What Makes a Room Suitable for Aseptic Processes?

Biological contaminants are ubiquitous. Microorganisms such as bacteria or fungi roam free in most environments and can cause disease. A major goal of aseptic applications, including surgery, pharmaceutical compounding or medical implant packaging is to prevent contaminants and the potential for disease, so how do we create the ideal setting?

Building a microorganism-free space is exactly what regulatory guidelines aim to achieve. Asepsis is the objective, and certified facilities are bound by regulations that dictate design and protocol for optimizing aseptic processing.

 

Building the ideal ISO-compliant room consists of a combination of design and materials, which we’ll discuss here, but after the cleanroom is ready for operation, continued success depends on other important issues:

  1. Establish and execute a robust training program for workers (gowning, work processes,
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