Abstract: A sterilizing grade filter including at least two non-sterile nanofiber membranes positioned in a stacked configuration is provided. The nanofiber membranes have a bubble point from about 10 psi to about 50 psi, a thickness less than about 300 microns, and a mass/area less than about 20 g/m2. The non-sterile nanofiber membranes are separated from each other by a distance d, which may be less than about 100 microns. The membranes may be adhered together produce a composite stacked filtration material. Methods of producing a sterilizing grade filter are also provided.

Abstract: A mycoplasma retentive filter having an LRV greater than 8 including at least two mycoplasma non-retentive fluoropolymer membranes positioned in a stacked configuration is provided. The fluoropolymer membranes a bubble point from about 30 psi to about 90 psi, a thickness less than about 10 microns, and a mass/area less than about 10 g/m2. The mycoplasma non-retentive fluoropolymer membranes are is separated from each other by a distance d, which may be less than about 100 microns. The fluoropolymer membranes may be laminated or co-expanded to produce a composite stacked filtration material. In exemplary embodiments, at least one of the fluoropolymer membranes is an expanded polytetrafluoroethylene membrane. In one embodiment, the surface morphology of the fluoropolymer membranes are substantially the same and contain no or substantially no free fibrils. Methods of producing a sterilizing grade filter are also provided.

Abstract: Improved cap assemblies which isolate materials in containers, e.g., bottles, vials, multi-vial trays, multi-well trays, etc., during processes while permitting vapor to pass into or out of the container, such as during freeze drying and the like, and facilitate subsequent closure of the container to cease such vapor passage (e.g., stoppering, etc.). The cap assembly optimizes containment of solute, prevents contamination, is easy to use and is readily compatible with validated industrial drying processes.