Class III Medical Device Build & Assembly Services in a Class 10K Cleanroom
The Litron Medical facility is equipped with a state-of-the-art class 10,000 cleanroom that is ideal for the assembly of your Class III medical device(s).
Customized for Your Class III Medical Device
We’ll develop an assembly process that is documented, controlled and fully validated based on your device. We understand that the assembly process is a critical step in the fabrication of your device and we’ll involve you in each step of the setup process to make sure you’re happy with the results.
Specifically Trained for Medical Device Assembly
The operators working on your Class III Medical Device have been specifically trained to do so. From soldering to the IPC J-STD-001 standard, to the ESD handling and protection requirements that go along with your build.
Class 10,000 Cleanroom
Our class 10,000 cleanroom is setup to simulate an extension of your internal cleanroom area. The room is complete with:
- ESD Compliant
- ESD Safe Flooring
- HEPA Filters
- Workstation Monitors
- Humidity Controls
- Helium Bombing
- Gross and Fine Leak Checking
- Visual Inspection
- Laminar Flow Benches
- Segregated Gowning Area and Transfer Room