Overview

In the production processes of pharmaceuticals, biopharmaceuticals, medical devices, and related industries, endotoxin contamination testing is a necessary step. If the actual presence of bacterial endotoxins cannot be detected, it may lead to disease or even death. Therefore, effective endotoxin testing is crucial for product quality and patient safety. When detecting endotoxins, the American horseshoe crab reagent (LAL, Limulus Amebocyte Lysate) or Chinese horseshoe crab reagent (TAL, Tachypleus Amebocyte Lysate) are usually used for analysis, which have high sensitivity and specificity. However, these assay methods have always been prone to errors, as they require hundreds of manual pipetting steps by laboratory personnel during the assay process, and the microplates may be exposed to environmental pollution.

The Sievers Eclipse Bacterial Endoxins Testing (BET) aims to simplify the endotoxin testing process. This detector adopts centripetal microfluidic technology, which not only reduces the time and operation steps required for setting up the assay, but also reduces the amount of American horseshoe crab reagent (LAL) or Chinese horseshoe crab reagent (TAL) used, while controlling and minimizing the risk of potential errors and environmental pollution. The core component of the Eclipse BET detector is the Eclipse microplate. Eclipse microplates are carefully designed and manufactured components that adhere to high-quality standards, ensuring users have full confidence in endotoxin testing results.

Quality specifications for Sievers Eclipse bacterial endotoxin detector microplate

Sievers Eclipse microplates undergo strict quality inspection and testing procedures from production to factory. Only when the batch of microplates meets specific performance specifications, will the Sievers quality control team release the batch of microplates for commercial use, ensuring that the batch of microplates has been optimized for bacterial endotoxin testing. This application manual outlines the quality control procedures and performance specifications that must be met for each batch of Eclipse microplates before they are put into commercial use.

Each batch of Sievers Eclipse microplates undergoes a separate batch disposal evaluation by an audit team composed of Eclipse BET experts from our company's technical, product management, and quality control departments. For each batch of Eclipse microplates, the audit team conducts quality control (QC) testing performance evaluations, commercial use risk assessments, and checks for differences between test data and documentation and specification requirements and related risks. Each batch of Sievers Eclipse microplates must pass the following two quality control checkpoints before being put into commercial use.

summary

The quality audit process for Sievers Eclipse microplates is very strict, ensuring that the technical personnel in the quality control laboratory can rest assured because the Eclipse microplates they use have strict quality control and meet key specification requirements. All quality testing of Eclipse microplates can be traced and patient safety is always prioritized.

The Sievers team provides services to users who use Eclipse bacterial endotoxin detectors (BET), including on-site setup, repair, maintenance, and remote support assisted by certified service engineers and technical support teams. The Sievers quality control team will also provide support in investigating product malfunctions or out of specification (OOS). In addition, our application and regulatory experts are always available to answer users' questions about method development and compliance. Under the comprehensive system support mentioned above, users of Sievers Eclipse can confidently and maximize the functionality of this detector, optimizing its bacterial endotoxin detection process.