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ASTM E3071-16

(Guide)

Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing

Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing

SIGNIFICANCE AND USE
5.1 This guide establishes the basic structure for education in the synthesis and processing of nanoscale materials at the undergraduate college level.  
5.2 Workers may transition in their roles in the workplace. Participants in such education will have a broad understanding of a complement of synthesis and processing topics, thus increasing their marketability for jobs within as well as beyond the nanotechnology field.  
5.3 This guide is intended to be one in a series of standards developed for workforce education in various aspects of nanotechnology. It will assist in providing an organization a basic structure for developing a program applicable to many areas in nanotechnology, thus providing dynamic and evolving workforce education.
SCOPE
1.1 This guide provides a framework for a basic workforce education in materials synthesis and processing at the nanoscale, to be taught at an undergraduate college level. This education should be broad to prepare an individual to serve within one of the many areas in nanotechnology research, development, or manufacturing.  
1.2 This guide may be used to develop or evaluate an education program for synthesis and processing applications in the nanotechnology field. This guide provides listings of key topics that should be covered in a nanotechnology education program on this subject, but it does not provide specific course material to be used in such a program. This approach is taken in order to allow workforce education entities to ensure their programs cover the required material while also enabling these institutions to tailor their programs to meet the needs of their local employers.  
1.3 While no units of measurements are used in this practice, values stated in SI units are to be regarded as 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 and health practices and determine the applicability of regulatory limitations prior to use.  
1.5 This standard does not purport to address all of the techniques, materials, and concepts needed for materials synthesis and processing at the nanoscale. It is the responsibility of the user of this standard to utilize other knowledge and skill objectives as applicable to local conditions or required by local regulations.

General Information

Status
Historical
Publication Date
30-Nov-2016
ICS
07.120 - Nanotechnologies
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.07 - Education and Workforce Development
Current Stage
Ref Project

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ASTM E3071-16 - Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and ProcessingASTM E3071-16 - Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing
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ASTM E3071-16 - Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing
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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: E3071 − 16
Standard Guide for
Nanotechnology Workforce Education in Materials
1
Synthesis and Processing
This standard is issued under the fixed designation E3071; 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 2. Referenced Documents
2
1.1 This guide provides a framework for a basic workforce 2.1 ASTM Standards:
E2456 Terminology Relating to Nanotechnology
education in materials synthesis and processing at the
nanoscale, to be taught at an undergraduate college level. This E2996 Guide for Workforce Education in Nanotechnology
Health and Safety
education should be broad to prepare an individual to serve
3
within one of the many areas in nanotechnology research, 2.2 ISO Standards:
ISO/TS 80004-2 Nanotechnologies – Vocabulary – Part 2:
development, or manufacturing.
Nano-Objects
1.2 This guide may be used to develop or evaluate an
ISO/TS 80004-8 Nanotechnologies – Vocabulary – Part 8:
education program for synthesis and processing applications in
Nanomanufacturing Processes
the nanotechnology field. This guide provides listings of key
topics that should be covered in a nanotechnology education
3. Terminology
program on this subject, but it does not provide specific course
3.1 Definitions:
material to be used in such a program. This approach is taken
3.1.1 For definitions of terms related to nanotechnology in
in order to allow workforce education entities to ensure their
general, refer to Terminology E2456 and ISO/TS 80004-2.
programs cover the required material while also enabling these
3.1.2 For definitions of terms related to nanotechnology
institutions to tailor their programs to meet the needs of their
synthesis and processing in general, refer to ISO/TS 80004-8.
local employers.
3.2 Definitions of Terms Specific to This Standard:
1.3 While no units of measurements are used in this
3.2.1 additive processing, n—adding a layer of new
practice, values stated in SI units are to be regarded as
material,inordertoleaveapatternofdepositedmaterialonthe
standard.
substrate. ISO/TS 80004-8
1.4 This standard does not purport to address all of the
3.2.2 materials processing, n—the technique(s) used to
safety concerns, if any, associated with its use. It is the
transform industrial materials from an initial or intermediate
responsibility of the user of this standard to establish appro-
state into modified or finished parts or products.
priate safety and health practices and determine the applica-
3.2.3 materials synthesis, n—process(s) or reaction(s) for
bility of regulatory limitations prior to use.
building up a complex material or structure by the union of
1.5 This standard does not purport to address all of the
simpler compounds or elements.
techniques, materials, and concepts needed for materials
3.2.4 nanoparticle, n—a nano-object with all external di-
synthesis and processing at the nanoscale. It is the responsi-
mensions in the nanoscale where the lengths of the longest and
bility of the user of this standard to utilize other knowledge and
the shortest axes of the nano-object do not differ significantly.
skill objectives as applicable to local conditions or required by
ISO/TS 80004-2
local regulations.
2
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
1
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech- Standards volume information, refer to the standard’s Document Summary page on
nology and is the direct responsibility of Subcommittee E56.07 on Education and the ASTM website.
3
Workforce Development. Available from International Organization for Standardization (ISO), ISO
Current edition approved Dec. 1, 2016. Published December 2016. DOI: Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
10.1520/E3071-16. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3071 − 16
3.2.5 subtractive processing, n—removal of material except 8. Synthesis and Processing Concepts and Techniques
where the surface is protected by the patterned resist. relevant to Nanotechnology Workforce Education
ISO/TS 80004-8
8.1 Material Considerations—Structure and basic processes
that affect properties:
4. Summary of Guide
8.1.1 Crystal structure.
4.1 This guide designates a list of nanoscale synthesis and
8.1.2 Defects.
processing subject areas relevant to nanotechnology workforce
8.1.3 Bonding.
education. Select
...

