QUESTION: Is it OK to use gamma irradiated wipes in place of validated sterile wipes for aseptic processes?

ANSWER: No, you should definitely use validated sterile wipes.

Gamma irradiated wipes are hit with a radiation dose that the manufacturer assumes will kill the bioburden. There are no metrics behind the sterility after irradiation, which is referred to as a Sterility Assurance Level (SAL).

Even if the dosage was in fact correct, you have absolutely no guarantee that the packaging has kept the wipes sterile. Ask yourself, what are the odds that a particular package of gamma irradiated wipes are sterile—10,000-to-1, 100-to-1, 10-to-1? There is no way of knowing.

Validated sterile wipes are also irradiated, but the dosage is carefully monitored and its efficacy is consistently tested according to regulatory guidelines. Our validated sterile wipes have an SAL of 10-6, which literally means that there are 1,000,000,000-to-1 odds that your wipes are sterile. Additionally, the packaging is strictly controlled to ensure that the wipes remain validated sterile.

Gamma irradiated wipes are significantly cheaper for a reason—a lot less goes into their production. Even if you are less concerned with regulations than expenses, consider the potential costs of tainted aseptic processes. Go validated sterile and protect your customers and your business.