For many years ASYS has been solving assembly tasks for customers in the most diverse industries such as automotive, consumer goods or industrial products. The INVENTUS business unit covers a wide range of automation processes and technologies to design customer-specific solutions. Especially for the Life Science industry, we have developed a new assembly platform and specifically tailored it to requirements of the regulated industry. We use modules from all business areas. This helps us to provide a process-safe and GxP-compliant solution in a short time. We realize complete assembly lines and factory automation from a single source.
The assembly platform, was developed in close cooperation with customers from the medical technology sector and meets the GxP regulations for production in the environment of 21 CFR Part 820 or ISO 13485. Through the deliberate modular design, the highly flexible platform, allows customized automation solutions, in short project durations. The frames are pre-configured in lengths of 1.5 / 2.0 and 2.5 meters and can be combined to individual cells or lines. The process components (robotics, testers, laser applications, handling, etc.) are mounted on the base plates and aligned with the highest precision. Accuracies of < 100μm @ 6 sigma and more can be achieved.
The assembly of hand-sized PCR cartridges for fast diagnostics at the Point-of-Care (POC) has been a trend not only since COVID-19. With the assembly line, realized in this project, approximately 20 individual components are assembled and laser-welded into a functional cartridge in a cycle time of <20 1/sec. Finally it is packed in an aluminium pouch. Precision, repeatability and traceability in the entire process is a must in this project. With this GxP-compliant Life Science Assembly line, we ensure that the cartridges are produced quickly, safely and economically.
The product is transported on product carriers by belts or magnetic mover systems creating a minimum of particles. Thus we achieve clean room class 5 according to DIN EN ISO 14644-1. The cartridge is picked and placed via a cartesian robot into the rotary table. From there, the cartridge is lifted into the chamber of the mask laser where different layers are laser welded.
Additional requirements for defined, local production conditions with low humidity of < 10% rH or controlled temperature conditions are generated with the optional LAMINO-Flowbox. Complemented by cooling or HEPA filter systems, we ensure that energy is only used where the product requires it. We provide validated environmental conditions at low media costs.
The material selection of the modules, the easy-to-clean design and the good accessibility ensure easy working. Monitoring and setting up from the front, material feeding from the rear. Clean separation of the material flows and of the operating area from the technology, makes it easy for operators and technical personnel.
The intuitive user interface SIMPLEX, optionally 21 CFR Part 11 compliant, is a unique human-machine interface (HMI) for controlling and monitoring production machines. Complex input tasks can be managed intuitively on large touch or multi-touch displays.
Our Smart Assistance System PULSE supports the operator in production. Machine messages such as advance warning limits are transmitted to the operator in the right time via smartwatch or tablet. This reduces micro-stops to a minimum.
The automation of the production of pacemakers is subject to high requirements. As a Class III medical device, the highest quality and reliability must be achieved. This project relies on our laser competence in welding. The subsequent marking is also realized with ASYS laser technology. The handling and integration of third-party equipment is part of our daily work. We ensure a perfect interaction of all process steps. Up to the autonomous loading and unloading through our AIVs. With us you are ready for the SMART Factory.