Help

JULY 2007 NEWS

 

Resignation and Appointment of Managing Director at Testo Limited

After 24½ years loyal service, Barry Whittaker, Managing Director of Testo Limited, has decided to resign. Barry has spent most of his working life in the field of test and measurement instrumentation. Barry formed Testo Limited in 1983, with the then Chairman of Testo AG, Gerd Knospe. The company has grown in the UK and internationally to be one of the leading suppliers of test and measurement instrumentation in the world, with a turnover of €130 million. Barry says: “It has been a privilege and a pleasure working to establish the brand of Testo in the UK and Ireland which has largely, been achieved. I leave the company on 29 June 2007 and believe the company will continue to achieve significant growth over the coming years.”

Barry will not be severing his relationship completely and will be working as a consultant for Testo AG, the German parent company of Testo Limited.

Barry’s successor as Managing Director of Testo Limited from 1 July 2007 is Tom Tonkins, formerly with Bacharach in the USA and Geotechnical Instruments of Leamington Spa. Tom has been with Testo for 18 months and is looking forward to his new challenge. Tom says: “Being part of the Testo organisation is very stimulating. It is a company with high quality and innovative instruments, with a product investment strategy unrivalled in our industry. The goal is to continue the growth that Testo Limited has enjoyed and to increase sales across a wider range of industries and applications with our product portfolio.”
About Testo:

Celebrating its 50th anniversary year, Testo provides a wealth of experience in the development and manufacture of high quality test and measuring instruments for a wide range of applications. The result is that every year, more and more customers benefit from our products and service excellence.

Testo provides a wide range of portable and stationary instruments for many parameters and applications including; temperature, humidity, velocity, pressure, refrigeration, flue gas, water analysis, light and RPM.

Testo also offers instrument service and calibration from its independently accredited ISO 9001:2000 and ISO 17025 laboratory. Testo’s service and calibration department offer a cost effective service with a typical turnaround time of just 3 working days. For further information please visit www.testo.co.uk/.

 

Test and Measurement Equipment from Techrentals

Techrentals, known for renting test and measurement equipment, can now offer much more. As well as short and long term rental, Techrentals offers a rental with purchase option, plus outright purchase of either NEW or ex-rental equipment.

Techrentals offers new equipment from manufacturers including Megger, Rohde & Schwarz, Hioki, Testo, Industrial Scientific, and Bruel & Kjaer and a team of highly experienced, technical sales people that have extensive industry backgrounds.
With more than 10,000 items in stock Techrentals are bound to have the gear you need, no matter what your industry or project.

Techrentals, a division of TR Corporation, is also able to organise the calibration and servicing of equipment, using one of our NATA accredited calibration laboratories. To learn more visit Techrentals at www.techrentals.com.au.

 

Middle East Pharmacy Manufacturing and Biotech Industries Set to Boom as International Companies Target the Region

The Middle East market for pharmaceutical manufacturing and biotechnology, already valued at over US$ 28 billion and with annual growth in double digits, looks set for even stronger growth as some of the world’s major players eye the regional market, according to the organisers of the region’s premier industry event – Pharmaceutical Manufacturing and Biotechnology Middle East (PABME). Event website for further information: http://www.pabme.com/.

Companies from around the world have already committed to the event, in April 27-29, 2008, during which Dubai will become the focal point of the regional and global pharmacy & biotech industry.

Although, the show is aimed at attracting the global industry, the regional pharmaceutical manufacturing industry has already gained significant investment especially into the established markets such as the Levant, North Africa and Iran, as well as the newer, rapidly evolving GCC states. An estimated 450 pharmaceutical manufacturers already operate in the Middle East, in a market valued at over US$ 18 billion and growing at more than 10 per cent per annum.

Talking of the importance of PABME 2008, Dr B R Shetty, MD & CEO of Neopharma said “This exhibition is like a shot in the arm for Middle East pharmaceutical manufacturers. Thanks to this unique gathering, companies such as Neopharma UAE now have their own exclusive platform to showcase, share and discuss the region’s world-class manufacturing prowess”. Neopharma is one of the major players in the Middle East Pharmaceutical manufacturing sector and a keen supporter of PABME event.

