STYL’One Evo GMP Module for efficient Small Batch Tablet Production

MEDELPHARM’s STYL’One Evo Compaction Simulator can be equipped with the GMP Production Module, offering a precise and efficient solution for small-scale tablet production. Designed for clinical trials and niche market applications, it ensures accurate dosing and strict compliance with GMP standards.

The STYL’One Evo with GMP Production Module offers an effective way to transition from R&D to production without the need for large-scale manufacturing equipment, providing flexibility and scalability for clinical batch production.

Batch Test and Trial Challenges

Traditional high-volume production rotary tablet presses are not suitable for small, controlled batches required in clinical trials, orphan drug manufacturing, and specialty product testing. This is because of problems maintaining consistent quality, with variations in tablet weight, hardness, and dosage during high-speed runs.

These small variations can pose a major problem for clinical batch production, where achieving GMP compliance requires meeting stringent regulatory standards with limited production capacity and flexibility.

The small quantities of sample material available for testing are often insufficient for full-scale production, leading to inefficiencies and waste. A further issue is speed of process, with difficulty in scaling up and maintaining product consistency from early-stage formulations to clinical batches resulting in slow transition from R&D to clinical production. One of the root causes of delays is inadequate data integration between testing and production.

The STYL’One Evo GMP Production Module: A Unique Solution

MEDELPHARM addresses these challenges with a compact and scalable system that enhances the high precision and versatility of the STYL’One Evo. By incorporating specialized accessories for handling, feeding, weighing, and sorting, the GMP Production Module offers an innovative approach to small-batch production.

Key benefits include:

• Bridging the gap between R&D and clinical manufacturing.
• Ensuring precise, GMP-compliant production while maintaining operational efficiency.
• Minimizing material waste and improving tablet quality.

GMP Module Features

The STYL’One Evo GMP Production Module combines advanced features designed for clinical batch production:

• Automatic Weight Regulation: Ensures consistent tablet quality by adjusting the depth of fill automatically. Non-compliant tablets are rejected via an integrated sorting chute.
• High-Capacity 7-Liter Hopper: Supports medium-sized batch production with smooth material feeding.
• Integrated Sorting Chute: Automatically removes out-of-specification tablets, improving efficiency and reducing waste.
• Real-Time Monitoring and Data Logging: Tracks critical production parameters for quality assurance and regulatory compliance.
• Plug-and-Play Design: Compatible with additional tools such as multi-layer production modules and advanced testing systems.
• GMP-Compliant Materials: Designed for use in sterile environments, meeting stringent regulatory requirements.

The module form and materials are fully GMP compliant, suitable for use in sterile environments, ensuring regulatory compliance during clinical trials and production. It is also scalable from small R&D batches to medium-sized pilot batch production.

Streamlining R&D to Production

The GMP Production Module transforms the STYL’One Evo into a powerful tool for:

• Reducing Waste: Precision handling minimizes material loss, even with limited sample availability.
• Enhancing Consistency: Automated processes ensure uniformity across batches.
• Improving Efficiency: Accelerates the transition from R&D to clinical production.
• Facilitating Compliance: Meets GMP standards, simplifying regulatory approval processes.
• Minimizing Human Error: Reduces the need for operator intervention with automated monitoring and controls.

Resources

Click on MEDELPHARM GMP Production accessories to learn more.
Click on MEDELPHARM STYL’One Evo Compaction Simulator for further information.