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Valutek case Studies[Cleanroom Catastrophes]

Contain Microbial Contamination and Achieve Compliance with Cleanroom Socks

Authored by Morgan Polen


Why Cleanroom Socks?

For decades, we’ve known that wearing disposable and launderable cleanroom socks and adhering to proper gowning room protocol is an effective method for containing operator generated contamination, particularly in environments where microbial contamination is a concern.

In August 2022, the European Union introduced GMP Annex 1 to prevent microbial, particulate, and endotoxin/pyrogen contamination in finished medical products. A significant update to past guidance and regulation includes the addition of cleanroom socks to the required facility garments that operators use. 


  • We know that operators generate contamination.
  • Sometimes it rains, floods or personnel step into a puddle on the way to work. Wet socks are a hotbed of microbial activity, so why not remove them from the equation?
  • The operator's socks are the only visible street clothing in the cleanroom. However, leaving the cleanliness of clothing up to operators introduces an uncontrolled variable in contamination control.
  • Wearing cleanroom socks is a simple and highly effective solution for managing risk and controlling contamination. Additionally, it helps avoid potential compliance issues.

Since 2008, international good manufacturing practices (GMPs) have advocated for cleanroom socks.

"Outdoor clothing including socks (other than personal underwear) should not be brought into changing rooms leading directly to grade B and C areas."


What is Annex 1?

Who Has to Comply?

Manufacturers licensed to sell pharmaceuticals and medical devices in the EU and PIC/S member countries must comply with Annex 1, regardless of country of origin. While the FDA has not revised its standards to reflect the same requirements as Annex 1, FDA inspectors may inspect facilities according to Annex 1 rules if the product is licensed for the EU or PIC/S countries. Despite this, some manufacturers are confused as to whether they need to comply with Annex 1.

The requirements outlined in Annex 1 contain the latest international regulatory thinking for contamination control governing medicinal products. It provides a baseline that considers a wide variety of facilities and environments where medical products are manufactured.

This case study series explores the significance of addressing microbial contamination and ensuring compliance with regulatory standards, particularly focusing on the role of cleanroom socks in maintaining cleanliness and adherence to protocols.

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