Abstract A package for objects such as sutures which are to be contained under conditions of complete sterilization is disclosed along with a method for in-line sterilization packaging of the objects on mass production basis. The package includes an inner packet in which is received a sterile surgical object such as a coil of suture material, the inner packet being substantially hermetically sealed and at least initially having a sterilizing gas confined therein. The sealed inner packet in turn is received in an outer packet of the same general construction as the inner packet and which also is substantially hermetically sealed and initially has a sterilizing gas confined therein. Both the inner and outer packets can be opened readily by peelably removing the respective packet closure lids from associated packet blisters which form the bottoms of the packets. The package is made by filling the inner packet blister with a sterile surgical object, then tacking a lid onto the blister and confining the inner packet in a vacuum chamber to remove air from the inner packet. A positive pressure of a sterilizing gas is then admitted to the chamber so as to initiate killing any bacteria on the surgical object and render it and the interior of the inner packet sterile. The lid is then completely sealed to its associated blister while still in the chamber so that a quantity of the sterilizing gas is captured within the sealed inner packet. The sealed inner packet is then removed from the vacuum chamber and placed in the outer packet blister and a closure lid is tacked in place on the blister. The outer packet and its contents is then placed in a chamber and subjected to a vacuum to remove air from the outer packet after which, a positive pressure of sterilizing gas is admitted to chamber to render the interior of the outer packet and exterior of the inner packet sterile. The lid of the outer packet is then completely sealed to its associated blister while still in the chamber and under pressure of the sterilizing gas thereby to capture within the sealed outer packet a quantity of such gas.
A method for in-line sterile packaging of surgical objects in inner and outer component packages which comprises receiving successive ones of said surgical objects in a box-like blister and tack-sealing closures on each blister to thereby provide the inner component of each package, introducing said inner components into a conditioning zone and subjecting them to a condition of vacuum, thereafter introducing a sterilizing gas into said conditioning zone at a positive pressure to initiate destruction of any bacterial agency present in the surgical objects and said inner components, thereafter hermetically heat-sealing the inner component closures to their respective blisters while in said conditioning zone, removing said sealed inner components from said conditioning zone and receiving them each in separate box-like blisters and tack-sealing closures on the last-mentioned blisters to thereby provide package outer components, then introducing said outer components into a conditioning zone and subjecting them to a condition of vacuum, thereafter introducing a sterilizing gas into said conditioning zone at a positive pressure to initiate destruction of any bacterial agency present in said outer components and on the exterior of said inner components, and thereafter hermetically heat-sealing the outer component closures to their respective blisters while in said conditioning zone.
Claim 2
Independent Claim
201 words
A method for in-line sterile packaging of surgical objects in inner and outer component packages which comprises receiving successive ones of said surgical objects in a box-like blister and tack-sealing closures on each blister to thereby provide the inner component of each package, introducing said inner components into a conditioning zone and subjecting them to a condition of vacuum, thereafter introducing a sterilizing gas into said conditioning zone at a positive pressure to initiate destruction of any bacterial agency present in the surgical objects and said inner components, thereafter hermetically heat-sealing the inner component closures to their respective blisters while in said conditioning zone, removing said sealed inner components from said conditioning zone and receiving them each in separate box-like blisters and tack-sealing closures on the last-mentioned blisters to thereby provide package outer components, then introducing said outer components into a conditioning zone and subjecting them to a condition of vacuum, thereafter introducing a sterilizing gas into said conditioning zone at a positive pressure to initiate destruction of any bacterial agency present in said outer components and on the exterior of said inner components, and thereafter hermetically heat-sealing the outer component closures to their respective blisters while in said conditioning zone.
Claim 3
Dependent Claim
19 words
The method of claim 1 wherein said sterilizing gas is a mixture of ethylene oxide and an inert gas.
Claim 4
Dependent Claim
27 words
The method of claim 2 wherein said ethylene oxide and inert gas are present in said mixture in percentages of substantially 12 percent and 88 percent respectively.
Claim 5
Dependent Claim
32 words
The method of claim 1 wherein the condition of vacuum to which said inner and outer components are subjected is in the range between about 1 in. Hg. and 29 in. Hg.
Claim 6
Dependent Claim
26 words
The method of claim 1 wherein the positive pressure at which said sterilizing gas is introduced into said conditioning chamber is up to about 1 PSIG.