For products that cannot withstand terminal sterilization
, Cousins explains that aseptic processing fills "the need to ensure the product is filled in a manner where there is a minimal chance for contamination by microbes, either from contacting the product contact surfaces (i.e.
Cases related to tissue bank B were linked to allografts from a common donor that were released inadvertently before standard terminal sterilization
procedures were conducted.
This Tyvek change also may be more significant for OEMs that use EtO sterilization as their terminal sterilization
Latest advances in sterilization include new validation methods for lower doses in radiation sterilization, which opens up the possibility of terminal sterilization
for products that might have been sensitive to traditional higher doses such as 25 kGy, including biologics or pharmaceuticals.
Therefore, when terminal sterilization
is planned, the materials used to create packaging or devices must allow for the sterilization conditions of both the drug or biologic as well as the resin materials themselves, to enable retention of the mechanical and physical performance of the package or device after sterilization.
The Sterizone VP4 Sterilizer is the only terminal sterilization
method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes - an industry first for any medical device sterilization process.
Very simply, ONE TRAY[R] reduces complete terminal sterilization
by 80+% to an efficient 20 minutes!
Selecting the most appropriate environmental monitoring and terminal sterilization
programs must be a function of product materials (for example, a given material may be more suitable for sterilization by gamma rays than by ethylene oxide exposure).
Aseptic processing involves more variables than terminal sterilization
. Before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes.