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JANUARY 2006 INDUSTRY NEWS

 

NIST Names Hockert Chief of Weights and Measures

The National Institute of Standards and Technology (NIST) announced Jan. 10 that Carol Hockert has been selected as the new chief of the NIST Weights and Measures Division. The division promotes uniformity in U.S. weights and measures laws, regulations, and standards to achieve marketplace equity.

Hockert, who will join NIST on Feb. 20, is currently director of the Minnesota Weights and Measures Division. She replaces Henry Oppermann who retired July 1, 2005. Hockert previously served as a technical expert for NIST’s National Voluntary Laboratory Accreditation Program (NVLAP) and as a vice president of NCSL International (formerly known as the National Conference of Standards Laboratories).

As chief of the Weights and Measures Division, Hockert will work with the National Conference on Weights and Measures (NCWM), and advise its Board of Directors. NCWM is a professional organization of state and local weights and measures officials and representatives of business that works to “advance a healthy business and consumer climate through fair and equitable weights and measures standards.”

Hockert also will oversee division programs that offer training for weights and measures officials and laboratory metrologists, develop test procedures for weighing and measuring devices, provide guidance on weights and measures laws and regulations, provide NIST input to the NCWM, coordinate U.S. input for international standards for legal metrology, and develop and publish NIST reports for weights and measures.

Further information on the NIST Weights and Measures Division can be found at www.nist.gov/owm.

 

Instron® Offers Onsite Temperature Calibration Services

Instron, a leading provider of testing equipment designed to evaluate mechanical properties of materials and components, offers onsite temperature calibration services for a variety of equipment. With more than 100 field service engineers located conveniently throughout the United States, all temperature, force, speed, displacement, strain and alignment calibration needs can easily be provided.
Calibrating temperature decreases incorrect test results or poor quality products. Providing assurance that test data is valid and processes are properly controlled, these temperature verification procedures meet the most common requirements of laboratories and related manufacturing processes, including ISO/IEC 17025. During the calibration, temperature profiles are created and used to characterize gradients, including oven and chamber uniformity surveys. Temperature calibration services cover a wide array of equipment types, including: environmental chambers and furnaces; temperature data loggers, circular or strip chart recorders; various temperature indicators; heat treating and finishing equipment; temperature control for various manufacturing processes; and all types of testing equipment that utilizes temperature control.

For more information on Instron’s products and services, visit www.instron.com. Click on ‘Contact Us’ to locate a sales, service and technical support office near you.

 

NVLAP Chief

Warren Merkel has resigned his position as NVLAP Chief effective January 6, 2006, and will be relocating to central Pennsylvania. Under Warren's leadership, NVLAP transitioned to compliance with newly adopted international requirements, increased its participation in international activities, and refocused its activities to more effectively respond to the needs of regulators and other government agencies. The NVLAP group wishes Warren the best of luck as he pursues a new career in education.

Doug Faison will be serving as Acting NVLAP Chief until a permanent replacement is selected for the Chief position. Doug came to NVLAP in 1993 and has served as the Senior Program Manager for the Calibration Program for the past 10 years.

For more information about NVLAP visit http://ts.nist.gov/ts/htdocs/210/214/214.htm

 

Team Torque’s Completion of New Calibration Lab and Customer Support Center

According to business owner and president Mark Anderson, operation at their new 6,000ft2 facility is scheduled to begin on January 23, 2006.

“This move is the realization of the longtime vision of Team Torque. This will help support the industrial community's ongoing commitment to quality torque tool maintenance,” reported Anderson.

Team Torque provides calibration and repair on all torque tools and is accredited to ISO 17025, which is the highest standard available for calibration labs in the nation. The company supplies free formal printed certificates with all tool calibrations, which help ensure quality system compliance for the end consumer.

Team Torque is an independent Torque Tool Calibration and Repair Laboratory, providing free NIST traceable certificates for all calibrations and repairs. Team Torque is located in Bismarck, ND and more company information can be found at www.teamtorque.com.

