Environmental Monitoring of Cleanrooms: Types and Why It is Needed

A clean environment is critical for the safe testing, manufacturing, and packaging of products designed for human consumption and contact. Industries where even minute airborne particles or microorganisms can lead to contamination rely on cleanrooms. But have you ever thought about a system that maintains the fundamental parameters of a cleanroom in proper settings? This is where environmental monitoring (EM) of cleanrooms comes in!

It is a critical practice used to ensure controlled environments comply with stringent practices. They make sure the air pressure, humidity, temperature, and non-viable and viable particle counts are at appropriate levels. 

Let’s take a closer look at environmental monitoring programs, which industries need them, and why. 

Industries that Need Environmental Monitoring Services

Product quality and safety and compliance with safety regulations are vital for numerous industries. Here are some industries that can benefit from environmental monitoring services:

• Pharmaceuticals – to ensure the sterility and purity of medications, vials, and safety cabinets
• Biotechnology – to ensure a controlled environment for the manufacturing of biological products
• Food production – for maintaining hygiene and safety standards in food manufacturing facilities
• Cosmetic – to protect the products from contamination during production and packaging

Laboratories and research facilities can choose from numerous EM programs, which offer daily, weekly, and quarterly testing services.  

Types of Environmental Monitoring

The needs and demands of every industry are different, which is why there are numerous EM programs. Let’s take a closer look.

Airborne Particulate Monitoring

Under this EM program, airborne particle counters are used to measure the number and size of particles in the air. Parameters include particle size, concentration, and type. The goal is to meet the intended cleanliness classification, such as ISO 14644-1. 

Microbial Monitoring

Here, the goal is to detect and enumerate viable microorganisms, such as bacteria, mold, and yeast, in the air and or surfaces. This can help research facilities or manufacturing plants measure the risk of contamination. Methods include active air sampling, surface sampling, and passive air sampling. 

Temperature and Humidity Monitoring

During this EM program, thermometers and hygrometers are used to measure temperature and humidity levels within the cleanroom. This is critical for preventing microbial growth and ensuring product stability. 

Pressure Differential Monitoring

Pressure differential monitoring ensures proper airflow and pressure gradients within the cleanroom. Pressure transmitters and room sensor monitors are used to measure pressure in Pascals (Pa). 

Why Do Cleanrooms Need Environmental Monitoring

In a cleanroom, both viable and non-viable particles can exist, and monitoring them is the first step toward industrial excellence. Here are five reasons EM programs are essential for cleanrooms:

• They can minimize the introduction, generation, and retention of contaminants in a cleanroom. 
• EM programs ensure compliance with industry standards set by institutions such as the Food and Drug Administration (FDA) and the World Health Organization (WHO).
• They can ensure product safety and integrity. 
• EM programs help laboratories, research facilities, and manufacturers maintain their reputations.
• EM programs provide an early warning sign for potential issues, allowing you to mitigate risks early on. 

With environmental monitoring programs, industries can make sure their cleanrooms are up to the standard.