ASTM E2503-13(R2020) pdf free download

ASTM E2503-13(R2020) pdf free download.Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
1. Scope
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus. 1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom ofthe vessel or sampling through the shaft). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro- priate safety, health, and environmental practices and deter- mine the applicability ofregulatory limitations prior to use. 1.5 This international standard was developed in accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4. Procedure
4.1 Background—The set-up, mechanical, and operational checks are used to minimize variability during dissolution testing to ensure the reproducibility of dissolution results. 4.2 Wherever possible, tools shall be traceable to an ac- cepted standard calibration source from a national or interna- tional calibration laboratory. 4.3 Apparatus Set-up—During apparatus installation or after replacement of parts or components, verify that the description and critical dimensions for each part meets the original description and dimension. 4.3.1 Vessel Dimensions—In the absence of a COA or COC, the vessel’s internal dimensions should be measured with an appropriate measuring device and vessel shape and condition should be noted. For example, for a cylindrical, hemispherical vessel, the vessel’s sides must be cylindrical, the internal dimension should be measured, and the vessel bottom should be smooth and without defects. The vessel must fit within the apparatus in such a manner as to ensure stable operation and centering of the shaft in the vessel. 4.3.2 Basket/Shaft Dimensions—In the absence of a COA or COC, an appropriate measuring device is used to measure the relevant basket dimensions. Critical dimensions to be mea- sured on each basket should include but are not limited to: shaft diameter, vent hole diameter, thickness of wide portion of the basket-to-shaft adaptor, total basket height, internal diameter at the top ofthe basket, outer diameter ofthe screen, height ofthe open screen, outer diameter of bottom, diameter of screen on the bottom, and screen mesh number. 4.3.3 Paddle Dimensions—In the absence of a COA or COC, an appropriate measuring device is used to measure the relevant dimensions of the paddle. Examples of dimensions to be determined on each paddle should include but are not limited to: shaft diameter, blade height, blade thickness, total blade length, length of flat portion on bottom of blade, radius ofthe angle on the top outer edge ofthe top ofthe blade, radius of the outside edge of the blade, difference between the distance from the midline of the shaft to the top outer edge for the two sides, and difference between the heights of both sides of the paddles at the outside top. 4.4 Maintenance—Consult the manufacturer’s maintenance recommendations and maintenance schedule to establish an appropriate maintenance program based on the frequency of apparatus use and quality system requirements. 4.5 Mechanical Calibration—Perform these tests on the frequency determined by the quality system or after repair or move. If the instrument is not in routine use, the mechanical calibration may be performed before performing the first dissolution test. Some instrument manufacturers supply special tools or incorporate automatic mechanical calibration devices within their equipment, and these may be used. Depending on the adjustments necessary to meet the mechanical calibration criteria, the position and orientation ofeach vessel may need to be noted to ensure proper subsequent set-up. 4.5.1 Shaft Wobble—A runout gauge is positioned so that the gauge probe touches the turning shaft about 2 cm above the top of the paddle blade or basket. The gauge is placed so that the probe slightly presses in on the turning shaft. The absolute value of the difference between the maximum and minimum readings is the wobble. The measured value must not exceed 1.0 mm total runout.