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Thermo Fisher Scientific Partners with Cerilliant Corporation to Offer Certified
Solution Standards for Forensic and Clinical Research Laboratories
SAN JOSE, Calif. (November 2009) - Thermo Fisher Scientific Inc., the world leader
in serving science, today announced a joint agreement with Cerilliant Corporation
to develop and manufacture certified solution standards for the Thermo Scientific
ToxSpec Analyzer. Under the marketing agreement, Cerilliant will develop a number
of cost-effective and ready-to-use certified solution standards for use with the
ToxSpec™ Analyzer, a complete, easy-to-use and cost-effective LC/MS solution for
drugs of abuse analysis in forensic and clinical research laboratories. This combined
solution addresses the need for standardization of controls and assays in testing
laboratories.
click
here for more information
Cerilliant Article The Uncertainty of Reference Standards Published in
Journal of Analytical Toxicology, October 2009
The Uncertainty of Reference Standards – A Guide to Understanding Factors Impacting
Uncertainty, Uncertainty Calculations, and Vendor Certifications Authors:
Kevin Gates, Ning Chang PhD, Isil Dilek PhD, Huahua Jian PhD, Sherri Pogue, Uma
Sreenivasan PhD
Abstract
Certified Solution Standards are widely used in forensic/toxicology, clinical/diagnostic,
and environmental testing. Typically, these standards are purchased as ampouled
solutions with a certified concentration. Vendors present concentration and uncertainty
differently on their Certificates of Analysis. Understanding the factors that impact
uncertainty and which factors have been considered in the vendor’s assignment of
uncertainty are critical to understanding the accuracy of the standard and the impact
on testing results. Understanding these variables is also important for laboratories
seeking to comply with ISO/IEC 17025 requirements and for those preparing reference
solutions from neat materials at the bench.
The impact of uncertainty associated with the neat material purity (including residual
water, residual solvent and inorganic content), weighing techniques, and preparation
of the solution standard on the overall uncertainty of the certified concentration
will be presented along with uncertainty calculations. For access to the complete
article please visit JAT - Cerilliant Uncertainty of Reference Standards Paper.
Cerilliant Divests of Austin Pharma Subsidiary
ROUND ROCK, TX – (September 30, 2009) – Cerilliant Corporation announces the divesture
of their subsidiary Austin Pharma. Austin Pharma which specializes in the manufacture
of active pharmaceutical ingredients is now owned by Insys Therapeutics, headquartered
in Phoenix, AZ, http://www.insystherapeutics.com.
Under the agreement with Insys Therapeutics, Austin Pharma will sublease manufacturing
space from Cerilliant. According to Cerilliant CEO Sherri Pogue, “the divesture
of Austin Pharma allows us to focus on our core business -- producing high quality
certified reference materials, certified solution based standards and certified
spiking solutions as well providing complimentary services such as packaging, analytical
services, and inventory management solutions for our core markets.”
Cerilliant Balances Detect Earthquakes 1000 Miles Away Accurate Balances Critical
to Accurate Results
On Monday, August 3, 2009, something unusual occurred in the labs at Cerilliant
Corporation in Round Rock, Texas. Cerilliant technicians Kevin Gates and Mike Plangklang
reported that their critical balances would not stabilize. Kevin observed one balance
reading jumping quickly back and forth by about ±1mg, then slowing down and rapidly
jumping up again. There were no signs of any local disturbances such as drafts,
vibrations, or electromagnetic interferences that could result in this odd behavior.
While the balances stabilized within 30 minutes, the reason was still unclear. However
upon further research, the cause turned out to be a series of earthquakes that occurred
in the Gulf of California over a thousand miles away from the Cerilliant facility.
(hyperlink to map here).
The balances, made by Mettler Toledo, were so accurate and precise that they were
able to measure the waves from an earthquake happening miles away.
As an ISO Guide 34 and ISO/IEC 17025 accredited company, Cerilliant has established
rigorous process controls covering every aspect of production. Analytical results
can only be as good as the calibrators used. One critical element of preparing any
reference standard is the weighing operation which includes balance selection and
qualification as well as establishment of minimum weighings and proper technique.
