SUEZ Water - Water Technologies & Water

Bacterial Endotoxins Testing (BET)

We know you want simpler, faster endotoxin testing so you can release products sooner while still ensuring safety and compliance. In order to do that, you need technology that makes BET assay setup easy, automated, and less prone to errors – and the technology has to be easy to validate and maintain. You shouldn’t have to dedicate so much analyst time to manual pipetting, training, and re-tests, when microfluidic automation can do the work for you – eliminating hundreds of pipetting steps and hours of unnecessary time, while reducing opportunities for error along the way.  

Bacterial Endotoxins Testing (BET)

We know you want simpler, faster endotoxin testing so you can release products sooner while still ensuring safety and compliance. In order to do that, you need technology that makes BET assay setup easy, automated, and less prone to errors – and the technology has to be easy to validate and maintain. You shouldn’t have to dedicate so much analyst time to manual pipetting, training, and re-tests, when microfluidic automation can do the work for you – eliminating hundreds of pipetting steps and hours of unnecessary time, while reducing opportunities for error along the way.  

Make endotoxin testing easier, compliant, and more sustainable

We believe in making complex measurements simple.  

For years, endotoxin testing has required well-trained technicians to carefully prepare samples and standards for gel clot and 96-well plate-based assays. These analytical approaches are slow to prepare, prone to error and retests, and don’t meet the latest data integrity guidelines. And while these methods benefit from the sensitivity and specificity of Limulus amebocyte lysate (LAL) for the detection of endotoxins, there is a desire to decrease the use of LAL reagent. This is because LAL is created from the blood of horseshoe crabs, and we all want to conserve and optimize the use of this resource as much as possible.  

Now, there’s an easier way to achieve compliant endotoxin testing and improve sustainability with a new compendial endotoxin assay using microfluidics. It simplifies test setup, decreases retest rates, fully complies with the latest data integrity guidelines, and reduces LAL usage by up to 90%.  

Portfolio

Despite the need for easier, automated, and more sustainable solutions for endotoxin testing, many platforms fall short of meeting key requirements or streamlining installation and validation for easy adoption. With the Sievers Eclipse, you get the benefits of significantly easier BET assay setup and full compliance, without the complexity of robotics or difficult implementation. 

  • The Sievers Eclipse BET Platform and enterprise software provide: 
  • 9-minute setup for 21-sample assay (time-savings of up to 85%)  
  • Reduction in LAL reagent by up to 90% 
  • Compliance with all requirements of the harmonized pharmacopeia: USP <85>, EP 2.6.14 and JP 4.01 
  • Highly customizable software with full compliance with 21 CFR Part 11 and ALCOA+ 

Looking for support along the way? Here is how the Sievers Eclipse team supports the implementation process: 

  • IQ/OQ/PQ Validation Support Package (VSP) to comprehensively validate the system, with Installation and validation completed in days 
  • Our team performs a full platform validation report 
  • Our Specific Software Protocol assists in Product Validation 
  • We help you switch methods (ex: Kinetic Turbidimetric → Kinetic Chromogenic) 
  • We offer a bridge study protocol to assist in bridging from your current kinetic chromogenic platform to the Eclipse platform 
  • Our comparability protocol executes a comparison study between the Sievers automated platform and the 96-well plate platform 

Products

Testing Requirements Sievers Eclipse BET Platform 
Requirements of USP <85>, EP 2.6.14, and JP 4.01  ✔️
Samples and PPCs in at least duplicate  ✔️
Minimum 3-point standard curve in at least duplicate using standardized endotoxin (RSE/CSE)  ✔️
Negative controls in at least duplicate  ✔️
Analyst and lysate lot qualification in at least triplicate  ✔️
Use of FDA licensed LAL  ✔️
Compliance with 21 CFR Part 11 and data integrity guidelines  ✔️

Resources

 

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