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Can you tell us about SUEZ -Water Technologies & Solutions and how the company’s current products and services help the pharmaceutical industry bring products to market?
SUEZ—Water Technologies & Solutions offers water technology and process expertise and provides a suite of solutions for testing quality in the pharmaceutical industry through its Sievers product line. From total organic carbon and conductivity to endotoxin testing, SUEZ strives to meet the needs of the industry through cutting-edge and compliant analytical instrumentation and consumables.
We understand the need to bring pharmaceutical products to the market in a safe and timely manner. Our TOC, conductivity, and endotoxin platforms help users save time and decrease costs by eliminating or reducing sampling, reducing laboratory errors, and producing trustworthy data every time. For example, online water monitoring using the Sievers M500 allows for real-time analysis of pharmaceutical grade water. Not only is water monitoring a regulatory requirement, but it also provides important data indicating quality. Water quality is critical because water is used in many steps of pharmaceutical manufacturing from cleaning to drug formulation. The M500 helps users identify out of trend (OOT) or out of specification (OOS) water before that water is used in a critical application. This helps manufacturers detect issues in a timely manner, saving time, money, and resources. This is just one example of how our products aim to ensure the continuity of production so that safe and quality medicines can reach patients.
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As the industry, and the world, turns its attention to the development and manufacture of vaccines – are you making any changes to your product line-up?
As a provider of analytical instrumentation, standards, consumables, and reference materials, SUEZ strives to meet and exceed the market needs. SUEZ has made product improvements and launched new products to continuously support the development and production of drug products. As biologics become increasingly manufactured around the world, SUEZ has kept up by offering novel solutions for total organic carbon, conductivity, and endotoxin analysis for these manufacturers.
The introduction of our groundbreaking endotoxin testing platform, the Sievers Eclipse BET Platform, comes at a time when automation, compliance, and productivity are more important than ever for vaccine manufacturers. Novel solutions like the Eclipse complement our Sievers TOC analyzers to make efficiency and compliance more easily achievable in QC labs.
Another example of products we’ve introduced to help with biologics manufacturing is within our TOC consumables line. It is common for protein drug products or APIs to be sticky when attempting QC analysis. This can result in under recovery and under reporting for tests such as cleaning validation swabs of critical equipment. Under reporting can lead to serious safety and cleanliness issues. SUEZ developed pre-acidified vials to combat this common issue. These vials prevent proteins from sticking to the vial surfaces and thus lead to accurate reporting of samples.
Since most, if not all, pharmaceutical companies are international, how do you provide products and services that meet the varied and stringent regulations of different regulatory agencies?
While our Analytical Instruments manufacturing site is based in Boulder, Colorado, we are an international company with experts all over the world. We understand that most of our customers sell into multiple markets across the globe and need to follow the respective regulations. Our team works hard to stay knowledgeable about country-specific regulations and industry guidance.
Our reference standards, instruments, and validation documents align with regulations internationally. For example, the Japanese Pharmacopeia requires TOC instruments to be challenged with SDBS whereas many other countries do not. SUEZ offers this standard in accordance with JP requirements so our customers can easily meet this requirement when needed.
Additionally, we have applications experts internationally who are ready to help with method development, method validation, instrument qualification, and new applications wherever our customers may need support.
Patient safety is always a paramount concern for pharmaceutical manufacturers. Can you detail any programs or services you currently offer to give pharmaceutical manufacturers more confidence around safety?
Patient safety is always of utmost importance when manufacturing drug products. In fact, cleaning validation requirements for the pharmaceutical industry were a result of safety issues many years ago. Since then, cleaning validation has become routine and integral to cleaning and manufacturing processes in GMP environments.
To make cleaning validation/verification and water testing as accurate and efficient as possible, SUEZ offers solutions for total organic carbon, conductivity, and endotoxin testing. These tests give the confidence that water for pharmaceutical purposes, equipment, and drug products have the highest degree of cleanliness and safety before reaching patients. In addition to analytical testing that meets quality and compliance guidelines to ensure risks related to safety are minimized, SUEZ has gone a step beyond quality to help manufacturers achieve quality and efficiency in their cleaning and environmental monitoring programs. For example, SUEZ offers a comprehensive solution for online cleaning validation wherein a TOC analyzer is directly integrated on a cleaning process for real-time, accurate results. This allows manufacturers to release equipment, detect, and remediate OOT or OOS results in real time, increasing equipment turnover from days to minutes.
About the Author
Michelle Neumeyer is the Life Sciences Product Applications Specialist for the Sievers line of Analytical instruments at SUEZ – Water Technologies & Solutions. Previously, Michelle worked in Quality at Novartis and AstraZeneca, ensuring compliant water systems, test methods and instrumentation. Michelle has a B.A. from University of Colorado, Boulder in Molecular, Cellular and Developmental Biology.