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Key Findings: Bacterial Endotoxins Testing Using Recombinant Reagents and Innovative Microfluidic Technology

rylee.lay@veolia.com — Fri, 15 Aug 2025 18:29:29 +0000

Key Findings: Bacterial Endotoxins Testing Using Recombinant Reagents and Innovative Microfluidic Technology rylee.lay@veolia.com Fri, 08/15/2025 - 14:29

August 13, 2025

We collaborated with Eli Lilly to present research on recombinant reagents and microfluidic technology for Bacterial Endotoxins Testing (BET)at the Parenteral Drug Association (PDA) Pharmaceutical Microbiology Conference.

Our findings, based on real-world sample data, demonstrate the accuracy and reliability of recombinant agents on modern microbiological detection platforms. Jay Holden and Hayden Skalski present research at PDA Microbiology Conference

Jay Holden and Hayden Skalski present research at PDA Microbiology Conference

Background: Limulus Amebocyte Lysate (LAL) vs. recombinant cascade reagents (rCR) in microfluidic BET assays

Pharmaceutical companies are increasingly adopting innovative technologies to meet evolving regulatory expectations while building more sustainable operations. Endotoxin testing is a prime example of this shift, as regulatory and sustainability pressures are transforming the BET landscape. Annex 1 encourages technological advancement to streamline manufacturing processes, and the recent publication of USP <86> on recombinant reagents for endotoxin testing represents a key opportunity to achieve both regulatory compliance and sustainability goals.

For these reasons, Veolia, in partnership with Eli Lilly, conducted a comparison study using the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform to compare results between traditional Limulus Amebocyte Lysate (LAL) and newer recombinant cascade reagents (rCR). The platform utilizes microfluidics and centripetal force; allows for assay set up in 85% of the time it takes to set up a traditional 96-well microplate; uses up to 90% less LAL or rCR; and automates the delivery of the LAL to samples. Beyond increasing efficiency, it assures precise and accurate results, allowing manufacturers to meet Annex 1 and sustainability goals while remaining in full compliance with regulations to assure patient safety.

This research outlines the results of the endotoxin tests with data obtained from real-world samples, providing a practical comparison between the two reagent types.

Comparison Study: Detecting naturally occurring endotoxins (NOE) and Reference Standard Endotoxin (RSE)

The purpose of this study was driven by two objectives. The primary goal was to evaluate the detection and recovery of both Naturally Occurring Endotoxins (NOE) and purified water spiked with Reference Standard Endotoxin (RSE). This evaluation was conducted using two different testing methods: traditional Limulus Amebocyte Lysate (LAL) and recombinant Cascade Reagent (rCR), with the goal of demonstrating reliable endotoxin recovery across both testing platforms.

Secondly, these capabilities were validated on the Sievers Eclipse BET platform by challenging it with both types of reagents. This validation was particularly significant as it aimed to demonstrate the system's suitability for real-world sample testing while offering two substantial benefits: a 90% reduction in reagent consumption and the option to use recombinant reagents, thereby promoting more sustainable testing practices in the industry.

Samples: rCR comparison study of 12 sample types

The following samples were used in the comparison study between Limulus Amebocyte Lysate (LAL) and recombinant Cascade Reagents (rCR):

Two monoclonal antibodies
Insulin
Peptide
NOE (see Figure 1)
Histidine and Sodium Acetate
LRW
Purified Waters
Purified Waters with RSE spikes
Polysorbate 80
Counterfeit products
Components (stopper, cartridge)
Yeastolate

Figure 1: Comparison of Naturally Occurring Endotoxins (NOE)

Results: LAL vs rCR - Performance and testing results

The following figure details Positive Product Control (PPC) recovery rates of sample and reagents.

Figure 2: Percent Recovery Comparison of Sample and Reagent

Conclusion: rCR performance in microfluidic platforms

This study showed equivalent performance between LAL and rCR using the Sievers Eclipse for the detection of bacterial endotoxins in real-world samples, as well as naturally occurring endotoxins. Based on the evidence, it can be determined that the Sievers Eclipse Bacterial Endotoxins Testing Platform is able to successfully utilize recombinant Cascade Reagents, provided that the sample's compatibility has been verified.

Automation via the Eclipse's centripetal microfluidic platform offers the simplest form of BET microfluidics available, providing significant time savings and reducing opportunities for error. With the availability of this innovative technology, BET assays can be streamlined while remaining fully compliant with compendia.

Benefits include:

USP <85> and <86> compliant
Proven to work with both LAL and rCR reagents
Up to 90% less reagent needed; aids in sustainability initiatives
27 total pipetting steps for 21 samples for increased efficiency
Innovative technology aligned with Annex 1 guidelines

Learn more about the Sievers Eclipse

Authors:

Jay Bolden: Jay Bolden is a Senior Director in the Eli Lilly and Company global Analytical Quality Control Organization. He is a bacterial endotoxins subject matter expert and leads a team with global QC oversight for endotoxins, microbiology, and virology test methods. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University and has over 25 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership. Jay is a member of the United States Pharmacopoeia Microbiology Expert Committee and has authored a book chapter and multiple peer-reviewed articles on endotoxins. Accordion content 1.
Meg Provenzano: Meg Provenzano is the Global Product Manager for Sievers bio-detection instruments at Veolia. Ela possui mais de 10 anos de experiência na indústria de testes de endotoxinas bacterianas e ocupou vários cargos em controle de qualidade, suporte técnico e gerenciamento de produtos. Prior to joining Veolia, Meg was a Product Manager with Charles River Laboratories. She is customer-centric and enjoys hands-on problem-solving, whether for technical issues, assay assistance, or software. Meg holds a B.S. in Marine Science and Biology from Coastal Carolina University, where she focused on Bottlenose Dolphin population research.
Brian Short: Brian Short is a Global Pharmaceutical Application Specialist at Veolia, providing strategic pharmaceutical biodetection and TOC application support for the life science industry. With 20 years of experience working in and with pharmaceutical quality control laboratories, Brian has supervised and supported high-volume in-process and finished product testing. Having held previous roles with Wyeth and Lonza, and with nine years of experience supporting the Sievers product line as part of GE Analytical Instruments, SUEZ, and now Veolia, Brian has deep expertise in endotoxin detection instrumentation and software, including installation, qualification, and training. Brian holds a Bachelor of Science degree in Biological Sciences from York College of Pennsylvania.
Hayden Skalski: Hayden Skalski is the Life Sciences Product Application Specialist for Veolia, specializing in bacterial endotoxins testing (BET). Hayden tem mais de 10 anos de experiência na indústria farmacêutica e em microbiologia de controle de qualidade e apresentou vários tópicos relacionados a testes de endotoxinas. Anteriormente, Hayden ocupou cargos na na Charles River Laboratories, na Regeneron e na Novartis, validando e executando protocolos de desenvolvimento de métodos para testes de endotoxinas, fornecendo suporte ao cliente, solução de problemas e suporte a testes de produtos de alto volume. Hayden é bacharel em Biologia pela Universidade de Albany (SUNY). Kelly Smith is a Senior Principal Biologist in the Eli Lilly and Company global Analytical Quality Control Organization. He is a bacterial endotoxins subject matter expert with over 25 years of industry experience and has a B.S. in chemistry from Butler University.

