Users of ethylene oxide sterilization services have the opportunity to validate parametric release. This revolutionary release method, achieved by replacing biological monitoring with enhanced physical process monitoring, allows superior control while at the same time accelerating product turnaround and release to market. Implementation of parametric release requires installation of analytical equipment, upgraded procedures, and a more extensive process validation protocol. The most effective program involves real time transmission of the sterilization device history records containing the process data to the client. In this way, sterile product is released to market based on the sole review of process data and not based on the incubation of biological indicators. In simple terms, product can be released the moment all chemical residuals fall below limits established by ISO 10993-7. Faster aeration yields faster turnaround.
We can provide everything necessary for EO parametric release from hardware solutions to process validation services. The current EO sterilization standard, ANSI/AAMI/ISO11135-1994, is vague when instructing users about parametric release. We can provide training seminars to help you and your Team understand the hardware requirements, validation techniques, safety concerns, and the basic outline of a routine parametric release program. Together we can complete a feasibility study to determine whether parametric release can significantly improve your productivity.
Our consultants are currently involved in the generation of the first AAMI Technical Information Report dedicated to providing guidance on achieving parametric release. It is due for publication sometime in 2001. We can therefore offer cutting edge guidance to total compliance.
Utilizing our years of medical device
sterilization experience, we are currently working closely with a
manufacturer of a non-dispersive mid-infrared spectroscopic
analyzer engineered specifically for ethylene oxide sterilizers.
This superior technology allows consistent and accurate EO
process control for parametric release. The analyzer can be used
as a stand alone monitoring system for relative humidity and
ethylene oxide, or can be interfaced with the sterilization
control system allowing the user to actually base process control
on the direct measurements.