The company has calibration and repair labs for all torque instruments, including torque wrenches, torque testers, multipliers, DC electric, and pneumatic torque tools.
The company offers service to Bobcat, Northwest Airlines, Costco, Kawasaki, Artic Cat, Boeing, Motor Coach Ind, Caterpillar, Butler Machinery, Firestone, Tires Plus, Horton Industries, GEM, Matco Tools, and government agencies.

 

Transcat Announces Fiscal 2006 Third Quarter and Nine Months Results

Transcat, Inc., a leading global distributor of professional grade test, measurement, and calibration instruments and a provider of calibration and repair services, announced financial results for its fiscal year 2006 third quarter and nine months ended December 24, 2005.

Fiscal 2006 Third Quarter and Nine Months Highlights:

  • Net sales for the fiscal year 2006 third quarter increased 15.6% to $16.2 million and 11.7% to $44.4 million in the fiscal year 2006 nine months.
  • The gross profit ratio decreased 1.3 points to 23.7% in the fiscal year 2006 third quarter and increased 0.9 points to 24.9% in the fiscal year 2006 nine months.
  • Operating income for the fiscal year 2006 third quarter was $0.4 million, essentially flat with $0.4 million in the fiscal year 2005 third quarter as a result of planned investments to enhance sales, marketing fundamentals and calibration service capacity. For the fiscal year 2006 nine months, operating income increased to $1.3 million from $0.2 million in the fiscal year 2005 nine months.
  • Net income for the fiscal year 2006 third quarter was $0.3 million or $0.04 per fully diluted share, essentially flat with $0.3 million in the fiscal year 2005 third quarter. Net income for the fiscal year 2006 nine months was $0.8 million or $0.11 per fully diluted share, as compared with a net loss of $0.2 million or $0.04 per fully diluted share in the fiscal year 2005 nine months.
  • Distribution Products - Net sales increased 16.7% to $11.5 million in the fiscal year 2006 third quarter and 12.1% to $30.3 million in the fiscal year 2006 nine months. The Distribution Products gross profit ratio for the fiscal year 2006 third quarter increased 0.7 points to 24.3%. For the fiscal year 2006 nine months, the gross profit ratio increased 1.4 points to 24.4%; of which 0.3 points of the increase was attributable to the timing of certain product purchase rebates earned during the nine months.
  • Calibration Services - Net sales increased 13.1% to $4.7 million in the fiscal year 2006 third quarter and 11.0% to $14.1 million in the fiscal year 2006 nine months. The Calibration Services gross profit ratio for the fiscal year 2006 third quarter decreased 6.1 points to 22.4%. For the fiscal year 2006 nine months, the gross profit ratio decreased 0.2 points to 26.1%. Calibration Services gross profit declined principally due to calibration service mix and investment in calibration service capacity.

For more information visit Transcat at: http://www.transcat.com/AboutTranscat/CompanyNews.asp

 

Whitehouse Scientific Increases Online Sales

Whitehouse Scientific has introduced an enhanced secure ordering and payment system on its website. With sales growing 20% year on year, the new system is designed to meet increasing worldwide demand for credit card purchase of the company’s calibration standards via the website.

Managing director Dr Graham Rideal anticipates a continued growth in demand for the high precision particle size, image analysis, filtration, sieve and other calibration standards for which Whitehouse has gained an international reputation.

“The technologies that our products support are now critical to the efficiency of a wide range of research, development and production processes,” he said. “The investment in and the application of these technologies may be highly significant in terms of financial and human resources. Ensuring that they perform properly and with maximum efficiency, reliability and traceability makes sound economic sense and our calibration standards and methodologies are part of this process.”

Whitehouse will introduce a number of novel products and line extensions in 2006, several of which will be launched at Analytica in Munich in April and ACHEMA in May.

 

Life Sciences Discussion Board Hosted By National Instruments

The new Life Sciences Discussion Board is the first industry-specific board in the
NI Discussion Forums. For scientists and engineers working in pharmaceutical,
biomedical/medical devices, and biotech applications, this new board provides a forum to discuss applications, events, and general topics of interest. In addition to asking technical support questions about completing a life sciences application, visitors have started conversations such as:

  • “Is anyone going to the Lab Automation tradeshow in February? I’ll be there and
    would like to get some information about the event.”
  • “Is anyone using LabVIEW biomedical imaging applications? I am interested in
    how they can be used.”