Each of these elements, if not properly controlled, can lead to significant error
and uncertainty of the reference. Cerilliant currently employs several Mettler Toledo
balances including XP205, XP504, XP1203S, XP64001L, XP56 and UMX2. For more information
about Mettler Toledo, please visit http://us.mt.com/us/en/home.html
Click here to view
USGS map
Mitzi Rettinger, VP Sales & Marketing for Cerilliant, presented a poster on Certified
Solution Standards for Clinical Applications at The International Association of
Forensic Toxicologists Conference (TIAFT) in Geneva, Switzerland, in August, 2009.
Ms. Rettinger presented the different approaches to reference standards and
the advantages of highly pure, well-characterized, solution based (Snap-N-SpikeTM
and Snap-N-Shoot®) standards as an efficient alternative to the use of neat materials.
The poster presents the elements critical to proper solution preparation to ensure
accuracy and reliability of clinical results and medical device performance and
factors associated with determination of uncertainty in accordance with ISO Guide
34 and ISO/IEC 17025. For more information, please view Cerilliant poster on Certified Solution Standards for Clinical Applications.
Mitzi Rettinger, VP Sales & Marketing for Cerilliant, presented a poster on Preparation,
Uncertainty, & Certification of Ethanol Standards at The International Association
of Forensic Toxicologists Conference (TIAFT) in Geneva, Switzerland, in August,
2009. Ms. Rettinger presented the importance of accuracy and traceability
in the determination of blood alcohol content to ensure compliance with regulatory
requirements and defensibility in courts of law. She presented elements critical
to the accurate preparation and certification of ethanol standards and the elements
for determination of uncertainty and traceability in accordance with ISO Guide 34
and ISO/IEC 17025. For more information, please view Cerilliant poster on Ethanol Standards.
Toxicology Testing Seminar Hosted by Phenomenex Highlights LC/MS/MS Technology Combined
with Cerilliant Certified Solution Standards for Toxicology Applications
September 1, 2009 – Torrence, CA. Phenomenex, Inc hosted a seminar focused on the
use of LC/MS/MS technology in toxicology applications. The seminar instructors included
Sky Countryman and Michael Campognone from Phenomenex with Matthew Clabaugh from
Applied Biosystems as the invited speaker. Derrell Johnson, MS, Cerilliant Technical
Service Liaison, was invited by Phenomenex to answer participant questions on the
use of Cerilliant certified solution standards. The seminar, one of several offered
by Phenomenex, teaches participants sample preparation techniques and the use of
liquid chromatography in LC/MS/MS applications testing for pain medications, SAMHSA/NIDA
drugs of abuse, and performance enhancers.
Phenomenex, Applied Biosystems, and Cerilliant have teamed to bring convenient and
cost effective LC/MS/MS solutions to the toxicology testing community. Cerilliant
is developing certified reference standard kits and certified multi-component solution
standards for LCMSMS toxicology testing applications. Phenomenex, Applied Biosystems,
and MDS Analytical Services are developing columns, instruments, and methods specific
for toxicology applications using LCMSMS technology. Read more about Phenomenex Chromatography Solutions: Toxicology and Applied Biosystems.
Peech S. Reddy, Ph.D. Cerilliant Synthesis Operations, Presented a poster on the
Synthesis and Analysis of Cyclohexyl Trideuteromethylphosphonic Acid at the August,
2009 National Environmental Monitoring Conference (NEMC) in San Antonio, Texas.
Dr. Reddy presented a comparison of two approaches to the synthesis of CHMPA-D and
demonstrated the importance of the synthetic pathway to the development of an internal
standard appropriate for its end use. For more information, please view Cerilliant poster on Synthesis of CHMPA-D.
Derrell Johnson MS, Cerilliant Technical Service Liaison Presented a poster on the
Preparation and Uncertainty of Pharmaceutical Solution Standards for Use in Drinking
Water Analysis at the August, 2009 National Environmental Monitoring Conference
(NEMC) in San Antonio, Texas.
