Smart Money – Leading Edge Compliance as a Marketing Advantage A Calibrated Formula for SuccessIntroductionGaining an edge in today’s competitive marketplace can mean the difference between beingsomewhat successful and being a market leader. In the same way, compliance protocols can beeither an unavoidable nuisance or a key to better products and services. Smart money ensuresboth – finely tuned internal documentation and enhanced customer satisfaction.The calibration of analytical instrumentation provides an excellent example of marketingadvantage to be gained through leading-edge technology. Regular calibration of instrumentsoperating on the principles of light absorbance/transmittance/scattering can provide benefits farbeyond mere confirmation of compliance. This attention to detail on the part of your staff shouldtranslate into specific and marketable customer benefits – money saved, better use of time, saferand environmentally friendlier operation, and validation of critical methodology.This is especially true when instrument capabilities are extended to conditions extending wellbeyond those governed by Beer’s Law. In response to the need for better technology ininstrument standardization, consider the availability of a stable, aqueous suspension of a uniformsubmicron co-polymer for broader instrument calibration – the In-Spec® and AMCO Clear®standards from GFS Chemicals (Columbus, OH; formerly available from APS Standards).Product/Process ValidationThe credibility of commercially available calibration standards is in part related to the way suchstandards connect to major validating agencies. In the case of these uniform, submicron styrene-divinylbenzene co-polymer suspensions, solid credentials have been established:NIST – Traceability of styrene-DVB polymeric suspensions to NIST standards further assuresconsistency of performance and calibration accuracy. (Reference particle standards have includedSRM 6190/1691 and 1963; in addition, SRM 935A/2034/930E are UV-Visible spectrophotometercalibration standards).AWWA (American Water Works Assoc., Standard Methods for Water and Wastewater) –Standard Method 5910B defines spectrophotometer use in the testing of Total Organic Carbon(TOC). Approval of In-Spec® standards provides assurance that the protocol for the UV-treatmentof organic by-products (disinfectant efficiency) for drinking water will be met.
EPA – The EPA standard method 415.3 cites the use of In-Spec® calibration standards forspectrophotometer check solutions. In addition, EPA Method No. 180.1 designates GFS AMCOClear® as an approved analytical standard for turbidity measurement.ISO – In 1999, ISO (International Standards Organization) quality assurance programs includedAMCO® standards (GFS Chemicals) in their turbidity method (No. 7027), thereby ensuring thatthis segment of testing conforms to the company-wide compliance protocols governed by ISO-certification.FDA – In-Spec® standards can be used to verify the performance accuracy of on-line processmonitors (UV-Vis spectrophotometers); this satisfies certain elements of FDA compliance andsaves FDA-regulated companies (and their customers) time as well as direct and indirect costs.Applications include visual process monitoring (e.g. fermentation/distillation processes) andbiomedical instrumentation (measurement of bacterial colony counts, protein/blood composition).Specifically, the FDA application is being rapidly incorporated into the Standard OperatingProcedures of many major pharmaceutical companies. In-Spec® standards are custom tailored tomeet each customer’s specific requirements for reference standards. This is also true for AMCOClear® turbidity standards.In addition, AMCO Clear® standards are certified for use in turbidimeters and haze meters by thefollowing regulatory bodies: • Standard Methods of Water & Wastewater, APHA-AWWA-WPOCF, 16th, 17th, 18th & 19th Edition to present • ASTM, D1889-88a, June 24, 1989 to present • ASBC – American Society of Brewing Chemists, 1986 to present • Analytica – EBC, Fourth Edition, 1987 to presentProblem-Solving AssuranceInstrument use is affected both by the nature of the product that is being used as a calibrationstandard and by the process by which instrument measurements are taken. Many instrumentmanufacturers do a good job of addressing measurement technique; however, there are manyfactors that contribute to error in data gathering and interpretation. The GFS In-Spec® calibrationverification standards are designed to minimize or eliminate both product and processuncertainty.Measurement ProtocolsAn immediate advantage is gained from the fact that a standard such as the In-Spec® product canbe custom tailored to specific instrument protocols (UV-Vis specifications). A well-designedstandard will validate proper lamp energy, and allow linearity checks using appropriatewavelength data (linearity limits will affect readings in higher absorbance ranges). Product kitsallow linearity checks and data gathering from 190 to 1100 nanometers. This helps to avoidinvalid assumptions based on Beer’s Law, thereby ensuring a higher degree of confidence in dataaccuracy and application.Proper and timely use of calibration standards minimizes the human error introduced in non-optimized laboratory technique. Proper compliance ensures that background solutions are used in
conjunction with photometric standards. With In-Spec® standards, concerns over calibrationsolution mixing, handling, storage, and disposal are eliminated.The importance of cuvette preparation and standardization, especially as applies to turbiditymeasurement, has been thoroughly discussed in the December, 2003 issue of U. S. Water News.Important factors such as light path interference and documentation of cuvette indexing, cleaning,storage and replacement were addressed. Documentation of this sort is especially important in theexecution of laboratory protocols validated by agencies such as the FDA and the USDA.Product CharacterThe In-Spec® products have inherent properties that afford it significant market advantage thatyou can transfer to your operation: • Stability backed by a certified one-year shelf life • Safety as a non-toxic, aqueous suspension • Ease of use and disposal • Product uniformity on both a macro and micro scale • Guaranteed +/- 5% inter/intra instrument varianceProduct Technical InformationGFS uses proprietary technology to produce uniform, submicron beads of a styrene-divinylbenzene co-polymer which can be formulated into a stable, aqueous suspension. Thefollowing criteria are consistently met: • Comprises a 20-200 nanometer particle size range (other distributions are possible) • Mean particle size 120 nanometers • Standard deviation 0.104 • Bead density 1.056 g/cc • Refractive index (120 nm) 1.5562 • pH of suspension, ca. 6.7Scanning electron microscopy has verified particle size and count.A separate GFS document (# ---) – Scanning Procedure for Spectrophotometric Standards – isavailable as a training tool and suggested audit protocol for both new and experienced techniciansinvolved in the calibration and operation of spectrophotometers. Simply put – the higher thedegree of validation required of your business, the greater your need for standardized protocols inthis area.SummaryThe need for more highly sophisticated instrument capabilities has accompanied the extension ofdetection limits for many analytical methodologies. As detection limits are pushed back,compliance with ever more stringent government regulations can be expected. The business thatdoes not adopt the best technology for dealing with issues of data measurement, interpretation,and reporting will lose ground to those who choose to do so.In the areas covered by this report, the “owner” of the best technology has distinct advantages interms of technical credibility, instrument validation, employee performance, environmental
responsibility, and safety. These added values provide a partnering advantage that will be quicklyrealized by companies seeking to operate on a similar level. Toward this end, the calibrationstandards offered by GFS are vitally important as both technical and marketing resources.For more information, visit www.amcoclear.com or e-mail email@example.com.