LGC, formerly the Laboratory of the Government Chemist, who provide chemical and biological analytical services and reference materials, has been acquired with management by Bridgepoint from LGV Capital in a transaction that values the business at £257 million.

John HammondStarna Scientific Ltd, 52–54 Fowler Road, Hainault Business Park, Hainault, Essex, IG6 3UT, UK

The Irish writer George Bernard Shaw once said: “England and America are two countries divided by a common language”. Whilst this statement generally refers to the over 4000 words in everyday use in the United States that are not in British English, in the scientific world “is it metre or meter”, or for spectroscopists, nanometre or nanometer?

However, irrespective of that debate, whatever the spelling, terms such as these have associated definitions, found in various reference texts, such as dictionaries, vocabularies or databases, and if we cannot agree on the spelling, what chance of achieving consistency in definition?

Fortunately, help is at hand, and it is the recent introduction of a “Concept Database” by ISO which has prompted this article.

Detailed below are just a few of the “databases” now available, and examination of the term “Resolution” is used as an example of each.

Starna Scientific has introduced an updated customer feedback system to assist compliance with ISO 17025:2005 guidelines. www.starna.com

Peter Jenksthe Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK

The 12th Biological and Environmental Reference Material symposium (BERM 12) is now over: held at Keble College, Oxford, UK, from 7 to 10 July 2009 it was, based on the feedback received, a resounding success, both scientifically and socially. The weather was perfect and the setting magnificent.

Before looking at the UK Meeting highlights it is important to put BERM into context: it is the original Symposium looking at Biological and Environmental Reference Materials. The first meeting, then known as “BRM” was organised by Dr Wayne Wolf and held in Philadelphia, USA, in September 1983: 26 years ago! Then 25 people shared 16 presentations. Indeed, back then the idea of the application of sound chemical metrology principles to biological matrices was somewhat novel.

Starna Scientific is offering pharmaceutical quality assurance laboratories a safe-to-handle toluene/methanol CRM for validating instrument resolution with derivative spectrophotometry analysis methods. The easy-to-use CRM offers safety benefits for users because the methanol is permanently heat-fuse sealed, ensuring that laboratory users no longer need to handle the volatile, flammable, toxic solvent. The CRM is suitable for pharmaceutical QA laboratories using derivative spectrophotometry procedures to validate instrument resolution following the guidelines specified in section 2.2.25 of the European Pharmacopoeia.

Starna Scientific Issue: 21/05 RSN: 108 More information via

Agilent Technologies has announced their new Complex Proteomics Standard, created to help researchers with protein biomarker discovery by validating mass spectrometry-based workflows for protein identification. It is applicable to a wide range of LC/MS- based applications and can be used with the Agilent 1200 series LC and 6000 series MS systems as well as MS instruments from other suppliers. The standard contains more than 1500 proteins covering a wide range of protein sizes/molecular weights, pI and hydrophobicity. Genetic distance between Pyrococcus furiosus and human—or other organisms typically subjected to proteomic studies—helps avoid erroneous protein identification.

Agilent Technologies Europe Issue: 21/05 RSN: 116 More information via

Isotopically-labelled non-radioactive peptides function as critical internal standards for protein quantitation experiments in MS and NMR experiments. Thermo Fisher Scientific now offers multiple grates of heavy peptides, enabling researchers to match the precision and cost of the internal standard according the assay development stage. The new HeavyPeptide Aqua Ultimate kit is designed for absolute quantification and the Aqua Quant Pro kit is a more affordable alternative when ultimate precision is not necessary.

Thermo Fisher Scientific Issue: 21/05 RSN: 115 More information via

With high diffuse reflectance values, Labsphere's Spectralon Reflectance Standards provide accurate calibration for a variety of testing equipment. Spectrophotometers, densitometers, integrating sphere systems, optical equipment, photographic equipment, reflectometers and remote sensing instruments can be calibrated according to NIST traceable standards. Available in a variety of reflectance values and colours, with values ranging from 2% to 99% reflectance values over the 250–2500 nm range, the diffuseness of the standards eliminate viewing angle errors. The standards come both calibrated and uncalibrated and are available individually and as sets. The units are thermally stable, washable and waterproof for use in a wide variety of environments from laboratory to production and quality control.

