The regulations are clear that if a medical device will be in contact with compromised human tissue that the SAL should be 10-6--meaning there is a one in 1 million chance that a device coming out of a terminal sterilization
process has a viable microorganism.
OEMs need to design their products with the terminal sterilization
method in mind," added Howard.
Regulators, when comparing aseptic processing to terminal sterilization
, are saying wherever possible terminal sterilization
is preferred," Masefield said.
Low temperature terminal sterilization
with the Sterizone VP4 Sterilizer offers a more effective solution, since it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms with a sterility assurance level of 10-6 (SAL-6).
Very simply, ONE TRAY[R] reduces complete terminal sterilization
by 80+% to an efficient 20 minutes
Aseptic processing involves more variables than terminal sterilization
As a result of the complex components of each combination product, sterilization commonly is outsourced to experts such as those at the STS Life Sciences division of Ethox International, which offers a range of terminal sterilization
services, such as EO and steam, as well as management services for gamma and e-beam.
Aseptic filling is a process in which fluid is transferred from one container to another in order to prevent potential contamination without the use of terminal sterilization
Irvine, CA Xenograft/allograft stabilizing and terminal sterilization
technologies for sports medicine and spine/neurology implantable devices
What sets this product apart from similar ones on the market today: Aplicare Sterile Skin Antiseptics are sterilized after the product has been placed in the packaging, using a proprietary terminal sterilization
process to achieve a 6-log assurance level.