ASTM F2103-18
(Guide)Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
SIGNIFICANCE AND USE
4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.
4.2 The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application.
4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
SCOPE
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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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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: F2103 − 18
Standard Guide for
Characterization and Testing of Chitosan Salts as Starting
Materials Intended for Use in Biomedical and Tissue-
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2103; 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.
INTRODUCTION
Biopolymers from marine sources have been studied and used in commercial applications and
product development for a number of years. Chitosan, a linear polysaccharide consisting of
glucosamine and N-acetyl glucosamine derived mainly from crustacean shells, has been used in many
technical applications such as water purification (as a flocculant), in cosmetics, and recently as a
proposed fat-binding weight control product. In solution, the cationic nature of chitosan gives this
polymer a mucoadhesive property. Chitosan and its salts can be used as a matrix or scaffold material
as well as in non-parenteral delivery systems for challenging drugs. Chitosan salts have been shown
to increase the transport of polar drugs across the nasal epithelial surface. The purpose of this guide
is to identify key parameters relevant for the functionality and characterization of chitosan and
chitosansaltsforthedevelopmentofnewcommercialapplicationsofchitosansaltsforthebiomedical
and pharmaceutical industries.
1. Scope central nervous system, kidney, and liver damage. Mercury, or
its vapor, may be hazardous to health and corrosive to
1.1 This guide covers the evaluation of chitosan salts
materials.Cautionshouldbetakenwhenhandlingmercuryand
suitable for use in biomedical or pharmaceutical applications,
mercury-containing products. See the applicable product Ma-
or both, including, but not limited to, tissue-engineered medi-
terial Safety Data Sheet (MSDS) for details and EPA’s website
cal products (TEMPS).
(http://www.epa.gov/mercury/faq.htm) for additional informa-
1.2 This guide addresses key parameters relevant for the
tion. Users should be aware that selling mercury or mercury-
functionality, characterization, and purity of chitosan salts.
containingproducts,orboth,inyourstatemaybeprohibitedby
1.3 As with any material, some characteristics of chitosan state law.
may be altered by processing techniques (such as molding,
1.5 The values stated in SI units are to be regarded as
extrusion, machining, assembly, sterilization, and so forth)
standard. No other units of measurement are included in this
required for the production of a specific part or device.
standard.
Therefore, properties of fabricated forms of this polymer
1.6 This standard does not purport to address all of the
should be evaluated using test methods that are appropriate to
safety concerns, if any, associated with its use. It is the
ensure safety and efficacy.
responsibility of the user of this standard to establish appro-
1.4 Warning—Mercury has been designated by EPA and
priate safety, health, and environmental practices and deter-
many state agencies as a hazardous material that can cause
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
1
dance with internationally recognized principles on standard-
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
ization established in the Decision on Principles for the
F04.42 on Biomaterials and Biomolecules for TEMPs.
Development of International Standards, Guides and Recom-
Current edition approved June 1, 2018. Published August 2018. Originally
mendations issued by the World Trade Organization Technical
approved in 2001. Last previous edition approved in 2011 as F2103 – 11. DOI:
Barriers to Trade (TBT) Committee.
10.1520/F2103-18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2103 − 18
2. Referenced Documents ISO 22442-1 Medical Devices UtilizingAnimal Tissues and
2 Their Derivatives — Part 1:Application of Risk Manage-
2.1 ASTM Standards:
ment
D2196 Test Methods for Rheological Properties of Non-
ISO 22442-2 Medical Devices UtilizingAnimal Tissues and
Newtonian Materials by Rotational Viscometer
Their Derivatives — Part 2: Controls On Sourcing,
F619 Practice for Extraction of Medical Plastics
Collection, and Handling
F748 PracticeforSelectingGenericBio
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2103 − 11 F2103 − 18
Standard Guide for
Characterization and Testing of Chitosan Salts as Starting
Materials Intended for Use in Biomedical and Tissue-
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2103; 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.
INTRODUCTION
Biopolymers from marine sources have been studied and used in commercial applications and
product development for a number of years. Chitosan, a linear polysaccharide consisting of
glucosamine and N-acetyl glucosamine derived mainly from crustacean shells, has been used in many
technical applications such as water purification (as a flocculant), in cosmetics, and recently as a
proposed fat-binding weight control product. In solution, the cationic nature of chitosan gives this
polymer a mucoadhesive property. Chitosan and its salts can be used as a matrix or scaffold material
as well as in non-parenteral delivery systems for challenging drugs. Chitosan salts have been shown
to increase the transport of polar drugs across the nasal epithelial surface. The purpose of this guide
is to identify key parameters relevant for the functionality and characterization of chitosan and
chitosan salts for the development of new commercial applications of chitosan salts for the biomedical
and pharmaceutical industries.
1. Scope
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both,
including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion,
machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of
fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware
that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 safety, health, and healthenvironmental 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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved March 1, 2011June 1, 2018. Published March 2011August 2018. Originally approved in 2001. Last previous edition approved in 20072011 as
ε2
F2103 – 01F2103 – 11.(2007) . DOI: 10.1520/F2103-11.10.1520/F2103-18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2103 − 18
2. Referenced Documents
2
2.1 ASTM Standards:
D2196 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational Viscometer
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Metho
...
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