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Industry Trends

USP <643> “Total Organic Carbon”

rylee.lay@veolia.com — Tue, 12 Aug 2025 04:32:46 +0000

USP <643> "Total Organic Carbon" rylee.lay@veolia.com Tue, 08/12/2025 - 00:32

August 11, 2025

What is USP <643> and why does it matter?

USP <643> is a general chapter in the United States Pharmacopeia that provides guidance on measuring total organic carbon (TOC) in pharmaceutical waters. It provides a standardized method for measuring TOC, ensuring that pharmaceutical water meets the required purity standards. By measuring TOC, pharmaceutical manufacturers can detect contamination or determine quality and purity of the water used in the manufacturing process, all of which can impact product quality and safety. TOC serves as one of a pair of essential chemical limit tests for validating chemical control in water purification systems. It is used in conjunction with USP <645> Water Conductivity testing, which specifically measures ionic contaminants, to ensure water quality standards are met.

Who is impacted by USP <643>?

Some of the industries and sectors impacted by USP <643> are:

Pharmaceutical and biopharmaceutical manufacturers, including research and development and ingredient manufacturers
Medical device manufacturers
Contract testing and quality control laboratories
Water purification system and instrument manufacturers
Some healthcare and veterinary facilities

Note: This list is not exhaustive.

USP <643> guidance and regulation overview

The chapter provides guidance on TOC measurement technologies and methodologies. While it does not endorse specific processes or technologies, it does require that methods are able to discriminate between inorganic and organic carbon. This discrimination can be achieved either by indirect measurement - determining inorganic carbon and subtracting it from total carbon - or by direct measurement - purging inorganic carbon before oxidation. TOC testing can be performed either online or as an off-line laboratory test.

The guidance also clarifies that TOC measurements, while capable of detecting organic materials that could support microbial growth, cannot substitute for endotoxin testing or microbiological control methods. Although organic carbon may function as a potential nutrient source for microorganisms, TOC levels do not directly correlate with microbiological activity in a quantifiable way.

USP <643> for bulk purified water

For bulk purified water, the chapter outlines requirements that include:

Instrumentation with detection limit of ≤ 0.05 mg/L (0.05 ppm)
Use of reagent water with TOC level of ≤ 0.10 mg/L
Preparation procedures for containers and labware to reduce or prevent contamination

System suitability testing is used to demonstrate the suitability of the instrument for TOC monitoring. Users must determine the frequency of system suitability based on the criticality of application and process risk assessment. The regulation defines an easy-to-oxidize solution (USP Sucrose Rs) and hard-to-oxidize solution (USP 1,4-Benzoquinone Rss) in order to show instrument suitability across a range of compounds. It should be noted, good manufacturing practices (GMP) are important for accuracy of solution preparation, as improperly prepared solutions could contribute to suitability failures and lead to additional investigations.

USP <643> for sterile waters derived from bulk purified water

For sterile water, USP <643> establishes more stringent limits and testing requirements, such as water for injection (WFI) or ingredient water as part of inhalation or irrigation products. Since these products have direct access to the bloodstream or respiratory system, the risks associated with contamination are significantly higher. Organic contaminants in these products could lead to severe adverse reactions, infections, or toxic responses. Additionally, organic compounds in these waters could interact with drug products, potentially affecting their stability, efficacy, or safety. Image Link The chapter details more stringent instrument detection limits for sterile waters and includes specific procedures for sample handling and testing. It also provides guidance for preparing system suitability and standard solutions for each category of container volume.

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Download now: USP <643> Sterile Water Testing Protocols: Implementing TOC Analysis for USP Compliance

USP <643> for sampling, instrumentation, procedures, and system suitability

The chapter details requirements for sampling, including proper container preparation, procedures for collecting representative samples, and sample handling.

Instrumentation requirements include regular demonstration of instrument suitability, specific detection limit requirements for both bulk and sterile water, and options for both online and off-line testing.

Procedures must be detailed and documented to include step-by-step testing and calculations for calibration, system suitability and sample analysis.

System suitability requirements include the use of specified reference standards, calculation of response efficiency, acceptance criteria as well as requirements for periodic verification of system performance.

Download Now: Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications

USP <643> and process verification

Process verification involves:

Demonstration of system suitability testing with an 85-115% response efficiency
Use specified reference standards (USP 1,4-Benzoquinone RS, and USP Sucrose RS)
Periodic demonstration of instrument suitability
Reagent water control must use water with TOC level ≤ 0.10 mg/L for bulk water testing and may require conductivity testing to ensure method reliability Sample container choice and preparation must document cleaning procedures and verification so as not to introduce contamination

Download now: Selecting the Best TOC Sample Vial for Your Application

USP <643> does not make specific recommendations for the following:

Process development: Organizations must ensure that sampling is truly representative of water quality
Location: Testing can be performed either online, at-line, or in a laboratory
Instrumentation: The choice should be based on suitability, manufacturing process, and intended use

Facilities must balance efficiency and other operational demands when implementing USP <643> guidelines, making compliance uniquely challenging for every organization.

