E18-36: Analytical Instrument Qualification from a Chemical Metrology Perspective

One-Day Course 
Wednesday, Nov. 14; 8:30am – 5:00pm

Dr. Jerry D. Messman, Stranaska Scientific LLC, Fort Collins, CO

The new USP Chapter <1058> on analytical instrument qualification (AIQ) provides only general information relative to the implementation of AIQ programs in quality control laboratories in the pharmaceutical industry. The unintended consequence of such limited guidance, punctuated by the glaring omissions of certain key subject areas, is the likely decrease in the confidence and scientific defensibility of the integrity of the measurement data derived from “under-qualified” laboratory instruments. This course provides the necessary background and scientific justification why moving beyond the current overly-simplistic “compliance-based” AIQ rationale is necessary, and how the “science-based” AIQ rationale entrenched in chemical metrology can be beneficial to the laboratory. The new scientific AIQ paradigm is described for UV/VIS spectrophotometers (both cuvette and microplate formats) but it applies also to absorbance detectors for liquid chromatography and dissolution flow systems, and photometric process analyzers. The science-based qualification paradigm for UV/VIS spectrophotometers transcends, in part, to many other types of analytical laboratory instrumentation as well.

This one-day course will benefit laboratory analysts and managers, calibration and metrology technicians and managers, instrument manufacturer service engineers, and quality examiners and auditors who have AIQ responsibilities for UV/VIS spectrophotometer and related laboratory instruments.

1. Application of USP Chapter <1058> to UV/VIS Spectrophotometers
a. Why AIQ is mission critical
b. Overview, misconceptions and critical omissions
c. Compliance-based AIQ – pitfalls and limitations
d. Science-based AIQ – improvements and laboratory benefits
2. Spectrophotometer AIQ Responsibilities and Business Models: In-House Versus Out-Sourcing
a. Laboratory
b. Corporate metrology
     c. Instrument manufacturing service group
d. Third-party calibration company
3. Spectrophotometer AIQ Standard Operating Procedures
a. Recipe for failure – outdated SOP “It’s the way we have always done it”
b. DO include these certain topics
c. DO NOT include these certain topics
     d. SOP laboratory commitment to science-based AIQ
4. Spectrophotometer Optical Designs and AIQ Impact
a. Scanning instruments
b. Photodiode array instruments
c.  Sampling configurations
d. Pitfalls of instrument validation software
5. Testing of Key Spectrophotometer Parameters
a. Resolution (spectral bandwidth)
b. Stray radiant energy (stray light)
c. Wavelength scale accuracy
d. Photometric scale accuracy and linearity
6. Metrological States of UV/VIS Calibration Standards
a. Holmium and didymium filters
b. Potassium dichromate solutions
c.  Neutral-density glass and metal-on-quartz filters
d. Chemical solutions and glass filters for stray light testing
e. Chemical solutions for resolution testing
7. Recertification of UV/VIS Calibration Filters
a. Calibration methodologies and scopes of calibration
b. As-received measurements and presumptive out-of-tolerance testing
c.  Calibration intervals
d. Report of calibration
8. Rating Analytics and Metrics
a. How to assess the scientific defensibility of your spectrophotometer AIQ
     b. Relative calibration impact (rci) factors for calibration methodology options
c. Scientific metrological index (smi) of calibration filters
9. Evaluation of Calibration and AIQ Provider Checklist – Buyer Beware “You Get What you Pay For”
a. Credentials and expertise in spectrophotometric metrology
b. Calibration methodologies offered
c. Scientific defensibility of traceability assertions and uncertainty expressions

Dr. Jerry Messman earned a PhD in analytical chemistry from the University of Maryland (College Park, Maryland USA). Jerry directed the NIST certification and renewal of hundreds of optical SRM transfer artifacts intended for the performance evaluation and qualification of analytical UV/VIS absorption spectrophotometers. For the past 24 years, Jerry has served as founder and managing director of Stranaska Scientific LLC where he has continued to build on his unique NIST heritage to systematically morph the company into a world-wide industry expert and critical thought leader in analytical UV/VIS absorption spectrophotometric metrology. The company is best known globally for supporting those FDA-regulated laboratories that appreciate and fully embrace science-based spectrophotometer AIQ from a chemical metrology perspective. Jerry has also leveraged his unique knowledge in analytical UV/VIS absorption spectrophotometric metrology to help educate criminal defense attorneys and government agency stakeholders on the key concepts of chemical forensic metrology and its critical role in blood and breath alcohol testing, drug analysis, crime laboratory testing and expert witness testimony. Jerry is a qualified forensic expert witness in the Commonwealth of Pennsylvania.