How is Investigative Analysis Different from Routine Testing?


Routine testing follows a controlled and predetermined set of protocols with an expectation of results that should either match or not match a defined outcome. This type of compendial testing can generate pages of data, and tell you whether quality control or regulatory specifications have been met.

Data from routine tests can provide information to, for example, verify components of a formulation, or confirm the concentration and purity of ingredients.

What can you do to get answers when your product is out of spec (OOS) due to contaminants, impurities, manufacturing failures, or product defects and routine tests can’t provide a complete understanding of non-conformance?

Our investigative, microanalytical approach may help to provide some answers to your questions when routine testing results or other anaylsis attempts are inconclusive.

Using advanced microanalytical techniques and instrumentation, we apply a detective-style approach to understanding the issues and finding answers at the microscopic level.

We collaboratively work with you to solve non-routine issues such as production contamination and product defects.

Our commitment to quality assurance (cGMP, ISO/IEC 17025:2017 A2LA accredited) ensures you’ll receive reliable, interpreted, peer-reviewed results, and not just a data dump.

When your testing results fall outside of acceptance or tolerance criteria, or exceed preventive controls (OOC), call us to speak to a scientist or submit your analysis request online. We’re here to help you find a solution.

Craig S. Schwandt, Ph.D. is the director of industrial services and a senior research scientist at McCrone Associates, and an instructor with Hooke College of Applied Sciences. He holds a Ph.D. in Geology from the South Dakota School of Mines and Technology, was the first geosciences postdoctoral appointee at Sandia National Laboratories, and was a contractor support scientist with NASA’s Office of Astromaterials Research. Craig’s extensive and diverse analytical capabilities include optical crystallography, X-ray diffraction analysis, electron microscopy, and X-ray spectrometry. He has been with McCrone Associates since 2007.

Mary Stellmack is a senior research chemist at McCrone Associates and an instructor with Hooke College of Applied Sciences. She earned a Master of Analytical Chemistry from Loyola University, Chicago, and has more than 30 years of experience, with particular specialization in plastic and polymer analysis, and identification of contaminants in pharmaceutical and industrial products. She has served on the board of directors of the Chicago Section of the Society for Plastics Engineers, and is a member of the Society for Applied Spectroscopy, the American Chemical Society, and the American Association of Pharmaceutical Scientists. Mary joined McCrone Associates in 1999.