Keep it Clean

Cleanrooms are vital when it comes to ensuring that medicines are contamination free – and yet the technology behind them is well over 50 years old. Is it time for a makeover?

By Stephanie Sutton

July/August 2016

Cleanrooms are such an important part of pharmaceutical manufacturing that it’s difficult to imagine a time when they didn’t exist. But surprisingly, cleanrooms are a relatively new invention compared to the history of the pharma industry as a whole. Many of today’s pharma giants trace their origins back to small apothecary shops in the late 1800s and larger-scale manufacturing didn’t take shape until the 1900s. At this time, there were no true cleanrooms, although efforts were made to minimize contamination by segregating certain areas, which had their own basic filtration and air conditioning systems as technologies began to emerge.

“The first clean room standard (FED 209) was published in the US 1963 and revised in the 1970s, but it was some time before these developments impacted other countries, such as the UK,” says John Challenger, chairman at the WH Partnership (WHP), an engineering company based in the UK. “At the time, operating theaters in the UK were relatively crude and included wooden doors and window frames, and plaster walls with virtually no radii at the junctions between walls and floors. Ceilings were often in suspended grid form with simple clipped-in tiles. Unidirectional airflow patterns were not common and invariably filtration was applied in plant rooms rather than at point of entry. Moreover, many old cleanrooms contained high levels of asbestos. In fact, I can recall replacing a large number of cleanrooms in a major vaccines manufacturing facility that had been built in the 1960s – we found white, blue and brown asbestos throughout.”

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