Part two explores gamma irradiation as a sterilizing technique for aseptic cleanroom garments.
Sterile garments are a regular part of any aseptic cleanroom. Most companies require that all components in this kind of controlled environment, including garments, be terminally sterilized to 10-6SAL. There are a few ways of accomplishing this.
In part 1, we discussed the first two of three methods of sterilizing these garments: steam autoclaving and EtO. While both methods have their upsides, neither is considered the most advantageous given the culture and needs of today’s cleanroom. This brings us to the third, most preferred method of garment sterilization: ionizing radiation.
This includes two forms, though gamma irradiation is the only one being successfully used in cleanrooms. The electromagnetic radiation of gamma rays has great penetrating power, like an x-ray, but with a shorter wavelength. Sterilization with these rays occurs after the garments have been laundered and packaged. Before gamma irradiation, however, you must follow validation protocol to determine the dosage required to obtain the desired sterility. Since this kind of radiation is destructive, it’s important to use the lowest possible dose, which may be lower than the 25 kilograys we know are sufficient. This will help extend the garment life significantly.
Liability also plays a role in using the lowest possible dosage. Garment service providers undergo extremely rigorous customer audits because if the process drifts out of control or the dose has not been set properly, it can put a person’s life at risk. Therefore, the calculated sterilization dose for gamma irradiation will be included in the customer specifications for the product.
When it comes to cleanrooms, every aspect of sterilization and sanitation affect compliance and validation. Gerbig Engineering Company knows how vital every detail is the overall process. If you need cleanroom validation or certification, or if you need cleanroom construction, reach out to us. We know what you need to achieve and maintain success: 888-628-0056; email@example.com.