In the realm of pharmaceutical and medical device manufacturing, ensuring product safety is paramount. Bacterial Endotoxin Testing (BET) plays a crucial role in this process, traditionally relying on significant volumes of Limulus Amebocyte Lysate (LAL) derived from horseshoe crabs. However, advancements in technology are paving the way for more efficient and sustainable testing methods.
Navigating the complexities of traditional BET
Traditional BET methods, such as the gel clot and 96-well plate assays, have been the standard for decades. While effective, these techniques often involve substantial volumes of LAL, raising concerns about sustainability and cost. Moreover, the manual nature of these assays can lead to increased labour, potential for human error, and challenges in maintaining compliance with stringent regulatory standards.
The need for meticulous documentation and validation further complicates the process, making it both time-consuming and resource-intensive.
The Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform emerges as a transformative solution addressing the limitations of traditional BET methods. Leveraging precise microfluidic liquid handling, the Eclipse platform automates kinetic chromogenic assays, significantly reducing manual intervention.
This innovation not only decreases assay setup time by up to 85% but also reduces LAL reagent consumption by up to 90%, promoting sustainability.
Furthermore, the platform fully complies with harmonised pharmacopeial requirements, including USP <85>, EP 2.6.14, and JP 4.01, ensuring data integrity and regulatory adherence. By simplifying workflows and enhancing precision, the Eclipse platform represents a significant advancement in endotoxin testing.
Chemetrix, as a trusted partner in laboratory solutions, offers comprehensive support for integrating the Sievers Eclipse BET Platform into your operations. Our services include installation and validation assistance, user training, and ongoing technical support to maximise the platform’s capabilities. With Chemetrix’s expertise, laboratories can confidently transition to more efficient and sustainable BET practices.
Achieving sustainability goals
The Sievers Eclipse BET Platform not only enhances operational efficiency but also contributes to environmental sustainability. By significantly reducing LAL usage, laboratories can lower their environmental impact and operational costs. Adopting the Eclipse platform reflects a commitment to ethical and environmentally conscious operations, aligning laboratory practices with broader sustainability objectives.
Laboratories that have adopted the Sievers Eclipse BET Platform report notable improvements, including increased throughput, enhanced data integrity, and regulatory confidence. These benefits underscore the value of modernising BET practices to meet current and future demands.
Elevate your laboratory’s endotoxin testing capabilities by embracing the Sievers Eclipse BET Platform. Chemetrix is ready to support your transition with expert guidance, comprehensive services, and ongoing support.
Contact Chemetrix today to learn how we can assist in enhancing your laboratory’s efficiency, sustainability, and compliance through innovative BET solutions.
Itās well known that around 70% of the Earthās surface is covered in water. Itās our most precious natural resource and great efforts have been made globally to protect the finite supply of water for the planetās inhabitants. Growing population, climate change, and industrial contamination are some of the issues that cause water stress and impact water quality. This is why analytical testing to ensure water quality and safety is essential for health and the ecosystem.
Thereās no denying that sustainability is a big topic for water management and resource conservation. As industries continue to prioritise eco-friendly practices, carbon monitoring will play a crucial role in achieving these goals, demonstrating a commitment to both innovation and environmental responsibility. But what does it mean to follow the carbon, and how does it benefit your operations?
What it means to follow the carbon
Following the carbon throughout your processes allows you to monitor processes or quality and pinpoint issues as they come about. Starting from the source water to the water that is used in the plant as utility and process water, and ultimately wastewater that is purified and discharged back into the environment, carbon monitoring can track the changing levels as the water moves throughout the facility and monitor levels if something goes awry. By monitoring carbon levels at each stage, facilities can gain valuable insights into their processes and quality control, enabling them to pinpoint issues as they arise and take timely corrective actions.
Some of the benefits of following the carbon include:
Process optimisation – Facilities can improve the efficiency of the treatment process, reduce chemical use, and lower energy consumption.
Quality control – Continuous carbon monitoring helps maintain consistent water quality, which is critical for processes that require precise conditions, such as pharmaceutical production and food processing.
Regulatory compliance – Accurate carbon tracking provides the necessary data for regulatory reporting, demonstrating a facilityās commitment to environmental stewardship and compliance.
Letās talk about TOC
Total Organic Carbon is a common measurement to gauge the amount of carbon-based compounds in water. TOC analysis aims to help corporations and municipalities reduce and optimise water use, comply with permit and regulatory requirements, and demonstrate safety and quality standards while maintaining asset reliability.
