Podifying Cleanroom Processes
With the advent of mobile, flexible cleanroom solutions that can be moved to wherever medicines are needed, are traditional cleanroom infrastructures about to become obsolete?
Maik Jornitz |
Containment is a key word in our industry and cleanrooms are an essential part of pharma manufacturing. As discussed in a previous issue of The Medicine Maker (1), the technology behind the modern day cleanroom dates back to the 1970s and there is doubt as to whether such static infrastructure is best suited for the needs of today’s industry, where flexibility is key. One of the main problems with traditional cleanrooms relates to scale up. Extending a cleanroom is a time-consuming and messy affair – and every time you scale up, you have to re-qualify the cleanroom infrastructure, which disrupts the manufacturing process. As soon as you start moving traditional gypsum walls, other problems can also become apparent. When speaking to peers in the industry, people have often said to me, “We opened up a cleanroom wall and found mold.” Contaminations like this are a hidden fact in the industry. Many cleanrooms are simply too outdated to fix – no matter how much money you throw at them. I don’t believe that cleanroom infrastructure should be a sunk cost. Many infrastructures are mothballed at the end of a product’s lifecycle because the investments would be too high to refurbish or modify the facility to meet the new processing criteria. This wouldn’t be a problem if we had autonomous, flexible cleanrooms that could either be repurposed for another application or transferred to another site – even another country.
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- S Sutton, “Keep it Clean”, The Medicine Maker, 21, 20–27 (2016). Available at: bit.ly/2fFcbhX.