Many organisations claim in their literature to have Clean Rooms for manufacturing, but in reality they are simply misleading the reader. By definition a clean room is a purpose built facility with :
- Approved air filtering and handling systems,
- Regulatory approval including GMP, and TGA in the case of medical products, and
- Approved procedures for operation.
A clean room is not a room with painted walls and an air-conditioner in the corner.
ASP has one of Australia’s most impressive and fully approved clean rooms of over 7,000 sq feet in size. Currently approved for class 3,500 this room can easily be upgraded to class 350 if required. The facility has internal removable partitions that allow the room to be readily subdivided by function, and allows for the operation of only part of the facility if required.
From a control perspective the facility is designed so that contaminants can not enter the room on raw materials and to this end all raw materials, air, water, etc are delivered directly to the moulding machines by sealed services columns.
Running a clean room facility requires a completely different management culture from normal manufacturing and ASP has a long demonstrated history of doing both.
If you want to manufacture electronic components or medical devices ASP have the facility and expertise to meet your needs.