Smarter Endotoxin Testing: Reducing Reagent Use Without Compromising Accuracy

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.

 

Embracing innovation

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.

 

Enhancing efficiency with Chemetrix’s support

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.

 

Realising the benefits of modern BET practices

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.

 

Partner with Chemetrix for advanced BET solutions

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.

A New Endotoxin Testing Platform: Sievers Eclipse BET

In this webinar, attendees will receive an introduction to the groundbreaking Sievers Eclipse BET Platform to understand why it was created and how it works to simplify and automate endotoxin assay setup, while maintaining full compliance with USP <85>. With Eclipse, compliant 21-sample assays can be set up in as little as 9 minutes, leading to substantial efficiency gains.

This webinar will also focus on how to evaluate this revolutionary technology. From comparability of analytical results across platforms to data integrity and validation testing, this webinar will leave attendees with a solid understanding of how the Eclipse platform stacks up next to other technology on the market, and how it can be evaluated and validated in a QC lab to demonstrate viability for routine endotoxin testing.

 

In this webinar you’ll learn:

  • Why and how the Sievers Eclipse platform was developed
  • How the Eclipse platform increases efficiency and automates endotoxin testing
  • How the Eclipse platform aligns with USP <85>, EP 2.6.14, and JP 4.01
  • Comparability of analytical results across different platforms
  • Data integrity
  • Validation testing and validation tools available to customers

 

Who should attend:

  • QA & QC personnel
  • Microbiology personnel
  • Validation personnel
  • Metrology personnel
  • Operations personnel

 

Ā Register Here >