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Peter Jenks and John Hammond continue their series on “CRMs and PT in an ISO 17025 accredited laboratory” with instructions on how you can prepare your own in-house certified reference materials.
Certified reference materials and proficiency testing in an ISO 17025 accredited laboratory. Part one: Defining the role
Peter Jenks looks at some current trends in the supply of CRMs and proficiency testing and highlights difficulties labs may have been when no commercial CRM is available. This will be followed with a second part looking at the production of in-house reference materials.
A new product line of analytical standards and reagents consisting of an initial portfolio of more than 200 pre-formulated reference materials and reagents for the scientific laboratory, the hallmark of which is absolute traceability.
Solvent-less standards used for calibration of GC retention indices, MS ion masses and target compound concentrations. The standards contain 13 compounds specifically customised for calibration and performance validation of the TRIDION GC-TMS.
Designed for use with US Pharmacopeia 232 testing for elemental impurities in pharmaceutical and nutraceutical compounds, the kit contains two USP standards, UPS-TXM1A and TXM1B which are not available separately.
An extension of their metal-on-quartz neutral density filters for the NIR produced under ISO/IEC 17025 and ISO Guide 34. This CRM is protected from oxidation, physical degradation and contamination by the use of a novel cover plate optically bonded to the surface providing extended lifetimes. Starna now also offer a range of solid state glass filters between 1% and 92% T in compliance with USP 〈1119〉 NIR protocols.
A range of neutral density filter certified reference materials which have been manufactured and produced within the Starna ISO/IEC 1702 and ISO Guide accreditation. In a format as per SRM 2013a, which is no longer available from NIST, the filter’s metallic surface, used to define the transmission characteristics, is overlaid by an optically bonded coverplate, protecting the reactive optical surface from oxidation, contamination or physical degradation.
Peter Jenks gains new respect for microbiologists and learns that the way they approach analytical quality control is different from chemists.
Chris Burgess and John Hammond respond to Peter Jenks' thoughts in the last issue's Quality Matters Column. Please join in the debate and add your comments at the end of the article.
The reasoning behind strict compliance to an ISO Standard is logical, but the consequences can be commercially questionable, if not unsound. Peter Jenks, and many other scientists, are starting to question the commercial viability of all this regulation. What is your opinion?
Peter Jenks is concerned at the lack of mutual help available on the Internet within the field of analytical chemistry. Other fields, outside science, have strong communities where enthusiasts give freely of their advice and time; why not in analytical chemistry? Please tell us your views by adding a comment to this column article.
Sigma-Aldrich has acquired the assets of Resource Technology Corporation (RTC) of Laramie, Wyoming, USA, manufacturer of analytical standards and certified reference materials. The acquisition of RTC's business complements Sigma-Aldrich's recently completed acquisition of Cerilliant.
LG Standards is offering Ultra Scientific's Ultragold, a new line of ISO Guide 34 CRMs which fulfil the need for CRMs at convenient concentrations of 1000 ppm and 10 ppm as well as incorporation REACH labelling into its products. ISO Guide 34 requires an extensive protocol of homogeneity, short term stability, long term stability, quality control and statistical analysis and the ISO Guide 34 CRMs meet this need.
NIST has developed new standard reference materials for measuring amounts of organic acids in dietary supplements formulated with Vaccinium berries—cranberries, blueberries and bilberries. The new references are SRM 3281, cranberry (fruit); SRM 3282, low calorie cranberry juice cocktail; SRM 3283 cranberry extract; SRM 3284, cranberry-containing solid oral dosage form; SRM 3285, mixed berry-containing solid oral dosage form; SRM 3287, blueberry (fruit); SRM 3291, bilberry extract.
The first group of graduates of a new European Master's degree received their diplomas at the European Commission's Joint Research Centre (JRC) in Geel, Belgium. The degree, “Measurement Science in Chemistry”, was based on training initiatives developed by the JRC's Institute for Reference Materials and Measurements (IRMM).
NLG Analytical has announced the release of its latest v-kit qualification system for LC-MS systems, suitable for single and triple quadrupole mass spectrometers. The package consists of software-driven protocols, standard operating procedures and traceable reference standards. Written on the v-kit Pro platform, the software features report creation, summary reporting and audit trail and user/manager access rights. The electronic logbook function allows the data from the entire qualification exercise to be quickly and easily assembled into a single document for storage or distribution. The kits can be provided for qualification by the user or as part of service delivery by approved v-kit service partners.
NLG Analytical Ltd
The 33rd meeting of the Reference Material Committee of ISO, ISO/REMCO was held in Hangzhou (China) from 3 to 7 May 2010, and was hosted by the Standardisation Administration of China and the China Association of Standardisation. ISO/REMCO now has a membership of 70 members of the International Organisation for Standardisation (ISO) and liaison with 18 international organisations and seven ISO-internal committees. The new ISO TC liaison introduced at this meeting is with ISO/TC 158 “Analysis of gases”, with Dr Adriaan van der Veen acting as the REMCO liaison officer.
Starna Scientific’s Calibration and Reference Material manufacturing laboratory has extended its range of certified reference materials, providing a comprehensive range of UV/visible/NIR materials currently available under the scope of ISO Guide 34 + ISO/IEC 17025 accreditation for Reference Material producers.
ISO Standard ISO 17025 is the cornerstone of the “Measured Once, Trusted Everywhere” concept and the accreditation of labs and testing establishment to ISO 17025 by accreditation bodies underpins the credibility. ISO 17025 is all about facilitating the free movement of goods and services and so helps to eliminate monopolies, cartels and all sorts of anti-competitive activities.
Peter Jenksthe Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK
ISO 17025 has been with us now for 12 years and in some industry sectors it is getting hard to find a commercial laboratory offering chemical testing that is not accredited to ISO 17025 for some or all of its scope. In just 12 short years the importance of “quality management” to a laboratory has undergone a seismic shift.