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.
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.