Download now: Best Practice for Analyzing Compendia Water Samples for USP <643> and <645>

We can support you with USP <643> compliance

Working with experienced partners who specialize in TOC testing and water system monitoring can help address any challenges you have when implementing USP <643>, as well as USP <645> Conductivity Testing. On the one comment on the 643 piece, I think I can correct the sentence to - Our experts can provide guidance on selecting appropriate instrumentation, applying proper testing procedures, and establishing effective SOPs for documentation and compliance.

After selecting suitable and compliant technology, comprehensive instrument qualification and method validation must be completed before data can be used for making quality decisions. Our industry-leading expertise ensures you are supported with thorough method validation and deployment strategies. With decades of specialized experience, we have refined these processes to meet the most stringent regulatory requirements while maintaining operational efficiency.

Modern efficiency improvements now enable dual testing of TOC and conductivity for compliance with USP <643> and <645> from a single sample using specialized vials that prevent ionic leaching and CO2 contamination. This approach enhances sample integrity while reducing analysis time compared to traditional methods. Additionally, many facilities have adopted online water monitoring for real-time testing (RTT), eliminating the need for manual sampling and streamlining the QC process. This implementation of process analytical technology (PAT) provides immediate measurement of quality attributes and demonstrates process control in a validated state, particularly when using compatible membrane conductometric technology.

Contact us for more information about TOC compliance, transitioning to real-time testing, or improving efficiency of USP <643> TOC testing.

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Life Sciences

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FAQs

Tecnologia avançada de dessalinização da Veolia para otimizar a produção de energia offshore para a Petrobras

rylee.lay@veolia.com — Mon, 09 Jun 2025 13:45:11 +0000

Veolia's advanced desalination technology to optimize offshore energy production for Petrobras rylee.lay@veolia.com Mon, 06/09/2025 - 09:45

June 9, 2025

Latin America

Multi-million dollar contract secured to provide advanced seawater desalination for two major FPSOs in Brazil's Santos Basin.
Innovative water treatment technology addresses critical environmental and operational challenges while maximizing production efficiency.
Advanced desalination systems protect reservoirs and flowlines while reducing the environmental footprint of offshore operations.
Veolia, the world leader in water technologies, leverages its expertise in desalination to find innovative and efficient solutions to optimize water use in the industrial sector.

Veolia, through its Water Technologies & Solutions business unit, has secured a multi-million dollar contract from Seatrium to provide advanced seawater desalination solutions for two major floating production storage and offloading platforms (FPSO) in one of Brazil's largest offshore developments. Located in the Santos Basin - Brazil's pre-salt reservoir and largest oil and gas offshore basin in the Western South Atlantic - this project marks a significant step toward more efficient offshore energy production. The contract includes project engineering, procurement, equipment supply and installation.

The project, which will serve Petrobras' P84 and P85 FPSOs, demonstrates how innovative water treatment technology can address critical environment and operational challenges in offshore energy production. Each platform will have the capacity to process 225,000 barrels of oil and 10 million cubic meters of gas daily, requiring sophisticated water management solutions to minimize environmental impact while maximizing production efficiency.

Oil and gas production relies on treated, desalinated seawater to be injected into reservoirs through sulphate removal units (SRU). At the heart of this innovative solution is a state-of-the-art SRU system for water injection production, featuring Veolia's ZeeWeed^TM Ultrafiltration and SWSR Series Nanofiltration membranes. These advanced systems will reliably process 1,960 cubic meters per hour of water per platform. By removing harmful sulphates and other ions, this technological solution protects reservoirs and flowlines while reducing the environmental footprint of injection operations and ensuring optimal performance.

Veolia's technology not only enhances oil recovery but also plays a crucial role in preventing well souring and scale formation, thereby extending the life of the infrastructure. This approach aligns with the industry's push toward more responsible practices in offshore operations.

This contract demonstrates Veolia's unique ability to balance local Brazilian capabilities and global expertise, meeting strict local content requirements while maintaining the highest quality standards. The company's regional leadership ensures close collaboration with Seatrium, Petrobras and other local stakeholders while leveraging worldwide capabilities to deliver optimized solutions.

Anne Le Guennec, CEO of Water Technologies at Veolia, commented: "This strategic partnership with Seatrium exemplifies how our advanced desalination technologies can drive both operational excellence and environmental responsibility in offshore energy production. Through our innovative solutions, we're helping secure vital energy needs while minimizing environmental impact - a perfect alignment with Veolia's Green Up strategic program. We are particularly proud to support Seatrium and Petrobras in the energy sector's journey toward more efficient and environmentally conscious operations."

This latest collaboration represents the fifth contract between Veolia and Seatrium, with three projects successfully delivered in the past three years.

ABOUT VEOLIA

Veolia's ambition is to become the benchmark company for ecological transformation. With nearly 218,000 employees on five continents, the Group designs and deploys useful, practical solutions for managing water, waste and energy that help to radically change the world. Through its three complementary activities, Veolia contributes to developing access to resources, preserving available resources and renewing them. In 2023, the Veolia group served 113 million people with drinking water and 103 million with wastewater services, produced 42 terawatt-hours of energy and recovered 63 million metric tons of waste. Veolia Environnement (Paris Euronext: VIE) generated consolidated sales of €45.3 billion in 2023. www.veolia.com

ABOUT VEOLIA WATER TECHNOLOGIES

As the global water technology experts of Veolia, we deliver on both performance and sustainability without compromise. We provide you with peace of mind knowing your business and communities are safeguarded, efficient and resilient. Together we protect, preserve and reuse resources, tackling today's environmental challenges while creating the water treatment and process solutions of tomorrow. www.watertechnologies.com

CONTACTS

VEOLIA WATER TECH LATAM
Diego Fuentes
Tel.+55 (11) 971 36 57 52
diego.fuentes1@veolia.com

VEOLIA WATER TECH GLOBAL MEDIA RELATIONS
Manon Painchaud
Tel.+1 418 573 2735
manon.painchaud@veolia.com

Perguntas frequentes: Qual é a diferença entre um sensor de COT e um analisador de COT?

rylee.lay@veolia.com — Wed, 21 May 2025 19:32:37 +0000

FAQs: What's the difference between a TOC sensor and a TOC analyzer? rylee.lay@veolia.com Wed, 05/21/2025 - 15:32

May 21, 2025

Pharmaceutical manufacturers rely on total organic carbon (TOC) measurements as one of the compendial requirements for release of water and equipment for production. Accurate and consistent TOC analysis is critical to meet the acceptance criteria limits for USP regulations.

