Total Organic Carbon Solutions for the Life Sciences Industry
Pharmaceutical-grade water systems and process equipment require Total Organic Carbon (TOC) and conductivity analysis to detect chemical impurities. When choosing TOC technology, it is important to ensure that it is fit for purpose and meets user and regulatory requirements for accuracy, precision, specificity, quantitative data and other important validation requirements. Strict compliance is the foundation of SUEZ’s Sievers M500 Total Organic Carbon (TOC) Analyzer detection technology, which offers true Carbon measurement without the risk of interference from compounds, which could affect accuracy.
TOC and conductivity are metrics that drug manufacturers must monitor to comply with complex regulations. The importance of these technologies is in the way they enable water users to go beyond compliance and achieve optimization and control. TOC and conductivity data help facilitate better understanding and control of process and product quality. TOC data can be used in a variety of applications to increase efficiency and optimize resource use through automation.
In the life sciences industry, where ultra-pure water (UPW) is critical to ensuring the safety of drugs and medical devices, Sievers M500 saves time during real-time pharmaceutical water-release testing, reducing water analysis costs and ensuring compliance with pharmacopoeia standards.
Many different compounds can be measured with TOC analysis for validation and cleaning verification, including APIs, detergents, degradants and excipients. Water soluble compounds can be analyzed using TOC analysis with little to no method variation. TOC Sievers analyzers, consumables and SUEZ’s expertise respond to diverse development methods to ensure a smooth operation.
Benefits of SUEZ Sievers
The M500 Sievers Series is the third generation of online TOC analyzers, designed for accuracy, efficiency and data integrity. Building on the proven results of the 500 RL series, the M500 series enhances SUEZ’s performance as an industry pioneer and adds a range of cutting-edge features, such as automated iOS 4-port samplers to improve efficiency as such, M500 is revolutionizing online detections of organics, new performance, design and data management features. A 50 percent reduction in analysis time facilitates the use of real-time data and enables early detection and process control. The 10-inch touch screen allows for quicker and easier setup and operation. Furthermore, its systematized and personalized protocols improve productivity.
During sampling, consistent swabbing techniques and null contamination are a must for cleaning validation. Thus, choosing the right, high-quality consumables for this application is critical for accurate TOC and conductivity measurements. SUEZ provides custom reference standards for unique applications, in addition to providing specialty vials and a wide range of accredited and certified reference materials.
Sievers instruments also improve processes to determine the suitability of verification systems that assess the relative recovery of two compounds: sucrose and benzoquinone. The instruments establish and validate adequate flow rates for a defensible and consistent methodology. This must be performed with a certain frequency, which must be determined internally based on the risk of failure.
Efficacy and Efficiency
Among the most outstanding innovations of SUEZ’s tools are their digital upgrades, including Wi-Fi, improved data transfer and management options and security features to preserve data integrity. Moreover, Sievers M500 powers industry-leading TOC data management tools to ensure data security. It is compliance with 21 CFR Part 11 and FDA guidelines regarding data integrity.
Sievers M500 TOC has a range of 0.03ppb to 2.5ppm, a detection limit of 0.03ppb and a limit of quantification of 0.1ppb. Its measurements follow USP, EP, JP, IP, ChP and KP pharmacopoeias and all other harmonized standards. Instruments offer a 50 percent reduction in analysis time, as well as simultaneous measurement of TOC and conductivity.