Cleanroom Injection Molding
Medical device clean room production provides ISO class 8 or better cleanroom standards for medical devices and components that require enhanced levels of protection. ISO level cleanroom tents effectively limit the number of particles within the room, allowing for a controlled environment for medical device injection molding.
Your #1 Cleanroom Molding Manufacturer
Springboard (Stack Plastics) is an FDA registered injection molding company with ISO 13485 certification and IQ, OQ, and PQ validation. All of our cleanroom manufacturing processes are completed in-house, allowing for complete control of all aspects of production. Request a quote today to begin discussing your clean room project requirements. Contact us for more information.
Medical Device Cleanroom Injection Molding
End-to-End Services with Lean Manufacturing
At Stack Plastics, we perform much of our cleanroom design, production, or assembly in house. We provide fast and reliable clean room manufacturing and production services with accurate results.
Our entire operation is based on Lean Manufacturing principles. We utilize the IQMS ERP System throughout our processes to manage our customer base, orders, and scheduling, including process monitoring, materials inventory, warehousing, and shipping. After discussing your cleanroom injection molding requirements with a specialist, we will assign you to a project manager who will oversee all aspects of production to ensure you receive the medical devices you need when you need them.
On-Site Cleanroom Technologies
- Arburg Allrounder 370S, 470S, 520S Molding Presses (40-250 tons in capacity)
- Arburg MultiLift H Robotic Cells (Enclosed) Clean Delivery Systems
- 1,100 ft2 Main Clean Room with Staged Entry/Gowning Area
- 256 ft2 Portable Clean Room
- Vacuum Heat Sealers
- Four Stage Compressed Air Filtration System
ISO Class-8 Clean Rooms for Medical Injection Molding
Stack Plastics follows quality assurance protocols for all aspects of the clean room manufacturing and assembly process, providing assurance that your medical device components are manufactured to your exact quality standards:
- ISO 13485:2016 certified for comprehensive quality assurance management in the manufacturing of medical components and subassemblies
- FDA registered
- IQ, OQ, & PQ validation, demonstrating our facilities & equipment meet current regulations set by the pharmaceutical, medical, and clinical industries
Complete In-House Cleanroom Manufacturing
Cleanroom medical device plastic injection molding areas provide an effective way to manufacture your medical device parts and components to your project’s specification requirements. Our 9 cleanroom molding presses range from 40 to 250 tons in capacity. Molded products from these machines are delivered to an FS209E class 100,000 / ISO class 8 certified clean room environment. The packaging process is also performed within this controlled environment to prevent any contamination.
Medical Applications for ISO Clean Rooms
- Medical Device Housings
- Emergency Room Products
- Cardiac Products
- Blood Delivery Housings
- Equipment Testing
Plastic Materials Used in Clean Room Injection Molding
Contact Stack Plastics for Cleanroom Plastic Injection Molding Today
For more information regarding our clean room medical device injection molding services, get in touch with our sales team or request a quote for direct pricing information today. Stack Plastics is your trusted source for ISO Certified cleanroom design, manufacturing, and assembly.