Did you know there is a difference between sensors vs analyzers for TOC testing?

Sensors are more commonly limited to monitoring applications (trending, diagnostics, or general monitoring), whereas analyzers are leveraged for applications that require process control and reporting (process validation, quality management, real-time release, cleaning validation, etc.). To satisfy regulatory requirements and ensure a reliable manufacturing process, it is essential for users to understand the differences between these two types of instruments.

Use of TOC in pharmaceutical applications

In pharmaceutical and biopharmaceutical manufacturing, TOC instruments serve as critical tools for ultrapure water testing/compliance monitoring, as well as validating or verifying cleaning samples. Choosing the right analytical instrument is important, and the selection depends on the pharmaceutical manufacturers' needs and the characteristics of the process or samples they need to measure.

While TOC sensors are more cost effective and accommodate faster response time, the ability of analyzers to report on critical quality decisions for compliance may serve as a better solution for many applications. Manufacturers seeking to implement process analytical technology (PAT) to the full capability of real-time release will be seeking a validated instrument that satisfies instrument qualification, method validation, and data integrity needs.

Technology Comparison: TOC Sensors

TOC sensors work by employing conductivity as a means to measure carbon; however they do not discriminate against interfering ions that may be contributing to the measurements. These technologies measure conductivity in a sample pre- and post-oxidation and derive the TOC result from the assumption that all measured conductivity post-oxidation arises from organic carbon conversion to CO2.

This can lead to over- and under-reporting of TOC.

Additionally, there is no differentiation between CO2 from inorganic carbon (IC) and organic carbon, as required by USP <643>[1]. Sensors can effectively pass the limit test, but because methods cannot be validated[2] during performance qualification for specificity and robustness, actual analytical performance for organic compounds is widely variable. Proper method validation is imperative in cGMP manufacturing settings, especially considering that pharmaceutical grade water touches many phases in the manufacturing process. TOC sensors are often selected for general monitoring applications, or as portable tools for trending.

TOC Analyzers

TOC analyzers, on the other hand, are carbon specific analyzers, wherein a gas-permeable membrane separates CO2 from interfering compounds to allow for accurate measurement of carbon. The selectivity of the membrane-based analyzers provides better accuracy for TOC measurements and makes these instruments most appropriate for compendial applications, cleaning validation, process control, and regulatory reporting. This technology accurately and precisely measures both organic and inorganic carbon as required by USP <643>, allowing for successful performance qualification and effective analysis for specificity and robustness compounds.

Benefits of TOC Analyzers

TOC analyzers offer precise, accurate, quantitative, and robust carbon analysis, giving manufacturers the ability to pass performance qualification and validation, thus providing users with an accurate assessment of the state of the water system. With validated and accurate results, data can be used to make important quality decisions for pharmacopeia compliance, release water and equipment, troubleshoot, and optimize water monitoring and cleaning processes.

Another benefit is avoiding under-reported values; this helps mitigate the risk of infecting byproducts and other harmful compounds that are present in water systems which could place the final product at risk of contamination. On the other hand, over-reporting TOC can cause unnecessary and time-consuming out-of-specification (OOS) investigations where no definitive root cause is identified.

Additional in-depth comparison

Comparing TOC analyzers and sensors for pharmaceutical applications reveals critical performance differences, supported by scientific evidence. While direct conductometric sensors are capable of detecting organic compounds, this study demonstrated significant accuracy issues (i.e., erroneously high, low, and non-linear responses) across multiple compound types:

For chlorinated organic compounds, sensors showed variable recovery (some 150% recovery, or greater), whereas membrane-based analyzers were much closer to 100% recovery
For a nitrogen-containing compound like nicotinamide, sensors showed ~150% recovery due to the formation of nitric acid during oxidation, while membrane-based analyzers maintained ~100% recovery
For conductive organic compounds (trimethyl amine and acetic acid), sensors produced unreliable results (less than 50%, or negative recovery) compared to membrane-based analyzers' consistent ~100% recovery

These findings align with third-party research that emphasizes, "robust analytical TOC method validation is essential to the success of any online TOC system, particularly systems that release pharmaceutical grade water in real time. Meeting USP <643> or EP 2.2.44 specifications may not eliminate risk."

Robust method validation is critical since sensors might not eliminate risks, particularly for real-time release of pharmaceutical-grade water. In contrast, the superior selectivity and consistent accuracy of membrane-based conductometric analyzers make them optimal for compendial applications, process control, cleaning verification, and reporting on critical quality decisions.

Download the "Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications" Application Note to explore the full study.

Conclusion

With TOC sensor technology, there can be risks to product safety due to over- or under-reporting of TOC. Sensors do not differentiate between CO2 from inorganic carbon (IC) and organic carbon, as required by USP <643>.

TOC analyzers use membrane-based conductivity to mitigate interferences experienced with TOC sensors, improving accuracy and precision. Analyzers are ideal for applications that require process control and reporting for pharmacopoeia compliance. TOC analyzers are available in portable, bench-top, or online configurations, allowing manufacturers to choose what fits their application best. TOC analyzers are more complex instruments that can handle multiple sample points and perform more detailed analysis with greater accuracy and additional parameters. Additionally, fully validated and compliant TOC analyzers can be deployed for PAT applications, supporting real-time monitoring and release. Learn more about the Sievers Instruments product line and what TOC instrument is right for your processes here.

