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PHARMACOPOEIAL COMPLIANCE AND VALIDATION

  • In order to meet your individual requirements, Copley provide a three tier approach to regulatory compliance and validation.
  • 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 (i.e. the friability drum) to provide documented verification of compliance with pharmacopoeial requirements. Available as an optional service.
  • Certificate of Compliance to USP/Ph.Eur.: Included with each unit. Written statement that the product, by design, complies with the current pharmacopoeial specifications.
  • 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. Available as an optional service. Please see the ordering information for further details on our verification and IQ/OQ/PQ services.

DESIGN AND CONSTRUCTION

  • Designed in accordance with the specifications as laid down in Eur.Ph. Chapter 2.9.7 and USP Chapter <1216>, the FR Series forms the basis of our range of friability testers. The standard FR Series operates at a constant speed of 25 rpm +/-
  • 1. It is available in two variants, that is to say, with either one (Model FR 1000) or two test drums (Model FR 2000). Similar in construction to the fixed speed FR Series, the Friability Series FRV differs only in having variable speed between 20 and 60 rpm. The speed is controlled via the membrane keypad in steps of 1 rpm. The variable speed allows the operator to subject the tablets under test to varying stresses and therefore determine an optimum for each type.
  • As on the FR Series, the duration of the test can be selected in either revolutions of the drum (1-999,999) or time (up to 99 hours, 59 inutes, 59 seconds).
  • During the test run, the nominal test duration and remaining test duration, in either revolutions or time, is indicated on the LCD screen, together with the selected speed. The control of all models is provided by a membrane keypad linked to a 4-line 20 character back-lit LCD screen.

DRUMS

  • The friability drum has been designed for testing the rolling and impact durability of tablets and has a single curved baffle which allows the tablets to be tested to rise and then drop through a distance of approx. 156 mm. Premature fracture or sign of wear at the edges indicates that such tablets may not withstand the rigours of transportation. All friability drums are now fitted with an aperture such that it is no longer necessary to remove and open the friability drum in order to load and remove the samples. At the start of the test, the drum automatically revolves until the aperture(s) faces the operator so that the tablets can be loaded. On completion of the test, the drum stops and then reverses automatically emptying the contents of the drum into the waiting collection tray(s). All friability drums are completely interchangeable, i.e. they will fit either side of the tester. Abrasion drums for carrying out tests into attrition are also available as an optional extra. The Abrasion drum comprises of a drum 20 cm diameter with a series of baffles which carry the tablets to a predetermined height before sliding off and reproduces the action of the tablets rubbing against each other during transport. All testers can be equipped with a choice of either USP friability drums and/or abrasion test drums. Dual drum units can for example be fitted with one friability and one abrasion drum thus allowing comparisons to be made between the two parameters under identical test conditions.

OPERATION

  • Considerable attention was paid to the design of the FR and FRV series to ensure that the number of actions necessary to perform a test are kept to a minimum. Consequently, once the method (number of revolutions or time) has been selected and the test duration set, it is only necessary to press the START key to initiate the test. The standard test procedure is to take a sample of 10 tablets (a sample equivalent to 6.5 grams should be taken if the tablets weigh less than 650 mg), the weight of which has already been determined (W1). The tablets should be de-dusted prior to weighing. The tablets are then placed into the test drum and allowed to rotate 100 times. The tablets are then re-weighed (W2) having first removed any accumulated dust and the results calculated in terms of % weight loss utilising the formula (W1-W2) x 100 divided by W1. In general, a maximum weight loss of not more than 1% is acceptable for most tablets. If necessary, repeat the test twice more basing the result on the mean of the three tests.
    Dimensions (mm):
    FR 1000 / FRV 1000 = 290 mm (W) x 360 mm (D) x 350 mm (H)
    FR 2000 / FRV 2000 = 297 mm (W) x 360 mm (D) x 350 mm (H)