Analytical life science laboratories regulated by the Food and Drug Administration (FDA) must demonstrate compliance with the requirements for several laboratory tasks that are intended to help ensure the quality of measurement test results. The laboratory tasks include analytical instrument qualification, analytical method validation, systems suitability testing (when relevant) and daily quality control checks. Analytical instrument qualification (AIQ) forms the infrastructural basis of the quality pyramid in the life science industry, and the other required laboratory tasks are sequentially built on the AIQ foundational platform. It is intuitively obvious that if the AIQ task is not completed properly, the results from the other quality building block tasks may be misinterpreted and therefore can not be trusted.

Despite the fact that the laboratory AIQ task is NOT TRIVIAL, it is apparent that many laboratories under-value the scientific ramifications of AIQ relative to the scientific efforts directed to the other required laboratory quality tasks. The tasks involving analytical method validation, systems suitability testing and daily QC checks are often conducted by laboratory analysts and scientists credentialed in analytical chemistry that usually includes formal training with a solid understanding of the analytical instrumentation typically applied to chemical analysis. On the other hand, the AIQ task is often outsourced to corporate metrology (or sometimes facility maintenance) or to commercial calibration companies, both of which generally rely on engineers or technicians not having credentials in analytical chemistry or applied science relative to chemical analysis for which the instrument is typically used. Despite perhaps having strong training in physical metrology and engineering, coupled with the lack of solid scientific guidance by USP, the AIQ task may often be completed in compliance but inadequate from a chemical analysis perspective. For example, certain optical filters used in a given AIQ test may be “calibrated” by an accredited laboratory but lack essential quality characteristics that only become apparent when the calibration certificate for the filters are reviewed by an analytical scientist formally trained in analytical UV/VIS spectrophotometric metrology.


A meaningful “qualified state” of an analytical UV/VIS spectrophotometer can only be determined if the reference material artifact used for the testing can be proven with confidence that it is an appropriate one having the highest scientific defensibility of the filters’ certified value assignment, assertion claims of metrological traceability, methods of data analysis and expression of measurement uncertainty, and audit-proof transparency. To fulfill this mission through its scientific innovation, Stranaska Scientific uniquely offers UV/VIS measurement standards and services that can be uniquely characterized by certifications using only advanced calibration methodologies that exceed the scientific rigor of the standard industry practice of competing commercial UV/VIS calibration laboratories, and in certain cases, even that of some national metrology institutes.