References

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Life Sciences

Sievers Resource Center Type

FAQs

Tecnologia da Veolia ajuda a transformar os efluentes de São Francisco em fonte de energia local descarbonizada

rylee.lay@veolia.com — Wed, 14 May 2025 12:48:53 +0000

Veolia technology to help transform San Francisco wastewater into local, decarbonized energy source rylee.lay@veolia.com Wed, 05/14/2025 - 08:48

May 14, 2025

North America

Veolia's innovative biogas upgrading technology will help transform San Francisco's largest wastewater facility into a renewable energy producer.
State-of-the-art MemGasTM membrane technology will convert biogas into pipeline-quality renewable natural gas, providing 100% beneficial use of the biogas generated at the Southeast Treatment Plant and at full capacity, will produce enough renewable energy to offset the natural gas needs equivalent to approximately 3,800 homes (68 GWh/yr).
The project demonstrates the circular economy in action, supporting San Francisco's decarbonization goals while creating a sustainable local energy source.

Veolia, through its Water Technologies & Solutions business unit, has earned a $34 million contract to supply biogas upgrading technology for the San Francisco Public Utilities Commission's (SFPUC) Southeast Treatment Plant. Built in 1952, this crucial facility is undergoing a $3 billion modernization that will transform it from a traditional wastewater treatment plant into a state-of-the-art resource recovery center, converting wastewater byproducts into renewable, decarbonized energy for local communities.

Veolia, the world leader in water technologies, will implement its innovative MemGasTM system to purify raw biogas from the plant's anaerobic digestion process to biomethane, a pipeline-quality renewable natural gas ready for injection into Pacific Gas & Electric's grid. The project will provide 100% beneficial use of the biogas generated at the Southeast Treatment Plant and at full capacity, will produce enough renewable energy to offset the natural gas needs equivalent to approximately 3,800 homes (68 GWh/yr). The system is expected to be operational by June 2027.

Daniela Brandao, Senior Project Manager, SFPUC, shared: "This project fulfills our commitments for beneficial use of the biogas generated at the Southeast Treatment Plant, supports California's state goals for in-state production and distribution of renewable natural gas, and aligns with the City's sustainability objectives. We are excited to see the positive impact this project will have on our community and the environment!"

"This transformative project showcases how cities can create truly circular systems that not only meet performance criteria but generate clean, renewable energy from what was once considered waste," said Anne Le Guennec, Senior Executive Vice President for Worldwide Water Technologies at Veolia. "The SFPUC exemplifies environmental leadership by creating a sustainable energy source right in their backyard, setting a powerful example for cities worldwide. This project is a concrete demonstration of our GreenUp strategy in action, perfectly embodying Veolia's ecological transformation objectives through its focus on decarbonization and circular solutions. By converting waste into renewable energy, we're showing how our innovative technologies can drive the ecological transformation for a sustainable future."

The Southeast Treatment Plant processes approximately 80% of the city's combined stormwater and wastewater, treating an average dry weather flow of 45 million gallons (170,300 cubic meters) of wastewater daily. This upgrade will capture the biogas produced during wastewater treatment and upgrade it through state-of-the-art gas conditioning and separation processes.

This project represents a significant advancement in sustainable infrastructure. The initiative will create a renewable energy source while reducing greenhouse gas emissions of 31,000 metric tons CO2e/yr, demonstrating how environmental protection and operational performance can go hand in hand.

Veolia technology feature

MemGasTM technology employs a sophisticated three-stage membrane separation process to transform biogas into high-quality biomethane. The system first pre-treats the biogas to remove unwanted components like hydrogen sulfide (H2S) and volatile organic compounds (VOCs), then compresses it before passing it through high-pressure gas separation membranes arranged in cylindrical cartridges.

This proven technology achieves exceptional purification efficiency with over 99% methane yield, while maintaining low energy consumption of 0.3 to 0.4 kWh per cubic meter of raw biogas.

The system operates without chemicals or water consumption and can handle flow rates from 30 to 10,000 Nm3/h of raw biogas, making it both environmentally friendly and highly efficient.

Learn more about how MemGas works.

ABOUT VEOLIA

Veolia group aims to become the benchmark company for ecological transformation. Present on five continents with 215,000 employees, the Group designs and deploys useful, practical solutions for the management of water, waste and energy that are contributing to a radical turnaround of the current situation. Through its three complementary activities, Veolia helps to develop access to resources, to preserve available resources and to renew them. In 2024, the Veolia group provided 111 million inhabitants with drinking water and 98 million with sanitation, produced 42 million megawatt hours of energy and treated 65 million tonnes of waste. Veolia Environnement (Paris Euronext: VIE) achieved consolidated revenue of 44.7 billion euros in 2024. www.veolia.com

ABOUT VEOLIA WATER TECHNOLOGIES

VEOLIA CONTACT - PRESS RELATIONS

WATER TECHNOLOGIES GLOBAL MEDIA RELATIONS
Manon Painchaud
Tel.+1 418 573 2735
manon.painchaud@veolia.com

Recuperação de Compostos Orgânicos Voláteis com Analisadores de Carbono Orgânico Total (COT)

rylee.lay@veolia.com — Fri, 09 May 2025 19:31:57 +0000

Recovery of Volatile Organic Compounds with Total Organic Carbon (TOC) Analyzers rylee.lay@veolia.com Fri, 05/09/2025 - 15:31

May 13, 2025

Introduction: TOC Analysis in Process Control

Total organic carbon (TOC) analysis provides valuable process data in industrial water treatment and drinking water treatment by efficiently measuring sample impurities through simple, comprehensive detection of organic contamination. A avaliação e a quantificação precisas de baixas concentrações de COT são essenciais para o controle do processo, a qualidade do produto e a proteção dos ativos. Organic contamination, such as volatile organic compounds (VOCs), can cause interference in production processes, contaminate finished products, cause non-conformity throughout a production lot as well as degradation of equipment.

The Challenge of Volatile Organic Compounds (VOCs) Detection

Compounds that are volatile or semi-volatile have uses in cleaning and cooling applications, while others emerge from source water or breakdown products. A capacidade de detectar esses compostos voláteis e semivoláteis pode ser obtida usando a análise de COT e é fundamental para identificar problemas, vazamentos ou ineficiências de processo no tratamento de água municipal e industrial. Como os compostos orgânicos voláteis (COV) são perdidos por meio de pulverização, eles podem ser difíceis de detectar, dependendo da ferramenta analítica selecionada. Algumas ferramentas exigem economia com um gás transportador, desenvolvimento de método especializado ou a compra de acessórios adicionais para suportar medições de VOC. These limitations may lead to delayed or improper decision-making due to inaccurate data.

