Charity

Cleanrooms and clean areas are defined in the GMP’s as having the following characteristics. There are three things that keep a cleanroom “clean”:

design, which we will now explain through an example. Typically, low moisture medicinal products such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential was positive to the corridor, the powder would escape out of the room and enter the corridor, and is likely then to be transferred into the next door cleanroom. Thankfully, most dry formulations do not readily support microbial growth, so as a general rule, tablets and powders are made in “clean corridor” facilities, as opportunistic microorganisms floating in the corridor don’t find environments in which to thrive. This means that the rooms are negatively pressurised to the corridor.

A clean room, in my mind are a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. In this blog I will attempt to explain the necessary characteristics of a regulated company clean room not producing potent chemicals or active or hazardous biologicals. If there are significant containment requirements, the requirements would be outside the scope of a “simplistic” blog like this. In a pharmaceutical sense, clean rooms are those rooms that meet the code of GMP requirements as defined in the sterile code of GMP, i.e. Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidance as required by local health authorities.

Small particles are all around you. Dust, bacteria, chemicals and other microscopic debris pollute the air and make it difficult to achieve a controlled environment. This can be detrimental to medical research, electronics manufacturing, aerospace engineering and other projects that require a low-pollutant work area. For this reason, many industries utilize cleanrooms in order to reduce the amount of air particles and contaminants. In particular, hardwall cleanrooms have proven beneficial to many businesses, and are now used in everything from pharmaceuticals to semiconductor manufacturing.

Modular cleanrooms are becoming increasingly popular in a wide range of industries. Quick to install and easy to maintain, this type of cleanroom can be suitable for many applications, ranging from medical and pharmaceutical work to manufacturing. If you're not sure whether a modular cleanroom design is right for your organization, why not take the time to learn about the benefits of this type of environment? The following could convince you to try out this type of cleanroom in your own company.