Efficient and rapid scaling is crucial in injectable device production to keep pace with fluctuating demands. This necessity is fueled by the drive for quicker market entry, a surge in new product launches, and the "fail fast" mindset, all of which significantly boost the demand for versatile and scalable manufacturing solutions.
At one end of the spectrum, large automated systems can assemble hundreds of pens and auto-injectors per minute. However, these systems may not be ideal for low-volume production runs, such as those needed for clinical trials, specialized medications, or early product launches.
Consequently, pharmaceutical companies and CDMOs are increasingly recognizing the importance of supplementing large systems with manual assembly platforms specifically designed for the agility and flexibility required to swiftly produce small batches.
The small-batch assembly solutions must adhere to the same stringent regulatory requirements and quality control standards as their high-capacity fully-automated counterparts. They must address the unique challenges of manual systems with excellent ergonomics and usability. Additionally, they need to seamlessly blend automated functions with human interaction, enhancing production efficiency while maintaining safety.
The Syntegon RMA platform is ergonomically designed to maximize operator efficiency, accuracy and safety, for fast production of small batches and quick, error-free changeovers.
Above all, these manual systems should be designed with the flexibility to easily integrate new device types from various manufacturers. This adaptability is essential for efficient production transitions, enhancing the system's overall versatility and responsiveness to evolving demands.
Syntegon's RMA Range Device Assembly Platform, designed in close partnership with pharmaceutical manufacturers and CDMO customers, meets the unique requirements of small-batch production for drug delivery systems. It includes a manual loading and unloading station, while the assembly process itself is fully automated, achieving the same assembly standards as higher-output machines.
Seamless Scalability
Pharmaceutical manufacturers and CDMOs increasingly recognize the need for a range of production solutions, complementing high-volume automated assembly systems with manual platforms offering the agility and flexibility needed to swiftly produce small batches.
Integrated into Syntegon's portfolio of medical device assembly systems, the machine represents a robust design philosophy focused on scalability. This ensures that customers experience a seamless transition to machines with higher output capacities. The system allows clients to increase device production from clinical stages to commercial scale without the need to revalidate the assembly process.
For instance, starting with small clinical trials conducted in doctors' offices, and advancing to market introduction, the system supports the ramp-up to full-scale mass production efficiently. This streamlined approach enables clients to meet rapidly changing market demands while maintaining regulatory compliance and ensuring product quality throughout the scaling process.
Flexibility
The RMA platform's modular design provides outstanding versatility, easily adapting to accommodate new devices from any manufacturer while ensuring consistent assembly across different sizes and types. It adheres strictly to the assembly specifications set by device manufacturers, maintaining precise measurements of distance, force, and resistance for uniform and repeatable outcomes.
A single machine is capable of handling various device types, enabling operators to execute quick and error-free changeovers in just a few minutes, thereby ensuring smooth and efficient transitions between formats or devices.
Ease of Operation
An intuitive HMI clear guidance to operators, ensuring ease of use. This system delivers precise instructions, enhancing operators' accuracy and efficiency. Its ergonomic design includes a height-adjustable screen capable of rotating 45 degrees.
A unique polycarbonate enclosure ensures safety while providing the operator with clear visibility of the process. This design enhances operator engagement and efficiency, enabling active monitoring and anticipation of each step. This results in fewer errors and faster processing, unlike competitor systems where operators simply insert and remove components, often leading to boredom and mistakes.
The front side of the table plate is angled at 45 degrees, allowing operators to feed and remove components ergonomically and effortlessly. This design reduces the need for operators to twist their torsos to access material storage next to the machine.
High OEE
Engineered for high Overall Equipment Effectiveness, the RMA platform delivers exceptional performance with minimal maintenance. It features lifetime lubrication on actuators, drives, and gears.
Product Safety
Once a process recipe is developed and validated, the machine autonomously oversees the process, ensuring each unit meets quality standards. Batch reporting on variables such as force and distance guarantees traceability and compliance with CFR 21 Part 11 standards.
Scalable Solution
Pharmaceutical manufacturers and CDMOs increasingly recognize the need to complement high-volume automated assembly systems with manual platforms offering the agility and flexibility needed to swiftly produce small batches. Syntegon's RMA platform enables the introduction of new devices in half the time of full production systems while adhering to the same stringent regulatory requirements and quality control standards.