Reasons why Cleanrooms are Crucial in Laboratories

Manufacturers and research institutes must be aware of and able to respond to changes in international standards.

FREMONT, CA: A Clean Room or cleanroom is a laboratory setting that maintains a deficient concentration of airborne particles. This space is segregated, actively cleansed, and protected against contamination by dust, airborne organisms, and vaporized particles, among others. The primary purpose of these rooms is to prevent the release of whatever particle is being treated inside. They are highly specialized environments in which numerous parameters are regulated.

The international organization for standardization (ISO) is a global federation composed of multiple national standard bodies that were founded to provide standards for similar technologies in various countries. In the context of cleanrooms, grades and standards have been devised to evaluate the air quality and cleanliness.

International Norms for the Monitoring Of Airborne Particles in Cleanrooms

In the United States Federal Standard 209 (A to D), the number of particles of 0.5mm per cubic foot of air is measured, and this quantity is used to categorize the cleanroom. Federal Standard 209E was the preliminary classification standard for clean zones and cleanrooms until 1999 when it was replaced by a new global standard (ISO 14644-1).

To assure the quality of the product being manufactured or the efficacy of the process being carried out in a cleanroom, the cleanroom's air quality must be adequate. Some airborne sampling is required to evaluate whether the cleanroom meets the worldwide standard.

It is crucial to note that readings of airborne particles in cleanrooms are frequently variable due to the contributions of dynamic particulate levels, variation in sampling technique, and variances or inconsistencies in equipment calibration and maintenance. However, ISO categorization provides a comprehensive framework for controlling the disparity between various instruments.

An ISO 14644-1-classified cleanroom is a room or confined environment in which particle counts must be kept low. ISO 14644-1 classifies cleanrooms as ISO 1 through ISO 9. Each cleanroom is graded based on the maximum particle concentration per cubic meter or square foot. ISO 8 is the second-lowest rating for cleanrooms and is the least sterile.

A cleanroom has multiple applications across multiple sectors. They are required for applications that require sterile and clean settings. Priority is placed on the safety and quality of items produced in a setting involving life sciences. If excessive particles penetrate the cleanroom, the raw materials, production processes, and final products may be negatively damaged.

An ISO 1 cleanroom classification is uncommon and only used for the most delicate research and development operations, such as those involving the fabrication of semiconductors or biotechnology. ISO 5 cleanrooms are considered to be of the highest quality and are required for pharmaceutical applications. This may involve the sterile filling and packaging of pharmaceutical medications. For sub-sterile applications, an ISO 7 facility is needed.

A cleanroom of ISO class 8 is the lowest allowable level of sterility. It is utilized when sterility is not the primary objective, but it is vital to maintain a minimum level of hygiene. Examples of such applications include pharmaceutical storage.

It is essential to note that these examples represent these primary uses in actual reality. The requirements are frequently determined by many criteria, which vary based on the cleanroom's intended use. Consequently, specific applications may fall anywhere between the levels specified by the standards.