ASTM E2503-13(2020)

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

Overview

ASTM E2503-13(2020), titled Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus, establishes the procedures for the mechanical calibration and qualification of dissolution testing equipment-specifically, basket and paddle apparatus. Developed by ASTM International, this standard is critical for ensuring the reproducibility and reliability of dissolution results in pharmaceutical and biopharmaceutical laboratories. Proper qualification as outlined in this practice helps laboratories comply with international standards and regulatory requirements.

Key Topics

• Mechanical Calibration Procedures: The standard specifies how to calibrate basket and paddle dissolution units, minimizing variability and ensuring accurate results.
• Setup and Alignment: Detailed guidance is provided on verifying and setting up apparatus components such as vessels, baskets, and paddles to meet defined dimensional and operational criteria.
• Measurement Tools: All tools used for calibration should be traceable to national or international standards, ensuring accuracy.
• Calibrated Units: Once a unit fulfills all specified mechanical requirements, further calibration with dissolution calibrator tablets is not required.
• Analyst Responsibilities: Users must verify dimensions upon receipt (via measurement or certification), perform regular calibrations, and ensure instruments are well-maintained.
• Routine Checks: The practice outlines checks for shaft and basket wobble, shaft verticality, vessel centering and verticality, paddle height, rotational speed, and temperature control.
• Operational Readiness: Prior to each analysis, apparatus and component integrity must be visually verified for defects, cleanliness, and correct assembly.

Applications

• Pharmaceutical Development: The calibration and qualification methods described support drug formulation, development, and quality control by ensuring precise dissolution testing results.
• Quality Assurance: Routine qualification reduces the risk of invalid results, safeguarding product quality and regulatory compliance.
• Automated Dissolution Testing: This standard is applicable even to modified or automated apparatus equipped for automated sampling or media replacement.
• Regulatory Submissions: Adherence to ASTM E2503-13(2020) supports compliance with global regulatory expectations for dissolution testing, facilitating product approvals and audits.
• Laboratory Accreditation: Following this standard aids laboratories seeking or maintaining accreditation by demonstrating adherence to recognized international standards for equipment qualification.

Related Standards

• USP <711> Dissolution: Addresses dissolution procedures in pharmaceutical testing and may reference apparatus requirements similar to those in ASTM E2503-13(2020).
• ASTM E2750: Standard Guide for System Qualification of Analytical Instruments, which may complement apparatus qualification practices.
• ICH Q2(R1): Harmonised Tripartite Guideline on Validation of Analytical Procedures, relevant for analytical method reliability and reproducibility.
• ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories, which underscores the need for proper calibration and equipment qualification practices similar to those in ASTM E2503.

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Keywords: ATPM E2503, basket dissolution apparatus, paddle dissolution apparatus, mechanical calibration, pharmaceutical testing, equipment qualification, dissolution testing, lab compliance, regulatory standards

Standards Content (Sample)

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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