Clean rooms have been in existence for decades, but their use is continually growing while equipment options and configurations are evolving. Even clean-room standards are changing, with updated rules released in December.
According to the International Organization for Standardization (ISO), Geneva, a clean room is a controlled environment where air quality and cleanliness are rigorously monitored and contamination is carefully mitigated and measured. The ISO has established maximum concentrations of allowable particulates, based on the level of clean room. The updated standard is ISO 14644.
What does all this mean in application? Let's say you're making a new product that needs to be manufactured in a clean room. There are a number of important considerations, such as:
• At what level does that clean room need to operate? What certification level must it meet?
• What are the general requirements of the end market? Industries such as the medical, pharmaceutical, food, optics and electronics markets all have their own requirements.
• Do you want a portable "clean cell" or a fully enclosed clean room?
• Do you want to incorporate data communication for traceability and record-keeping?
• Are you subject to ISO standards for medical devices? Do you have customer-specified particulate tolerances, or do you just want to ensure the quality of the product?
This report provides updates on equipment for clean rooms, configuration options, integration, robotics and other trends.
Lisa Jo Lupo, correspondent
