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ASTM E2503-13(2020)

(Practice)

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

SIGNIFICANCE AND USE
2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.  
2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
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 of the 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
31-Mar-2020
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.12 - Process Applications
Current Stage
Ref Project

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ASTM E2503-13(2020) - Standard Practice for Qualification of Basket and Paddle Dissolution ApparatusASTM E2503-13(2020) - Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
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ASTM E2503-13(2020) - Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2503 − 13 (Reapproved 2020)
Standard Practice for
Qualification of Basket and Paddle Dissolution Apparatus
This standard is issued under the fixed designation E2503; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Procedure
1.1 This practice covers the set-up and calibration of the
4.1 Background—The set-up, mechanical, and operational
paddle and basket dissolution apparatus.
checks are used to minimize variability during dissolution
testing to ensure the reproducibility of dissolution results.
1.2 Use of this practice may be applied to apparatus that
have been modified to enable automatic dissolution testing
4.2 Wherever possible, tools shall be traceable to an ac-
(that is, a valve in the bottom of the vessel or sampling through
cepted standard calibration source from a national or interna-
the shaft).
tional calibration laboratory.
1.3 The values stated in SI units are to be regarded as
4.3 Apparatus Set-up—During apparatus installation or after
standard. No other units of measurement are included in this
replacement of parts or components, verify that the description
standard.
and critical dimensions for each part meets the original
1.4 This standard does not purport to address all of the
description and dimension.
safety concerns, if any, associated with its use. It is the
4.3.1 Vessel Dimensions—In the absence of a COA or COC,
responsibility of the user of this standard to establish appro-
the vessel’s internal dimensions should be measured with an
priate safety, health, and environmental practices and deter-
appropriate measuring device and vessel shape and condition
mine the applicability of regulatory limitations prior to use.
should be noted. For example, for a cylindrical, hemispherical
1.5 This international standard was developed in accor-
vessel, the vessel’s sides must be cylindrical, the internal
dance with internationally recognized principles on standard-
dimension should be measured, and the vessel bottom should
ization established in the Decision on Principles for the
be smooth and without defects. The vessel must fit within the
Development of International Standards, Guides and Recom-
apparatus in such a manner as to ensure stable operation and
mendations issued by the World Trade Organization Technical
centering of the shaft in the vessel.
Barriers to Trade (TBT) Committee.
4.3.2 Basket/Shaft Dimensions—In the absence of a COA or
COC, an appropriate measuring device is used to measure the
2. Significance and Use
relevant basket dimensions. Critical dimensions to be mea-
2.1 This practice outlines a procedure for the mechanical
sured on each basket should include but are not limited to: shaft
calibration of paddle and basket dissolution units to ensure
diameter, vent hole diameter, thickness of wide portion of the
reproducibility of results.
basket-to-shaft adaptor, total basket height, internal diameter at
2.2 Once a unit meets all of the mechanical specifications the top of the basket, outer diameter of the screen, height of the
included in this practice, it is considered calibrated and further open screen, outer diameter of bottom, diameter of screen on
calibration with dissolution calibrator tablets is not required. the bottom, and screen mesh number.
4.3.3 Paddle Dimensions—In the absence of a COA or
3. Analyst Responsibilities
COC, an appropriate measuring device is used to measure the
3.1 Verify the vessel, basket, and paddle dimensions on
relevant dimensions of the paddle. Examples of dimensions to
receipt through measurement or Certificate of Analysis (COA)
be determined on each paddle should include but are not
or Certificate of Conformity (COC).
limited to: shaft diameter, blade height, blade thickness, total
blade length, length of flat portion on bottom of blade, radius
3.2 Ensure the instrument is calibrated and fit for perform-
of the angle on the top outer edge of the top of the blade, radius
ing dissolution analysis.
of the outside edge of the blade, difference between the
distance from the midline of the shaft to the top outer edge for
This practice is under the jurisdiction of ASTM Committee E55 on Manufac-
the two sides, and difference between the heights of both sides
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi-
of the paddles at the outside top.
bility of Subcommittee E55.12 on Process Applications.
Current edition approved April 1, 2020. Published April 2020. Originally
ɛ1
4.4 Maintenance—Consult the manufacturer’s maintenance
approved in 2007. Last previous edition approved in 2013 as E2503 – 13 . DOI:
10.1520/E2503-13R20. recommendations and maintenance schedule to establish an
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2503 − 13 (2020)
appropriate maintenance program based on the frequency of between the bottom of each of the paddle blades or baskets and
apparatus use and quality system requirements. the bottom of the vessels. An adjustable depth gauge or other
device can be used to verify that the paddle/basket height is
4.5 Mechanical Calibration—Perform these tests on the
within 8 % of desired height. For example, for a paddle at 25
frequency determined by the quality system or after repair or
mm from the bottom, the height needs to be 62 mm.
move. If the instrument is not in routine use, the mechanical
4.5.7 Rotational Speed—A tachometer is used to measure
calibration may be performed before performing the first
the rotational speed of the paddle or basket. The rate of rotation
dissolution test. Some instrument manufacturers supply special
must be within 2 % or 62 rpm of the stated rate, whichever is
tools or incorporate automatic mechanical calibration devices
larger.
within their equipment, and these may be used. Depending on
4.5.8 Vessel’s Temperature Sensor—If the system has a
the adjustments necessary to meet the mechanical calibration
thermal sensor in each vessel to check the temperature of the
criteria, the position and orientation of each vessel may need to
medium, the performance of each thermal sensor should be
be noted to ensure proper subsequent set-up.
verified against a traceable standard.
4.5.1 Shaft Wobble—A runout gauge is positioned so that
the gauge probe touches the turning shaft about 2 cm above the 4.6 Operation—Before each dissolution test perform the
top of the paddle blade or basket. The gauge is placed so that
following:
the probe slightly presses in on the turning shaft. The absolute
4.6.1 Vessel Examination—Each vessel must be free of
value of the difference between the maximum and minimum
scratches, cracks, pits, and residue.
readings is the wobble. The measured value must not exceed
4.6.2 Basket Examination—Each basket must be free of
1.0 mm total runout.
defects such as rusting or corrosion, any wires sticking out
4.5.2 Paddle and Basket Shaft Verticality—Use an accurate
beyond the basket, clogged mesh holes, and dented mesh sides
bubble level or digital leveling device to determine that the
or bottom. Make sure the basket is not deformed from its
shafts are vertical in two directions 90° apart around the
original configuration. Verify that the method of attaching the
vertical axis while the drive unit is in the operating position. If
basket to the shaft (that is, clips, O-rings, and so forth) is the
a bubble level is used, the bubble should be centered within the
one described in the analytical method to be used.
lines of the level. If necessary, the verticality may be checked
4.6.3 Paddle Examination—Each paddle must be visually
with the sha
...

