Validated Sterile wipes are sterilized using gamma-ray bombardment. In addition, to confirm their sterility levels, they also undergo testing according to the appropriate Sterility Assurance Level (SAL). Sterility assurance means confidence that a product or unit claimed to be sterile is sterile. This assurance is achieved through carefully controlled practices and procedures. The irradiation dosage is closely monitored, and its effectiveness is regularly tested to comply with regulatory guidelines.
To satisfy the standards for Validated Sterile wipes, the minimum sterilizing dosage is based on the average bioburden levels of the product. Once the mean bioburden and minimum validated sterilizing dose is established, the product can enter production with a sterile claim. However, regular dose audits are conducted to ensure that the bioburden levels or their sensitivity to gamma irradiation have stayed the same over time. Both bioburden and dose audits are required for continued sterile validated claims.
It’s important to note that, unlike gamma-irradiated wipes, customers can be confident that Validated Sterile wipes have a SAL of 10-6 and are documented as sterile. Their dosage is carefully monitored, and their effectiveness is consistently tested according to regulatory guidelines.
Most validated sterile wipes that are widely used have a probability of only one non-sterile unit for every one million sterile units. Furthermore, the packaging is strictly controlled to ensure the wipes remain sterile over the shelf life assigned to the product.
The Sterile SatPax® line of presaturated IPA nonwoven and knitted polyester wipers are validated sterile. They are gamma irradiated and sterile validated to a 10-6 Sterility Assurance Level per ANSI/AAMI/ISO guidelines. Validated sterile presaturated wipers provide a cost-effective and easy-to-use solution versus traditional bulk handling of solvents, maintenance of squirt bottles, and inconsistent wetting and cleaning associated with wetting a dry wiper.