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ASTM F2900-11

(Guide)

Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)

Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)

SIGNIFICANCE AND USE
This guide describes methods for determining the key attributes of hydrogels used in regenerative medicine (that is, their biological properties, kinetics of formation, degradation and agent release, physical and chemical stability and mass transport capabilities). See Table 1.
SCOPE
1.1 Hydrogels are water-swollen polymeric networks that retain water within the spaces between the macromolecules; and maintain the structural integrity of a solid due to the presence of cross-links (1-3). They are mainly used in regenerative medicine as matrix substitutes, delivery vehicles for drugs and/or biologics, and environments for cell culture. In these applications, hydrogel efficacy may depend on the ability to: support the permeation of dissolved gases, nutrients and bioactive materials; sustain cell growth and migration; degrade; release drugs and/or biologics at an appropriate rate; and maintain their shape.
1.2 Hydrogels used in regenerative medicine can be composed of naturally derived polymers (for example, alginate, chitosan, collagen (4, 5)), synthetically derived polymers (for example, polyethylene glycol (PEG), polyvinyl alcohol (PVA) (4, 5)) or a combination of both (for example, PVA with chitosan or gelatin (6)). In clinical use, they can be injected or implanted into the body with or without the addition of drugs and/or biologics (7).
1.3 This guide provides an overview of test methods suitable for characterizing hydrogels used in regenerative medicine. Specifically, this guide describes methods to assess hydrogel biological properties, kinetics of formation, degradation and agent release, physical and chemical stability and mass transport capabilities are discussed.
1.4 The test methods described use hydrated samples with one exception: determining the water content of hydrogels requires samples to be dried. It is generally recommended that hydrogels that have been dried for this purpose are not rehydrated for further testing. This recommendation is due to the high probability that, for most hydrogel systems, the drying-rehydration process can be detrimental with possible alterations in structure.
1.5 This guide does not consider evaluation of the microstructure of hydrogels (for example, matrix morphology, macromolecule network structure and chain conformation).
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide provided an overview of test methods suitable for characterizing hydrogels used in regenerative medicine.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
14-Mar-2011
Withdrawal Date
14-Jan-2020
ICS
11.120.10 - Medicaments
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
15-Mar-2011
Referred By
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
15-Mar-2011

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ASTM F2900-11 - Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)ASTM F2900-11 - Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
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ASTM F2900-11 - Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2900 − 11
Standard Guide for
Characterization of Hydrogels used in Regenerative
1
Medicine
This standard is issued under the fixed designation F2900; 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 1.5 This guide does not consider evaluation of the micro-
structure of hydrogels (for example, matrix morphology, mac-
1.1 Hydrogels are water-swollen polymeric networks that
romolecule network structure and chain conformation).
retain water within the spaces between the macromolecules;
and maintain the structural integrity of a solid due to the 1.6 The values stated in SI units are to be regarded as
2
presence of cross-links (1-3). They are mainly used in standard. No other units of measurement are included in this
regenerative medicine as matrix substitutes, delivery vehicles standard.
fordrugsand/orbiologics,andenvironmentsforcellculture.In
1.7 This standard does not purport to address all of the
these applications, hydrogel efficacy may depend on the ability
safety concerns, if any, associated with its use. It is the
to: support the permeation of dissolved gases, nutrients and
responsibility of the user of this standard to establish appro-
bioactive materials; sustain cell growth and migration; de-
priate safety and health practices and determine the applica-
grade;releasedrugsand/orbiologicsatanappropriaterate;and
bility of regulatory limitations prior to use.
maintain their shape.
2. Referenced Documents
1.2 Hydrogels used in regenerative medicine can be com-
3
posed of naturally derived polymers (for example, alginate,
2.1 ASTM Standards:
chitosan, collagen (4, 5)), synthetically derived polymers (for
D4516 Practice for Standardizing Reverse Osmosis Perfor-
example, polyethylene glycol (PEG), polyvinyl alcohol (PVA)
mance Data
(4, 5)) or a combination of both (for example, PVA with
F748 PracticeforSelectingGenericBiologicalTestMethods
chitosan or gelatin (6)). In clinical use, they can be injected or
for Materials and Devices
implanted into the body with or without the addition of drugs
F895 TestMethodforAgarDiffusionCellCultureScreening
and/or biologics (7).
for Cytotoxicity
F2027 Guide for Characterization and Testing of Raw or
1.3 This guide provides an overview of test methods suit-
Starting Biomaterials for Tissue-Engineered Medical
able for characterizing hydrogels used in regenerative medi-
Products
cine. Specifically, this guide describes methods to assess
F2064 Guide for Characterization and Testing of Alginates
hydrogel biological properties, kinetics of formation, degrada-
as Starting Materials Intended for Use in Biomedical and
tion and agent release, physical and chemical stability and
Tissue Engineered Medical Product Applications
mass transport capabilities are discussed.
F2103 Guide for Characterization and Testing of Chitosan
1.4 The test methods described use hydrated samples with
Salts as Starting Materials Intended for Use in Biomedical
one exception: determining the water content of hydrogels
and Tissue-Engineered Medical Product Applications
requires samples to be dried. It is generally recommended that
F2150 Guide for Characterization and Testing of Biomate-
hydrogels that have been dried for this purpose are not
rial Scaffolds Used in Tissue-Engineered Medical Prod-
rehydrated for further testing. This recommendation is due to
ucts
the high probability that, for most hydrogel systems, the
F2214 Test Method forIn Situ Determination of Network
drying-rehydration process can be detrimental with possible
Parameters of Crosslinked Ultra High Molecular Weight
alterations in structure.
Polyethylene (UHMWPE)
F2315 Guide for Immobilization or Encapsulation of Living
Cells or Tissue in Alginate Gels
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.
3
Current edition approved March 15, 2011. Published March 2011. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F2900–11. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to a list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2900 − 11
F2347 Guide for Characterization and Testing of Hyaluro-
...

