Critical Manufacturing

Critical Manufacturing encompasses a variety of industries including medical device, automotive paint spray, injection molding, avionics, medical equipment, pharmaceutical and a number of other related industries.

Most companies have cleanrooms that operate to ISO 14644 requirements, while others may rely upon sub-vendors with cleanrooms for assembly and packaging. There are a number of articles on cleanrooms and controlled environments, but the primary purpose of any ISO certified room is to maintain airborne particulates to a specified limit, generally defined as the number of particles per cubic meter at a specified particle size.

Cleanrooms are classified from ISO 3 to ISO 8, with ISO 3 being comparable to the old Federal Standard 209E Class 1 cleanroom. The GSA cancelled the FED STD 209E in 2001, but many still refer to their rooms using the old standard.

The most common source of contamination originates from employees. Unless the room is controlled, and unless workers are properly gowned to the room’s specification, hair, skin flakes, saliva, lotions, make-up, perfumes, coughing/sneezing, and perspiration can create the majority of airborne contamination problems in cleanrooms.