• Needle and Hub Assemblies

    • Endoscopy

    • Laparoscopy

    • Cardiovascular Systems

    • Drug Delivery

    • Neurological Surgery

    • Robotic Surgery

    • Patient Monitoring and Care

    • Orthopedic Devices

Clean Room Molding

We have expertise in Clean Room Molding and Assembly in our ISO 14644-1 Class 8 Clean Room. We control and monitor our facility for temperature, humidity, bioburden, and electrostatic discharge (ESD).

We meet or exceed the requirements of US FDA’s current Good Manufacturing Practices (cGMP) and have a team dedicated to Quality Assurance and Regulatory Compliance.

Common solutions we provide to our customers:

  • Clean Room Molding Presses from 22T - 390T with variable shot size to accommodate any program

  • Assembly including welding, staking, curing and bonding

  • Sterile Packaging and managed packaging validations

  • Managed Ethylene Oxide (EtO) or Gamma Sterilization programs. 

  • Kitting

  • Labeling

  • Mold in Color and Color Matching to meet ISO Color Standards