User example: from gel method to photometric method to detect bacterial endotoxin - Eclipse bacterial endotoxin detector-Chemical Instrument Network

Prior to the Bacterial Endoxins Testing (BET) method specified in the current pharmacopoeia, the pyrogenicity of drugs was determined using the Rabbit Pyrogen Test (RPT). In the 1970s, the FDA approved the use of Limulus Amoebocyte Lysate (LAL) as a new, more sensitive, and consistent method for drug pyrogen detection. The innovation of tachypleus amebocyte lysate began with the manual gel method, gradually evolved into the end point photometric method, and finally produced the dynamic photometric method (dynamic chromogenic method and dynamic turbidimetric method).

In China, many pharmaceutical enterprises still use the gel method to determine bacterial endotoxin. The gel method is mainly used for the qualitative and semi quantitative detection of endotoxin. Although this method is considered the standard method for endotoxin detection,But its detection range has certain limitations, and there are specific requirements for the detection water and detection conditions.

At present, when pharmaceutical manufacturers use the gel method to detect endotoxin, the major pain points are:

How to ensure data reliability
Easy to be interfered by other components in the sample, affecting the accuracy of the detection results
Unable to detect low concentrations of endotoxins

Faced with the above challenges, more and more pharmaceutical companies are seeking solutions——From gel method to photometric method that is more sensitive, accurate and more consistent with data reliability requirements.

A recent user example is that a listed pharmaceutical enterprise in South China has switched from gel method to dynamic photometric method for bacterial endotoxin test. After conducting comparative experiments and comparing various different devices, they choseSievers^®Eclipse bacterial endotoxin detectorUsed for the research and quality control of its new drug development, while also taking into account the bacterial endotoxin testing of the user's pharmaceutical water.

Sievers EclipseBacterial endotoxin detector provides sample demonstration for users

The user has been using the gel method for endotoxin testing, and has been faced with serious challenges in data management and detection limits. Given the high specification requirements and trend towards data reliability in new drug projects, users began researching photometric methods and commissioned third-party laboratories to conduct sample testing, ultimately confirming the need to introduce photometric methods.

When selecting photometric detection equipment, compared to using traditional 96 well plates, the Eclipse endotoxin detector comes with pre embedded PPCs and standards on the microplate, which eliminates the need for analysts to create standard curves (as they are already integrated into the microplate). This innovation has aroused great interest among users. After further demonstration, users were amazed by the convenience and compliance value of the Eclipse endotoxin detector.At the same time, highly integrated microfluidic design has pushed the balance between quality control, sample speed (simplification), and cost control to a new height.

Today, more and more pharmaceutical enterprises hope to change the gel method to a more accurate, more automated and more reliable photometric method for bacterial endotoxin detection.The Sievers analyzer team provides you with strong support, to assist you in completing the entire implementation process of the Eclipse bacterial endotoxin detector.

Gel method → dynamic color development method

The gel method is usually used for the detection of difficult sample matrices and products. Many laboratories still use the gel method for the detection of water and other sample types, but at the same time, they also hope to implement simpler quantitative analysis methods. The following are suggested conversion steps:

Carry out method applicability test, compare the inhibition/enhancement effect of Eclipse and gel method, and prove that Eclipse can fully recover bacterial endotoxin.
For samples that do not require dilution or other pre-treatment methods to overcome interference factors, such as ultrapure water, this process can be further simplified.
Generally speaking, when switching methods or technologies, it is recommended to re validate the final product release test in three batches.
Once the dilution and method required to overcome interference are determined, users can use the validation function in Eclipse software to test the required batch quantity at their own pace when there are samples available (customizable settings). After completion, a clear validation summary report will be provided for each sample that meets the established standards, and users can then begin routine testing of these samples on the Eclipse detector.

Sievers^®Eclipse bacterial endotoxin detector

The following eight advantages are just a small part of what our customers have praised after implementing the Sievers Eclipse bacterial endotoxin detector:

Quick and easy to set upIt meets all relevant requirements of regulations such as the Chinese Pharmacopoeia ChP<1143>, the United States Pharmacopoeia USP<85>, the European Pharmacopoeia EP 2.6.14, and the Japanese Pharmacopoeia JP 4.01, with a sensitivity of up to 0.005 EU/mL.

Reducing pollution and opportunities for errors, the professional Sievers Eclipse microplate provides powerful analytical performance through precise microfluidic technology,Only 27 pipetting steps are requiredThe laboratory test can be completed.

canReduce by 90%The usage of horseshoe crab reagent，Supports both photometric detection and the use of recombinant reagents for detection.

pre-embeddingThe reference standard endotoxin (RSE) and positive product control (PPC) are matched with multiple reagents, without the need for reconstitution or dilution of the standard.

Quickly start the assay：Automated standard curve and negative control; Support setting and calling assay templates without the need for repeated settings. This means that once your sample is ready, the assay can begin.

Improve operational efficiencyEach analysis can run at most simultaneously21 samples.

Data reliability: Compliant21 CFR Part 11 and ALCOA+Standard software, easy to operate, customizable through permissions and analysis templates to meet the needs of different personnel.

Simplify trainingDue to Eclipse eliminating complex detection settings and supporting Chinese display, training and analyst certification are very simple and clear. Once the system is fully validated, analysts can complete training and certification using templates in the software within one day.

用户实例：从凝胶法转至光度法检测细菌内毒素——Eclipse细菌内毒素检测仪

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