Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
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: bit.ly/2beVls0. 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: bit.ly/2aAiYvd. Accessed August 10, 2016.

Enjoy our FREE content!

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE and always will be!

Login if you already created an account

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login as a Guest or via Social Media

About the Author

Stephanie Sutton

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent seven years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

Register here

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register

December Issue of The Medicine Maker