Mr. Johnson presented the preparation, uncertainty, and stability of Cerilliant
Certified Snap-N-Shoot® Solution Standards for EPA Methods 1694 and 1698. As
well, Mr. Johnson discussed the importance of Uncertainty statements on a vendor’s
Certificate of Analysis in conveying the factors which impact the uncertainty of
the reference standard. For more information, please view Cerilliant poster on Pharmaceutical Standards for Drinking Water
Analysis.
Cerilliant Introduces Certified Reference Materials of Reb-A (Stevia) in Solution
Format
ROUND ROCK, TEXAS – July 1, 2009 - Cerilliant introduces two new certified reference
standards, Rebaudioside A (Reb-A) and multi-component Rebaudioside-A Impurities,
in an accurate and convenient solution format. click here for more information click here for more information
Cerilliant Adds State-of-the-Art 400 MHz NMR System
June, 2009 – Cerilliant has upgraded its NMR system adding to the analytical capabilities
of its quality control laboratory. The JEOL ECS-400 NMR has been fully qualified
and represents a substantial upgrade over Cerilliant’s previous 400 MHz NMR system.
The new NMR includes a shielded magnet and is equipped with gradient shimming and
automatic probe tuning and matching functionality. Its analytical capabilities include
the analysis of numerous paramagnetic nuclei such as 1H, 13C,
15N, 31P, and 19F. The NMR system contains software
for automatic sample measurement as well as variable temperature applications for
sample analysis at high or low temperatures. It also offers advanced capabilities
for 2D NMR gradient experiments including COSY, NOESY, TOCSY, HMBC, and HMQC.
Cerilliant Receives ‘Supplier Excellence’ Recognition from Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has selected Cerilliant for its ‘Supplier Excellence’
award in 2008. Each year, Siemens selects a small number of suppliers to receive
this recognition, which is based on high-quality products, timely deliveries and
cooperation on issues. Additional criteria for this recognition include the supplier’s
ability to partner with Siemens on cost reductions and new product development for
Siemens' customers.
Siemens Healthcare Diagnostics is the leading clinical diagnostics company offering
products and services designed for efficient delivery of patient test results. For
more information, visit
http://www.siemens.com/diagnostics.
Cerilliant Completes 3,000sf Expansion of Synthesis Lab
Cerilliant recently completed a 3,000sf expansion to its organic synthesis laboratory
bringing its total synthesis department to more than 6,500sf. The expansion included
the addition of one bench hood plus three walk-in hoods in hepa-filtered suites
with gowning rooms that can be utilized for GMP or non-GMP organic synthesis, a
room dedicated to chromatography which will include Cerilliant’s various prep-scale
systems, a dedicated glassware wash room incorporating two qualified Miele brand
washers, and store rooms for reagent and other lab supplies. The expansion provides
Cerilliant additional capacity for the manufacture of compounds to support custom
synthesis projects for clients as well as our growing catalog offering. Cerilliant
chemists currently produce approximately 150-200 compounds annually including those
incorporated in approximately 70% of our manufactured catalog items. See
synthesis capabilities to learn more about our custom synthesis offering.
Cerilliant’s Chief Science Advisor Presents “The Uncertainty of Reference Standards”
at May, 2009 SAT Conference
Uma Sreenivasan PhD. and Cerilliant Chief Science Advisor, presented a talk entitled
“The Uncertainty of Reference Standards” at the Spring 2009 meeting of the Southwestern
Association of Toxicologists in San Antonio, Texas on May 2, 2009. The presentation
focused on providing the audience an understanding of the factors to be considered
in evaluating the uncertainty of reference standard solutions, whether prepared
internally or purchased externally, in accordance with ISO requirements and the
importance of each. She presented an overview of Cerilliant’s uncertainty model
and calculations which were developed in connection with Cerilliant’s accreditation
to ISO/IEC 17025 and ISO Guide 34.
Cerilliant Technical Service Expert Presents “Certified Solution Standards for Therapeutic
Drug Monitoring” at May, 2009 SAT
Derrell Johnson MS, Cerilliant Technical Service Liaison, discussed the suitability
of Certified Solution Standards for Therapeutic Drug Monitoring and other quantitative
applications at the Spring meeting of the Southwestern Association of Toxicologists
in San Antonio, Texas on May 2, 2009. The presentation provided a comparison of
approaches for reference solution preparation and outlined critical aspects of the
design and preparation of reference standard solutions and how these may impact
accuracy and stability.
