Requirements for clean rooms are taken from current Good Manufacturing Practice (GMP) regulations and are common between the United States, Canada and the European Union. There are three main criteria that keep a clean room clean, 1) control and quality of air, 2) internal surfaces and equipment, and 3) operating procedures of workers. Room cleanliness is determined by the number of particles per cubic meter of a specific size. Continuous monitoring and reporting on room cleanliness is required by all regulatory bodies to make sure airborne particulates of certain sizes stay within safe levels.
Puren Solutions products are tailored for rapid GMP compliance right out of the box and for point of use cleanrooms in sterile environments. All Puren Solutions air filtration units are designed to develop an ISO Class 5 minimum cleanroom environment in 30-minutes or less for facilities less than 2,000 square feet or 186 square meters. Facilities up to 4,000 square feet or 371 square meters will take slightly longer to reach ISO Class 5 status, but are easily maintained at that level once achieved. All Puren Solutions products are designed to be chemically sanitized to ensure sterile facility compliance.
Safety & Integrity
The Puren Solutions line of products are designed to meet and maintain ISO cleanroom conditions.