Introducing a new medical device can take a long time. Aside from conducting clinical trials and earning FDA approval, device makers must also establish that their production processes conform to current good manufacturing practices (cGMP). These guidelines detail the minimum requirements that manufacturers must meet to ensure that their products are consistently high in quality, from batch to batch.
The last thing device makers need, then, is a delay in ramping up production. To reduce engineering time and get their products to market faster, many device makers are turning to standardized automated assembly platforms.
One of the newest such platforms is the Meditec series from PIA Automation. The line includes cells for manual, semiautomatic and fully automatic assembly.
The most basic unit is the Meditec F-MAP, a standalone, single-process workstation. With the F-MAP, a seated assembler loads parts in and out of the cell, which can be equipped with a single processing tool, such as a servo press, an automatic dispensing system, or a laser marker. The cell includes an HMI and arms for holding work instructions or part racks.
The work area measures 1,000 by 1,500 millimeters, and the table height is 980 millimeters. A light curtain provides access to the work area and ensures operator safety. Machine controls are integrated into the cell.
For fast changeover, the cell is equipped with PIA’s Clictec technology, which enables standardized, modular fixtures to be exchanged quickly and easily with just one click.
The Meditec V‑RAC is a flexible, compact robotic assembly system for drug delivery devices. Photo courtesy PIA Automation
For higher volume production, there’s the Meditec V‑RAC, a flexible, compact and efficient assembly system for GLP 1 pens, autoinjectors, safety syringes and other drug delivery devices. It is designed for preclinical and clinical production, as well as the manufacture of small and medium batch sizes. It is ideal for companies that require high-quality, GMP-compliant assembly processes, but also want maximum flexibility and short start-up times.
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Measuring 1.8 meters long, 2.1 meters wide and 2 meters tall, the Meditec V‑RAC is equipped with a Siemens control system and Stäubli SCARA robot. Parts are loaded and unloaded manually, but the robot does all the handling within the cell.
Compatible with class ISO 7 clean room standards, the cell can be equipped with a variety of assembly processes, including pressing, dispensing, labeling and vision inspection. The cell can also be equipped with digital add-ons for smart factory integration.
It can produce up to eight parts per minute. Faulty assemblies are automatically ejected.
For fully automated assembly, the Meditec series offers two options.
This rotary indexing system can run up to 60 cycles per minute. Photo courtesy PIA Automation
A rotary indexing system can run up to 60 cycles per minute. The indexing drive unit is located beneath the base plate, and the system includes space for up to eight feeding tracks.
Compatible with class ISO 6 clean room standards, the compact system can accommodate parts up to 80 millimeters long.
This linear transfer system can run up to 200 cycles per minute. Photo courtesy PIA Automation
A linear transfer system can run up to 200 cycles per minute. Assemblies are transported from station to station on pallets to accommodate variable processing times.
Compatible with class ISO 6 clean room standards, the system can accommodate parts 60 millimeters wide and 160 millimeters long.
For more information on medical device assembly, read these articles:
Modular Automated Cell Assembles Medical Devices
Automated Assembly Cells
Micro-Scale Leak Testing of Medical Devices
