Healthcare
CLAYENS NP is the preferred partner of recognized healthcare players. Whatever their field of activity (pharmaceutical companies, diagnostic laboratories, medical device manufacturers, etc.) and size (multinational or innovative start-up), we support and secure the development of their medical devices and pharmaceutical packaging.
Our recognized expertise in plastic injection and plastic machining enables us to offer demanding customers complete, tailor-made support, from device design through production, in accordance with international regulatory requirements (ISO 13485- 2016, ISO 15378 and QSR - 21 CFR part 820).
The Clayens NP Healthcare offer
R&D
Expertise
• Mock-up / concept design
• Product design and development (CAD, rheology, drawings, etc.)
• Cost optimization / process automation / laboratory controls and testing
Infrastructure / facilities
• Rapid prototyping and 3D printing
• R&D laboratory: functional and dimensional validation
• Pilot line (ISO7) for clinical batch production
Technologies
• Plastic injection
• Two-shot injection
• Overmolding
• Plastic machining
• Thermoforming
• Additive manufacturing
• Assembly
• Marking
• Inspection
• Packaging
• Sterilization (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 testing (subcontracted)
Regulatory affairs:
• Regulatory monitoring
• Support for technical documentation and CE registration
• Support for FDA registration
Production
Manufacturing in a controlled environment (ISO7)
• 5 ISO 7 cleanrooms
• 129 injection molding machines dedicated to healthcare (25 to 320 tons)
• 2-, 3- and 5-axis machining
Production from very small runs to very high volumes
Global footprint (4 plants dedicated to healthcare in 3 different countries
Our healthcare certifications
Our market segments:
Medical devices
Our expertise enables us to support the development and manufacture of custom Class I, II and III medical devices:
Surgical kits (orthopedics, dental, ophthalmology, etc.)
We are pioneers in the design and development of single-use, procedure-specific and customized surgical kits.
Our kits are used, for example, in spine surgery to repair vertebral fractures.
We also manufacture a wide range of ancillary devices using overmolding technologies for implant placement or removal, and in particular suture anchors.
Implant delivery and positioning systems (ophthalmology, aesthetics, orthopedics, etc.)
Our experience with systems for delivering solid or viscous implants is widely recognized, notably in ophthalmology (intraocular implant injectors for cataract surgery, implant delivery systems for glaucoma), aesthetics (extra-long 1 ml syringe for hyaluronic acid injection for wrinkle filling) and orthopedics (bone substitute injectors, suture anchor placement systems).
Hospital kits (dialysis, acute care, etc.)
Our offering also includes specific hospital kits and systems, designed in collaboration with medical device companies for many applications: components used in dialysis, chest drainage systems, epidural catheters, filtration systems and catheter connectors.
Implants (orthopedics)
We manufacture suture anchors for leading orthopedics players, used to fix tendons and ligaments to bone. We also produce PEEK implants for orthopedic and dental applications, using injection and machining technologies.
Implant packaging (orthopedics and dental)
We manufacture implant or instrument packaging systems for dental and orthopedic applications. These packaging solutions, which allow sterilization of implants and ancillaries, can be plastic (Radel), stainless steel, or hybrid (plastic and stainless steel). The standard AIP Medical range can be customized to meet our customers' needs.
Pharmaceutical packaging
The Clayens NP Healthcare division is a leader in pharmaceutical packaging
thanks to the performance of its manufacturing facilities and the trust of leading pharmaceutical partners.
Our expertise now supports a wide range of pharmaceutical and biotechnology applications.
Injectable drug delivery systems (primary packaging)
Major pharmaceutical companies rely on our capabilities to manufacture injectable drug delivery systems. We notably produce autoinjectors (autoinjectors for viscous products and autoinjectors for emergency medicines).
Our expertise also extends to primary packaging. We can meet the most demanding requirements for injectable drug delivery systems, as demonstrated by our ready-to-fill COC syringe.
Secondary packaging
Thanks to our pharmaceutical packaging expertise and production capacity, we manufacture syringe packaging components called Tubs (tub packaging) and Nests (nest packaging) at several of our sites (Mexico, France and Poland).
Drug delivery system components
For many years, the Clayens NP Healthcare division has successfully manufactured drug delivery system components.
We produce spray system components such as pumps, sprays, special tips, inhalers, etc.
We also manufacture syringe safety systems (caps), finger flanges and plunger rods.
Diagnostics
For more than thirty years, the Clayens NP Healthcare division has been involved in the design, industrialization and manufacture of in vitro diagnostic kits.
The skills of our teams and the performance of our facilities have earned the trust of our leading in vitro diagnostic partners.
A leader in outsourcing in vitro diagnostic kit manufacturing, our company produces a wide range of diagnostic applications:
Cell culture kits (microbiology)
Our long-standing expertise enables us to produce culture kits such as Petri dishes in lean, high-speed flows. Our industrial know-how (stack molds, high-cadence automation processes, molding of transparent consumables) meets every requirement, including the most demanding.
Diagnostic consumables (clinical diagnostics, immunoassays, etc.)
Our offering also includes specific, customized diagnostic consumables for a wide range of applications. They are the result of effective collaboration with diagnostic companies, global leaders or start-ups.
Hygiene & Safety
For more than thirty years, the Clayens NP Healthcare division has been involved in the design, industrialization and manufacture of safety and hygiene products. The trust of leading partners and the performance of our production resources place us in a leadership position for outsourcing the manufacture of a wide range of safety and hygiene applications.
Needle and syringe collectors
Thanks to our expertise in high-throughput automation processes and our molding experience, the Clayens NP Healthcare division can handle every request in this field, including sharps collectors for healthcare waste with infectious risk (DASRI).
Contamination-free transfer system
Our technical expertise and state-of-the-art ISO7 facilities play a key role in the success of our critical products. We manufacture components used in "clean" or even "aseptic" transfer that meet the highest cleanliness and particulate level requirements.
A project or a question? Contact us!
Our teams are available to answer your questions and support you in developing your projects.
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