Cerilliant Announces Partnership with PureCircle for the Development and Supply of
Certified Reference Materials for Stevia Based Sweeteners
ROUND ROCK, TEXAS (March 4, 2009) – Cerilliant Corporation announces that it is
partnering with PureCircle (Florham Park, New Jersey) for the development and global
supply of Certified Reference Materials manufactured and certified to ISO Guide
34 guidelines and validated analytical methods for stevia based sweeteners. This
will provide food and beverage companies the necessary quality standards and support
to ensure the safety of consumer products using stevia based ingredients.
Click here for more information
Cerilliant Announces Additional ISO Accreditations
ISO Guide 34 and ISO/IEC 17025 Accreditations Received
ROUND ROCK, TX – (November 21, 2008) – Cerilliant Corporation adds the accreditations
of ISO Guide 34 and ISO/IEC 17025 to its arsenal of quality credentials as certified
by ACLASS Accreditation Services, an internationally-recognized accreditation company
and a participant in the International Laboratory Accreditation Cooperation (ILAC).
Cerilliant has been certified to the ISO 9001:2000 standard since 1997 and now offers
its customers the assurance of this triple certification to ISO standards.
Click here
for more information
Click here to view ISO 34 Certificate & Scope
Click here to view ISO 17025 Certificate & Scope
Cerilliant Announces Alliance with Phytolab
ROUND ROCK, TX – (August 19, 2008) – Cerilliant Corporation is pleased to announce
an alliance with PhytoLab GmbH & Co. KG, a German-based laboratory specializing
in high-quality reference materials for the testing of plant-based products. Through
an agreement signed July 16, 2008, Cerilliant becomes the exclusive distributor
of PhytoLab’s phyproof™ reference substances in the United States and Canada.
Click
here for more information
Cerilliant Adds State-of-the-Art LC/MS System
In May 2008, Cerilliant announced the addition of an Agilent 6400 Series Triple
Quad LC/MS system to the analytical capabilities of its quality control laboratory.
The triple quad LC/MS system offers features for quantification of pharmaceutical
products, determination of trace-level impurities on a sub-femtogram level, and
identification of numerous compounds relevant to the pharmaceutical, forensic, and
environmental industries. The triple quad's advantage over ion-trap LC/MS systems
involves its robustness in quantification and sensitivity.
Cerilliant Appoints Johnson to New Product Development Position
Cerilliant announced the promotion of Derrell Johnson to the New Product Development
Manager/Technical Liason on January 14, 2008. Johnson's primary responsibilities
include new product development with a focus on innovation and the customer/market
perspective. He is also serving as a technical expert on Cerilliant's Senior Technical
Team for Cerilliant products, both internal and external. Johnson, 34, joined the
company in 1999 as a synthesis chemist and spent the last three years working as
an analytical chemist in the Quality Control Laboratory. He received a Master's
degree in organic chemistry from Texas A&M University, College Station, and will
have completed an MBA from Texas State University, San Marcos, in December 2009.
Cerilliant Completes 12,000 Square Foot Expansion
In September 2007, Cerilliant announced the completion of a 12,000 square foot expansion
to its facility. The expansion included the installation of a new controlled substance
vault and critical systems back-up power. The new vault significantly increases
storage capacity for Cerilliant's controlled substance products and offers secure
storage with state-of-the-art security and monitoring features. The back-up power
system includes a UPS(uninterruptible power supply) for critical systems in the
facility, including analytical instruments, electronic monitoring systems, security
and emergency systems, and network and phone systems. A 300kW generator was added
to provide continuing power to these systems as well as climate control for material
storage.
Cerilliant signs distribution agreement with National Measurement Institute Australia
In July 2007, Cerilliant and the National Measurement Institute of Australia (NMIA),
an Australian government entity, entered into an agreement grantingCerilliant rights
to distribution of NMIA reference materials. The addition of NMIA products allows
Cerilliant to offer an extensive line of steroid and pesticide reference standards
unavailable elsewhere. Each NMIA product is accompanied by a NMIA certificate of
analysis
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