The world saw earth-shaking technological revolutions over the years. Technologies are evolving in pharmaceutical industry as well. HME (hot melt extrusion) techniques are developed and increasingly applied in the pharmaceutical industry to handle drug ingredients, especially APIs, that are not easily soluble by using traditional wet granulation method. For example, Pfizer got Covero-HS approved and Merck got Noxafil approved by FDA, and these clinical medicines are all produced by HME.
Same as other pharmaceutical production process, HME also needs to be conducted in a sterile and dust-free environment, that is, inside a cleanroom. This is why our client reached to us in the first place: they need a cleanroom that is specifically used for hot melt extrusion process.
One of the most outstanding features of this cleanroom lies in the special ceiling grids that support room-side replaceable HEPA filter installation. Standard and conventional configuration adopts top-side replacement, which needs at least 600mm space above the cleanroom ceiling. In this case, however, the height is limited while the cleanroon needs to be guaranteed enough clear space inside. As a result, room-side replacement structure is utilised, which not only provides convenience for future filter replacement, but also makes full use of the space.
This cleanroom is divided into two rooms which constituting L-shaped layout. Operators can enter into the cleanroom through change room and air shower, so as to bring minimum contamination to the cleanroom. Materials on the other hand are transferred in and out of the cleanroom by pass through. In addition, US standard power outlets are installed to the cleanroom.
The cleanroom is modular and prefabricated in Airkey factory and delivered after the tests results meet all the requirements. This lego-like installation method will definitely help save labor costs and save the client from the headache of construction wastes.
If you want to learn more about Airkey cleanrooms, feel free to visit our website www.airkeyx.com
