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  • Who We Are
    • Who We Are
    • Plastikos Medical
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    • Micro Mold
    • Leadership Team
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    • What We Do
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    • Precision Mold Manufacturing
    • Medical Injection Molding
    • Advanced Plastic Processing
    • Value Added Operations
  • Our Market Focus
    • Our Market Focus
    • Medication Delivery Systems
    • Surgical Devices
    • Micro Fluidic and Gas Instruments
    • Digestive Health
    • Endoscopic Devices
    • Electronic Connectors
  • Why Us
    • Why Us
    • Engineering Horsepower
    • Industry Recognition
    • Risk Mitigation
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Medical Injection Molding

  Being a leader means remaining  
  at the forefront of technology.  

Medical Injection Molding

Experts in medical injection molding, we remain focused on delivering high-quality components for patient critical devices utilized for Medication Delivery, Surgical Eye Care, Endoscopic Treatment, Digestive Health and more. 

 

We employ a standardized approach when investing in new equipment such as: machines, software, auxiliary equipment, robotics, etc.  This further ensures we can confidently transfer a mold from one machine to another in production and match plastic variables (i.e., cavity pressure).

ISO 7 (CLASS 10,000) CLEAN ROOMS

ISO 7 CLEAN ROOMS

Two separate, state-of-the-art facilities with more than 50,000 square feet of combined cleanroom infrastructure with press tonnages ranging from 66T to 350T. All cleanroom machines are equipped with 3-Axis robotics to enable part handling and cavity separation.

ISO 8 CLeanroom

ISO 8 CLEAN ROOM

One stand-alone cleanroom with 8 medical molding machines ranging from 88T – 220T. Each ISO 8 cleanroom machine is equipped with its own 3-axis robot.



ENGINEERING EXPERTISE

IQ/OQ/PQ Validation

Experienced Quality Engineering staff is trained on the latest IQ/OQ/PQ mold validation protocols consisting of: First Article Inspection, process DOE, Gauge R&R, CpK Analysis, etc.

ISO 13485 CERTIFICATION

ISO 13485 certification

As an ISO 13485 certified facility, we continue to deliver the internationally recognized quality standard for the design and manufacture of Medical Devices. We are also ISO 14698 compliant and conduct routine bio-burden testing throughout the facilities.

INTEGRATED ROBOTICS

INTEGRATED ROBOTICS

Each medical molding machine is equipped with its own multi-axis robotics system. Part handling and cavity separation are achieved utilizing integrated robotics. These systems are also tied into our process monitoring system to discard product that may drift outside our molding parameters, which are establish during our rigorous mold validation.

ADVANCED PROCESS MONITORING

Advanced Process Monitoring

Process Engineers are trained at Multiple RJG Master Molder Levels through their rigorous standards. Also, we routinely utilize cavity pressure sensors with process monitoring technology to achieve 100% monitoring and traceability on patient-critical-applications

Medical Molding Equipment
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  • ISO 13485
  • ISO 9001
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