What is a Cleanroom Certification? Everything You Need to Know

There are various kinds of cleanroom certifications available. Let us discuss ISO 14644-1, FS 209, Terra Universal, and NEBB. The strategies, protocols, and evaluations are necessary for achieving the desired results. These documents also include essential information such as the required minimum airflow rates and pressures in a cleanroom. This article also discusses the difference between the standards and the types of cleanrooms.

FS 209

If your business produces biological materials, you may be interested in FS 209 Cleanroom Certification. This certification recognizes cleanrooms that meet specific standards, such as ISO 14644-1. The U.S. General Services Administration first developed the FS 209 Cleanroom Certification program. Later, the International Organization for Standardization (ISO) set its cleanroom standards known as FS 209E, and several working groups developed new requirements and standards.

While ISO and FS standards may seem complicated, PortAll software takes care of all the calculations for you. Whether you need to calculate airborne particle concentration or determine cleanroom classification, PortAll can help. The software calculates the required sample volume and results for you. The sample volume must be the largest size, and the software will provide all the necessary procedures. After the data is entered into the spreadsheet, you can view your results in a spreadsheet.

ISO 14644-1

In September 2014, the ISO 14644-1 standard for cleanrooms was updated to include “monitoring to provide evidence of cleanroom performance.” This new version addresses testing and validating a cleanroom and its air quality, requiring a calculated selection of sampling locations. In addition to its broader scope, the updated version of ISO 14644-1 addresses how often a cleanroom needs to be tested.

ISO 4644-1 Cleanroom standards are set by the International Standards Organization (ISO). They describe how many particles can enter a room, their size and concentration, and the number of changes in airflow per hour for HEPA filtered rooms. A cleanroom must meet specified requirements to receive Cleanroom Certification, including continuous monitoring and action alarms for cleanroom certification companies. FS 209E assumes that particle size and concentration follow a logarithmic relationship. Therefore, some classes of cleanrooms do not require testing for some particle sizes, while others do. Whether a cleanroom has an ISO 8 rating or an ISO 14644-1 classification depends on the industry involved.

Terra Universal

The end-to-end solutions provided by Terra Universal include cleanroom outfitting, cleanroom certification, and controlled environment testing. Its manufacturing know-how and integrated design capabilities allow customers to customize their controlled environments for a specific task or production environment. Their cleanroom solutions combine versatility, flexibility, and complex and soft-wall options to meet customers’ needs in any industry. With various cleanroom configurations and AirLock designs, Terra is the solution for your needs.

Terra’s cleanrooms use chlorinated polyvinyl chloride (C-PVC) wall panels to meet the ISO 5 – 8 standards. The high-performance C-PVC panels resist particle emission and microbial growth, and Their unique silicone adhesive provides a strong, rigid structure. They come with an optional PVC coving for easier cleaning. If you’re unsure of the size or configuration of your cleanroom, ask a sales associate to help you plan the space.


Applicants who wish to become NEBB Cleanroom Performance Testing Professionals (CPT) must first complete a comprehensive application form and pass the appropriate written and practical exams. CPT Technicians can take the CPT exam concurrently with Professional exams. Applicants must be employed by a company that performs cleanroom testing for at least 1000 hours per year. In addition, these professionals should be competent, reliable, and have high ethical standards.

The National Environmental Balancing Bureau (NEBB) is an international organization that develops and tests cleanrooms. It also develops and operates programs for the certification of individuals and firms that create and maintain these environments. Cleanroom performance testing is an essential part of maintaining a clean room, and a NEBB certified service provider can help you get started. Cleanroom performance testing services can help you assess your cleanroom’s overall performance and identify any deficiencies.

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