CLAYENS and its companies, NP Plastibell & AIP medical, are the chosen partners of recognised players in the health industry. Whatever the business sector (pharmaceutical companies, diagnostic laboratories, medical device manufacturers, etc.) and size (multinational or innovative start-up) of our clients, we support and secure the development of their medical devices and pharmaceutical packaging.
Our recognised know-how in plastic injection molding and plastic machining enables us to offer our discerning clients comprehensive and customised support, from the design of their devices through to production, in accordance with international regulatory requirements (ISO 13485-2016, ISO 15378 and QSR - 21 CFR part 820). .
Clayens Healthcare Services
Our multidisciplinary R&D team takes charge of your project, whatever its stage of development, from concept to market launch, by integrating the expertise necessary for the success of the device.
Much more than a medical supplier, we support our partners throughout the industrialization phase of their project to develop with them a high quality, tailor-made process.
We respect an efficient quality protocol, in accordance with international health standards. The most important requirements in terms of process qualification and product validation are assured.
With more than 30 years of experience in manufacturing plastic parts in a controlled environment, we meet industrial requirements and ensure compliance with the standards of highly critical sectors such as health.
R&D
Expertise
- Mock up design
- Usability Engineering
- Product design and development (CAD, rheology, drawings, etc.)
- Price optimisation / Process automation / Controls and laboratory tests
Infrastructure / facilities
- PoC (proof of concept)
- Rapid prototyping and 3D printing
- R&D laboratory: functional and dimensional trials
- ISO7 R&D clean room for the production of clinical batches
Technologies
- Injection molding
- 2K injection
- Overmoulding
Plastic machining
Thermoforming
Additive manufacturing
- Manual / automated assembly
- Secondary operations : welding, gluing, siliconization, labeling, ...
- Control : manual, automated, dimensional, functional, visual, ...
- Packaging : double bags PE, blisters, tub & nests, ...
- Sterilisation (subcontracted)
Qualification
Process validation:
- FOT (first of tool)
- SAT (Site Acceptance test)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Operational Qualification)
Product validation :
- Functional product validation
- Shelf life validation
- Transport validation
- Biocompatibility (subcontracted)
Regulatory Affairs :
- Regulatory watch
- Support for technical documentation and CE registration
- Support for FDA registration
Production
Manufacturing in a controlled environment (ISO7)
- 7 ISO7 clean rooms
- 129 injection moulding machines for health (from 25 to 320 tons)
- 2, 3 and 5-axis machining
Production available in very small series/very large series
Global footprint (7 plants dedicated to health in 3 different countries)
Our markets segments :
