Controlled environments and cleanrooms have similarities, but the terms are not interchangeable. There are significant enough differences to impact how your project is engineered. We’ll explore controlled environment/cleanroom specifics and differences, including International Organization of Standardization (ISO) requirements.
WHAT IS A CLEANROOM?
Cleanrooms are controlled environments that are free of dust, microorganisms, mold, and other contaminants. They are classified per regulatory requirements as to the maximum number of acceptable particles in the air per cubic meter (there are nine classifications identified by ISO 14644-1). Particle size is also a major consideration. A cleanroom must be tested on a regular basis to ensure compliance with its exact classification.
Prudential Cleanroom Services provides Rx compounding companies compliant cleanroom gowning systems that are required for USP 797. PCS specializes in cleanroom garment processing services for aseptic, particulate & ESD controlled environments. All PCS Cleanroom Services Garment Processing Facilities (excludes Cleanroom Service Centers) are validated for sterile garment processing, and have a quality management system that is ISO 9001 certified.
This post is related to:
Contamination Control: Cleanrooms, Gloveboxes, Hoods, Isolators