It provides reliable data and is written in many regulatory guidelines around the world and across various industries.
TOC and conductivity analysis aids in detecting chemical impurities in pharmaceutical-grade water systems and process equipment. Using TOC to understand the comprehensive cleanliness of water and equipment allows manufacturers to consistently deliver safe, high-quality drug products. Many TOC technologies work by oxidising organic molecules using UV or chemical oxidation and measuring the resulting CO2.
Water soluble compounds can be analysed using TOC analysis with little to no method variation. Compounds that do not readily solubilise in water can still be detected using small adjustments such as: agitation, pH, or temperature. With Sievers TOC Analyzers, consumables, and expertise from Veolia, you can be confident your method development will go smoothly.
The Veolia TOC-R3 Online Total Organic Carbon (TOC) and Total Nitrogen (TN) Analyzer is designed to solve critical industrial and environmental water challenges. From source water contamination and condensate leaks to wastewater optimisation and discharge, the TOC-R3 is a peace of mind analytical tool that provides responsiveness and repeatability.
Following the carbon in process water is an essential practice for modern industrial facilities. By systematically monitoring carbon levels, companies can protect their assets, optimise processes, maintain high-quality standards, and ensure regulatory compliance. This not only contributes to operational efficiency and cost savings but also supports environmental sustainability. As industries continue to prioritise eco-friendly practices, carbon monitoring will play a crucial role in achieving these goals, demonstrating a commitment to both innovation and environmental responsibility.
Organic load is one of the most important parameters for discharge control of municipal and industrial wastewater. Permissible limits are guided through regulations and must be monitored accordingly. However, further opportunity to optimize plant performance exists by monitoring organic loading in upstream treatment processes.
The use of on-line controls allows limit values to be adhered to, products to be saved, and plants to be protected against unforeseen events. Total Organic Carbon (TOC) is the most suitable parameter to measure organic load. The use of TOC analysis offers shorter measuring cycles without hazardous waste and is better suited for on-line analysis compared to conventional methods such as COD or BOD.
What youāll learn
Differences between TOC, BOD and COD, and why TOC is more suitable for on-line control
Differences in TOC technologies
How TOC can help optimize your plant
Examples and case studies of how TOC can be utilized
The Food and Beverage industry is constantly faced with demands to meet product quality and production goals. Some of the challenges to this include product recalls, equipment maintenance, and meeting compliance, all of which may be impacted by water quality. Product contamination tops the list of reasons why product recalls occur and errors during the process can be very costly. Water quality monitoring helps mitigate the risks of contamination, product loss, and costly fines.āÆJoin this webinar to find out how monitoring for organics by specifically using Total Organic Carbon (TOC) can help your F&B facility achieve production and quality goals.
What Youāll Learn
What isāÆTOC?
Areas that can benefit from TOC monitoring in your Food & Beverage facility
TOC compared to other monitoring methods
TOC monitoring solutions
Speaker
Melvyn Lam, APAC Application Specialist for the Sievers* instrument product line by SUEZ
Melvyn Lam is the APAC Applications Specialist for SUEZ. He has 12 yearsā experience in engineering and offering application support for industrial and environmental markets. Most recently he served as the APAC Application Specialist supporting business growth in Pharmaceutical and Industrial markets for a cartridge filter device company. Melvyn holds a Bachelor of Chemical Engineering and a Masters in Science, Management of Technology.
Join our webinar which will guide you through efficiency gains with TOC for cleaning validation. We call it a ābeginnerās guideā, but this webinar will benefit long-time TOC users as well as those new to using TOC for cleaning validation. We will cover step-by-step the āwhat, why, and howā for gaining efficiency and getting the most out of TOC for cleaning validation.
This webinar is designed to get back to basics as a refresher for seasoned users or as an introduction for those new to total organic carbon (TOC) and conductivity analysis, USP <643>, and USP <645>.
Join this interactive discussion to learn practical tips for day-to-day use of TOC for compendial water testing and cleaning validation.Total organic carbon (TOC) and conductivity analysis can be used in a variety of applications and are very useful in assessing cleanliness, water quality, and process performance.
It is compulsory for manufactures to abide by the regulations for TOC and conductivity, however, not all end users understand how the technology works and why it is important. In this webinar weāll cover the basics and provide quick tips for success from the userās perspective.
This webinar will cover:
Regulations: Understanding USP <643> Total Organic Carbon, USP <645> Conductivity, data integrity, and regulatory expectations for cleaning validation
Basic principles of TOC and conductivity: Overview of Sievers technology and applications