Associated Vendor :
Tell us a little bit about SUEZ – Water Technologies & Solutions and the addition of the Eclipse Bacterial Endotoxins Testing (BET) Platform to the Sievers product line.
SUEZ’s Water Technologies & Solutions is an established leader providing water technology and process expertise across industries worldwide, including the life sciences. We believe that when our customers win, we win. With industry-leading water technology expertise, we partner with our customers to build optimized solutions for lasting success.
The Eclipse BET platform is an excellent example of our philosophy and approach to innovation. Our mission is to create highly differentiated solutions to meaningful customer problems. For years, we researched our customers’ biggest concerns and needs around endotoxin testing in order to develop a comprehensive solution to answer all of them. Similar to what we have accomplished with TOC analysis in terms of simplification and compliance, we are excited to offer the Eclipse BET platform, a thoughtful solution for today’s most pressing endotoxin testing needs. We took the setup and testing of a difficult assay and made the process extremely simple, while maintaining compendial compliance to the letter of the law. By providing a product that is easy to use, fast, compliant, consistent, and conserves natural resources, we have fulfilled all requirements and desires communicated by our customers.
Our portfolio of TOC analyzers has provided easy, fast, and accurate results to support our life sciences customers for over 30 years. We look forward to providing the same value to our endotoxin customers for the next 30 years.
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What are some of the industry drivers for new automated technologies in endotoxin testing?
Customers are continuously looking for easier, faster, and more consistent data that meet all compendial requirements. Thoughtfully developed automated technologies can help customers accomplish these goals. However, robotics and automation can also mean complex installation and validation processes, which can prevent market acceptance. When developing new products, we focus on criteria that are critical to the success of our customers, such as compliance, analytical performance, ease of use, and robustness, to name a few.
The Eclipse BET platform delivers automation to the quality control lab in a compliant, consistent, and easy-to-use format. Installation and validation only take two days when following our comprehensive validation protocol, which includes software validation in accordance with data integrity guidelines.
What makes a good partnership between endotoxin testing suppliers and drug manufacturers in 2021?
Whether it was learning how to produce the same amount of with only 50% of the workforce or managing supply chain shortages, COVID-19 brought many challenges to drug manufacturers. A good partnership in 2021 starts with open communication to understand goals and expectations and the ability to deliver upon those expectations. The pandemic has intensified manufacturers’ needs for their trusted suppliers to continue to deliver products and services so that production capacity can be maintained.
In addition to providing consistent quality supply on demand, drug manufacturers need suppliers to continually innovate to improve efficiencies that allow more scalability— with minimal intervention. Continuing to provide security in the supply chain along with creating efficient and environmentally sustainable solutions will be important for the rest of 2021 and into the future.
From ‘inventory to batch release’ – what does that mean to customers, and why should analytical instrumentation be designed with the whole pharmaceutical plant in mind?
By designing solutions with the whole pharmaceutical plant in mind, we deliver more value to our customers. Considering how our solutions impact inquiry to order, receipt, and use/disposal enables us to develop products that create a more efficient, sustainable, and scalable environment. Pharmaceutical plants are striving to increase process understanding and control, and as we continue to pursue PAT, Pharma 4.0, and advanced manufacturing platforms, automation of analytical technologies is needed to operate more efficiently. While the functional analytical performance of new technologies is key in the lab, the integration of the technology into the plant is becoming equally as important. A seamless and secure integration of data with ERP, MES, and LIMS platforms is necessary to drive efficiency throughout the entire value chain.
We designed the Eclipse BET platform as a solution with all functional areas in mind – including procurement, warehousing, in-process testing, quality control, quality assurance/regulatory, and batch release. When creating new products, it is important to consider the touch points the product and data will have within the facility, as well as the product life. The Eclipse delivers not only ease of use, but also ease of implementation and integration. With technologies needing to last 10+ years, sustainability is also a very important design consideration. For example, with the Eclipse BET platform, we reduce LAL reagent use by up to 90% and provide a room temperature storage consumable in place of a cold storage consumable.
How has COVID-19 drawn even more attention to the need for innovation in quality control labs and endotoxin testing?
COVID-19 brought new challenges to all aspects of business, and pharmaceutical manufacturing was no exception. Pharmaceutical manufacturing was deemed an essential industry, but social distancing regulations meant utilizing 50% of the workforce to accomplish 100% of the production. COVID-19 also tested the global supply chain and required new approaches to never-before-seen problems. Manufacturers worked with their most trusted partners to secure their supply chain and deploy automated technologies that were more efficient and required less labor.
During COVID-19, quality control labs weren’t spared from these challenges either. Like other areas in the business needing to maintain production with fewer resources, they were tasked with finding ways to keep up sample throughput with fewer people on site. Quality control testing and results are key for raw material release, environmental monitoring of production suites, in-process testing, and final batch release testing. This can be stressful as technicians have to cross train and take on more responsibilities with less time to accomplish them. Automated technologies that are easy to use, consistent, compliant, and low maintenance help labs increase efficiency to maintain the sample throughput required by the manufacturing plant capacity.
These same features are hallmarks of the Eclipse – ease of use, consistency, compliance, and low maintenance – and mean endotoxin testing doesn’t have to be complex or time consuming. Efficiencies can still be gained, sample throughput can be increased, and training can be fast with the Eclipse platform. In fact, analysts can be trained and certified in a single day and can easily set up a 21-sample assay in as little as 9 minutes. Additionally, using up to 90% less LAL not only drastically reduces the use of a natural resource, but it also minimizes supply chain dependencies. While concerns around efficiency and supply chain security have always existed in pharmaceutical manufacturing, COVID-19 has certainly drawn more attention to them. We’re proud to innovate solutions to address these issues and allow for greater productivity not just in the quality control lab, but throughout the entire pharmaceutical plant.
Author Biography
Dave Kremer leads Global Sales for the Sievers product line of analytical instruments within SUEZ’s Water Technologies & Solutions business. Dave previously served as the Global Product Management and Applications Leader, steering the commercialization of SieversTotal Organic Carbon Analyzers and development of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform. As a 20-year veteran in the life sciences industry with expertise in BET instrumentation and reagents, Dave has held senior management roles within the endotoxin testing market and in pharmaceutical quality control and microbiology. Dave earned his Bachelor of Science degree in Biochemistry and Cell Biology from the University of California, San Diego.