Design and Manufacture of Medical Devices and Technical Parts
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Plastibell, a subsidiary of DTP Holdings, develops, manufactures and validates complex parts, medical devices and high-quality functional modules.
The company has a development centre and six facilities in France, Poland and Mexico to efficiently serve its international customers. Plastibell is committed to maintaining a high level of quality and employing a permanent team effort with all of its customers in order to meet their requirements.
All plans comply with ISO 9001-V2011, ISO 13485, ISO 15378, ISO 16949 with FMEA, PPAP and metrology laboratory or ISO 13485 directive 98/79/CE with GMPs, IQ-OQ-PQ qualification, six sigma programmes, risks analysis ISO 14971, USP class six raw materials, microbiology and metrology laboratory requirements to reassure clients that Plastibell products are manufactured to the highest industry standards.
Specialist manufacturing facilities for the health sector
Plastibell possesses three specialised units equipped with clean room ISO 7 certification, and a development and trial centre that are well-suited to serve the pharmaceutical and biotechnical sectors. These facilities in Rhone-Alpes and Normandy contain 29 injection moulding machines that can handle material measuring between 40t to 300t, and are entirely automated with protection and laminar flow units. In order to conserve the control standards of the facilities, monitors measure the units for excessive pressure, particle and microbiological levels.
Permanent staff receive regular training to ensure everyone is up-to-date on the latest industry legislation and enforce a high standard of code of conduct when working inside the manufacturing facilities.
Workshops are integrated for the mechanical maintenance and modification of the moulds. Previous healthcare projects include ophthalmic, orthopaedics surgery, dialysis and analysis.
Innovative medical device design
Plastibell creates innovative designs for medical devices and technical parts, and can also co-design products with clients to achieve a final product that is as close to their original idea as possible. Plastibell is accredited with QI/QO/QP qualifications, and has ISO 13485, ISO 15378 and ISO 16949 Quality Insurance.
Plastibell's product and assembly room security plans contain 2,000m² of clean space adhering to ISO 7 and ISO 8 accreditation that can accommodate low, middle and high output of finished products.
Injection moulding process for medical device production
The company's skilled, stable and experienced team have in-depth technical experience and competence capable of working in co-development throughout the conception, design, prototype, mould manufacturing and injection moulding processes of the product lifecycle.
Plastibell's production sites inject, assemble and decorate all types of thermoplastics for medical devices, and by continuously camera-monitoring all processes the team can ensure perfect traceability.
The injection moulding manufacturing facilities use multi-die moulds, which provide higher output production than regular die moulds and zero-defect production. The systems can develop a quick start-up of new runs, whether they are complex or require high technology.
Assembly of medical devices and injection mould products
Once the devices have been manufactured in Plastibell's facilities, the finished product is assembled by bonding and overmoulding processes. Each item is individually packaged and labelled in order to trace each item and ensure it arrives at the customer's destination undamaged.