Controlled Environment Products

A controlled environment, sometimes called a critical environment is any type of space where there are regulated factors. This can be a simple as temperature or humidity; however, operational needs can require particle control, static control, sterility and more. Most often in production manufacturing, we’re regulating for particle control, meaning the environment must meet a requirement for the volume of particulates in the airoo

Cleanrooms are used in a wide variety of industries. Some of the cleanroom industries we support include (but are not limited to):

• Aerospace and defense
• Automotive
• Biotechnology
• Cosmetics
• Medical device
• Pharmaceutical
• Food and beverage
• Semiconductor
• Vivarium

ISO (International Organization for Standardization) is an independent organization that develops international standards. ISO 14644-1:2015 classifies air cleanliness by looking at the volume of airborne particles in cleanrooms and controlled environments. These classifications include ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9 with ISO 1 being the “cleanest” by requiring the lowest particle count.

The Federal Standard 209 (FS 209) is an obsolete classification system which also provides classes dependent on the concentration of airborne particles in a regulated space. This standard was replaced by IS0 14644-1 but is still widely referenced in the industry today. The FS 209 classifications include Class 100,000, Class 10,000, Class 1,000, Class 100, Class 10, Class 1. Many people working within cleanrooms and controlled environments will use ISO and FS 209 classifications interchangeably. The chart below shows the ISO classification and its FS 209 equivalent.

Depending on the regulations and requirements of the specific cleanroom, a cleaning protocol will be established that provides guidelines for proper cleanroom cleaning, and what cleaning products are to be used. Cleanrooms will either be cleaned through the hiring of an outside janitorial service that specializes in cleanrooms or will be cleaned using internal resources.

Contact your Thomas Scientist Cleanroom/Controlled Environments Specialist if you need help establishing a cleaning protocol and determining the right cleaning supplies for your requirements. CleanroomSolutions@ThomasSci.com

A cleanroom gowning protocol or a cleanroom gowning procedure is the proper process of donning (putting on) and doffing (taking off) cleanroom garments and personal protective equipment (PPE) to not contaminate the apparel. A gowning protocol is unique to each environments requirements and is established to protect the operator from potential workplace hazards as well as safeguard the cleanroom from outside contaminates or particulates.

A new cleanroom would be built to the specific requirements of the application it will be used for. The construction would consider the particulate count that the environment needs to meet. A newly constructed cleanroom can be an integrated structure or a modular turn-key option depending on the budget and the requirements.

To learn more about cleanroom construction check out our on-demand training with our partners at Angstrom Technologies – Cleanroom Masterclass: How to Successfully Design and Build Your Cleanroom.

Most often, cleanrooms are validated by third-party validation agencies. This entails a thorough inspection and several tests, whereafter the cleanroom is certified to a specific class indicating its level of control, usually to an ISO 14644-1 class.

Cleanroom validation has several phases, beginning with design qualification, and ending in final certification. Some of the tests performed in these phases include airflow volume and velocity tests, HEPA/ULPA filter leak testing, air movement visualization (smoke testing), room pressurization, room recovery, airborne particle count tests, relative humidity, temperature, and other testing conditions.

Once initial certification is complete, it is important to regularly recertify to ensure that your cleanroom continues to operate as it did when it was built. At a minimum, annual certification is recommended. Depending on industry and product, semi-annual or even quarterly certification may be required.