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ASTM E3059-16

(Guide)

Standard Guide for Workforce Education in Nanotechnology Infrastructure

Standard Guide for Workforce Education in Nanotechnology Infrastructure

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide 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, nanomaterials characterization, or nanomaterials research.  
5.2 The basic education should prepare an individual for varied roles in the nanotechnology workplace. The material in this guide may require a post-secondary two-year science or technology background to be understood sufficiently. Depth on the topics should be sufficient to transfer between various applications of nanotechnology such as nanomaterial fabrication, nanomaterial characterization, nanolithography, and patterning.  
5.3 Nanoscale materials might present unique health and environmental hazards due to their unique properties. The hazards, if any, presented by nanomaterials can be very different from those presented by bulk/macroscopic materials.  
5.4 Because nanotechnology is a rapidly developing field, the individual educated in nanotechnology needs to be cognizant of changing and evolving safety procedures and practices. Individuals should be aware of how to keep current on the technology and have a base education that enables synthesis of emerging safety procedures and practices.
SCOPE
1.1 This document provides guidelines for basic workforce education in the infrastructure topics related to nanotechnology to be taught at an undergraduate college level. This education should be broad to prepare an individual to work within one of the many areas in nanotechnology research, development, or manufacturing. The individual so educated may be involved in material handling, manufacture, distribution, storage, use, or disposal of nanoscale materials.  
1.2 This guide may be used to develop or evaluate an education program for the infrastructure used 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 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 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 methods and concepts pertaining to the infrastructure for nanotechnology. It may not cover knowledge and skill objectives applicable to local conditions or required by local regulations.

General Information

Status
Historical
Publication Date
31-Mar-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 E3059-16 - Standard Guide for Workforce Education in Nanotechnology Infrastructure
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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: E3059 − 16
Standard Guide for
1
Workforce Education in Nanotechnology Infrastructure
This standard is issued under the fixed designation E3059; 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 document provides guidelines for basic workforce 2.1 ASTM Standards:
educationintheinfrastructuretopicsrelatedtonanotechnology E2456 Terminology Relating to Nanotechnology
to be taught at an undergraduate college level. This education E2996 Guide for Workforce Education in Nanotechnology
Health and Safety
should be broad to prepare an individual to work within one of
3
the many areas in nanotechnology research, development, or 2.2 ISO Standards:
ISO/TS 80004-1 Nanotechnologies – Vocabulary – Part 1:
manufacturing. The individual so educated may be involved in
material handling, manufacture, distribution, storage, use, or Core Terms
ISO 14644-1 Cleanrooms and Associated Controlled Envi-
disposal of nanoscale materials.
ronments – Part 1: Classification of Air Cleanliness
1.2 This guide may be used to develop or evaluate an
education program for the infrastructure used in the nanotech-
3. Terminology
nology field. This guide provides listings of key topics that
3.1 Definitions:
should be covered in a nanotechnology education program on
3.1.1 For definitions of terms related to nanotechnology in
this subject, but it does not provide specific course material to
general, refer to Terminology E2456 and ISO/TS 80004-1.
be used in such a program. This approach is taken in order to
3.2 Definitions of Terms Specific to This Standard:
allow workforce education entities to ensure their programs
3.2.1 nanomanufacturing, n—intentional synthesis, genera-
cover the required material while also enabling these institu-
tion or control of nano-materials, or fabrication steps in the
tions to tailor their programs to meet the needs of their local
nanoscale, for commercial purposes. ISO/TS 80004-1
employers.
3.2.2 nanomaterial, n—material with any external dimen-
1.3 The values stated in SI units are to be regarded as
sion in the nanoscale or having internal structure or surface
standard. No other units of measurement are included in this
structure in the nanoscale. ISO/TS 80004-1
standard.
3.2.3 nanoscale, adj—having one or more dimensions from
1.4 This standard does not purport to address all of the
approximately 1 to 100 nanometres (nm). E2456
safety concerns, if any, associated with its use. It is the
3.2.4 nanotechnology infrastructure, n—the basic equip-
responsibility of the user of this standard to establish appro-
ment and facilities (such as controlled environments) that are
priate safety and health practices and determine the applica-
needed to properly conduct nanoscale research and develop-
bility of regulatory limitations prior to use.
ment or nanomanufacturing.
1.5 This standard does not purport to address all of the
methods and concepts pertaining to the infrastructure for
4. Summary of Guide
nanotechnology. It may not cover knowledge and skill objec-
4.1 This guide designates a list of topics on nanotechnology
tives applicable to local conditions or required by local
infrastructurerelevanttonanotechnologyworkforceeducation.
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 April 1, 2016. Published April 2016. DOI: 10.1520/ Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
E3059-16. 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 ----------------------
E3059 − 16
Selection of the techniques, concepts, and materials are based the infrastructure used in nanomanufacturing, nanomaterials
oninputsfromindustry,nanotechnologyeducators,andsubject characterization or nanomaterials research.
matter experts.
CONTROLLED ENVIRONMENTS
4.2 In this list, the first two topics pertain to controlled
8.2 Cleanroom Classification:
environments. The subsequent topics cover vacuum systems
8.2.1 Cleanliness level standards – ISO 14644-1 versus the
...

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SIGNIFICANCE AND USE
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1.1 This guide provides a framework for a basic workforce education in material properties 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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SIGNIFICANCE AND USE
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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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.  
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SIGNIFICANCE AND USE
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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5.3 Workers may transition in their roles in the workplace. Participants in such education will have a broad understanding of a complement of topics related to the infrastructure required for advanced research and manufacturing, thus increasing their marketability for jobs within as well as beyond the nanotechnology field.  
5.4 Because nanotechnology is a rapidly developing field, the individual educated in nanotechnology needs to be cognizant of changing and evolving safety procedures and practices. Individuals should be aware of how to maintain an up-to-date understanding of the technology and have sufficient base education to enable the synthesis of emerging or evolving safety procedures and practices.  
5.5 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
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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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