Gamma Irradiated Wipes are wipes that have been treated with high doses of gamma rays to eliminate microbiological contamination that may be present. This process is known as bioburden destruction and is commonly used in clean rooms where maintaining a sterile environment is crucial. Gamma-irradiated wipes are exposed to a radiation dose the manufacturer assumes will eliminate bioburden. However, no metrics to determine their sterility level after irradiation, known as a Sterility Assurance Level (SAL), exist. It’s important to note that continual validation may only sometimes be necessary.
Irradiating at >25 kGy and claiming microbial control (where validated sterile claims are not required) is a viable option for some situations. For example, if the finished product is terminally sterilized, then there may not be a need for a validated sterile wipe.
Although gamma-irradiated wipes are cost-effective, validated sterile wipes are more rigorously produced. If you prioritize cost over regulations, consider the potential costs of incurring contaminated processes. Validated sterile wipes provide assurance to protect your customers and your business.
The Gamma Wipe® line of nonwoven and knitted polyester wipers is validated sterile. They are gamma irradiated and sterile validated to a 10-6 Sterility Assurance Level per ANSI/AAMI/ISO guidelines. Validated sterile wipes are certified to meet the rigorous requirements of the most demanding aseptic environments where the slightest contamination can lead to