ASTM F3320-18
(Guide)Standard Guide for Coating Characterization of Drug Coated Balloons
Standard Guide for Coating Characterization of Drug Coated Balloons
SIGNIFICANCE AND USE
5.1 The methods described herein allow for in-vitro characterization of DCB drug coating attributes that, along with pre-clinical and clinical safety and effectiveness data, establish that the DCBs, with the characterized coating attributes, are safe and effective. Clinical safety and therapeutic benefit may be affected by non-uniform distribution of the active pharmaceutical ingredient, coating anomalies on the device, and particulate release. Variability in drug coating may result in insufficient or excessive drug availability and inconsistent device performance.
5.2 Individual characterization tests may not have direct clinical relevance, although bench-based characterization results can be combined with other data to provide insight to characteristics that influence clinical safety and effectiveness. Bench testing is performed under repeatable and controlled conditions, providing information about drug coating integrity, thickness, uniformity, particulate shedding, particulate identity, and particulate crystallinity.
5.3 Distribution of the drug coating is characterized by coating integrity, thickness, and uniformity. Particulate counts can provide a measure of manufacturing repeatability, and may provide an indication of in vivo safety if simulated use particulates and in vivo particulates are shown to be similar, or if particulate testing results are correlated to in vivo safety. Chemical identity of particulates and crystallinity may further advise the kinetics related to the potential for particulate persistence, dissolution or other characteristics which may relate to in vivo safety. Conducting this testing and gathering the data further allows for the potential comparison of devices (e.g., demonstrating equivalence between pre-clinical and clinical devices for these coating attributes).
5.4 The methods described in this guide are for characterization purposes and are not intended for production release testing of drug coated balloon catheters. How...
SCOPE
1.1 This guide describes recommended acute in-vitro characterization methods for drug coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically, this guide details:
1.1.1 Characterization of integrity by inspection of the coated balloon surface.
1.1.2 Measurement of coating thickness.
1.1.3 Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially.
1.1.4 Quantitation of the number of particulates released, in various size ranges, during simulated use testing (insertion, tracking, deployment, retraction, and withdrawal) along with chemical and crystallinity characterization of particulates.
1.2 This document does not address:
1.2.1 Mechanical testing of drug coated balloons (DCBs).
1.2.2 Drug substance evaluation (e.g., assay, related substances, uniformity of dosage units) of DCBs.
1.2.3 Production release and stability testing, although some sections may be applicable in whole or in part.
1.2.4 Standard analytical testing (e.g., drug content, drug related substances, drug uniformity of dosage).
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 T...
General Information
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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: F3320 − 18
Standard Guide for
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Coating Characterization of Drug Coated Balloons
This standard is issued under the fixed designation F3320; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This guide describes recommended acute in-vitro char-
acterization methods for drug coated balloon (DCB) coatings.
2. Referenced Documents
These methods include: coating integrity, coating thickness,
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2.1 ASTM Standards:
drugcoatinguniformity,andreleasedparticulates.Specifically,
F2743Guide for Coating Inspection and Acute Particulate
this guide details:
Characterization of Coated Drug-Eluting Vascular Stent
1.1.1 Characterization of integrity by inspection of the
Systems
coated balloon surface.
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2.2 AAMI Standard:
1.1.2 Measurement of coating thickness.
AAMI TIR 42Evaluation of Particulates Associated with
1.1.3 Quantitationofdrugcoatinguniformity(uniformityof
Vascular Medical Devices
drug distribution over the balloon surface) longitudinally and
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2.3 USP Standards:
circumferentially.
USP <788>Particulate Matter in Injections
1.1.4 Quantitation of the number of particulates released, in
USP <905>Uniformity of Dosage Units
various size ranges, during simulated use testing (insertion,
3. Terminology
tracking, deployment, retraction, and withdrawal) along with
chemical and crystallinity characterization of particulates.
3.1 Definitions:
3.1.1 tracking, n—navigationofaguidewire,guidecatheter
1.2 This document does not address:
or introducer sheath, and/or balloon system through actual or
1.2.1 Mechanical testing of drug coated balloons (DCBs).
simulated vascular anatomy.
1.2.2 Drug substance evaluation (e.g., assay, related
substances, uniformity of dosage units) of DCBs.
3.1.2 vascular model, n—a model that simulates or repli-
1.2.3 Productionreleaseandstabilitytesting,althoughsome
cates the geometry of a clinically relevant, sufficiently chal-
sections may be applicable in whole or in part.
lenging anatomical vasculature for the intended anatomy
1.2.4 Standard analytical testing (e.g., drug content, drug through which the system will be placed. There should be a
related substances, drug uniformity of dosage).
deployment site within the model or mock vessel attached to
the model for balloon deployment.
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this 3.2 Definitions of Terms Specific to This Standard:
standard. 3.2.1 acute, n—the timeframe including accessory and bal-
loon delivery, deployment, and withdrawal.
1.4 This standard does not purport to address all of the
3.2.2 background assessment, n—a test measuring the
safety concerns, if any, associated with its use. It is the
number/size of particulates within the Particulate test system
responsibility of the user of this standard to establish appro-
without accessories or test articles.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.2.3 drug coated balloon (DCB), n—medical device com-
1.5 This international standard was developed in accor-
prised of a drug coating over the surface of vascular dilatation
dance with internationally recognized principles on standard-
balloon.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
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This guide is under the jurisdiction ofASTM Committee F04 on Medical and Available from Association for the Advancement of Medical Instrumentation
Surgical Materials and Devices and is the direct responsibility of Subcommittee (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
F04.30 on Cardiovascular Standards. www.aami.org.
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Current edition approved June 1, 2018. Published July 2018. DOI: 10.1520/ Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
F3320–18. Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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