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SCOPE
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5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for medical-related professions within the cannabis and hemp industries.  
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for medical-related professions within the cannabis and hemp industries listed in Table 1.  
1.3 For purposes of this guide, a medical professional is defined as a person qualified and licensed as required by the jurisdiction to provide guidance or recommendations regarding a person's health or fitness.  
1.4 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. It is part of a series of guides denoting certification requirements for professions within the cannabis and hemp industries (Guides D8346, D8347, D8348), and supporting Practice D8403 for associated certificate programs.  
1.5 This guide's content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
1.6 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E2810-23(Practice)
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

SIGNIFICANCE AND USE
4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.  
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.  
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.    
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.  
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.  
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.  
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance r...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter  Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.  
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.  
1.3 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM D8270-23b(Terminology)
Standard Terminology Relating to Cannabis

SCOPE
1.1 This terminology is a compilation of definitions of technical terms used in the cannabis industry. Terms that are generally understood or adequately defined in other readily available sources are not included.  
1.2 When a term is used in an ASTM document for which Committee D37 is responsible it is included only when judged, after review by Subcommittee D37.91, to be a generally usable term.  
1.3 Definitions that are identical to those published by other ASTM committees or other standards organizations are identified with the committee number (for example, D20) or with the abbreviation of the name of the organization (for example, IUPAC, International Union of Pure and Applied Chemistry).  
1.4 A definition is a single sentence with additional information included in discussions.  
1.5 Definitions are followed by the committee responsible for the standard(s) (for example, [D37.01]) and standard designation(s) in which they are used (for example, D8219).  
1.6 Abbreviated Terminology:  
1.6.1 Abbreviated terminology is intended to provide uniform contractions of terms relating to cannabis that have evolved through widespread common usage. The compilation in this standard has been prepared to avoid the occurrence of more than one abbreviated term for a given cannabis term and to avoid multiple meanings for abbreviated terms.  
1.6.2 The abbreviated terminology and descriptions in this standard are intended to be consistent with usage in the cannabis industry and the standards under D37 jurisdiction. Other ASTM committees may assign a different word-phrase description to the same abbreviated terminology. In such cases, the abbreviated terms in this standard shall apply to usage in D37 standards, or if widespread misunderstanding could result from conflicting abbreviated terminology descriptions, the abbreviated terminology for the word-phrase shall not be used in D37 standards.  
1.6.3 Acronyms and Initialisms—A word formed from the letters or parts of words of a longer word-phrase, usually from the initial letters or parts of the words. An acronym is pronounced as a word (for example, radar for radio detection and ranging). An initialism is pronounced as a series of letters (for example, DOT for Department of Transportation).  
1.6.4 The acronym or initialism description is the origin word-phrase for the acronym or initialism, not a definition.  
1.7 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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