Cleanroom technology has always been closely allied to the development and manufacturing of pharmaceuticals – whether that is protecting personnel from highly potent active ingredients, ensuring the cleanliness of equipment between batches, or preventing microbiological contamination of the finished product.
But the burgeoning biologicals sector has turned many accepted practices on their head. Methods that were suitable for use with chemically synthesised drugs are not appropriate for biopharmaceuticals. For example, terminal sterilisation is simply not an option when the product itself contains living cells.
Signs of change are already evident, with a number of pharma manufacturers investing in sterile fill/finish facilities. Others are converting their operations to single-use, plug-and-play systems, where sterile fermentation vessels and pipework are put together in the required format and then disposed of once the batch is finished. WuXi Apptec, for example, has just completed the first run on the world's largest (2,000 litre) disposable bioreactor.
Pall Life Sciences, Merck Millipore and ATMI are all companies who are benefiting from such trends.
Automation is also becoming more prevalent in the area of cell culture. This is more likely to take place in a small, self-contained production unit than a large-scale cleanroom, using systems such as the Cellmate Mk9 from TAP Biosystems, a company which is in the process of being acquired by Sartorius Stedim Biotech.
The biotech boom is well under way and set to continue for many years, providing a potential opportunity for those in the cleanroom sector ready to take the plunge.