Agilent Dissolution Seminar Series

Transcription

1 Agilent Dissolution Seminar Series The Dissolution Apparatus Drive unit Paddle shaft Locking rings Touch screen Water bath Vessel plate Lift mechanism DISSOLUTION APPARATUS Support plate Water heater/circulator Adjustable leveling feet Paddle and Basket Stirring Elements Interchangeable Shafts Interchangeable paddle and basket shafts may be utilized Vessel Alignment Indicator Vessels Dissolution Vessels are be constructed of glass or other suitably inert material The vessels are cylindrical with a hemispheric bottom Alignment indicators on the vessel flange and vessel plate may be used to allow for replacement of the vessel in the exact position from which it was removed All Rights Reserved 1

2 Vessel Retention Clips, Evaporation Covers and Ports Vessel Media Temperature Vessels must be securely held in place and ports in the covers should be available for dosage form introduction and sampling Media temperature readings must be taken at least twice during the dissolution test, at the start and end of a test. AutoTemp In-Vessel Temperature Evaporation Covers and Alignment Posts In-vessel temperature monitoring with non-resident probes: Indicates that the media in all of the vessels is at temperature May trigger the start of a test Document media temperature throughout the run Alignment posts and DDMs secure the evaporation covers in the proper orientation to allow movement of the automated sampling cannula and temperature probe. Tablet Introduction Manual Sampling Tablet introduction may be performed manually or automatically Dosage forms may be introduced simultaneously or sequentially but they must be introduced into nonrotating media Evaporation cover shown with Dosage Delivery Module (DDM) Sampling may be performed manually with a specialized cannula fitted to a syringe. 2

3 Auto Sampling Heater/Circulator Automated systems may be utilized to automatically raise and lower the sampling cannulas The heater/circulator is integrated into the back of the apparatus in order to save valuable bench space Vibration isolators are used to prevent vibration transfer to the apparatus Apparatus Control Internal Parts: Spindles and Motor Assembly Control of the apparatus may be performed from the instrument or automated systems Spindle motor Speed control sensor Pulleys (drive and idler) Belt Internal Parts: Spindle Sub Assembly Secure Connections Spindle bearing block Spindle body Spindle pulley Locking ring Cables and accessories must be properly connected on the rear of the 3

4 A very sturdy surface should be used to support the dissolution The apparatus with full water bath and full vessels may weigh up to 100 kg. Benches should not impart vibration on the dissolution Vibration has been shown to have a significant effect on dissolution rates. Effects of both higher and lower dissolution rates have been seen. Sources of Vibration Fume hoods Vacuum pumps Construction Mechanical shakers Bench top centrifuges Ultrasonic baths Heater circulators or pumps Worn parts or bearings Lighting should be sufficient to perform visual observations. Visual observations may offer clues to dissolution behavior. Unusual observations should be documented Considerations should be made for light sensitive products. Local sinks and purified water sources for media prep and disposal Media handling and preparation equipment must not impart vibration to the dissolution apparatus Suitable media degassing equipment Dedicated vessels and shafts (each apparatus) Proper safety equipment Mops and buckets for spills and/or floor safety matting Sufficient bench space for sample handling and analytical measurement Preventative maintenance should be performed at regularly scheduled intervals as suggested by the manufacturer Major repairs should be undertaken only by a qualified service personnel Improper alignment of pulleys, belts, or spindle assemblies can significantly impact operability and affect the hydrodynamics within a dissolution system Inspect all power sources and connections for damage or wear. Wipe down stainless steel surfaces with light machine oil Check spindle bearings every 500 hours (as indicated by elapsed time indicators or estimates based on usage) or so for binding or tightness due to normal wear and tear. These bearings are permanently lubricated, so no lubrication is required. Contact service for advice if a problem is noted. 4

5 Lower the drive head to the full down position. Turn off the power and remove the power cord from the drive unit. Remove the top cover of the drive unit. Check the spindle drive belt for unusual wear, fraying, or tension approximately every 500 hours. Lubricate idler pulleys with lithium grease. Acrylic water baths should be maintenance free, except for routine cleaning. Do not use cleaning compounds containing ammonia, these can cause deterioration of the plastic. Use only cleaners approved for plastic materials. These can be found in the catalogs of most scientific supply houses. Do not use abrasive cleaners that will scratch the plastic. Besides the unsightliness of the scratches, they also provide active sites for the propagation of algae. A water bath algaecide or clear bath product is recommended Ensure it is compatible with Acrylic and vinyl plastics The flow paths in most heater/circulators are primarily stainless steel and should tolerate most clear bath formulations. Check with the manufacturer of the circulator to be sure. Care must be taken when removing dissolution vessels so they do not drip circulator water into clean vessels Clean and replace the back vessels before cleaning the front vessels. 5