BiomedicalDesign and high standards of quality
The vocation of Plax Biomedical is to support customers in the biomedical sector, providing experience in the design and production of thermoplastic medical devices. The technical experience and the capacity for innovation that distinguish the entire Plax Group allow us to offer appropriate and specific solutions for the Healthcare market.
For over 60 years, the Plax Biomedical division has supplied multinational customers such as pharmaceutical companies, diagnostic laboratories and medical device manufacturers.
Medical devices for the Healthcare sector
The wide variety of custom-made medical devices requires a multi-technology approach involving:
- Molding and assembly in cleanrooms;
- Management of high-productivity, multi-cavity molds;
- Medical grade tolerances and raw materials;
- On board automation for assembly.
The Plax Biomedical production processes comply with the standards of medical devices and ISO13485 certificates.
Medical containers and devices for the medical and pharmaceutical sectors
With reference to the more complex requirements and the technological contents of biomedical products, Plax produces containers necessary for the primary and secondary packaging of items in the medical/pharmaceutical sector.
Here are some of the containers produced by
- Trays and cradles for medical devices;
- Circuit organizers;
- Weldable blisters;
Medical devices for diagnostics
In the field of diagnostics, Plax Biomedical offers ad hoc products designed for:
- Handling liquid samples with manual pipettes and other components for sampling systems;
- Consumables, such as cuvettes, suction cones, tubes, cups, etc.
The services and technologies at Plax Biomedical are designed to provide instruments of excellence, compliant with the latest certifications and in step with technological progress.
Plax products are made using materials with high degrees of transparency and purity, free of stabilizers and plasticizers, making them totally non-toxic.
These products can also undergo further sterilization after packaging. These articles are produced entirely within our ISO 8 certified (class 100,000) clean rooms.
The injection molding service is performed in a sterilized cleanroom with the following characteristics:
- ISO 7 and ISO 8 compliant environment;
- High and controlled degree of cleanliness;
- Integrated control of particles and microbiology;
- Constant updating with dedicated assembly workshops.
The raw materials used by Plax Biomedical are certified according to the law:
HDPE – PP – LDPE - PS
PA 6 – PA66 – PBT – POM – ABS – PSU – SILICONE
Super Technopolymers (resistant to high temperatures)
PPA – PPS
TPU - TPE
Overmolding is an injection molding process that allows molding in two successive phases, using two different methods to obtain a component with final characteristics different from the two original materials.
Plax Biomedical quality control includes the following:
- Plant certification;
- Use of a CMM;
- Construction and use of dedicated equipment (pass / fail, gauges, setup)
- Continuous control during molding cycles.
Co-design and industrialization
We find the most effective solution for every customer by listening to their input and their needs: through co-design, we can achieve complete, turnkey solutions.
Plax Biomedical is responsible for the entire validation cycle of complete processes: parts, multi-cavity molds, injection machines, robots, finishing.
Several validation protocols further certify the process: product acceptance tests , process acceptance tests, IQ, OQ , PQ.