Advancements in science and technology are exciting and impactful. Improvements in efficiency, accuracy, sensitivity, and other aspects of testing equipment help drive discoveries, product enhancement, effectiveness, and safety. For these reasons, one may ask “Why not always use the newest equipment and model available?” The latest cutting-edge techniques and equipment can provide significant improvements, but in a regulated scientific industry upgrading and switching to these newer instrument models isn’t as easy as it may seem. As a result, keeping older equipment available in the laboratory can make sense for various reasons. At PTL, we use the term “legacy” equipment or instrument when referring to these older models and systems.
Method Transfers
A primary position in favor of maintaining legacy equipment is to assist with transferring test methods to newer models. Having the legacy and latest model instrument available side by side provides a distinct advantage when moving a method to a new instrument. Assuming the sample preparation has been developed properly and shown to be appropriate for the testing goal, analyzing the same sample preparation on both instrument models provides a valuable data set for comparison and statistical evaluation.
PTL’s approach to comparison of procedures focuses on reducing variables in the evaluation between instrument generations. This is accomplished by maintaining the same sample preparation steps whenever possible and minimizing differences between instrument settings. Keeping these method parameters consistent produces data most reflective of the newer model’s capability and aims for minimal impact on the results.
An in-depth discussion of method transfer due to instrument retirement is outside the scope of this article, but, for the context of this discussion, having the legacy system available during this process means a complete dataset can be built to support and justify the instrument change.
Other Considerations
Another reason to maintain legacy equipment is related to various standardized methods championed by organizations such as ASTM, ISO, USP, PhEur, etc. Typically, guidance documents and industry-standard methods lag behind technology for a variety of reasons:
- Extensive work goes into building the new proposal, taking time, effort, and resources.
- The intensive review and impact assessment by approval boards takes time.
- Specific interests of companies and instrument manufacturers may defer the change.
This can mean older models or techniques are still referenced in these industry standards for several years even though newer technology may exist. These organizations have the challenging task of providing unified guidance in an attempt to harmonize results across an industry while trying to minimize impact on companies’ existing filed procedures, historical data, and specifications. For these reasons, changes to the recommendations and standards require time and thorough consideration before implementing and activating within an industry.
Furthermore, finding legacy resources can often be challenging for late adopters of a new guidance. So, as with any procedural change, a risk-based approach and careful attention are typically the best course of action.
PTL values being proactive concerning these changes. We aim to strike a balance between timely notification, so our clients are aware of changes in technology and have time to respond and implement changes, considering maintenance of legacy equipment that has a shrinking support window. Industry manufacturers help by providing end-of-life target dates but can only offer best-effort support for obsolete models.
Conclusion
Our team of particle characterization experts can help transfer your test method from a legacy instrument to the latest models available from the leading manufacturers in the field. We can help prepare you for technology advancements to prevent delays in product supply chains. Contact us today to discuss how we can assist with your method transfer and legacy instrument testing needs.
By William Kopesky, Director of Analytical Services.
