If you have a sterile fluid pathway, is this considered your Sterile Barrier System? What would you suggest for validation of this SBS? Is outer packaging considered protective?
The following response was provided by Mike Scholla of DuPont, Convener ISO TC198 WG7 group that wrote and maintains responsibility for revising ISO 11607.
A sterile fluid path is a special case when it comes to a sterile barrier system, which is why there is a specific definition in ISO 11607. In a sterile fluid path system, fluids flow through a lumen, the critical characteristic is that the inside of the tube is sterile. This is in contrast to a typical medical device, where is it critical that the outside of the instrument is sterile. The sterility of the sterile fluid path system is maintained by the closure system of the fluid path, and it must be demonstrated that the closure system maintains sterility until point of use. Sterilization validation is usually conducted by exposure to an aerosol of spores followed by sterility testing of the lumen.
As many sterile fluid path systems are packaged in pouches, a common sterile barrier system, it is important to determine in each case what is providing the sterile barrier and to make sure that the package is labeled accordingly. Without such labeling a user may assume the pouch is providing the sterile barrier. If the sterile fluid pathway is labeled as such, then the pouch enclosing may be considered protective packaging and validated as part of the packaging system.