RTRT(Real-time-Releasing Test)

Real-Time Release Testing (RTRT) revolutionizes biopharmaceutical manufacturing quality control by leveraging in-process data to evaluate product quality. Unlike traditional off-line end-process testing, which relies on Statistical Process Control (SPC) to identify and eliminate variability, RTRT provides realtime insights, enhancing efficiency and product assurance.RTRT employs advanced process monitoring technologies such as Near Infrared (NIR) and Raman spectroscopy, combined with multivariate analysis. These methods monitor critical parameters like active substance content, polymorphism, water content, and blending homogeneity during manufacturing. This approach can replace traditional end-product testing, ensuring consistent quality without repeated post-production inspections.By integrating RTRT, manufacturers can achieve greater assurance of product quality, streamline the release process, and enhance overall operational efficiency. This method allows for real-time quality control, minimizing delays and ensuring regulatory compliance.

MOEXT Team specializes and help in the implementation and integration of Real-Time Release Testing (RTRT) tools with various process analytical technologies (PAT). Their capabilities include:
Customized Solutions:
Tailoring RTRT systems to meet specific manufacturing needs and regulatory requirements.
Advanced Analytics:
Utilizing multivariate analysis and real-time data processing to ensure product quality.
Integration with PAT Tools:
Seamlessly integrating RTRT with technologies like NIR spectroscopy, Raman spectroscopy, and other in-line sensors.
Regulatory Compliance:
Ensuring that RTRT systems comply with guidelines from regulatory bodies such as the EMA and FDA.
Process Optimization:
Enhancing manufacturing efficiency by reducing reliance on end-product testing and enabling real-time quality control.
Training and Support:
Providing comprehensive training and ongoing support to ensure effective use of RTRT systems.