The regional biotechnology market is smaller (US$ 10 billion) than pharmaceutical manufacturing but is growing even faster, at 15-18 per cent per annum. The industry is attracting large amounts of private and public investment, and Dubiotech, the region’s first dedicated biotechnology research park covering 30 million square feet, is at the heart of this frenetic industry activity, which is being driven by investor friendly Governments and free zone environments. The show will be instrumental in helping exhibiting companies to find major investors to finance some of the key biotechnology research projects awaiting breakthrough for medical sciences industry worldwide.

PABME is set against a very dynamic international background as Dubai offers logistical conveniences, ideal access to global markets, stable and secure economy and an excellent multi-cultural atmosphere for companies from all over the world to flourish their businesses.

Simon Page, Director of the Healthcare Division at IIR Middle East, confirms that companies from every continent, from developed and emerging markets, have registered for PABME: “PABME will serve as the region’s only networking platform for industry players to converge, network and discuss new business alliances and joint ventures. Participants at PABME will get to meet and do business with not only the Middle East’s key decision makers but also the world’s key industry figures. Alongside the exhibition, the show will be running Conference that will focus on key issues ranging from intellectual property rights through to outsourcing and contract manufacturing/research. The event will be a global destination for the Pharma and Biotech industry and an opportunity not to be missed.”

 

Pharming Facilities Obtain GMP Status

Biotech company Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) announced that its facilities for the manufacturing of Rhucin® have successfully passed all inspections conducted by the European Medicines Evaluation Agency ("EMEA") establishing that they comply to the standards of Good Manufacturing Practice ("GMP") for pharmaceutical production.

The EMEA has confirmed that all facilities and processes that are involved in the manufacturing of Rhucin®, Pharming's lead product, operate according to GMP standards. These facilities include Pharming's facilities for transgenic rabbits, the external facilities where milk and product are stored and processed and the Company's headquarters in Leiden as far as it is concerned with quality aspects of Rhucin®.

Dr. Bruno Giannetti, Chief Operations Officer at Pharming, commented: "Obtaining the GMP status for our facilities and processes is a major achievement for our Company. It is a critical step in the review and approval process of Rhucin® and it is difficult to overestimate the importance of achieving this milestone. It is testimony to the hard and excellent work that our team has put in to convert a research idea of 'turning milk into medicine' into a well developed and GMP-approved manufacturing process. Our transgenic rabbit facility is the first of its kind in the world to obtain this status."

Pharming has filed a marketing authorization application for Rhucin® in Europe and has recently submitted answers to the list of questions from the EMEA. Based on the timelines associated with the review of this product, Pharming expects an opinion of the scientific committee of the EMEA in the second half of 2007. In the USA, Pharming aims to finalize its placebo-controlled randomized clinical trial in the second half of 2007. The Company will present results from the clinical trials of Rhucin® for the treatment of HAE in the third quarter of 2007.

 

Training Course on Reference Materials

A training course on the use of reference materials and the estimation of measurement uncertainty will be held at the Institute for Reference Materials and Measurements (IRMM) in Geel, Belgium on 10 and 11 October. The IRMM is part of the European Commission's Joint Research Centre (JRC).

The course will provide participants with the theoretical basis for the estimation of measurement uncertainty and establishing traceability. It is suitable for laboratory managers and practitioners in analytical laboratories who use reference materials for statistical quality control, method validation and calibration.

