Sterility is a major part of every cleanroom, be it the equipment, the tools, the product, or the structure. In aseptic cleanrooms, the garments must also be sterile. Most companies require all components in an aseptic cleanroom – including garments – to be terminally sterilized to 10-6SAL. There are three methods of achieving this: autoclaving, ethylene oxide (EtO), and ionizing radiation (gamma or electron beam.)
Let’s look at the first two.
As the name suggests, sterility is attained in this method using steam and pressure. The garment is wrapped in a vapor-permeable bag and placed under a high temperature. The steam carries heat to every surface of the garment. So long as the object in the autoclave isn’t heat, pressure, or moisture-sensitive, this method is reasonably efficient and convenient. However, it typically shrinks garments up to two sizes. Aside from the obvious problem here, it degrades the material more quickly. Wrinkles also set in, making the garments unsightly.
This is a gas that kills microorganisms, and this sterilization method was used widely for years. It works by using a vacuum chamber to evacuate the air from wrapped objects and replace it with EtO. After sterilization, the gas is evacuated and air replaced. The greatest downside to this is EtO’s dangerous effects on humans. Items sterilized with this method had to be quarantined up to two weeks while the EtO dropped to a safe level. For this reason, extra garments need to be on hand to use while other garments are outgassing.
Ionizing radiation requires a more thorough explanation, and we will cover it in part two of this series. For questions about sterilization, or for cleanroom validation or certification, contact Gerbig Engineering Company. We can help you understand compliance, and we are very through in our services. Look at what we offer on our website or contact us at 888-628-0056; email@example.com.