Labsphere Inc Issue: 21/02 RSN: 154

The US Pharmacopeial Convention has announced the release of its first certified reference material, dextromethorphan hydrobromide. This release provides pharmaceutical manufacturers with a new class of reference standard that ensures improved information for measurement of their products when meeting requirements set forth in the US Pharmacopeia–National Formulary. Each CRM comes with a Certificate of Analysis containing data on certified property value, uncertainty value and an expiry date, all of which aim to produce a higher level of trueness and traceability in the measurement of product and ingredient specifications.

Issue: 21/01 RSN: 109

Peter J. Jenksthe Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK. E-mail: peter@jenks.info

At the beginning of October 2008 I took part in an International Symposium on Pharmaceutical Reference Standards, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and held between 9 and 10 October 2008 in Strasbourg, France. For those interested, the proceedings can be found on the EDQM Website (http://www.edqm.eu/site/Download-527.html). They are a number of pdf files towards the bottom of the very long page...

LGC has introduced a set of low sulphur certified reference materials to meet the needs of fuel testing laboratories when the new limits of 10 mg kg–1 sulphur in fuel come into force on 1 January 2009. These CRMs have been produced for use by laboratories to develop and validate reliable analyical methods to measure sulphur in fuels at these increasingly low levels. Of particular value to organisations in meeting the requirements will be the CRMs containing 8 mg kg–1 and 20 mg kg–1 in petrol and 10 mg kg–1 sulphur in diesel.LGCIssue: 20/06 RSN:

Christopher BurgessBurgess Analytical Consultancy Limited, “Rose Rae”, The Lendings, Startforth, Barnard Castle, Co. Durham DL12 9AB, UKJohn HammondStarna Scientific Ltd, 52–54 Fowler Road, Hainault Business Park, Hainault, Essex IG6 3UT, UK

Spectroscopy and spectrometry have been around for a long time. In the “modern” era, spectroscopic instruments have been with us in one form or another for over 70 years. This is particularly true for those old “workhorse” techniques, UV-visible and infrared. So by now it might be reasonable to think that we would enjoy a standardisation and calibration environment that would make the assurance of our spectral data quality a matter of routine. Perhaps or perhaps not! Nothing stands still in the application of analytical science to assuring quality. As the column title rightly suggests Quality does Matter.

The rate of change of instrumentation and its application base accelerated during the 1980s with the availability of substantial data processing power and new technologies being incorporated into the humble spectrometer. Suddenly some of the reference materials we relied upon for qualifying and calibrating our spectrometers were no longer “fit for purpose”. Not only were end users in the laboratory faced with these issues but also the instrument manufacturers. At the same time as these technological changes were occurring so too were regulators. Regulatory bodies in a variety of fields, pharmaceuticals, medical devices, environmental, food to name but a few were becoming increasingly interested in the quality of the data coming from our laboratories to ensure compliance with national and international standards.

When discussing the need and role of standards, we need to consider the major changes that have taken place over the last 50 years in four key areas: The National Metrology Institutes (NMIs), the instrument manufacturers, the user base and the globalisation of regulation through international regulatory bodies.

Full Text (1.49 Mb)

To simplify the operational qualification of micro-plate readers, Starna has released a new Reference Cell Micro-plate Adaptor that enables laboratory professionals to use existing sealed-cell and filter reference materials in a horizontal format. The design of the adaptor allows the location of eight “pairs” of read position and minimises the potential for bubble interference adversely impacting measurements. The adaptor enables companies to extend their NIST traceable and ISO 17025/ISO Guide 34 accredited certified reference materials for use in a micro-plate format. The device is suitable for quality assurance requirements in pharmaceutical and clinical research applications where new drug compounds and candidates are being screened using automated systems that require formal qualification using appropriate certified reference materials. Using the new adaptor now offers researchers the ability to use existing reference values and compare micro-plate reader data against measurements performed on a conventional spectrometer.Starna ScientificIssue: 20/05 RSN:

Possible consequences of the EU REACH Directive on the analytical laboratory

Peter J. Jenksthe Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK

National laws, implementing the REACH Directive, came into force across the EU on 1 June 2007. The Directive aims to ensure that all chemicals used commercially in Europe shall be registered and the toxicity, bio-toxicity and persistence properly documented. In some cases, based on this registration process, the use of certain chemicals may be either severely restricted or completely prohibited. A new EU Chemicals Agency (ECHA, www.echa.europa.eu) has been established in Helsinki, Finland, to be responsible for this work.