This fundamental shift in discussion board use lends itself to a more community-centric environment, giving you the opportunity to learn more about the entire Life Sciences industry.

Since the NI Discussion Forums upgrade last November, there has been an increase not only in the amount of discussion activity but also in the types of discussions. Because the new environment is more user-friendly, many visitors find themselves using the forums as a general meeting place to share fun ideas,talk about common experiences, make new contacts, and catch up with friends. Because these types of conversations fall outside traditional Discussion Forums use, NI has created new discussion boards specifically for social interactions. You now can search for
LabVIEW jobs, discuss industry topics, and just have fun with fellow wireworkers in the NI Discussion Forums.

To get involved with these social boards and the NI Discussion Forums, visit ni.com/info and enter nsi5322 today!

 

NCSLI’s New Technical Publication - MEASURE

The new NCSLI technical publication MEASURE, which will begin with the March, 2006 issue, is accepting New Product or Service Announcements from NCSLI Member Organizations. Go to the NCSLI web site for full details: http://www.ncsli.org/measure/psa.cfm

NCSLI MEASURE is accepting for publication technical manuscripts of interest to the NCSLI membership; this includes papers on technical or management issues related to the operation of calibration laboratories, as well as general metrology review articles. Prospective authors should consult the Author Manuscript Instructions on the NCSLI web site: http://www.ncsli.org/measure/ami.cfm

Guidance for Industry; INDs — Approaches to Complying with CGMP During Phase 1

This guidance is intended to assist persons producing drug and biological products (investigational drugs) for use during phase 1 development (21 CFR 312.21(a)) in complying with relevant current good manufacturing practice as required by § 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Controls for producing an investigational new drug for use in a phase 1 study are primarily aimed at ensuring subject safety. The Agency believes that applying quality control (QC) principles to the production of investigational products (i.e., interpreting and implementing CGMPs consistent with good scientific methodology) will facilitate the initiation of investigational studies in humans and protect study subjects. When finalized, this guidance will replace the 1991 Guideline on the Preparation of Investigational New Drug Products (Human and Animal) for the production of IND products for phase 1 clinical trials described in the Scope section of this guidance.

This guidance is being issued concurrently with a direct final rule (and companion proposed rule), which specifies that the particular requirements in Part 211 (21 CFR 211) need not be met for most investigational drugs manufactured for use during phase 1 development. Instead, the Agency recommends the approaches outlined in this guidance for complying with § 501(a)(2)(B) of the FD&C Act.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

eCalibration.com editor’s note: Calibration is mentioned in Section I. Recordkeeping

The Guidance is available at: http://www.fda.gov/cder/guidance/6164dft.doc

 

LSS Introduces New Calibration Service

Lab Safety Supply has unveiled a new, affordable and fast calibration service designed to ensure the accurate performance of precision instruments, tools and other equipment.

All calibrations under the new LSS service are directly traceable to the National Institute of Standards and Technology. An A2LA Accredited (ISO/IEC 17025) and ISO 9001:2000 registered metrology lab will perform the calibrations within five business days.

LSS also offers precalibration services on stock products — everything from manometers, microscopes and volt meters to pH meters, thermometers and pressure gauges — before they ship to ensure their accuracy. Customers can also sign up to receive recalibration reminders to help them stay on schedule.

Lab Safety Supply is North America’s leading business-to-business direct marketer of industrial and safety supplies. For more details on the LSS calibration service, call 1-800-356-0783 or go online at www.LSS.com/calibration.

 

FDAs cGMP China Training Program Presentations

The U.S. Food and Drug Administration, Peking University, and ISPE are co-sponsoring a training program to provide the latest updates from the FDA on current regulations and guidances, and interactive training workshops on oral solid dosage, and API manufacturing. The presentations from a December 5-7, 2005 meeting in Bejing, China are available for viewing. To learn more about the training initiative visit http://www.fda.gov/cder/meeting/CTP2005.htm

The FDA cGMP Inspections presentation includes the role of calibration in the Laboratory Controls System and the Facilities & Equipment System.

