APR Sept/Oct 2023 - 29

Veolia Water Technologies &
Solutions, Sievers Instruments
6060 Spine Road
Boulder, CO 80301
Tel: 1-800-255-6964
www.watertechnologies.com/sievers
COMPANY DESCRIPTION
Life science manufacturers need simpler and more effi cient analytical
testing solutions for quality control and process monitoring in order to
ensure patient safety. Complex measurements need to be simplifi ed, 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, rapid bioburden, and
bacterial endotoxins testing (BET) drive effi ciency gains and enable realtime
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
effi cient, accurate, and compliant.
COMPANY BACKGROUND
Sievers Instruments was formed in 1984 by two colleagues from the
University of Colorado. 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 simplifi es
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.
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 effi ciency while ensuring safe, quality products for patients.
PRODUCTS, SERVICES & CAPABILITIES
Total organic carbon (TOC) & conductivity
Sievers TOC Analyzers off er unmatched effi ciency 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, certifi ed services,
and specialized support off er 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.
Rapid bioburden monitoring
Integrating Sentinel Monitoring Systems, a real-time microbial monitoring
company, into the portfolio will provide customers access to the full
range of 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.
www.americanpharmaceuticalreview.com |
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APR Sept/Oct 2023

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