Applied Biosystems and MDS Analytical Technologies have announced the availability of a suite of integrated mass spectrometry-based solutions for conducting targeted quantitative proteomics studies. Designed for their triple quadrupole and hybrid triple quadrupole/linear ion trap MS systems, these solutions include software packages and consumables which enable scientists to quantify proteins more effectively in biomarker research or cell biology. The new tools include mTRAQ reagents, which are chemical labelling kits for use in targeted proteomics experiments using MRM analysis that can be used to create global internal standards to provide an internal reference for every protein, peptide and post-translational modification in a sample in a simple one-hour step; Scheduled Multiple Reaction Monitoring, a feature that focuses instrument cycle scans for specific analytes based on the timeframe that those analytes will be entering the instrument; MRMPilot software, a new software program for use with their Q Trap systems which enable rapid development of robust MRM assays for peptides and proteins using data acquired during discovery experiments; MultiQuant software, a new software package for use with the company's mass spectrometers which process MRM data for quantitative information.Applied BiosystemsIssue: 20/04 RSN:

John HammondStarna Scientific Ltd, 52–54 Fowler Road, Hainault, Essex IG6 3UT, UK

In the first of our new Quality Matters columns (Issue 20/1), I introduced the new team of contributors and mentioned that John Hammond would be writing, from his position as the UK Industrial Delegate to the ISO-REMCO Committee, about the workings of that important body and looking to the future following some important decisions taken at the June 2007 meeting in Japan. This is his first of what will be a regular series of reports on the workings of REMCO.Peter Jenks

A stable material has been developed by Dr Chris Burgess in conjunction with Starna which exhibits similar characteristics to pure DNA. The robust and durable standard reference material allows quick and reliable quality control and assurance of the DNA 260/280 nm measurement process. This control material has been specifically designed to assure the wavelength accuracy in critical nucleic acid measurements. The reference has a quoted production batch, 260/280 corrected absorbance ratio of 1.9 ± 0.1. Spectrophotometric measurements falling within this tolerance indicate that the wavelength scale is accurate to ±1nm. If values are outside this ratio they provide diagnostic evidence of the wavelength error. The standard is produced in an ISO 17025 and ISO Guide 34 accredited environment, meeting the highest regulatory standards. The DNACON260/280 ­material has been created for use as a reliable NIST traceable quality control standard by clinical and bioscience laboratories analysing and evaluating the purity of a range of nucleic acids such as DNA, RNA, RNAi and ssDNA. It comes in a flame sealed far-UV cuvette which ensures that it is a re-usable and long-lasting standard for common nucleic acid assays.Starna ScientificIssue: 20/03 RSN:

UV-vis/NIR certified reference materials sets supplied by Starna Scientific now feature set identification labels and support documentation that contain unique serial number bar codes. This facility is detailed on every new or re-certified set and is particularly relevant in the pharmaceutical industry and other highly regulated environments. The bar codes enable accurate tracking of reference type and serial number within the customers' laboratory and QA department as well as when CRM sets are returned for re-certification. The bar code initiative saves time and potential transcription errors by eliminating the need for manual entry of the set identifiers into computer-based systems such as LIMS.Starna ScientificIssue: 20/02 RSN:

Peter J. Jenksthe Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK.

In the final RM Column, I concluded with the words “To cover this enhanced scope the editorial team will expand: there will be a couple of new names joining me in the preparation of the new column”. In this, the very first Spectroscopy Europe Quality Matters Column, I’m delighted to be able to announce our new columnists as Christopher Burgess and John Hammond.

Chris Burgess brings to the column a wealth experience gained over more than 30 years working in the pharmaceutical industry. Now an independent consultant he spent much of his working life within the Analytical Division of Glaxo Operations at Barnard Castle responsible for pharmaceutical Quality Assurance and Analytical R&D. In parallel he has been much involved with the Royal Society of Chemistry, indeed he is a Fellow of the Royal Society of Chemistry (RSC), a Qualified Person on the Indicative Register of Analytical Chemists of the RSC, a Chartered European Chemist and a qualified ISO 17025 assessor.

