ISO Class 8 cleanroom injection molding and assembly
Molding, assembly and packaging for medical devices inside an ISO 14644-1 Class 8 cleanroom, with a monitored environment, scientific molding and EtO or gamma sterilization coordinated for you.
UTP Solutions molds, assembles and packages medical device components in an ISO 14644-1 Class 8 cleanroom. Cleanroom presses run from 22T to 390T, including a 28T vertical for micro and insert overmolding, with scientific (decoupled) molding, and we monitor temperature, humidity, bioburden and electrostatic discharge. Parts can be molded, assembled and packaged without leaving the controlled space, then sent for EtO or gamma sterilization that we coordinate. ISO Class 7 certification is available for programs that require it, and a controlled environment is available when a full cleanroom isn't needed.
Cleanroom capabilities
| Classification | ISO 14644-1 Class 8 · Class 7 certification available for programs that require it |
|---|---|
| Cleanroom presses | 22T–390T, including a 28T Arburg vertical for micro and insert overmolding such as needle hubs and cannulas |
| Process | Scientific (decoupled) molding · DOE · documented process windows · SPC |
| Inside the cleanroom | Molding · in-process inspection · assembly · packaging with bar, pouch and tray sealers inside the room |
| Environmental monitoring | Temperature · humidity · bioburden · electrostatic discharge (ESD) |
| Materials | Medical-grade and high-temperature resins including PEEK, PPSU, Ultem (PEI) and polycarbonate · mold-in-color with color matching |
| Sterilization | EtO and gamma sterilization coordinated through qualified providers |
| Validation | IQ / OQ / PQ support for molding processes · first article inspection |
| Alternative | Controlled-environment molding when a cleanroom isn't required |
| Quality system | ISO 13485 certified · FDA-registered facility |
Do you need cleanroom molding?
Not every medical component needs a cleanroom. The decision comes from your device's risk assessment and what happens to the part after molding. A cleanroom usually makes sense when:
- The part contacts tissue, blood or a sterile fluid path, or is part of a sterile barrier
- Your bioburden or particulate limits are tight and there's no validated cleaning step after molding
- The part goes straight into assembly and packaging and then to sterilization
- Your customer or regulatory strategy specifies a classified environment
ISO 14644-1 classifies cleanrooms by airborne particle count. Class 8 allows up to 3,520,000 particles of 0.5 µm or larger per cubic meter of air, and Class 7 allows up to 352,000. Class 8 covers most molded medical components. Class 7 is typically specified for more contamination-sensitive programs. When a classified room isn't required, a controlled environment keeps cost down. A UTP engineer can help you decide during DFM.
How a cleanroom program runs
Gowned entry
Operators gown before entering to protect the controlled environment.
Molding
Parts are molded on a validated, decoupled process window inside the cleanroom.
Inspection and assembly
In-process inspection and assembly happen in the same space, so parts aren't exposed between steps.
Packaging
Parts are packaged and sealed to your specification on in-room bar, pouch or tray sealers before leaving the controlled space.
Sterilization coordination
We coordinate EtO or gamma sterilization through qualified providers and manage the paperwork and logistics.
Cleanroom molding questions
What is the difference between ISO Class 8 and Class 7 cleanrooms?
ISO 14644-1 sets the limits. Class 8 allows up to 3,520,000 particles of 0.5 µm or larger per cubic meter, and Class 7 allows up to 352,000, ten times fewer. UTP's cleanroom is ISO Class 8, with Class 7 certification available for programs that require it.
Does my medical part need to be molded in a cleanroom?
It depends on the device's risk assessment, contamination limits and downstream cleaning and sterilization. Parts in a sterile fluid path, tissue contact or a sterile barrier often need one. Many other components can be molded in a controlled environment. An engineer can help you decide during DFM.
Can you assemble and package in the cleanroom?
Yes. Molding, in-process inspection, assembly and packaging can all happen inside UTP's cleanroom, so parts aren't exposed between steps. Bar, pouch and tray sealers are inside the room.
Do you sterilize parts?
We coordinate EtO and gamma sterilization through qualified sterilization providers, so finished, sterilized product ships from one source.
How is the cleanroom environment monitored?
We monitor temperature, humidity, bioburden and electrostatic discharge in the cleanroom.
What size presses run in the cleanroom?
Cleanroom presses run from 22T to 390T, including a 28T Arburg vertical for micro and insert overmolding. Larger parts run on our 22T–950T molding floor, with controlled-environment molding available when a cleanroom isn't required.
Talk to an engineer, not a call center.
Send the part, the material and your contamination requirements. A UTP engineer replies within two business days with a recommendation.