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Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing

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5.1 The purpose of this guide is to provide, at the undergraduate college level, a basic educational structure in the synthesis and processing of nanoscale materials to organizations developing or carrying out education programs for the nanotechnology workforce. This guide helps to describe the minimum knowledge base for anyone involved in nanomanufacturing or nanomaterials research.  
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1.1 This guide provides a framework for a basic workforce education in materials synthesis and processing at the nanoscale, to be taught at an undergraduate college level. This education should be broad to prepare an individual to serve within one of the many areas in nanotechnology research, development, or manufacturing.  
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5.1 The purpose of this guide is to provide, at the undergraduate college level, a basic educational structure in the infrastructure aspects of nanotechnology to organizations developing or carrying out education programs for the nanotechnology workforce. This guide helps to describe the minimum knowledge base for anyone involved in nanomanufacturing or nanomaterials research.  
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ASTM
ASTM E3324-22(Test Method)
Standard Test Method for Lipid Quantitation in Liposomal Formulations Using Ultra-High-Performance Liquid Chromatography (UHPLC) with Triple Quadrupole Mass Spectrometry (TQMS)

SIGNIFICANCE AND USE
5.1 Liposomes are vesicles of nanoscale dimensions, composed of lipid bilayers, which are used for various diagnostic and therapeutic applications (9). The growing interest in liposomal formulations in the delivery of various drugs, antisense oligonucleotides, cloned genes, or recombinant proteins by the biopharmaceutical industry, warrants QC and thorough characterization of the constituent lipids. Lipid structure, composition, and concentration are key attributes in determining the quality and efficacy of a liposomal drug product as they influence the stability of liposomes, drug loading, release kinetics, biodistribution, and pharmacokinetic properties (9). Cholesterol modulates the lipid membrane fluidity, elasticity, and permeability; hence, it plays a key role in controlled drug release and increased stability of the liposome (10).  
5.2 This test method provides a rapid and reliable protocol for the determination of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations using UHPLC-TQMS. Assessment of the stability of the analytes in terms of their degradation profiles is not included in this test method (11). This test method will benefit the biopharmaceutical industry in ascertaining quality assessment of liposomal formulations and monitoring batch-to-batch consistency for large-scale production, thereby facilitating safe and efficient drug development and regulatory review.  
5.3 UHPLC-MS/MS measurements are analytically more sensitive and specific for lipid analysis compared to other contemporary techniques using universal detectors, such as a charged aerosol or an evaporative light-scattering detector. For liposomes, MS/MS has further advantages over ultraviolet detectors, as lipids lack chromophores for detection. In this test method, TQMS has been used as the MS/MS technique of choice because of its high selectivity, sensitivity, S/N, accuracy, and broad linear range of quantitation, thereby allowing reproducible quantitation of the analytes,...
SCOPE
1.1 This test method describes the determination of lipid components in liposomal formulations, which includes sample solubilization in methanol followed by separation of the analytes using ultra-high-performance liquid chromatography (UHPLC) and detection with tandem mass-spectrometry (MS/MS). This test method adheres to multiple reaction monitoring (MRM) mass spectrometry on a triple quadrupole mass spectrometer (TQMS).  
1.2 This test method is specific for liposomal formulations containing cholesterol, 1,2- distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy (polyethylene glycol)-2000] (DSPE- PEG 2000), and hydrogenated (soy) L-α-phosphatidylcholine (HSPC).  
1.3 This test method is applicable to report the absolute concentrations of cholesterol, DSPE-PEG 2000, and HSPC and their ratio (DSPE-PEG 2000: HSPC: cholesterol) in liposomal formulations. Assessment of the stability of the analytes in terms of their degradation as a result of oxidation or hydrolysis is beyond the scope of this test method.  
1.4 This test method includes calibration and standardization, sample preparation, UHPLC-TQMS instrumentation, potential interferences, method validation with acceptance criteria, sample analysis, and data reporting.  
1.5 The detection limits for cholesterol, DSPE-PEG 2000, and HSPC using this test method are 5.3, 0.5, and 0.5 ng/g, respectively. In addition, the quantitation limits for cholesterol, DSPE-PEG 2000, and HSPC are 10.6, 0.8, and 0.5 ng/g, respectively.  
1.6 This test method is intended for concentration ranges of 8-1600 ng/g for cholesterol, and of 2-400 ng/g for DSPE-PEG 2000 and HSPC.  
1.7 All observed and calculated values shall conform to the guidelines for significant digits and rounding as established in Practice D6026.  
1.8 Units—The values stated in SI units are to be regarded as the standard. Where appropriate, c.g.s units in addition to SI units are included in this standard.  
1.9 Th...

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