Featured Article
Sievers Instruments, Inc. was formed in 1984 by two colleagues from the University of Colorado, Dr. Misha Plam and Professor Robert Sievers. The company’s most widely used product line evolved from work done under a NASA contract to develop an instrument to monitor drinking water quality in space. The Model 800 total organic carbon (TOC) analyzer was a breakthrough in TOC analysis with the introduction of membrane conductometric technology. Since its introduction in 1993, this technology has grown into a product family that has earned market leadership positions in both pharmaceutical and semiconductor industries. In 1996, Sievers Instruments was acquired by Ionics, forming Ionics Instruments. In January 1997, a Sievers TOC instrument developed for NASA was tested successfully on the Atlantis/Mir space shuttle mission and its successor was subsequently installed on the International Space Station.
In 2005, the General Electric Company sought to expand its rapidly growing portfolio of water purification offerings by acquiring the Ionics group of companies. The former Ionics Instruments became part of GE Water & Process Technologies as the Analytical Instruments business, providing a wide range of instrumentation solutions. On September 30, 2017, GE’s former Water & Process Technologies business became part of SUEZ. The Sievers product line was part of this divestiture to SUEZ (see Figure 1).
Figure 1 – Company timeline.TOC applications
Since the 1970s, TOC analysis has been an environmental analytical method for measuring water quality. In May of 1997, TOC methodology was adapted by the U.S. Pharmacopeia with an established acceptance criterion of water for pharmaceutical use. Water quality testing is still a major application for TOC instruments; however, applications have expanded across many global industries and beyond compliance testing. TOC applications now include cleaning validation (see Figure 2) and verification in industries such as pharmaceutical, food and beverage, cosmetics, and medical devices and testing for leachables and extractables.
Figure 2 – Cleaning validation.Improved efficiency in laboratory and online testing
Global industry application demands are driving innovation for TOC technology. One example of this is the need to have flexibility in deployment locations for analytical instrumentation. Efficiency can be gained by moving from laboratory testing to online analysis, both for compendia water testing and cleaning validation in the pharmaceutical industry. This shift is driven through the FDA’s Process Analytical Technology (PAT) initiative, which encourages a move from the lab to online testing for greater efficiency, quality assurance, and automation capability.
Another industry demand that is driving TOC innovation is the need for automation, real-time testing, and/or real-time release of water for pharmaceutical use. Again, the efficiency gains that can be achieved from these initiatives are driving pharmaceutical manufacturers to implement these applications. Online deployment and method validation streamline the production process by removing time-consuming laboratory testing and using real-time testing as the instrument of record. Similarly, efficiency can also be gained by online deployment and method validation for cleaning applications. The ability for manufacturers to run validated cleaning processes and release equipment into production in real time is a game changer in the industry for driving efficiency. As such, manufacturers of analytical instruments must develop technologies that can facilitate the application needs of the industry.
TOC performance
As with any technology, improvements in TOC performance are also being driven by the global industry. Some of these include greater linear dynamic ranges, greater sensitivity and precision, as well as more extreme environments in which the technology can be deployed. An example of greater linear dynamic ranges can be seen in pharmaceutical cleaning validation and verification. While traditionally only the final rinse of a validated cleaning cycle was measured and reported, the need for better process understanding and process control has led to more and more manufacturers wanting to monitor intermediate steps. This enables them to look at process effectiveness step-by-step throughout the cleaning cycle. In order for TOC instruments to meet these demands, a greater linear dynamic range is needed.
Figure 3 – M9 laboratory TOC analyzer.Application-specific support
In addition to technology demands, the pharmaceutical and life science industries are demanding greater support from technology manufacturers for products and applications. SUEZ offers a range of solutions, services, and support for its Sievers product line to ensure the success of customers across various application needs. The Sievers M-Series Analyzers (Figure 3) offer PAT-enabled TOC technology and enable users to realize efficiency and automation gains. Whether for compendia water testing or cleaning validation, automated online deployments are gaining popularity and driving the industry to innovate toward those goals.
Lukas Swanson, M.Eng., is life science applications engineer, SUEZ, 6060 Spine Rd., Boulder, CO 80301, U.S.A.; tel: 720-622-0241; e-mail: [email protected]; www.sieversinstruments.com