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medical injection molding manufacturer

CLAYENS NP 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). .

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Ambiance Ambiance

 

Clayens NP Healthcare Services

 

 

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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.

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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.

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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.

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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.

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R&D

RD

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

medical device manufacturer
  • Injection molding
  • 2K injection
  • Overmoulding
medical device manufacturer
  • Plastic machining

  • Thermoforming

  • Additive manufacturing

plastic injection molding
  • 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

plastic injection molding

Process validation:

  • FOT (first of tool)
  • SAT (Site Acceptance test)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Operational Qualification)
medical device manufacturer

Product validation :

  • Functional product validation
  • Shelf life validation
  • Transport validation
  • Biocompatibility (subcontracted)
injection molding medical device

Regulatory Affairs :

  • Regulatory watch
  • Support for technical documentation and CE registration
  • Support for FDA registration

Production

Manufacturing in a controlled environment (ISO7)

  • 5 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 (4 plants dedicated to health in 3 different countries)

 

Our certifications

 

 

Our markets segments :

A project, a question? Contact us!

Our teams are at your disposal to answer your questions and assist you in the development of your projects.

healthcare

Locations : Healthcare

NP Plastibell

150-400 ZI La Plaine
01580 Izernore – France

NP Savoie

Parc d'Activités Val Guiers
520 Route de Tramonet
73330 Belmont Tramonet
France

NP Plastibell North

Blvd. San Pedro
S/N Parque Industrial Ferropuerto Torreón,
Coahuila México, CP 27400 – México