The importance of microbiological control in cleanrooms

Currently clean rooms are a key element in many production and research processes. In recent years, the number of these facilities has increased considerably beyond the hospital setting in places such as pharmaceutical laboratories, assisted reproduction laboratories, and blood and tissue banks. 

Clean rooms are the industry´s big ally

The term is defined in UNE EN ISO 171340 as a “room with specific structures and facilities to control contamination and appropriate environmental parameters.” On the other hand, it is common to see other similar terminology such as “clean controlled environments.” The latter are defined in UNE-EN 17141:2021 as a “defined zone in which microbiological contamination is controlled by specific means,” which in turn encompasses the concept of clean room.  

The control of aseptic conditions is essential in this type of facility

In short, a white or clean room is an area designed to work under aseptic conditions and prevent contamination of sterile materials, components and aseptic surfaces. 

A large number of parameters such as particle concentration in the air, temperature, humidity, pressure, etc. are monitored in these installations to create an optimal working environment that minimizes the risk of contamination. 

Microbiological control of clean rooms

All clean room facilities must implement an environmental control plan, which allows the risk of microbiological contamination to be assessed and controlled, and ensures the effectiveness of the hygiene and safety measures implemented.  

Its microbiological control is essentially based on two controls: air control and surface control.