The creation of modern medical devices requires specialized conditions that maintain the cleanliness of the manufacturing and packaging process. At Proven Process, we ensure the ideal environment through the maintenance of a 1800-sq-ft facility that meets the requirements for a Class 7 (ISO 14644) and Class 10,000 (FED STD 209E) clean room. Devices that require a pristine environment are manufactured and packaged within this clean room.
A Class 7 clean room that conforms to ISO 14644 must provide an environment where particles of a given size do not exceed the concentration limits set forth in the table below.
The conditions of our manufacturing and packaging environment are of utmost importance to us, and our clean room is fully integrated into our quality control process. Our clean room maintains a low level of particles by the use of a sealed environment with constantly filtered air at a higher pressure than the surrounding areas. A multisensor particle-monitoring system ensures that contaminant levels remain low throughout the room, and our well-trained technicians carefully follow all procedures for the minimization of contamination. Compliance is audited by FDA and ISO registrars on a regular basis.