SterileWipes™ and Sterile Flexpacks were developed by Texwipe to clean sterile environments quickly and easily, without compromising the sterile nature of those environments. Although wipers are not medical devices, The Texwipe Company LLC has chosen to follow the guidelines of the Association for the Advancement of Medical Instrumentation (AAMI) concern ing the validation of radiation sterilization and the requirements of the United States Pharmacopeia 23 (Supplement 1 <161> Transfusion
and Infusion Assemblies and Similar Medical Devices) for endotoxin testing.
Sterilization, Validation, Documentation
Wipers are typically sterilized by gamma irradiation, electron beam, or steam autoclaving. Table 1 (see page 2) summarizes the features of gamma irradiation and electron beam sterilization.
Texwipe has chosen gamma irradiation over other sterilization techniques for the following reasons:
- Gamma irradiation has more penetrating power than electron beam. Figure 1 (see page 2) illustrates this point.
- Gamma irradiation is a relatively easy process to validate. This is especially important because Texwipe sterile products adhere to AAMI standards.
- Gamma radiation leaves no residues from treatment.
- Gamma radiation is compatible with many of the wiper materials and solutions used in Texwipe products.
- Gamma irradiation has been shown to reduce endotoxin levels to a greater extent than electron beam irradiation. (Bacterial endotoxins, or pyrogens, are fever-causing materials from the outer cell membranes of Gramnegative bacteria. These will be discussed in more detail on page 2 of this TechNote.) Steam autoclaving does not reduce endotoxin levels.1 Figure 2 (see page 2) depicts the reduction of endotoxin levels after gamma and electron-beam irradiation.