Clean Room

We have a Class 100,000 (ISO Class 8) clean room available for building product, especially single-time use disposable devices. Our clean room is fully maintained and certified as required by ISO 13485, 14694, and 14698. All clean room certification and maintenance records are available to our clients for their review.

Along with device manufacturing in our clean room, other capabilities include:

• Sterile packaging
• Pouch or blister/tray package and sealing capability
• Packaging validation services
• Sterilization validation services using outside sourcing of either Ethylene Oxide, Gamma, or e-beam sterilization methods.

The clean room is set up modularly to accommodate a variety of circumstances, including light pilot production to substantial commercialized product builds, all in compliance with GMP, proper line clearance, lot history traceability and sterilization protocol. All of our procedures and specifications are released under our Quality System Document Control.

With the sterilized disposable device development and manufacturing capability, we are able to ensure comprehensive integration of sterilized disposables with a complete system as both are developed at the same time in the same place.