ATMI Offers Helium Integrity Testing System in Point of Use Format for Validation of Single-Use Bags and Assemblies
April 22 2013 - 7:00AM
ATMI, Inc. (Nasdaq:ATMI), a global technology company and leader in
single-use bioprocess solutions, today announced that its
proprietary helium integrity testing (HIT™) system has been made
available to end-users for on-site application. Originally
introduced in 2011 as add-on testing for ATMI bioprocess vessels
and manifolds, the HIT system is now also available in an
easy-to-use technical transfer format that end-users can apply to
standard and custom disposable bags and 3-D single-use assemblies
starting from 300 Liters, with plans for application up to 1,200
Liters. The new offer is part of ATMI's initiative to promote the
advancement of quality and standardization in the single-use
industry. ATMI will exhibit an HIT system and feature the
technology behind it in presentations held from April 23rd-–25th
during INTERPHEX trade show in New York, NY at the ATMI
LifeSciences booth #3319.
"Though many of our customers liked the idea of executing
integrity testing with the HIT system on their products prior to
shipping, their ultimate desire was to be able to test single-use
bags and manifolds at the point of use," offered Director of
Applications for ATMI LifeSciences, Richard Bhella. "In other
cases, we found that companies who were not yet ATMI customers
wanted access to this level of technology and testing. As these
requests continued to come in, we reconfigured the format to enable
application at the customer sites just prior to process use. We
fully advocate open advancement in the single-use industry, so this
is a step we are happy to take."
The HIT system offers a much more sensitive level of testing
than standard pressure decay testing, and provides the ability to
test the whole assembly rather than just the bag body. During the
test, the single-use bag assembly or manifold is placed in a closed
test chamber, a vacuum pump removes all the air in the chamber, and
then a measured quantity of helium is injected into the assembly.
Any helium leakage is measured by a mass spectrometer and the size
of any defect is calculated. The test is capable of detecting
defects as small as 10µm, which is smaller than the threshold
defect size for microbial ingress under typical bioprocess
conditions.
"This type of testing is the most advanced of its kind and
addresses a real quality gap in the market," commented Senior Vice
President and General Manager of ATMI LifeSciences, Mario Philips.
"Drug products accrue value at an exponential rate as they move
downstream, with batch costs reaching into the millions of dollars.
Batch failure due to leakage or sterility breach can represent
great financial loss and, as the reliance on single-use
technologies has grown in the bioprocess industry, the need to
guarantee their integrity has also grown. This technology transfer
for on-site customer use is about giving customers access to
innovative solutions in a format that fits their specific
needs."
The new, innovative HIT platform is currently available for
purchase. All transactions come with support from dedicated ATMI
application specialists who also scale the technology to individual
customer needs. For customers that do not wish to acquire the
technology for on-site use, ATMI continues to offer integrity
testing with the HIT system as an add-on test for ATMI vessels and
systems.
To learn more about the HIT system, please visit ATMI at booth
#3319 during INTERPHEX, or email Richard Bhella directly at
rbhella@atmi.com.
About ATMI
ATMI, Inc. provides specialty semiconductor materials, and safe,
high-purity materials handling and delivery solutions designed to
increase process efficiencies for the global semiconductor, flat
panel, and life sciences industries. For more information, please
visit www.atmi.com.
About ATMI LifeSciences
ATMI LifeSciences is an acknowledged technology leader in the
field of single-use bioprocess systems and consumables for the
pharmaceutical and biopharmaceutical industries. Its innovative,
market-leading portfolio of custom-engineered, flexible packaging
solutions, single-use storage systems, mixers and bioreactors is
driving bioprocess efficiency and delivering value for
biopharmaceutical companies around the world. For more information,
please visit www.atmi-lifesciences.com.
ATMI, the ATMI logo, Integrity and HIT are trademarks, or
registered trademarks, of Advanced Technology Materials, Inc., in
the United States, other countries or both.
Forward-Looking Statements
Statements contained herein that relate to ATMI's future
performance, including, without limitation, statements with respect
to ATMI's anticipated results of operations or level of business
for 2013 or any other future period, are forward-looking statements
within the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such statements are based on current
expectations only and are subject to certain risks, uncertainties,
and assumptions, including, but not limited to, changes in
semiconductor and life sciences industry growth (including, without
limitation, wafer starts) or ATMI's markets; competition, problems,
or delays developing, commercializing, and delivering new products;
customer-driven pricing pressure; potential loss of key customers;
problems or delays in integrating acquired operations and
businesses; uncertainty in the credit and financial markets;
ability to protect ATMI's proprietary technology; and other factors
described in ATMI's Form 10-K for the year ended December 31, 2012
and other subsequent filings with the Securities and Exchange
Commission. Such risks and uncertainties may cause actual results
to differ materially from those expressed in our forward-looking
statements. ATMI undertakes no obligation to update any
forward-looking statements.
CONTACT: ATMI Contact:
Troy Dewar
Director of Investor Relations
203.207.9349
tdewar@atmi.com
Media Contact:
Beth Willers
Impress Labs
415.846.9891
beth@impresslabs.com
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