For more information, please visit:
http://www.irmm.jrc.be/html/events/index.htm

 

Lab Equipment Qualification – 3 Day GMP Education Course
19-21 September, Copenhagen, Denmark
www.gmp-compliance.org/daten/training/ECA_Lab_Equip_Quall_07.pdf

Calibration and qualification of equipment are key requirements in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, and FDA‘s Code of Federal Regulations, 21 CFR Part 211). These requirements also apply to equipment and systems in analytical laboratories of the pharmaceutical industry. Besides calibration and qualification, the validation of computerised systems is another key issue. The software components associated with the instruments and systems must be shown to be fit for their intended purpose. Computer validation requirements and guidances for the pharmaceutical industry are laid down, amongst others, by the EU (Annex 11 to EU GMP Guide), the PIC/S (Good Practices for Computerised Systems in Regulated “GXP” Environments”), GAMP (Good Automated Manufacturing Practice), and FDA‘s Part 11.

In 2006 the United States Pharmacopoeia (USP) has published a new Draft General Chapter <1058>, Analytical Instrument Qualification, which is likely to be adopted in the first supplement of USP 30.

The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software validation of computerised systems and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems.

Key requirements of the new USP General Chapter <1058> will be presented and discussed.

The course will cover the following instruments and systems amongst others:

  • Spectrophotometers (UV/VIS, NIR and IR)
  • Balances and Masses
  • Temperature Measurement
  • pH
  • Dissolution Apparatus
  • HPLC and GC
  • Chromatographic Data Systems
  • Excel® - Spreadsheets
  • Interactive workshops will allow the participants to discuss key areas of interest and to exchange practical experiences.

This GMP Education Course will be of practical value to scientists and engineers in analytical laboratories and contract laboratories in an FDA-/GMP-regulated environment who are responsible for the calibration and qualification of their laboratory equipment and for the validation of the computerised systems used in their laboratories.

 

Introduction to Estimating Measurement Uncertainty Training in Australia

Australia’s National Measurement Institute (NMI) offers training and consultancy in various fields of chemical, physical and legal metrology.

Are you having trouble with uncertainty estimation? This one-day introductory course will give you the grounding needed to develop an uncertainty budget. Suitable for staff from calibration and testing laboratories, the course will give you a clear step-by-step approach to uncertainty estimation with practical examples. You will learn techniques covering the whole process from identifying the sources of uncertainty in your measurements right through to completing the uncertainty budget.

The course provides participants with the skills to:

  • understand the concepts involved in the calculation of measurement uncertainty
  • calculate measurement uncertainty in a practical and pragmatic manner
  • apply ISO's Guide to the Expression of Uncertainty in Measurement successfully in the workplace

Course is being offered 27 September 2007 at Hotel Grand Chancellor, Brisbane QLD.

Visit http://www.nmi.gov.au/index.cfm?event=object.showHome and click on the Training link.

 

UKAS Calibration Service Expanded at Don Whitley Scientific (DWS)

Don Whitley Scientific (DWS) has expanded its UKAS-accredited calibration service to include individual temperature probes with sensors or recorders in addition to laboratory autoclaves, media preparators, ovens, environmental chambers and water baths. Laboratory equipment must be accurately calibrated in order to deliver the highest quality test results for rapid diagnosis and treatment.

As well as supporting own-label products, DWS engineers provide calibration and validation for all brands of temperature-controlled devices. The onsite service allows work to be carried out efficiently with prompt supply of easy to understand certification and documentation.

For laboratories with large installations, it is now possible to perform checks in-house following calibration of the reference probe by DWS. To avoid expensive call outs and project delays, routine servicing is coordinated with calibration testing as much as possible to ensure minimal laboratory downtime. The DWS UKAS accredited service is a key part of the company's one-stop shop for the supply, validation, calibration and service of laboratory equipment.

To access the full press release visit http://www.dwscientific.co.uk/pressreleases.php.

 


eCalibration.com
PO Box 830 ~ State College, PA 16804
P: 800-982-2388 ~ P: 814-234-2417 ~ F: 814-234-7077
editor@ecalibration.com
News ~ Events ~ Directories ~ Careers ~ Resources ~ Global ~ Life Sciences ~ Home
Terms of Use ~ Privacy Statement
© Blue Mountain Quality Resources
eCalibration and The Premier Calibration Resource are Trademarks of Blue Mountain Quality Resources