Comparative Analysis: TOC Oxidation Methods

In a recent study comparing the recovery of volatile compounds with different total organic carbon (TOC) analyzers, the following three TOC oxidation methods were used:

High temperature catalytic combustion
Two staged advanced oxidation
UV persulfate oxidation with membrane detection (used in Sievers M-Series TOC Analyzers)

All the listed methods were able to detect VOCs when functioning in the proper mode; however, Sievers M-Series are the only analyzers able to detect volatile organics in the standard mode of operation without the use of a carrier gas. Isso é benéfico porque a economia com um gás transportador pode resultar na perda de compostos orgânicos voláteis e semivoláteis. Além disso, o uso de um gás transportador para um detector NDIR requer um separador de gás-líquido para remover qualquer umidade que afete negativamente sua operação. Sievers M-Series Analyzers remove these risks by measuring CO2 in the liquid phase (rather than the gas) via membrane conductometric detection.

Identifying leaks or process inefficiencies quickly and at low concentrations can save time and money by protecting equipment and finished products. A detecção precoce de problemas no processo permite que os usuários tomem decisões informadas, usando dados para mitigar riscos e controlar processos. Os analisadores de COT Sievers série M atendem a esse requisito com o menor limite de detecção (LOD) e limite de quantificação (LOQ), juntamente com a análise de baixo nível mais precisa de compostos voláteis. Combining analytical accuracy, overall ease of use, and the lack of requirement to purchase optional accessories makes Sievers M-Series TOC Analyzers the ideal solution for detection of volatile organic compounds.

Learn more about this study here.

Sievers Resource Center Industry

Industrial and Environmental

Sievers Resource Center Type

Industry Trends

Capítulo da USP <86> Teste de endotoxinas bacterianas usando reagentes recombinantes

rylee.lay@veolia.com — Fri, 09 May 2025 19:17:59 +0000

USP Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents rylee.lay@veolia.com Fri, 05/09/2025 - 15:17

May 8, 2025

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In May 2025, the U.S. Pharmacopeia (USP) will officially introduce Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, which permits the use of non-animal-derived reagents for endotoxin testing. As a critical step for safety and quality control in pharmaceutical manufacturing, endotoxin testing traditionally uses Limulus Amebocyte Lysate (LAL), a natural reagent sourced from horseshoe crabs, to detect or quantify bacterial endotoxins present in a sample.

Chapter <86> aligns with USP's commitment to expanding animal-free methods by incorporating recombinant Factor C (rFC) and recombinant cascade reagent (rCR), which utilize endpoint fluorescence and chromogenic techniques, respectively, derived from gene sequences of factors found in the horseshoe crab. These recombinant reagents serve as alternatives to naturally sourced LAL, providing opportunity to reduce impact on the horseshoe crab population.

As an alternative to the traditional USP Chapter <85> Bacterial Endotoxins Test (BET), Chapter <86> requires users to verify the suitability of these recombinant reagent-based methods for their specific products, in line with USP <1225> and <1226> guidelines. A transição da <85> para a <86> envolve a demonstração da adequação do método específico do produto, uma prática consistente com os requisitos da <85>, garantindo uma mudança perfeita para métodos de teste mais sustentáveis. It marks an important milestone in endotoxin testing by allowing users to choose between traditional Limulus Amebocyte Lysate (LAL) and recombinant reagents without the need for an additional validation step.

To learn more about USP Chapter <86>:

Read our Application Note that demonstrates the compatibility of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform with rCR across various pharmaceutical products
Watch our 10-minute Q&A video with Mike Auerbach, Editor in Chief of American Pharmaceutical Review.

Sievers Resource Center Industry

Life Sciences

Sievers Resource Center Type

Industry Trends

A Veolia adquire a participação de 30% da CDPQ na Water Technologies and Solutions, alcançando a propriedade total para acelerar a criação de valor

rylee.lay@veolia.com — Wed, 07 May 2025 16:16:01 +0000

Veolia acquires CDPQ's 30% stake in Water Technologies and Solutions, achieving full ownership to accelerate value creation rylee.lay@veolia.com Wed, 05/07/2025 - 12:16

May 7, 2025

Europe

Veolia has signed an agreement with CDPQ for the acquisition of its 30% stake in Veolia's subsidiary Water Technologies and Solutions ("WTS"), allowing Veolia to achieve full ownership of WTS, enabling to unlock more value potential, simplify further its structure and extract additional run-rate cost synergies of ~€90m.

This acquisition is a logical step in the deployment of Veolia's GreenUp strategic roadmap, with an efficient capital allocation to strengthen the Group's anchoring in Water technologies activities and in the United States, both identified as priority growth "boosters".

The acquisition of CDPQ's minority interests will further strengthen Veolia's unique positioning as a global leader in Water Technologies. The Group is perfectly positioned to take advantage of the growing demand for innovative water treatment technologies and solutions, fueled by macro-trends such as water scarcity, adaptation to climate change, health concerns and the development of strategic industries such as semiconductors, pharmaceuticals and data centers.

The acquisition of the remaining 30% of Veolia's subsidiary WTS will allow full operational control, enabling it to enhance operational performance and seize all opportunities for development and innovation, through a complete integration process. Following the acquisition, the Group will be able to unlock additional ~€90m of run-rate cost synergies by 2027. Those synergies are already well-identified and benefit from a very low execution risk, given the deep and intimate knowledge of the asset and Veolia's proven track-record in synergies extraction. The acquisition is expected to be accretive from 2026 and will contribute to improve Group ROCE.

The purchase price for the acquisition will be $1.75bn (~€1.5bn), corresponding to ~11x EV/post-synergies 2025e EBITDA. Post-transaction, Veolia will still maintain headroom compared to its Net Debt / EBITDA target of 3x, allowing the Group to retain strategic flexibility to continue to deploy its GreenUp strategic plan.

