Healthcare
CLAYENS NP is the preferred partner of recognized healthcare players. Whatever their field of activity (pharmaceutical companies, diagnostic laboratories, medical device manufacturers…) and size (multinational or innovative start-up), we support our customers and secure the development of their medical devices and pharmaceutical packaging.
Our recognized expertise in plastic injection molding and plastic machining enables us to offer demanding customers comprehensive, tailor-made support, from device design through to production, in compliance with international regulatory requirements (ISO 13485- 2016, ISO 15378 and QSR - 21 CFR part 820).
The Clayens NP Healthcare offering
R&D
Expertise
• Mock-up / Concept design
• Product design and development (CAD, rheology, drawings…)
• Cost optimization / Process automation / Laboratory controls and tests
Infrastructure / facilities
• Rapid prototyping and 3D printing
• R&D laboratory: functional and dimensional validation
• Pilot line (ISO7) for clinical batch production
Technologies
• Injection Plastique • Bi-injection • Surmoulage
• Usinage plastique • Thermoformage • Fabrication additive
• 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 presses dedicated to healthcare (25 to 320 tons)
• 2-, 3-, and 5-axis machining
Production of very small runs / very large runs
Global footprint (4 healthcare-dedicated plants in 3 different countries
Our healthcare certifications
Our market segments:
Medical devices
Our expertise enables us to participate in the development and manufacture of custom medical devices in classes I, II, and III:
Surgical kits (orthopedics, dental, ophthalmology...)
We are pioneers in designing and developing single-use, 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 ancillaries using overmolding technologies for implant placement or removal, especially suture anchors.
Implant positioning systems (ophthalmology, aesthetics, orthopedics...)
Our experience in solid or viscous implant delivery systems is recognized, notably in ophthalmology (intraocular implant injectors for cataract surgery, glaucoma implant delivery systems), aesthetics (extra-long 1 ml syringe for hyaluronic acid wrinkle filling), and orthopedics (bone substitute injectors, suture anchor placement systems).
Hospital kits (dialysis, acute care...)
Our offering extends to specific hospital kits and systems, designed with medical device companies for many applications: parts used in dialysis, chest drainage systems, epidural catheters, filtration systems, and catheter connectors.
Implants (orthopedics)
We manufacture suture anchors for major orthopedic players 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 systems, which allow sterilization of implants and ancillaries, can be plastic (Radel), stainless steel, or hybrid (plastic and steel). The standard AIP Medical range can be customized to customer needs.
Pharmaceutical packaging
La division Healthcare de CLAYENS NP s’impose comme leader de packaging pharmaceutique
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 biotechnological applications.
Injectable drug delivery systems (primary packaging)
Major pharmaceutical companies rely on our capabilities to manufacture injectable drug delivery systems. We notably produce auto-injectors (for viscous products and for emergency injection products).
Our know-how 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 nests) and Nests (nest trays) at several of our sites (in Mexico, France, and Poland).
Drug delivery system components
For years, the CLAYENS NP Healthcare division has successfully manufactured components for drug delivery systems.
We produce, for example, spray system components such as pumps, sprays, special nozzles, inhalers, etc.
We also manufacture syringe safety systems (caps), finger rests, 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.
Our teams' skills 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 know-how enables just-in-time, high-speed production of culture kits such as Petri dishes. Our industrial expertise - stack molds, high-speed automation, molding of transparent consumables - meets all demands, including the most demanding.
Diagnostic consumables (clinical diagnostics, immunoassays...)
Our offering also includes specific, customized diagnostic consumables for a wide range of applications. They reflect successful 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 make us a leader in outsourcing manufacture of a wide range of safety and hygiene applications.
Needle and syringe collectors
Thanks to our high-throughput automation processes and molding experience, the CLAYENS NP Healthcare division can handle all requests in this field, including sharps collectors for infectious healthcare waste (DASRI).
Contamination-free transfer system
Our technical mastery and state-of-the-art ISO7 facilities play a key role in the success of our critical products. We manufacture parts used in “clean” or even “aseptic” transfer that meet the highest cleanliness and particulate 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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