Clean Room Injection Molding

Medical Grade, Without the Surgery

Experience precision with our clean room injection molding services. Combining state-of-the-art technology, controlled cleanroom environments and an ISO 13485:2016-certified QMS, we deliver consistently manufactured medical device components for applications where quality and cleanliness are critical. Our ISO Class 7 hard wall clean rooms with a Bioburden Grade C classification are specifically designed to reduce viable airborne particles that can contribute to the contamination of a device. PreciKam also operates five ISO Class 8 soft-walled (portable) clean rooms. This allows us greater flexibility when doing clean room injection molding.

Medical and pharmaceutical sectors generally require clean room injection molding to ensure that quality and safety remain uncompromised. Our certified and experienced clean room operators work meticulously across three shifts a day to ensure that your devices are not exposed to bacteria or dust of any kind. When your solution requires strict cleanliness and control, count on PreciKam to deliver industry-standard clean room injection molding.

Details Matter

Clean Room Injection Molding for Low to Medium Volumes

Access to cleanroom injection molding can be difficult when you need low to medium production volumes. Building and operating a cleanroom environment requires significant investment and ongoing expenses and controls, which are often optimized for higher-volume production.

As an ISO 13485:2016 certified manufacturer, PreciKam supports small and medium volume production in controlled clean room environments to meet your quality, traceability, and risk management requirements, while maintaining flexibility across production schedules.

With decades of experience across multiple industries, we understand that performance often comes down to the details. Choose a manufacturer that can align process controls, documentation, and capacity with your specific requirements.

moulage par injection plastique en salle blanche
moulage par injection plastique en salle blanche

Details Matter

PreciKam has served numerous industries for decades, knowing that the devil is in the details. We offer standard and clean room injection molding services that meet strict engineering requirements.

We know how difficult it is to get access to a Certified clean room to do your parts, especially with low to medium volume requirements. Building a clean room comes with exorbitant costs, and the volumes produced must justify these costs. However, PreciKam can run low and medium volumes from our Certified clean rooms. Benefit from unmatched quality, safety, and the flexibility of varying production runs. Choose a manufacturer that can match your specific requirements.

moulage par injection plastique en salle blanche

Details Matter

PreciKam has served numerous industries for decades, knowing that the devil is in the details. We offer standard and clean room injection molding services that meet strict engineering requirements.

We know how difficult it is to get access to a Certified clean room to do your parts, especially with low to medium volume requirements. Building a clean room comes with exorbitant costs, and the volumes produced must justify these costs. However, PreciKam can run low and medium volumes from our Certified clean rooms. Benefit from unmatched quality, safet,y and the flexibility of varying production runs. Choose a manufacturer that can match your specific requirements.

Built to MilSpec and Never Lethal

The Clean Room Injection Molding Protocols and Requirements

The clean room injection molding protocols and requirements are critical for the production of medical devices, as they guarantee the quality and safety of precision-molded components. These protocols and requirements are essential steps to ensure the sterility of your devices.

  • Clean Room protocols, which include, for example, gowning protocols, cleaning protocols, scheduled internal air quality and procedure audits, and restricted access to Certified team members.

  • Bioburden Certification is also known as viable particle and biocontamination. A viable particle is a particle that consists of, or supports, one or more live microorganisms. Biocontamination is the contamination of materials, devices, individuals, surfaces, liquids, gasses or air with viable particles.

  • Third-party Certification every year.

  • Dedicated equipment and assembly systems in clean rooms.

  • Medical level document and process control available.

  • Risk Management.

  • Just to mention a few aspects of Clean Room functioning.

Clean Room Injection Molding Applications

PreciKam develops and manufactures custom components and assemblies for various applications that require strict tolerances, complete traceability, and rigorous quality control. Below are examples of some products for which we offer clean room plastic injection molding and assembly services.

  • Science and research devices.
  • Forensic testing trays.
  • Aerospace electronics.
  • Microelectronics facility.
  • Semiconductor.

Clean Room Injection Molding Applications

PreciKam develops and manufactures custom components and assemblies for various applications that require strict tolerances, complete traceability, and rigorous quality control. Below are examples of some products for which we offer clean room plastic injection molding and assembly services.

Medical Devices & Healthcare
  • Measurement sensor cartridges.
  • Medical device housings.

  • Medical implantables.
  • Pediatric devices.
  • Surgical instruments.
  • Dental products.
Science & Research
  • Science and research devices.

  • Forensic testing trays.
Technology & Advanced Manufacturing
  • Aerospace electronics.
  • Microelectronics facility.
  • Semiconductor.

Experts in Medical Device Injection Molding

At PreciKam, we are specialists in clean room injection molding for the medical and pharmaceutical industries. In addition to our clean room injection molding services, we offer precision molded plastic component manufacturing, precision tooling design and injection molding assembly. Feel free to contact us to discuss your projects and requirements with one of our injection molding experts.

Interested in working with us?

We invite you to visit our facility, view our operation and meet our team.

Do you have a complex project to fulfill?

We like new challenges. Reach out to our experts, they can
help!

Interested in working with us?

We invite you to visit our facility, view our operation and meet our team.

Do you have a complex project to fulfill?

We like new challenges. Reach out to our experts, they can help!