HAMAMATSU Corp is showcasing a prototype at IFPAC of KAX Groups SpeKtrµM software integrated with their NIR-PAT Module. This integration is intended to revolutionise the way tablets are analysed.

KAX Group software SpeKtrµM is a new universal connection software enabling OEM partners to connect instruments directly and apply VEKTOR DIREKTOR™ Models in this case via the HAMAMATSU NIR-PAT module.

This is the first partnership of this kind with this new software and HAMAMATSU Corp will be exclusively, presenting the prototype during IFPAC at Booth #509

The ability to analyse tablet formulation in real-time to enable RTR – Real-Time-Release is a hot topic in pharmaceutical R&D and Manufacturing. But why is RTRT so important and how has it become integral to Pharmaceutical Manufacturing AND what are the challenges to implementation?

1. Enhanced Quality Assurance: RTRT allows for continuous monitoring of the manufacturing process, ensuring that each batch meets quality standards before it is released. This reduces the risk of releasing substandard products.

2. Increased Efficiency: By identifying and addressing issues in real-time, manufacturers can avoid the delays associated with traditional end-product testing. This leads to faster production cycles and quicker time-to-market for new drugs.

3. Cost Reduction: RTRT helps in minimizing waste by detecting and correcting problems early in the process. This reduces the need for costly rework or disposal of entire batches.

4. Regulatory Compliance: RTRT aligns with modern regulatory guidelines, such as those from the International Council for Harmonisation (ICH), which emphasize the importance of continuous process verification and quality by design.

5. Improved Product Safety: Continuous monitoring ensures that any deviations from the desired process parameters are detected and corrected immediately, leading to safer and more reliable pharmaceutical products.

Implementing RTRT successfully can be challenging for pharmaceutical manufacturers for a wide variety of reasons not least those outlined below.

1. Technical Complexity: Integrating advanced sensors and analytical technologies into the manufacturing process can be technically demanding. Ensuring these systems work seamlessly and provide accurate, real-time data requires significant expertise and investment

2. High Initial Costs: The upfront costs for setting up RTRT systems can be substantial. This includes the cost of new equipment, software, and training for personnel

3. Regulatory Compliance: Meeting regulatory requirements for RTRT can be complex. Different regions may have varying guidelines, and ensuring compliance with all relevant regulations can be challenging

4. Data Management: The volume of data generated by RTRT systems can be overwhelming. Efficiently managing, analyzing, and storing this data requires robust IT infrastructure and data management strategies.

5. Process Integration: Integrating RTRT into existing manufacturing processes without disrupting production can be difficult. It requires careful planning and coordination to ensure a smooth transition

6. Continuous Monitoring: Maintaining continuous monitoring and ensuring the reliability of real-time data over long periods can be challenging. This includes regular calibration and maintenance of equipment

KAX Group are working hard with partners on software development and solutions that try to take the pain out of implementation and enable turnkey plug-in solutions for OEM customers who serve pharmaceutical manufacturers.

Be sure to stop by KAX Group at Booth 516 and visit our Partners HAMAMATSU Corp at Booth 509 to see the prototype.