Reinforced film for biocontainers
A material for biocontainers comprising a film formed of two or more layers forming a body to the film, the film having an interior and exterior side, and a substrate incorporated in the body of the film wherein the substrate is formed of a fibrous material, wherein each of the at least one of the two or more layers comprises an ethylene vinyl acetate resin. A non-constrained pressure test is also disclosed.
1 . A material for biocontainers comprising:
three layers, wherein the three layers are ordered as an inner contact zone, a gas impermeable zone, and an outer strength zone comprising two layers of polyethylene;
wherein the inner contact zone comprises a first interior side layer and an exterior side layer, the first interior side layer comprising an ethylene vinyl acetate and the exterior side layer comprising ultra-low density polyethylene;
wherein the gas impermeable zone comprises an ethylene vinyl alcohol material; and
a stress-inhibiting substrate disposed between the inner contact zone and the gas impermeable zone, wherein the stress-inhibiting substrate is formed of a fibrous polyamide material and wherein the stress-inhibiting substrate is embedded within an ethylene vinyl acetate resin, forming a discontinuity wherein cracks cannot propagate into or through the inner contact zone;
a first tie layer comprising ethylene vinyl acetate disposed between the gas impermeable zone and the stress-inhibiting substrate; and
a second tie layer comprising ethylene vinyl acetate disposed between the stress-inhibiting substrate and inner contact zone, forming a flexible material having an embedded substate that is resistant to stress concentrations and cracks, maintaining sterility.
2 . The material of claim 1 wherein the stress-inhibiting substrate is formed of a material selected from the group consisting of woven and non-woven fibrous material.
3 . The material of claim 1 wherein the stress-inhibiting substrate is a woven material selected from the group consisting of polymer fibers, metal fibers, carbon fibers and glass fibers.
4 . The material of claim 1 wherein the stress-inhibiting substrate is formed of a non-woven fibrous material selected from the group consisting of polyamide, polyester, aramids, carbon, metal, glass and polyolefins.
5 . The material of claim 1 wherein the stress-inhibiting substrate has one or more openings formed in it to provide a device selected from the group consisting of a viewing window and a port.