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Three New ASTM International Standards

in the Works for Committee on Nanotechnology


 

 

W. CONSHOHOCKEN, Pa., 12 October 2005--Although ASTM International Committee
E56 on Nanotechnology was just established this year, it has already begun an
ambitious program of developing new standards. Committee E56 is currently
developing the following proposed standards, which deal with environmental
safety issues, hemolytic properties and particle size measurement. Interested
parties are invited to participate in the development of any of these proposed
standards.

WK8985, Guide for Handling Unbound Engineered Nanoparticles in Occupational
Settings

Academic, government and industrial laboratories are currently performing
nanotechnology research and development and the scope and breadth of this work
is expected to grow dramatically. Manufacturing processes involving
nanomaterials have begun and commercially available nano-based products have
been introduced.

All of this activity in the nanotechnology realm has created the need for the
establishment of environmental, health and safety (EHS) methodologies to
prevent harmful employee exposures in occupational settings during both
research and development activities and manufacturing processes. A proposed
new standard being developed by Subcommittee E56.06 on Risk Management and
Product Stewardship will address these concerns.

According to Steven Brown, Technology Development, EHS Industrial Hygiene,
Intel Corporation, WK8985, Guide for Handling Unbound Engineered Nanoparticles
in Occupational Settings, will be utilized by organizations involved in the
handling and processing of nanomaterials in occupational settings to develop
internal EHS nanotechnology control programs. "The proposed standard will
provide specific guidance on EHS nanotechnology control program elements and
workplace administrative and engineering controls to prevent harmful exposure
to employees," says Brown.

Brown points out the necessity of such a standard by noting that, as
industrial uses of nanomaterials increase, there will be more employees
working with them, creating a corresponding increase in the risk of harmful
exposures in the absence of EHS controls.

Subcommittee E56.06 is actively soliciting volunteers with knowledge of health
and safety plan development or nanotechnology processes in research and
development or manufacturing settings who wish to participate in the further
development of WK8985.

For further technical information, contact Steven Brown, Intel Corporation,
Cloverdale, Ore. (phone: 971/563-6198; mailto:steven.w.brown@intel.com ).

Three New ASTM International Standards in the Works for Committee on
Nanotechnology/Add One

WK8997, Practice for Analysis of Hemolytic Properties of Nanoparticles

Subcommittee E56.02 on Characterization has begun working on proposed new
standard WK8997, Practice for Analysis of Hemolytic Properties of
Nanoparticles. This proposed standard would provide a suitable procedure for
establishing the safety of nanoparticulate materials that will be used in
vivo, such as nanoparticles for therapeutics and diagnostics.

"Nanotechnology products will be used in medical areas, primarily for in vitro
diagnostics, in vivo imaging and for drug delivery to targeted tissues," says
Scott McNeil, director, Nanotechnology Characterization Laboratory. McNeil
points out however, that products used for medical applications will need to
meet special criteria for biological responses. In addition to performing the
functions for which they were built, nanotechnology products used in the
medical realm will need to be biocompatible. WK8997 is an adaptation of
biocompatibility standards developed by ASTM Subcommittee F04.16 on
Biocompatibility Test Methods, which is under the jurisdiction of Committee
F04 on Medical and Surgical Materials and Devices.

Nanoparticles that are to be used in contact with the blood stream must be
composed of materials that meet hemocompatibilty standards. One of these tests
is for damage to red blood cells, which can result in hemolysis, that is,
rupturing of the cells. WK8997 is particularly based on Subcommittee F04.16's
F 756, Practice for Assessment of Hemolytic Properties of Materials. "F 756
for blood contacting devices has been around for years but was originally
designed for materials that are in abundant supply, such as joint replacement
devices," says McNeil. "Nanoparticulate materials, on the other hand, are
generally not available in large quantities and the specimen size needed for F
756 is prohibitive." McNeil notes that the general concepts in F 756 are
maintained in WK8997, but the methodology uses available micro methods, such
as 96-well plates, and is appropriate for the use and availability of
nanoparticulate material.

Subcommittee E56.02 is actively seeking participation in the development of
WK8997. Current stakeholders include representatives of the U.S. Food and Drug
Administration, the nano-biotechnology community and drug developers.

For further technical information, contact Scott McNeil, director,
Nanotechnology Characterization Laboratory, Frederick, Md. (phone: 301/846-
6939; mailto:mcneils@ncifcrf.gov ).

WK8705, Measurement of Particle Size Distribution of Nanomaterials in
Suspension by Photo Correlation Spectroscopy (PCS)

Subcommittee E56.02 was formed to answer questions regarding characterization,
such as size and shape of materials. Another proposed new standard under the
jurisdiction of Subcommittee E56.02 is WK8705, Measurement of Particle Size
Distribution of Nanomaterials in Suspension by Photo Correlation Spectroscopy
(PCS), which deals with the vital issue of size characterization. The purpose
of the proposed standard is to set and define the standards for measurement of
size distribution in the nano-region.

Three New ASTM International Standards in the Works for Committee on
Nanotechnology/Add Two

"Photo correlation spectroscopy is the most important particle size
distribution technique for material under 100 nm," says Alan Rawle, divisional
manager -- applications support, Malvern Instruments, Inc. Rawle notes that,
while other methods, such as electron microscopy, can provide individual
particle and morphology information, there are problems associated with these
methods, most importantly being the small amount of sample that is effectively
measured. PCS is one of the few techniques that allow the measurement of
particle size and distribution on a statistically significant mass of sample.

Rawle says that an early draft of WK8705 is in progress and invites anyone
interested to contribute to its further development.

For further technical information, contact Alan Rawle, Malvern Instruments,
Southborough, Mass. (phone: 508/480-0200; mailto:alan.rawle@malvernusa.com ).

Committee E56 will meet May 15-17, at the May Committee Week in Toronto,

Canada. For membership or meeting details, contact Pat Picariello, ASTM

International (phone: 610/832-9720; mailto:ppicarie@astm.org ).

Committee E56 is one of 138 ASTM technical standards-writing committees.
Established in 1898, ASTM International is one of the largest standards
development and delivery systems in the world. ASTM standards are accepted and
used in R&D, product testing, quality systems, and commercial transactions
around the globe.

 

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