Presentations from the Dec., 2005 FDA cGMP Training Program in Bejing, China

  • Presentations (12/14/2005)
    • FDA Overview [PowerPoint]
    • Solid Oral Dosage Forms, [PowerPoint] Nicholas Buhay, CDER
    • cGMP in the USA, [PowerPoint] Nicholas Buhay,CDER
    • Counterfeit Drugs, [PowerPoint] Nicholas Buhay, CDER
    • FDA cGMP Inspections, [PowerPoint] Robert C. Horan, Ph.D., CDER
    • FDA API Inspections, [PowerPoint] Robert C. Horan, Ph.D., CDER
    • The FDA Process for Approving Generic Drugs [PowerPoint]

 

Audio Precision Plans Accredited Calibration Lab for Spring 2006

Audio Precision, the world leader in audio test and measurement, announced the company will be opening a calibration facility that will operate under ISO/IEC 17025:2005 and related standards. The facility will be located at the company's headquarters in Beaverton, Oregon, providing accredited calibration for Audio Precision analyzers beginning in the spring of 2006.

“This is a significant investment by Audio Precision that provides validation for our instruments to standards that are recognized worldwide," said Bruce Hofer, co-founder and chairman of Audio Precision. "It assures our customers of the legitimacy of our specifications, and supports those who are implementing ISO 9000 programs within their corporations."

Most new Audio Precision analyzers shipped after the calibration lab opens will receive an initial calibration at no cost. Audio Precision analyzers in the field can be shipped to our headquarters for accredited calibration at a moderate cost.

Audio Precision will undergo an annual audit by an internationally recognized accreditation agency to maintain its accredited status. Audit activities include review of laboratory equipment, procedures and staff proficiency.

Audio Precision has been designing and marketing audio test instruments for over two decades. As the industry leader, Audio Precision provides solid solutions to help customers worldwide design and build audio products that meet or exceed the highest performance standards. For more information, visit the Audio Precision Web site at http://www.audioprecision.com/index.php?page=about&id=1100001048.

 

Sypris Wins Eastman Kodak Contract

Sypris Test & Measurement Inc., a provider of calibration services, test and component sourcing services, has been awarded a multiyear contract from Eastman Kodak Corporation.

Sypris will provide a suite of on-site and depot services to Kodak's Rochester, N.Y., campus, including all metrology-related functions. Sypris will also provide logistical and technical services related to the calibration and repair of electrical, mechanical and thermodynamic test and measurement equipment.

Sypris Test & Measurement Inc. is an Orlando-based subsidiary of Sypris Solutions Inc.

 

Hope You Enjoyed New Year's Eve a Second Longer!

You should have tooted your New Year's horn an extra second this year, say physicists at the National Institute of Standards and Technology (NIST). Along with the rest of the world's atomic timekeepers, NIST's time and frequency experts inserted a second (known as a leap second) into their time scale on Dec. 31 for the first time in seven years.

From 1972 (when the world went to the current system of atomic timekeeping) until Dec. 31, 1998, 22 seconds were added to Coordinated Universal Time (the official world time known as UTC) to keep it in sync with the Earth's rotation (which can speed up or slow down due to many factors). Since 1999 until recently, that rotation and UTC had stayed closely enough in harmony to not require the adjustment of adding a leap second.

This year's leap second has been implemented by adding an extra second to atomic clocks at NIST in Boulder, Colo., and other sites around the world. Normally, the last second of the year would be 23:59:59 UTC on Dec. 31, 2005, while the first second of the new year would be 00:00:00 UTC on Jan. 1, 2006. The leap second was added at 23:59:59 UTC (06:59:59 p.m. Eastern Standard Time) on Dec. 31, so that atomic clocks will read 23:59:60 UTC before changing to all zeros.

A recent proposal to eliminate leap seconds altogether in the future is still under consideration by the international bodies in charge of coordinating world time.

For more information on leap seconds, go to http://tf.nist.gov/timefreq/general/leaps.htm.
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