COMPANY DESCRIPTION
Life science manufacturers need simpler and more efficient analytical testing solutions for quality control and process monitoring in order to ensure patient safety. Complex measurements need to be simplified, and compliance cannot be compromised.
Sievers Instruments simplify compendial water testing, process monitoring, and cleaning validation for pharmaceutical and biopharmaceutical manufacturers around the world. Complete solutions for total organic carbon (TOC), conductivity, and bacterial endotoxins testing (BET) drive efficiency gains and enable real-time testing (RTT) of pharmaceutical water, automation, process control, and risk mitigation. Manufacturers rely on Sievers instruments, software, consumables, services, and expertise to make critical testing easier, more efficient, accurate, and compliant.
COMPANY BACKGROUND
Sievers Instruments was formed in 1984 by two colleagues from the University of Colorado. The widely used Sievers TOC product line evolved through a contract to develop an instrument to monitor drinking water quality in space. Since the introduction of Sievers TOC Analyzers with membrane conductometric technology, the product family has grown into a market leader in the pharmaceutical industry. The Sievers product line became part of Ionics, Inc in 1996, which was acquired by GE in 2005. In 2017, SUEZ acquired GE Water & Process Technologies, and in September 2022, SUEZ – Water Technologies & Solutions became part of Veolia.
With the recent launch of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform, manufacturers can achieve easier, compliant endotoxin testing. The Sievers Eclipse is an automated system that simplifies endotoxin testing – reducing assay setup time by up to 85% and reducing Limulus Amebocyte Lysate (LAL) reagent use by up to 90% while meeting all requirements of the harmonized pharmacopeia: USP <85>, EP 2.6.14 and JP 4.01.
In 2022, the Sievers Analytical Instruments portfolio was broadened with SUEZ – Water Technologies & Solutions’ acquisition of Sentinel Monitoring Systems, a real-time microbial monitoring company.
MARKETS SERVED
The Sievers product line provides deep expertise to pharmaceutical, biopharmaceutical, medical device, and other life science manufacturers.
Sievers Instruments are used globally for compendial water testing, cleaning validation, process monitoring, and other applications to maximize efficiency while ensuring safe, quality products for patients.
PRODUCTS, SERVICES & CAPABILITIES
Total organic carbon (TOC) & conductivity
Sievers TOC Analyzers offer unmatched efficiency and compliance for pharmaceutical applications. Whether in the lab, at-line, or online, Sievers products can be used to simplify testing and lean out processes, all while complying with the latest data integrity guidelines. Capabilities include compendial water testing, real-time testing (RTT), simultaneous TOC and conductivity testing, and cleaning validation.
Beyond analytical instrumentation, Sievers consumables, certified services, and specialized support offer customers a complete solution. Application experts are available to help develop methods, determine feasibility, and implement new applications as needed.
Endotoxin testing
The Sievers Eclipse BET Platform combines groundbreaking technology and ease-of-use to simplify endotoxin assay setup without altering reaction biochemistry or compliance. It improves how quickly and easily the assay can be started, drastically decreases the demand on LAL reagent, and minimizes the level of training required for analysts.
The Eclipse platform uses commercially available, FDA licensed LAL and meets all requirements of the harmonized global pharmacopoeia. Software was designed with ALCOA+ principles at the forefront to provide a highly customizable enterprise solution with 21 CFR Part 11 and data integrity compliance features.
Bioburden monitoring
Integrating Sentinel Monitoring Systems, a real-time microbial monitoring company, into the portfolio will provide customers access to the full range of compendial water testing methods, including TOC, conductivity, BET, and bioburden. With rapid microbiology methods (RMMs), manufacturers can quickly detect microbial contamination and take action to ensure safety, quality, and compliance.