In order to keep up with our ever-growing client base and their individual requirements, the team at ReAgent has introduced a new cleanroom into its factory.
In this post:
How do Cleanrooms Work?
A cleanroom is a facility within manufacturing premises that maintains an environment free from airborne contaminants such as dust and small particles.
Cleanrooms achieve this environment through the use of filters. Put simply, outside air is drawn in through the filters, pushed downwards towards the floor and then driven out of the cleanroom at its base. This ensures a constant circulation of fresh, filtered air that is always under positive pressure, ensuring no outside air enters without filtration.
The success of cleanrooms is demonstrated by the fact that in a typical urban area, the air contains approximately 35,000,000 particles per cubic metre. Cleanrooms, on the other hand, contain just 12 particles per cubic metre and each of these is much smaller in size, as well.
What is ReAgent Using it For?
As we close in on achieving our ISO 13485 accreditation, and gear up towards manufacturing products for medical devices, we have to ensure that we eliminate as much as possible the risk of product contamination.
When manufacturing for medical devices, it is critical that the quality of products remains as high as possible. This is because the purpose of the products will be to perform medical testing. Contamination is a high risk here because any impurities present in the product could impede tests by giving false results.
Ensuring Quality
The effect of the filters in the cleanroom is that by pushing filtered air out under pressure ensures any contaminating particulates will be removed. This ensures a safe environment where the product can be packed without compromising its integrity.
After the products have been manufactured in our factory, a dispensing line will lead from the mixing vessel to inside the cleanroom where the product will be packed.
During this packing stage, the product is passed through in-line filtration down to a 0.2μm (micron) particle size. This is extremely small, being the equivalent of 0.0002mm, and means that any particles in the solution that are larger than 0.2μm will not enter the product. Instead, they will be retained in the filter on the filling line between the vessel and bottle.
Controlling the Environment
In order to reduce contamination as much as possible, cleanroom operators will also be required to wear appropriate protective clothing. These include things like overalls, hairnets, gloves and shoe covers. This safeguards the cleanroom and product from any external contaminants.
We will also conduct frequent monitoring and testing through random sampling of the products in order to ensure that the stringent quality requirements are being fulfilled.
What are the Features of ReAgent’s New Cleanroom?
The most obvious difference between our old and new cleanroom is that the new one is much larger. This is an aspect that has not only been facilitated by our increased manufacturing space but also necessitated by the needs of our clients.
In order to meet the needs of our expanding customer base, ReAgent’s new cleanroom has been purpose built to the dimensions we need in terms of size and shape. It has also been designed to accommodate the processes we will be undertaking and has a lot of available room inside for operators to move around without restriction.
Instead of walls, our cleanroom is contained within heavy duty, polythene sheets. These create an effective duct barrier that the inside air can easily exit through. Polythene sheets also have the added advantage of being more cost-effective and efficient without compromising the quality of the environment.
The overall benefit of installing a new cleanroom is the extra measures it puts in place in terms of ensuring a contamination-free environment. With this new addition to the factory, ReAgent is continuing to go above and beyond the standards of quality.
