Pharma Focus Asia


Enabling efficiency & compliance with Sievers TOC Analysers

Dave Kremer, Senior Leader, SUEZ’s Water Technologies

Pharmaceutical and biopharmaceutical manufacturers across the globe are increasingly tasked to improve productivity without sacrificing quality or compliance. At the same time, budget pressures and resource consolidation continue to intensify, forcing manufacturers to do more with less in a highly regulated environment.

Faced with these demanding pressures, manufacturers turn to technologies and solutions that can help them improve output and increase efficiency. SUEZ, through its Sievers Life Science product line of TOC Analysers, consumables, and instrumentation, enables efficiency and compliance for compendial water testing, cleaning validation, and other applications across pharmaceutical QA/QC, Production, R&D, and Facilities.

Dave Kremer, Senior Leader at SUEZ’s Water Technologies & Solutions - Analytical Instruments business, talks about industry trends in analytical instrumentation, Data Integrity, and efficiency gains for water testing and cleaning validation.

It’s been about two years since GE Analytical Instruments and Sievers products became part of SUEZ. Tell us more about the transition.

It’s been exciting! As part of SUEZ, we not only provide our core expertise in life sciences water testing and cleaning validation, but we also contribute to important challenges related to water scarcity, productivity, and process control in various industries across the world. Water is an important resource in all industries, and sustainable management of this resource is playing a more important role than ever in business. In the life science industry, we’ve been known for making extremely accurate and reliable instruments for water monitoring – not just for quality control but also process control. By helping companies become more efficient and understand their processes, we can lean out and optimise the use of resources like water.

What is some of the history of Sievers analysers?

Most of our customers in the pharmaceutical market recognise the Sievers name. The company Sievers Instruments was formed in 1984 by two colleagues from the University of Colorado here in Boulder where our headquarters remain. A fact some people don’t know is that our most widely used product line of TOC Analysers evolved through a contract to develop an instrument to monitor drinking water quality in space! That instrument family has since been acquired multiple times – most notably by GE and then SUEZ – and has grown into one of the leading TOC technologies in the pharmaceutical industry.

Besides instrument performance, what other factors come into play for successful TOC analysis?

Beyond accurate and easy-to-use analytical instrumentation, Sievers certified consumables, services, and specialised support offer customers a complete TOC solution. For example, when using Sievers vials and standards, companies can take advantage of our out-of-specification, or OOS investigation support. In the event of a sample, system suitability, or verification failure, our quality team will troubleshoot and thoroughly investigate in-house variables and onsite instrument performance. We will then discuss the findings in a failure analysis report, providing complete traceability.

We constantly ask for feedback from customers related to how they are using our instruments and the challenges they run into. This input from customers has enabled us to develop not only new instruments and instrument enhancements, but also new consumables and services that lead to the success of the TOC program overall. Recently we launched our Pre-Acidified Vials for cleaning validation and verification. These specialty vials improve protein recoveries and can help avoid a false sense of cleanliness. We developed a version of these vials that is pre-filled with water, specifically to address the needs of customers measuring swab samples. These vials ensure consistency and reduce risks associated with sample preparation, ultimately helping customers reduce cleaning sample failure rates. The application-specific products and support we offer are unmatched in the industry.

TOC analysis is used in various areas of pharma. What are some of the trends you see in where and how companies are implementing TOC?

Whether in the QC lab, production, R&D, or engineering facilities, Sievers TOC Analysers can be deployed to meet compliance and lean out processes. Common applications for TOC include UPW monitoring, real-time testing, cleaning validation (plus cleaning verification and monitoring), and testing for leachables/extractables. We see many companies expanding their use of TOC from UPW testing to using TOC for process understanding, control, and troubleshooting. It’s amazing the efficiency many of our customers have gained from using TOC.

Take online monitoring and real-time testing (RTT) of pharmaceutical waters – this is an area where Sievers instruments enable better process understanding so customers can perform corrective actions in real time and ensure quality. We deliver ultra low-level accuracy and reliability without the false positive and false negative readings associated with other simplified TOC technologies. Customers want continuous, online quality assurance, consistent with regulatory requirements for process control and RTT. That’s where we help them achieve success and increase efficiency.

Another trend we see is the use of Turbo mode to enable real-time profiling for water testing, troubleshooting, or cleaning validation. This is available for online, grab, or lab samples and allows for quick analysis and identification of transient TOC excursions. Again, this level of control and speed is what customers want to maximise productivity.

Overall, with the trend and desire of our customers to increase efficiency and move to online testing, we aim to make online deployment and the potential for automation as easy as possible. When it comes to transitioning from the lab to online deployment of our instruments, leveraging Sievers membrane conductometric TOC technology enables the Process Analytical Technology, or PAT, transition to be seamless with like-for-like technology.

We hear about Data Integrity and data security constantly these days. How important are these concepts when designing analytical instruments for the pharmaceutical industry?

It’s extremely important that we meet the needs of our customers by ensuring our instruments and software are fully compliant with 21 CFR Part 11 and the latest Data Integrity guidelines. Especially as we continue to see FDA warning letters associated with Data Integrity, we know this is something the industry is taking seriously.

When we think about the definition of Data Integrity from various government organisations, we think about the completeness, consistency, and accuracy of data over its lifecycle. However, there are many aspects related to the practical implementation of these concepts that are not clear. That’s where companies tend to run into trouble.

For Sievers products, we are committed to helping manufacturers stay on the leading edge of Data Integrity. For example, based on feedback we were hearing in the market, we created a new validation support package specifically to address Data Integrity by validating TOC software. This validation support is unique in the industry and addresses the need for a complete validated solution from instrument to data storage.

You mentioned your instruments are used in the QC lab but also online and for real-time applications. How does SUEZ keep pace with changing needs and ensure successful implementation of different applications?

With limited time and resources, pharmaceutical manufacturers want to lean out processes, increase productivity and automation, and troubleshoot effectively. We observe this in QC, Production, R&D, Engineering, and other areas of pharma. Yes, we do see a trend in customers wanting to implement applications such as real-time testing and online cleaning validation, but they aren’t always sure how to do so effectively.

As instrument manufacturers, we’ve learned the success of our customers depends on a lot more than just an instrument. We take pride in the expertise our team can provide, from helping with method development and feasibility to implementing new applications. We also developed validation support packages for qualification (both instrument and software), RTT, and cleaning validation to help customers navigate the validation process and enable efficient and compliant implementation.

What can we expect in terms of future Sievers Life Science products?

As you have seen from our history, Sievers products are defined by expertise and innovation. You can expect to see some ground-breaking innovations in the near future that will broaden the solutions we provide to the industry and enable customers to lean out additional processes in Quality Control – of course without compromising compliance! We are constantly engaged with customers to identify their most pressing needs and innovate better solutions for their analytical challenges. We look forward to showcasing our latest innovations next year. Stay tuned!

--PFA Issue37--

Author Bio

Dave Kremer

Dave Kremer is a Senior Leader within SUEZ’s Water Technologies & Solutions - Analytical Instruments business, formerly GE Analytical Instruments. As part of GE, he led Global Product Management and Applications for the Sievers product line across the Life Science and Industrial industries. Now, as part of SUEZ, Dave is the Global Leader of Sales and Business Development. Before joining GE, Dave served in senior management roles for Associates of Cape Cod, a global leader in endotoxin products, and in Quality Control for pharmaceutical manufacturing.

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