• Dec 15, 2017
  • Quality Assurance and Methods Compliance
  • By Rebecca Wolfrom

Evolution of Particle Characterization Instrumentation – Advancing Test Methods for Upgraded Instrumentation

Over time, advancements in technology have led to changes in many aspects of our lives. These advancements include improvements to tried-and-true scientific instruments, including those in the science of particle characterization.

Academic research continues to hone theories, and in turn the theories are built into software codes, hardware configurations, and even CFR Part 11 compliance programming. This means the instruments used while establishing a test method may be superseded by a newer model. In some fields, this may have a minimal effect on test results. But in particle characterization, it can mean significant differences in sensitivity, detection range, sample handling, or other factors. Any of these could mean a change in result relative to your specification – and no one likes surprises when it comes to meeting a specification.

This is where Particle Technology Labs comes in. At PTL, we’ve used particle characterization instrumentation all day, every day, for over 25 years. This translates to a high level of familiarity with the different techniques, theories, and upgraded equipment models. We stay up-to-date with the latest offerings from the manufacturers and are here to help with applying your method to the ever-evolving instrumentation.

Manufacturers can make a multitude of changes to their hardware in a single model upgrade. Such changes can include extended detection ranges, reconfigured flow paths, increased sensitivity, modified data capture rates, and automated sequences, to name just a few. While these features are often marketed as user-friendly benefits, they can present challenges when a body of work has already been established using a prior model. Some of the most interesting projects at PTL are those where the chemists investigate the effects of the new settings on the results and experiment until the puzzle is solved.

To meet the challenge presented by new instrument models, PTL first conducts internal studies to establish statistical equivalency between the legacy and new instrument model using reference materials. Each resulting report is available upon request to clients who are evaluating the need to make a move. Since the equivalency is demonstrated using model materials only, it is important to evaluate the results specific to the client’s own material. To do so, we first perform exploratory work to experimentally translate instrument settings from legacy to new model, and then we can add replicate testing to build confidence in the new method before it becomes routinely used. The scope of work is customizable to fit the client’s requirements.

PTL typically offers three levels of instrument model related method upgrades to choose from, at three different cost structures:

• A protocol-driven method transfer with repeat testing includes preliminary evaluation of the existing legacy method on the new instrument model, replicate analyses using the new method, statistical evaluation of the results with a comparison to historic method results if available, a copy of the new method, and a protocol and report both formally edited and approved by the client and PTL. The scope of the package is adjustable according to client need.

• A non-protocol-driven method change with repeat testing would include all of the above, but in place of the collaboratively reviewed protocol and report the client receives a PTL-generated standard report of analysis.

• A non-protocol-driven method change would include one analysis using the new instrument method based on PTL SOPs and scientific judgement and a PTL-generated standard report of analysis.

In all cases, the new method aims to maintain the same sample preparation procedures as employed in the legacy method (unless justified and approved by the client), but it adapts instrument settings as appropriate for the new hardware. If the legacy instrument is available at PTL, side-by-side analyses on both instrument models may be performed. Throughout the method change process, PTL standard operating procedures for both instrument operation and method revisions are upheld.

Do keep in mind that if a manufacturer has developed a new instrument model, it will only be a matter of time before the legacy model is removed from their maintenance and support plans. As such, PTL too will have to retire it. As a result, the original method cannot be sustained long-term. We make every effort to contact clients who are affected by these instrument retirements. We want to work with you to make the method change as smooth and scientifically supported as possible.

By Rebecca Lea Wolfrom – Technical Compliance Manager

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