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Class 100,000 clean room - EuroPlast injection molding

EuroPlast Ltd. is an ISO 9001:2008 and ISO 13485:2003 certified medical injection molding company.

In collaboration with you, we will:

  • Help you minimize patient risk while meeting the rigors of FDA governance around validation of machinery and processes
  • Operate in a highly regulated, climate-controlled environment
  • Provide full program documentation and component/device traceability
  • Perform routine material supplier assessments and auditing to ensure compliance based on the complexity of the supply chain

For over 25 years, we have been supplying medical injection molded device parts and assemblies to some of the biggest names in the healthcare industry.  We work closely with our customers to fulfill their clean room assembly and packaging requirements by offering design services and custom fixture building to aid in the assembly process.

In addition to our medical injection molding services, we offer a complete set of services that include Pad Printing, Hermetic Seal Ultrasonic Welding, Ultrasonic Inserting, Heat Staking, Solvent Bonding, Laser Etching, Contract Assembly and complete Product Packaging services.

EuroPlast maintains a Class 100,000 clean room for producing plastic parts for the medical and health care markets. This controlled environment ensures a significantly reduced level of airborne particles that might affect product quality of medical device parts.  The Class 100,000 clean room standard corresponds to the Class 8 clean room of the ISO standard.

Call 608-587-2333 or email Harald to start the conversation about helping your efforts in the medical industry.