Facts about Clean Room Certification

by Kevin Smith Author

Clean Room Facts

Clean rooms differ from a room that is simply thoroughly cleaned. A clean room refers specifically to a controlled environment that allows only a fixed number of particles of a certain size per cubic meter. There are different levels of clean room certification. These range from an ISO 9, which corresponds to average outdoor air, to a highly-controlled ISO 1, which allows for only particles of 3 microns or smaller, and only 12 or fewer particles per cubic meter.

Controlled Environment Industries

Certified clean rooms are critical in industries where the slightest contaminant can compromise the integrity of the research or product. Pharmaceutical, biotechnology, aerospace, microelectronics, semiconductor, and medical device manufacturing industries all require clean rooms. This not only ensures the quality of the products, but helps prevent any potential danger to technicians or researchers.

Clean Room Requirements

Clean rooms employ HEPA filters that remove unwanted particulate matter such as dust, vapor, and microbes. They usually employ an airlock to maintain positive pressure. Technicians may be required to go through certain hygiene protocols, as well as to wear "bunny suits," sterile gloves, masks, and shoe covers.

International Standards

The International Standards Organization (ISO) is in charge of the global standards for clean room classifications. There are multiple categories, and you must meet or exceed the ISO standards to gain certification. Requirements will include everything from particle counts to proper documentation. Different types of controlled environments have different standards that need to be met for certification.

Expert Certification

When you need controlled environment services, look for an experienced company with highly trained engineers and technicians that specialize in clean room certification. They can ensure that best practices are being implemented. If there is an issue, engineering experts will be able to identify the problem, and provide guidance in rectifying the issue so that certification can be granted.

Clean room management is very complex. Different labs within the same field may need to meet different requirements. Experts must have an outstanding knowledge of regulations across the spectrum of different industries using controlled environments.

Leading Edge Companies

Highly trained technicians will establish that clean room protocols are being met, and that the client is in full regulatory compliance. A clean room certification service should have extensive experience in all phases of clean room management, from technical services, equipment, consulting, and design, to maintenance, monitoring, and repairs for clean room equipment.