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DISINTEGRATION TESTERS SERIES DTG
  • PHARMACOPOEIAL COMPLIANCE AND QUALIFICATION
  • The most critical factors in the design of any disintegration 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 are documented.
  • Copley offer a three tier approach to address these points:
  • • Certificate of Compliance to USP/Ph.Eur.: Provided free of charge 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.
    Please see the ordering information for further details on our verification and qualification services.
  • DESIGN AND CONSTRUCTION
  • All of the DTG series feature a motor drive operating at a fixed speed of 30 rpm (+/- 1) and a stroke of 55 mm (+/- 1).
  • Depending on the model, the DTG has the capacity of testing one, two, three or four different tablet batches of six tablets/capsules simultaneously, under identical test conditions.
  • The control of all models is provided by a membrane keypad linked to a 4-line 20 character back-lit LCD screen which together with the electronics is mounted in the head of the instrument so as to avoid any accidental spillages in the test area.
  • Particular attention has been given to the design of the basket rack assembly in respect of its removal and cleaning.
  • The novel quick-release basket design not only provides a firm and rigid location for the basket during operation but also allows the basket to be removed from the instrument for rapid cleaning.
  • Another unique feature of the basket design is the use of thumb screws to hold the various components together.
  • This means that if it is necessary to disassemble the basket before cleaning, this can be done very quickly and without the use of any specialised tools.
  • A common problem associated with fabricated water baths, used for warming the media, is that of leaks.
  • This problem has now been eliminated through the use of a one-piece water bath vacuum formed in rigid PETG. This construction not only eliminates any possibility of leaks but also makes it far easier to clean because of its rounded corners. The bath is fitted with a sturdy 8 mm clear view lid and secured to the base by four easily removed thumb screws.
  • The temperature of the warming solution is controlled by means of an independent heater/circulator to an accuracy of +/- 0.2 degrees C. This has two advantages: firstly, it removes the necessity for priming and secondly, it can be removed for cleaning without dismantling the whole disintegration tester. A low-water level alarm indicator is built into the unit as standard.