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DISSOLUTION TESTER DIS 8000
  • PHARMACOPOEIA COMPLIANCE AND QUALIFICATION
  • The most critical factors in the design of any dissolution tester are (a) that it complies with the respective Pharmacopoeia, (b) that this compliance can be proved or qualified and (c) that both compliance and qualification can be documented.
  • Copley offer a three tier approach to address these points:
  • Certificate of Compliance to USP/Ph.Eur.: Included with each unit. Written statement that the product, by design, complies with the current pharmacopoeial specifications.
  • Laser Numbering and Certification: Identification and measurement of critical components to provide documented verification of compliance with current pharmacopoeial specifications. Available as an optional service.
  • IQ/OQ/PQ Qualification Documentation: Comprehensive documentation to guide the user through the installation, operating and performance checks of the equipment in its operating environment, using specified test protocols. It provides a comprehensive record of the suitability of the equipment to perform its specified task, to be created and archived.
  • SUMMARY OF KEY FEATURES
  • Standard
  • Rugged, compact and easy-to-use
  • Conforms to all current Ph.Eur. and USP specifications
  • User friendly operating procedure via membrane keypad and 4-line LCD screen
  • Screw-in baskets/paddles allow method changes in seconds such that no further adjustments are necessary
  • Individual clutches allow each basket/paddle to be raised, lowered and engaged independent of the drive head
  • Uncluttered design allows maximum access to working area
  • 316 stainless steel teflon coated vessel support plate
  • Easy-Centre vessel centring dystem
  • One piece PETG water bath; no leaks; easy to remove and clean
  • Independent digital heater/circulator with over-temperature cut-out and indicator. Easily removed for maintenance
  • Full printed test report on completion of the run (user selectable)
  • RS232 bi-directional interface and parallel printer port
  • Menu guided calibration procedure (with print-out)
  • Options
  • Laser numbering, certification and IQ/OQ/PQ documentation
  • Gold-plated baskets/paddles for aggressive media
  • Amber coated UV-Resistant vessels and lids
  • Low evaporation membrane sealed vessel lids
  • Electronic temperature calibration kit