1、 Technical optimization: Improve detection accuracy and speed

Automated sample processing and detection

Multi channel parallel detection: The intelligent instrument supports simultaneous detection of 10-96 well plates, increasing the sample size by 5-10 times compared to traditional methods and shortening the detection cycle to within 2 hours.

Microfluidic technology integration: precise sample distribution and reagent mixing are achieved through microfluidic chips, reducing human operational errors and reducing the amount of horseshoe crab reagent by 90%.

High sensitivity and anti-interference ability

Application of recombinant horseshoe crab reagent: The recombinant reagent synthesized by genetic engineering technology eliminates the interference of G factor in traditional horseshoe crab reagent, reduces false positive rate, and is especially suitable for samples containing β - glucan.

Dual wavelength detection technology: combining 405nm and 660nm wavelengths to eliminate interference from sample color or turbidity, ensuring accurate detection of low concentration endotoxins.

2、 Standardization of processes: reducing human error and operational risks

Integration of preset detection templates and SOP

The instrument is equipped with standard testing processes such as the Chinese Pharmacopoeia and USP-NF, and users can directly call templates to automatically set parameters such as temperature and time, avoiding manual configuration errors.

Real time monitoring and abnormal warning

Real time monitoring of temperature and absorbance changes in the reaction system is achieved through photoelectric sensors and temperature probes. If temperature fluctuations or abnormal absorbance are detected, an alarm is immediately triggered and the detection is paused to prevent the generation of invalid data.

3、 Data Management: Achieving Full Process Traceability and Compliance

Electronic Records and Audit Tracking

The instrument automatically generates electronic reports containing sample numbers, detection times, parameter settings, raw curves, result judgments, and other information, and encrypts them for storage in local or cloud databases. It supports multi-dimensional retrieval by time, batch, product type, and other dimensions.

AI assisted result analysis and trend prediction

Integrate machine learning algorithms to mine historical detection data, identify fluctuations in endotoxin levels, and provide early warning of potential quality risks.

4、 Personnel training: reducing operational barriers and skill dependence

Interactive operating interface and remote guidance

Equipped with a 10 inch touch screen and graphical operation process, beginners can complete steps such as sample loading and parameter setting through animated demonstrations, reducing training time from traditional 2 days to 4 hours.

Support remote assistance function, experts can view the instrument status in real time through mobile phones/computers and guide operations.

Simulation testing and skill assessment module

The instrument has a built-in virtual detection scene, allowing users to practice standard operating procedures without sample conditions. The system automatically scores and generates improvement suggestions, ensuring a 100% proficiency rate for operators.

5、 Application scenario expansion: covering the entire lifecycle detection requirements

Screening of active pharmaceutical ingredients and intermediates

In the process of raw material storage, intelligent instruments are used to quickly detect endotoxin content, replacing the traditional 72 hour cultivation method and avoiding production delays caused by waiting for test results.

Final product release and stability assessment

Before product release, use the instrument's high sensitivity to detect low concentrations of endotoxins to ensure compliance with the standard of 0.5EU/mg in the Chinese Pharmacopoeia; In stability testing, regular detection of changes in endotoxin content in samples provides data support for setting expiration dates.

Verification of Medical Device Cleaning

Perform endotoxin testing on medical instruments such as surgical instruments and endoscopes after cleaning to verify the effectiveness of the cleaning process.

Meets the requirements of ISO 15883-1 standard for the quality of medical device cleaning, reducing the risk of patient infection.