Change Up Your Routine (Analysis)

By June 23, 2020

Enhancing performance, mitigating risk, and improving efficiency


Today, Waters introduced the Arc HPLC, a modern liquid chromatography system that replicates established test methods while delivering improved performance. HPLC has been a cornerstone of routine analytical testing for decades. It has proven to be particularly important for quality control and manufacturing support laboratories in the pharmaceutical industry. This is an area where data quality and data integrity are critical in key decisions supporting the safety and efficacy of pharmaceutical products.

While LC methods that were originally developed on older instrumentation and separation consumables are still widely used for these analyses, and while there has been recent interest in improving the existing methods to allow the use of modern technology, there is more than one way to get better results.

As you seek to improve the accuracy of your measurements, the consistency of your analyses and ultimately your confidence in your results, should you change your methods or change your technology?

Modernize your method

Regulatory observations in pharmaceutical laboratories routinely cite concerns regarding the suitability of analytical methods, particularly chromatographic methods that require analysts to intervene, adjust or repeat testing. If you’re concerned that the method you currently use is deficient, flawed or unsafe, or if you need to improve the efficiency of routine tests, modernizing your method may be right for you, and it likely includes modernizing your technology as well. Whatever the reason, managing your methods using a lifecycle approach can help improve the consistency, ruggedness and quality of separations to enable right-first-time analyses.

If you’re considering re-developing existing methods and deploying them for routine analysis using a platform built to support Analytical Quality by Design method development and highly reproducible analyses, the ACQUITY HPLC System can help. Doing this can mitigate the risk of invalidated data, continually adjusted or manual peak integrations and system suitability failures.

Modernize your technology

The best analytical methods are robust, consistent, and easy to use. Let’s face it, while there are many good and valid reasons to consider modernizing your method, many existing HPLC methods generally satisfy these requirements today and the pain of changing may not be equal to the reward. Yet, if you have nagging doubts about the throughput of your existing methods, about measurement accuracy, and confidence in the quality of your results, we can help. Or, if you are worried about your ability to transfer your methods effectively, whether from instrument-to-instrument, lab-to-lab, or company-to-company, while preserving the reproducibility of the analysis, then modernizing your HPLC instrument may be right for you.

Modern and rugged systems designed for routine HPLC testing, like the Arc HPLC, can seamlessly receive and run transferred methods with improved performance and precision compared to traditional HPLCs, ensuring data quality, avoiding system suitability failures and the invalidation of results.

No matter which way you go

Whether you’re developing a new method, re-developing an existing one, or managing the deployment of your method in routine testing, the Arc family of LC systems can help. When paired with the appropriate Waters’ column technology and Empower compliant-ready software, you can ensure robust performance and results. Whether it’s routine analysis, facilitating data review, eliminating burdensome documentation or improving the overall quality of laboratory data, Arc can take your lab to the next level.

Learn more about the new Arc HPLC and how it can provide you with the enhanced HPLC performance you need and the results you can trust.

When is the right time to upgrade? In a previous blog, we reviewed some practical considerations to help you decide whether upgrading your technology makes smart business sense. With the pressure on to improve efficiency, there is no better time than now to take a look at the challenges of maintaining your older instrumentation. When you upgrade your assets, you upgrade your entire business efficiency. With the Waters FlexUP Technology Renewal Program, you easily and cost-effectively replace your older instruments with state-of-the-art technology to stay protected from obsolescence and its high degree of risk.

Categories: Regulatory Center