Chris started out as a research chemist, following his PhD at Loughborough with a post doctorial research posts at both the University of Hong Kong and at the University of Southampton. He has published more than 60 papers and books, including Standards in Absorption Spectrometry on behalf of the Ultraviolet Spectrometry Group. His interests include the automation and software control of analytical operations, the application of mathematics to analytical chemistry, and diode array spectrometry in analytical chemistry.

Chris brings a unique combination of skills and experiences to the column: his first contributions will focus on Quality Matters in the pharmaceutical industry and in particular the consequences of the growth of ISO 17025 within the analytical side of the pharmaceutical industry.

John Hammond is Technical Manager for Analytical Products at Starna Group, including Optiglass spectrophotometer cells. In the 1950s Optiglass developed a technique for fusing the parts of a spectrophotometer cell only by heat without distorting the optical surfaces. This led to the production of filled, sealed cells for use as optical property CRMs. The growing requirement for laboratory accreditation by a recognised quality standard such as GLP, ISO 17025 or ISO 9000 with “evidence of control” increased demand for all types of CRMs with a traceable path to internationally recognised primary materials or procedures. Starna was one of the very first CRM producers to achieve accreditation to ISO 17025 plus ISO Guide 34 as a RM producer.

John has been closely associated with the changes caused by ISO 17025: he recently was appointed the UK Industrial Representative on the ISO REMCO Committee, succeeding the late Peter Ridsdale. Like Chris he has been much involved with the Royal Society of Chemistry (RSC) and is a Fellow of the Royal Society of Chemistry, a Chartered Chemist and a Chartered Scientist. John also serves as chairman of ASTM Sub-committee E13.01 on UV-Visible Spectrophotometry, and is a member of the UK Reference Materials Working Group.

John’s first article will be “What’s ISO-REMCO all about”—a review of the 30th anniversary meeting in Tsukuba, Japan, in June 2007, will explain more about the aims and objectives of ISO REMCO. He will follow this with a report of the 31st REMCO meeting, which will take place in Rio, Brazil, during June 2008.

In addition to the two new contributors I will continue to write on the use and application of reference materials in analytical chemistry and how their role underpins the practical application of ISO 17025. Although it seems as though ISO 17025 has been around for many years, 17025 accreditation is very new and there are still many laboratories for whom ISO 17025 is a novel experience and the journey to accredited status filled with pitfalls. Many of the new wave of ISO 17025 accredited labs are to be found in academia: a very readable overview from one such laboratory was published last year in the journal Accreditation and Quality Assurance1 (better known as AQAL). The authors, D. Zapata-García, M. Llauradó and G. Rauret from the Analytical Chemistry Department, Faculty of Chemistry, University of Barcelona describe the experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory, in this case the Environmental Radiology Laboratory.

It was obvious that implementation in a university institution was a difficult task, since the setting and environment are both unfavourable when compared with industry. In particular the collaboration of many independent units of a university and the involvement of academics and researchers who have to coordinate all the different requirements of ISO 17025 especially as the number of people working is variable is a challenge. Some specific aspects of the system are discussed by the authors who conclude that implementation of an ISO 17025 quality system is completely achievable and desirable as the discipline, as they put it, “puts university members in touch with the real world and broadens their minds”—undoubtedly this can only have a positive impact on research studies and academic content.

Reference

D. Zapata-García, M. Llauradó and G. Rauret, Accred. Qual. Assur. 6, 317–322 (2007). PDF Version (63.36 Kb)

New liquid certified reference materials for the NIR region of the spectrum are now available from Starna. The Starna NIR reference provides 13 certified and traceable peak values using a new material developed by the company. This new heat-sealed traceable liquid CRM comes in a format where, in one orientation, it can be used as a 10 mm path length transmittance reference and, when rotated by 90°, becomes a 5 mm transflectance reference—in this orientation the rear cell window has a reflective coating. All Starna references are produced in an ISO Guide 34/ISO 17025 accredited environment, satisfying ILAC guidelines.Starna ScientificIssue: 20/01 RSN: