Sterile rooms or clean rooms? Contrary to popular belief, the two terms are not interchangeable. Take a deep dive into the subject with KleanLabs, learning about where sterile manufacturing is used, what classifications are applicable and find out about some best practices applied in sterile manufacturing.

WHAT DIFFERENTIATES STERILE ROOMS FROM CLEAN ROOMS?

Clean rooms are highly controlled indoor environments where the number of particles and contaminants in the air, the temperature, humidity and pressure are all restricted by predetermined standards, including the number of micron and tenth micron particles. In practice, air entering the clean environment is filtered and controlled to given denominators by the air handling unit equipped with HEPA filters or fan filter units in some cases.

Sterile environments, however, go a step further - they are completely bacteria and microorganism free. Sterile manufacturing is usually required for some very specific tasks such as filling of vaccines.

WHAT INDUSTRIES PREFER STERILE MANUFACTURING AND STERILE ENVIRONMENTS?

Among others, injections, infusions, organ transplant solutions, but also ophthalmic preparations require a sterile environment. For these processes, it is of vital importance that they are not contaminated with microbes during manufacturing, processing or storage. A sterile environment is a clean room where the possibility of this is entirely ruled out, since the system is closed, microorganism cannot be found.

Sterility adds a whole new dimension to clean environments. In case of invasive procedures, certain strains must be protected from other strains. This is why aseptic techniques are essential in some industries such as the medical field or pharmaceutics. However, the required level of sterility may also differ, which can influence the build up of a clean room. While in certain cases a laminar flow must assure the highest level of sterility, the environment where final sterilization may take place has less strict requirements.