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SCOPE
1.1 This standard shall classify various types of cannabis/hemp flower vaporizer devices.  
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1.4 Vaporizer devices intended for use with materials other than cannabis flower, a dried cannabis flower, or ground dried cannabis flower, or combination thereof, are not in the scope of this classification.  
1.5 This classification shall apply to vaporizer devices used to consume cannabis flower from a cannabis plant regardless of the type of cannabis plant from which it is derived. For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant (cannabis/hemp).  
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SCOPE
1.1 This standard shall classify the various types of cannabis/hemp extract vaporizers.  
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4.5 Reference to a type characteristic in this guide is not intended in any manner to denote endorsement or approval of said type by ASTM International.
SCOPE
1.1 This guide is intended to define characteristics, functions and technologies commonly present in personal cannabis/hemp plant growing appliances  
1.2 This guide will provide clarity and understanding to the industry, government, consumers and the general public on different features and technologies that may be present and/or are used in the design and manufacture of personal cannabis/hemp plant growing appliances.  
1.3 This guide shall be used in conjunction with Classification D8390.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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 E3219-20(Guide)
Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

SIGNIFICANCE AND USE
4.1 Guidelines for unintended human exposure to active pharmaceutical ingredients (APIs) are required by various global regulations as part of international quality requirements, needed as good product stewardship, and are considered the industry standard.  
4.2 Application of the approach described within this guide applies a scientifically justified, data-driven, approach to deriving safe limits for unintended exposures to individual substances. These limits can then be further used to calculate cleaning limits used in quality risk assessment for the manufacture of pharmaceuticals. The HBEL approach considers substance-specific properties (type of effect, potency, pharmacology, safety profile, and so forth). Specific approaches are applicable to different categories of substances and in specific stages in drug development.  
4.3 The basis for the HBEL derivation is all available substance-specific data. Interpretation of these data considers the quantity and robustness of the database and the reliability and relevance of the data. Typically, adjustment factors (AFs) are used to address variability and uncertainty in different parameters to determine a safe human exposure limit, although alternative, purposefully conservative, approaches [for example, threshold of toxicological concern (TTC), read-across] may be used as appropriate.  
4.4 This guide supports, and is consistent with, elements of the European Commission (EU) Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (27, 28) and guidance from the International Society of Pharmaceutical Engineers (ISPE) (29) in which it is mentioned that relevant residue limits should be based on a toxicological evaluation.  
4.5 Key Concepts—This guide applies the following steps: (1) hazard characterization, (2) identification of the critical effect(s) including dose-response assessment, (3) determination of one or several points of departure (PoD)s, (4) application of PoD-spe...
SCOPE
1.1 This guide describes the scientific procedures underlying the integrative interpretation of all data concerning an active pharmaceutical ingredient (API) taking into account study adequacy, relevance, reliability, validity, and compound-specific characteristics (for example, potency, toxicological profile, and pharmacokinetics) leading to a numerical value for the API, which is used further in the quality risk management (ICH Q9) of cross contamination during the manufacture of different products in the same manufacturing facilities.  
1.2 This guide describes general guidance for calculating and documenting a health-based exposure limit (HBEL). It should serve the involved qualified experts as a reference for HBEL derivations and should harmonize the different approaches and nomenclature to the greatest extent possible.  
1.3 This guide should be used for calculating and documenting an HBEL, when required or necessary, for APIs (including biologics), intermediates, cleaning agents, excipients, and other chemicals (that is, reagents, manufacturing residues, and so forth) used for cleaning validation and verification (Guides F3127 and E3106). In scope is the cleaning and cross contamination of surfaces of manufacturing equipment and medical devices but does not include leachables/extractables (21 CFR 211.67, 21 CFR 610.11, 21 CFR 820.70, and 21 CFR 111.27).  
1.4 The principles in this guide may also be used as a basis for setting occupational exposure limits.  
1.5 The principles in this guide may be applied during the development and commercial manufacturing of small or large molecular weight medicines as well as isolated pharmaceutical intermediates.  
1.6 Subsequent-product HBEL values may be set for specific routes of exposure (for example, oral, inhalation, and parenteral) when necessary (for example, because of differences in bioavailability) and for specific patient populations (for example, children) if ...

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