Veolia confirms all 2025 guidance and GreenUp targets previously communicated both at Group level and at Water Technologies level, and now aims to achieve an EBITDA CAGR of at least +10%(1) over the 2023-2027 period for its Water Technologies division.

"This acquisition marks a pivotal step in unlocking the full value potential of Water Technologies, a growth booster identified as a priority in our GreenUp strategic plan, and a segment where we are already a market leader. Full ownership will enable us to accelerate growth, enhance operational efficiency and synergies as well as deepen the alignment with strategic priorities. This move is especially crucial given the urgent and rapidly evolving needs of the market, allowing us to respond faster and more effectively to emerging opportunities and challenges," said Estelle Brachlianoff, Veolia's Chief Executive Officer.

"We are proud of WTS' achievements since our investment in 2017, as it has grown into a global market leader in water technologies. Through our partnership, we helped strengthen the company's foundations and position it for sustained growth and long-term value creation. We are grateful for the close collaboration with the management teams at WTS and Veolia, and we wish them every (1) At constant forex success in this next chapter," said Albrecht von Alvensleben, Managing Director, Head of Private Equity Europe at CDPQ.

The closing of the transaction is expected by the end of June 2025.

Veolia Water Technologies segment

In FY2024, Veolia Water Technologies segment achieved revenues of €4.97bn (41% North America, 25% Europe, 13% Asia Pacific, 13% Africa Middle-East and 8% Latin America) and EBITDA of €612M. The business serves over 8,000 clients in 44 countries, with 38 technological sites and 11 dedicated R&I laboratories.
Veolia Water Technologies activities include both Veolia WT, 100% owned and Water Technologies and Solutions "WTS" subsidiary, 70% Veolia-30% CDPQ

Water Technologies and Solutions "WTS" subsidiary

WTS was formed as a 70%-30% joint venture between Suez and CDPQ in 2017, before becoming a subsidiary of Veolia following the Veolia-Suez merger in 2022, with CDPQ keeping its 30% minority stake. In FY2024, WTS achieved revenues of €3.3bn ($3.6bn) and EBITDA of €472M ($511M).

ABOUT VEOLIA

IMPORTANT DISCLAIMER

Veolia Environnement is a corporation listed on the Euronext Paris. This press release contains "forward-looking statements'' within the meaning of the provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from the forward-looking statements as a result of a number of risks and uncertainties, many of which are outside our control, including but not limited to: the risk of suffering reduced profits or losses as a result of intense competition, the risk that changes in energy prices and taxes may reduce Veolia Environnement's profits, the risk that governmental authorities could terminate or modify some of Veolia Environnement's contracts, the risk that acquisitions may not provide the benefits that Veolia Environnement hopes to achieve, the risks related to customary provisions of divestiture transactions, the risk that Veolia Environnement's compliance with environmental laws may become more costly in the future, the risk that currency exchange rate fluctuations may negatively affect Veolia Environnement's financial results and the price of its shares, the risk that Veolia Environnement may incur environmental liability in connection with its past, present and future operations, as well as the other risks described in the documents Veolia Environnement has filed with the Autorité des Marchés Financiers (French securities regulator). Veolia Environnement does not undertake, nor does it have, any obligation to provide updates or to revise any forward-looking statements. Investors and security holders may obtain from Veolia Environnement a free copy of documents it filed (www.veolia.com) with the Autorités des marchés financiers.

This document contains "non-GAAP financial measures". These "non-GAAP financial measures" might be defined differently from similar financial measures made public by other groups and should not replace GAAP financial measures prepared pursuant to IFRS standards.

CONTACTS

MEDIA RELATIONS
Laurent Obadia - Evgeniya Mazalova
Anna Beaubatie - Aurélien Sarrosquy
Charline Bouchereau
Tel.+33 (0) 1 85 57 86 25
presse.groupe@veolia.com

INVESTOR RELATIONS
Selma Bekhechi - Ariane de Lamaze
Tél. + 33 (0)1 85 57 84 76 / 84 80
investor-relations@veolia.com

A Veolia conquista US$ 750 milhões em novos contratos emblemáticos em tecnologias de água para energia e semicondutores, refletindo o sucesso de seu posicionamento estratégico

rylee.lay@veolia.com — Wed, 07 May 2025 15:13:26 +0000

$750M of new flagship contracts for Veolia in water technologies for energy and semiconductors, reflecting the success of its strategic positioning rylee.lay@veolia.com Wed, 05/07/2025 - 11:13

May 7, 2025

As a global leader in Water Technologies, Veolia confirms the success of its strategic positioning in this dynamic market, with several key contract wins announced in the first quarter of 2025, including two major ones in energy and semiconductors, corresponding to its priority offers, and to a series of strategic contracts for the implementation of sulfate removal technologies from injection water to optimize the efficiency of oil operations. These gains located in Brazil, the United States, and the United Arab Emirates represent a total amount of more than 750 million dollars.

Water management for the semiconductor industry in the United States

Ultrapure water for key industrial sectors, such as microelectronics, is one of the five priority offers identified by Veolia for the development of its Water Technologies. With this $550M contract, Veolia commits to the design, construction, and operation for 16 years of a state-of-the-art facility to treat water and wastewater from a semiconductor manufacturing plant in the Midwest. It will be equipped with the latest generation of ultrafiltration and reverse osmosis membrane technologies, including ZeeWeed™ hollow fiber membranes, and will be able to recycle about 8,000 m3 (2.1 million gallons) of water per day.

This contract fully aligns with Veolia's growth strategy in the United States, driven by underlying trends such as the relocation of industrial production, and actively supports the re-establishment of semiconductor production in the country.

Production of biomethane from wastewater in San Francisco

As part of a $34M contract, Veolia will equip the Southeast wastewater treatment plant in San Francisco, United States, with its MemGas™ technology which purifies raw biogas from the anaerobic digestion process into biomethane. This essential facility, which currently treats about 80% of the city's combined stormwater and wastewater, averaging 215,800 m3 (57 million gallons) per day, is thus transforming into a resource recovery center capable of turning wastewater treatment by-products into decarbonizing local energy (68 GWh/year). At the end of the process, the biomethane will be injected into the Pacific Gas & Electric network, which provides natural gas and electricity services to around 16 million people, thus contributing to the City of San Francisco's greenhouse gas emission reduction targets.

