Case Study Series

Contain Microbial Contamination and Achieve Compliance with Cleanroom Socks

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.

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.

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.

Don’t Let These Common Mistakes Turn into BIG Problems

The three contaminant types we need to manage in a life science cleanroom are particulates, bacteria, and endotoxins.

Sterile, medical-grade gloves may contain multiple contamination types because:

• They are not made in a cleanroom.
• They are not cleaned prior to sterilization
• They are not designed for longer working conditions.

This case study discusses the critical importance of managing particulates, bacteria, and endotoxins in a life science cleanroom environment, and underscores the necessity of addressing potential sources of contamination associated with sterile, medical-grade gloves with real-world practices.