Nye Clean Rooms Update
Currently, Nye Lubricants has qualified two clean rooms.
The Technical Products team is now working in a certified Class 100,000 Clean Room. This team produces ultra filtered grease and oil products for a variety of industries, specializing in filtered greases used in precision bearings. In order to certify a Class 100,000 clean room to ISO Class 7 standards, fourteen locations were mapped out on a grid of the room and monitored in the room during working hours and at rest. The air was passed through a filter at an average flowrate of 1 cubic ft/min and particles were collected and sized. Our Technical Products production area had less than 20,000 particles > 0.5 micron per cubic foot of air, meeting the Class 100,000 specification of less than 100,000 particles > 0.5 micron per cubic foot of air.
Our MAC room has been tested and certified to a Class 10,000 Clean Room, testing to ISO Class 8 room with an average particle count of less than 2,000 particles > 0.5 micron per cubic foot of air during normal production hours. All the equipment in the MAC room is dedicated to MAC, preventing any possibilities of cross contamination.
When visiting Nye’s Clean Room facilities, one will notice that special garments are in place for production employees and visitors. All of our employees that access the room have been trained on special procedures for gowning. Hair nets, booties, gloves, and gowning are all required to ensure the materials produced and filtered in these rooms meet the stringent ISO and customer requirements.
In the month of March 2015, Nye has had an independent certification company test our cleanrooms. Nye has added an additional certified cleanroom, our medical silicone room. This is a standalone room dedicated to silicone chemistries used in precision applications. This room will be certified to ISO 13485 standards, which focus on raw material control, process control, equipment qualification, training, and adherence to procedures.
Nye Lubricants has also been audited to and received a “Recommendation for Certification” to ISO 13485, the ISO standard covering the standards for medical device manufacturing. This certification, as well as our certified cleanrooms, makes Nye an ideal manufacturer for medical device, aerospace, semiconductor, and micro precision bearing lubricants.
