The document discusses how using leading-edge calibration standards can provide marketing advantages beyond mere compliance. It describes GFS Chemicals' In-Spec and AMCO Clear uniform submicron polymer standards for instrument calibration. These standards offer benefits like validated performance, time and cost savings, and assurance that methods meet regulatory standards from agencies like NIST, EPA, FDA, ensuring credibility. The standards minimize errors from improper technique or unstable products, helping users gain technical credibility and partnering advantages in today's competitive marketplace.
Transcript: #StandardsGoals for 2024: What’s new for BISAC - Tech Forum 2024
In-Spec UV Vis Standards and Good Lab Practice
1. Smart Money – Leading Edge Compliance as a Marketing Advantage
A Calibrated Formula for Success
Introduction
Gaining an edge in today’s competitive marketplace can mean the difference between being
somewhat successful and being a market leader. In the same way, compliance protocols can be
either an unavoidable nuisance or a key to better products and services. Smart money ensures
both – finely tuned internal documentation and enhanced customer satisfaction.
The calibration of analytical instrumentation provides an excellent example of marketing
advantage to be gained through leading-edge technology. Regular calibration of instruments
operating on the principles of light absorbance/transmittance/scattering can provide benefits far
beyond mere confirmation of compliance. This attention to detail on the part of your staff should
translate into specific and marketable customer benefits – money saved, better use of time, safer
and environmentally friendlier operation, and validation of critical methodology.
This is especially true when instrument capabilities are extended to conditions extending well
beyond those governed by Beer’s Law. In response to the need for better technology in
instrument standardization, consider the availability of a stable, aqueous suspension of a uniform
submicron 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 Validation
The credibility of commercially available calibration standards is in part related to the way such
standards 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 assures
consistency of performance and calibration accuracy. (Reference particle standards have included
SRM 6190/1691 and 1963; in addition, SRM 935A/2034/930E are UV-Visible spectrophotometer
calibration 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-treatment
of organic by-products (disinfectant efficiency) for drinking water will be met.
2. EPA – The EPA standard method 415.3 cites the use of In-Spec® calibration standards for
spectrophotometer check solutions. In addition, EPA Method No. 180.1 designates GFS AMCO
Clear® as an approved analytical standard for turbidity measurement.
ISO – In 1999, ISO (International Standards Organization) quality assurance programs included
AMCO® standards (GFS Chemicals) in their turbidity method (No. 7027), thereby ensuring that
this 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 process
monitors (UV-Vis spectrophotometers); this satisfies certain elements of FDA compliance and
saves FDA-regulated companies (and their customers) time as well as direct and indirect costs.
Applications include visual process monitoring (e.g. fermentation/distillation processes) and
biomedical instrumentation (measurement of bacterial colony counts, protein/blood composition).
Specifically, the FDA application is being rapidly incorporated into the Standard Operating
Procedures of many major pharmaceutical companies. In-Spec® standards are custom tailored to
meet each customer’s specific requirements for reference standards. This is also true for AMCO
Clear® turbidity standards.
In addition, AMCO Clear® standards are certified for use in turbidimeters and haze meters by the
following 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 present
Problem-Solving Assurance
Instrument use is affected both by the nature of the product that is being used as a calibration
standard and by the process by which instrument measurements are taken. Many instrument
manufacturers do a good job of addressing measurement technique; however, there are many
factors that contribute to error in data gathering and interpretation. The GFS In-Spec® calibration
verification standards are designed to minimize or eliminate both product and process
uncertainty.
Measurement Protocols
An immediate advantage is gained from the fact that a standard such as the In-Spec® product can
be custom tailored to specific instrument protocols (UV-Vis specifications). A well-designed
standard will validate proper lamp energy, and allow linearity checks using appropriate
wavelength data (linearity limits will affect readings in higher absorbance ranges). Product kits
allow linearity checks and data gathering from 190 to 1100 nanometers. This helps to avoid
invalid assumptions based on Beer’s Law, thereby ensuring a higher degree of confidence in data
accuracy 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
3. conjunction with photometric standards. With In-Spec® standards, concerns over calibration
solution mixing, handling, storage, and disposal are eliminated.
The importance of cuvette preparation and standardization, especially as applies to turbidity
measurement, 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 the
execution of laboratory protocols validated by agencies such as the FDA and the USDA.
Product Character
The In-Spec® products have inherent properties that afford it significant market advantage that
you 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 variance
Product Technical Information
GFS uses proprietary technology to produce uniform, submicron beads of a styrene-
divinylbenzene co-polymer which can be formulated into a stable, aqueous suspension. The
following 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. 6.7
Scanning electron microscopy has verified particle size and count.
A separate GFS document (# ---) – Scanning Procedure for Spectrophotometric Standards – is
available as a training tool and suggested audit protocol for both new and experienced technicians
involved in the calibration and operation of spectrophotometers. Simply put – the higher the
degree of validation required of your business, the greater your need for standardized protocols in
this area.
Summary
The need for more highly sophisticated instrument capabilities has accompanied the extension of
detection limits for many analytical methodologies. As detection limits are pushed back,
compliance with ever more stringent government regulations can be expected. The business that
does 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 in
terms of technical credibility, instrument validation, employee performance, environmental
4. responsibility, and safety. These added values provide a partnering advantage that will be quickly
realized by companies seeking to operate on a similar level. Toward this end, the calibration
standards offered by GFS are vitally important as both technical and marketing resources.
For more information, visit www.amcoclear.com or e-mail amcoclear@gfschemicals.com.