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Business & Regulation Facilities, Technology and Equipment, Technology and Equipment, Small Molecules, Standards & Regulation

Keep it Clean

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.”

Controlling Contamination

A typical human sheds more than

  • 58 million skin cells per day 
  • That’s around 40 thousand skin cells shed every minute 
  • Of these, around 10 percent 
  • carry microorganisms 
  • The outer layer of human skin can host up to one million microorganisms per square centimeter

Movement can generate particles in a cleanroom:

  • Sitting without moving = 100,000 particles per minute
  • Moving a hand or arm = 500,000 particles per minute
  • Standing up or sitting down = 2,500,000 particles per minute
  • Rapid movement = 10,000,000 particles per minute

Common cleanroom contaminants include:

  • Human hair
  • Human skin flakes
  • Dust
  • Bacteria
  • Mold

Other sources of cleanroom contamination:

  • Water
  • Air/ventilation
  • Items being moved in/out 
  • of cleanrooms
  • All equipment, furniture and stationery in a cleanroom must be specially made so as not to generate particles.

Cleanroom classifications:

  • Cleanrooms are rated depending 
  • on the number of particles per cubic meter
  • A typical urban environment contains 35,000,000 particles per cubic meter 
  • The cleanest cleanroom is an ISO class 1 cleanroom, which can only contain 12 particles per cubic meter, which must be no bigger than 3μm

Data for infographic obtained from:

  1. T Sandle, Institute of Validation Technology, “Peer Reviewed: Cleanroom Contamination”, (2014). Available at: Accessed August 10, 2016.
  2. E Proksch, JM Brandner and JM Jensen, “The Skin: An Indispensable Barrier”, Exp Dermatol 12, 1063-72 (2008). PMID: 19043850.
  3. DuPont, “Contamination Risk by People”. Available at: Accessed August 10, 2016.

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Stephanie Sutton

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