The system will be operational by January 2027 and will allow for the total recovery of the biogas generated by the Southeast station.

Implementation of membrane technology for sulfate removal for offshore production in Brazil and in the United Arab Emirates

With a combined value of nearly $170M, three contracts have been signed with major players in the energy sector aiming to provide complete water treatment solutions for injection into Floating Production Storage and Offloading (FPSO) in Brazil and in the United Arab Emirates for an offshore production platform. These include engineering, procurement, and manufacturing of modules incorporating membrane technologies to enhance the efficiency of oil operations while securing the integrity of infrastructures. Veolia will implement ultrafiltration and nanofiltration membrane technologies to treat seawater to eliminate harmful sulfates and ions, thereby protecting reservoirs and pipelines from acidification and scale formation while ensuring optimal performance. The world's number one in offshore injection water production has also been putting digital at the heart of its model for over 10 years to optimize the industrial process continuously and improve the operational performance of the units. Equipment deliveries will begin from mid-2026.

In the Santos basin, off the coast of Brazil regarding the contract signed with MODEC for a Shell FPSO (Gato do Mato). This is the 7th international contract signed between Veolia and Modec over 10 years, which strengthens the long-term relationship between the two companies.
In the Santos basin, still in Brazil, regarding the contract with Seatrium for two major units (the FPSO P84 and P85) of Petrobras. At the heart of the project: a cutting-edge SRU system featuring Veolia's ZeeWeed™ ultrafiltration membranes and SWSR series nanofiltration membranes. This collaboration represents the 5th contract linking Veolia to this key partner, even as three projects have been successfully delivered over the past three years.
In the United Arab Emirates for an offshore production platform.

These contract wins are part of a current trend of increasing demand in the energy sector, which faces challenges regarding the quantity and quality of water necessary for securing its activity. Beyond the installation of equipment, Veolia's expertise is recognized, in Brazil as well as in the Middle East, for its ability to propose and deploy custom designs, adapted to climatic and maritime conditions.

"Veolia is emerging as a key technological player, perfectly positioned to respond to the critical issues of quantity and quality of water for industries and communities. Thanks to our proprietary technologies, and our know-how in engineering and design, we offer innovative, high-performance and differentiating solutions. This technological advance allows us to create value and win key contracts in markets with growing demand for securing water resources for more efficiency and competitiveness," declares Anne Le Guennec, Senior Executive Vice President, Worldwide Water Technologies.

ABOUT VEOLIA

CONTACTS

MEDIA RELATIONS
Laurent Obadia - Evgeniya Mazalova
Anna Beaubatie - Aurélien Sarrosquy
Charline Bouchereau
Tel.+33 (0) 1 85 57 86 25
presse.groupe@veolia.com

INVESTOR RELATIONS
Selma Bekhechi - Ariane de Lamaze
Tél. + 33 (0)1 85 57 84 76 / 84 80
investor-relations@veolia.com

Como o teste de validação de limpeza no laboratório se compara à validação de limpeza on-line ou em linha?

rylee.lay@veolia.com — Wed, 23 Apr 2025 17:05:04 +0000

How Does Cleaning Validation Testing in the Lab Compare to Online or At-line Cleaning Validation? rylee.lay@veolia.com Wed, 04/23/2025 - 13:05

April 23, 2025

Cleaning validation is an integral component to cGMP manufacturing in the pharmaceutical industry to ensure safety and purity of products. Total organic carbon (TOC) and conductivity are important quality metrics used in cleaning validation to understand and control the cleanliness of equipment, and advances in technology now allow monitoring to be faster and more reliable than ever. With process analytical technology (PAT) and automation, users have the opportunity to build quality and efficiency into their cleaning programs and decrease human interaction, out-of-specification (OOS) investigations, and equipment downtime.

The three common deployments of TOC technology are laboratory, at-line, and online analysis. When choosing which deployment will best support the overall validation strategy and sampling methods, consider the following to ensure you get the most out of the technology.

Laboratory Analysis (TOC testing performed offline, typically in the QC laboratory):

Benchtop TOC analyzers and software are available that allow you to stack protocols, run system protocols, run large volumes of samples at a time, manage data, and electronically sign and export data. With laboratory analysis, it is inevitable that grab samples must be taken from equipment or purified water points of use.

At-line Analysis (TOC testing performed on the manufacturing floor next to equipment being cleaned):

At-line deployment uses a portable TOC analyzer located directly next to the process to be monitored, reducing downtime. Isso pode proporcionar ganhos de eficiência para a aplicação correta em comparação com a análise laboratorial. O monitoramento em linha evita o fluxo de trabalho de CQ e gera dados em minutos após a coleta da amostra. This can significantly reduce the amount of time that manufacturing equipment sits idle.

Online Analysis (TOC testing performed from final rinse of cleaning cycle):

Online TOC and conductivity testing allows you to go from days to minutes for equipment release time. A validação de limpeza on-line com os analisadores de COT Sievers pode fornecer dados validados em tempo real com o mais alto grau de integridade de dados, compreensão de processo e controle de processo. Junto a ganhos de eficiência e relatórios contínuos, você obtém uma avaliação abrangente da limpeza com menos riscos de erro. Online analysis allows you to assess the real-time rinse down profile of your process, and leverage 3 key quality metrics for process understanding - inorganic carbon, TOC, and conductivity.

Whether deploying laboratory, at-line, or online TOC analysis for cleaning validation or water testing, consider your goals around efficiency, analytical performance, and data integrity. Instrumentos analíticos que podem fornecer alta precisão, exatidão e integridade de dados, ao mesmo tempo que oferecem oportunidades de economizar tempo, serão os mais valiosos para os seus programas de monitoramento. Contact a Sievers expert to learn more about what method of analysis is right for you.

Sievers Resource Center Industry

Life Sciences

Sievers Resource Center Type

FAQs