with regulatory standards.
Maintenance Personnel: Responsible for maintaining the rotary evaporator in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the rotary evaporator for cleanliness and integrity before use.
4.1.1.2 Ensure that the glassware, water bath, and control panel are functional and clean.
4.1.1.3 Check that the vacuum pump and condenser are in good working condition.
4.1.2 Preparation
4.1.2.1 Clean the glassware with a suitable solvent.
4.1.2.2 Prepare the sample for evaporation according to the specified protocol.
4.1.2.3 Assemble the glassware onto the rotary evaporator and secure it properly.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the rotary evaporator and set the desired water bath temperature and rotation speed.
4.2.1.2 Start the vacuum pump and adjust the vacuum level according to the procedure.
4.2.1.3 Begin the evaporation process and monitor the solvent collection in the receiving flask.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the rotary evaporator and samples.
4.2.2.2 Avoid touching the hot water bath or glassware during operation to prevent burns.
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 rotary evaporator and allow the glassware to cool before disassembly.
4.3.1.2 Remove the solvent and sample from the glassware and clean all components with a suitable solvent.
4.3.1.3 Document any deviations in temperature, vacuum level, or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the glassware, water bath, and control panel with a suitable solvent.
4.3.2.2 Inspect the vacuum pump and condenser for any signs of wear or damage and service them as necessary.
4.3.2.3 Calibrate the temperature and rotation speed settings periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the rotary evaporator log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Rotary evaporator log
Temperature and vacuum level records
7) Reference, if any
Manufacturer’s manual for the rotary evaporator
Pharmacopeial guidelines for solvent evaporation in pharmaceutical manufacturing
8) SOP Version
Version 1.0
