Packaged pharmaceutical product
First Claim
1. A sterile pharmaceutical package comprising:
- a) a translucent, resilient polymeric bottle formed of a material capable of withstanding sterilization temperatures without vapor leakage through the walls thereof;
b) a cap and means for securing said cap to the open top of said bottle;
c) sealing means positioned between the inner surface of the top wall of said cap and the rim of said bottle, said sealing means serving to absorb pressures developed by expansion of said bottle and prevent deformation of said cap during sterilization thus eliminating leakage therebetween; and
d) a blister pack formed of a prescribed polymeric material suitable for use in a sterilization procedure without melting, a closure lid placed along the open side of said blister pack and formed from a non-woven textile material having the characteristics of being permeable, said closure lid being sealed to said polymeric material around the open side thereof, and capable of remaining sealed during said sterilization procedure.
4 Assignments
0 Petitions
Accused Products
Abstract
A method of filling, sealing and sterilizing a pharmaceutical package including a polypropylene bottle containing a balanced salt solution includes the steps of filling each bottle to maximum capacity to exclude residual air, the introduction of a silicone rubber gasket into the bottle cap to absorb pressure and prevent leakage during a steam sterilization procedure, and the enclosure of the filled bottles in a blister pack before steam sterilizing. The blister packs have Tyvek™ lids and are placed blister-side-up during the sterilization process to eliminate deformation of the blister during sterilization. Maximum filling of the bottle with liquid and the substantial elimination of air prevents dimpling of the bottle.
560 Citations
9 Claims
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1. A sterile pharmaceutical package comprising:
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a) a translucent, resilient polymeric bottle formed of a material capable of withstanding sterilization temperatures without vapor leakage through the walls thereof; b) a cap and means for securing said cap to the open top of said bottle; c) sealing means positioned between the inner surface of the top wall of said cap and the rim of said bottle, said sealing means serving to absorb pressures developed by expansion of said bottle and prevent deformation of said cap during sterilization thus eliminating leakage therebetween; and d) a blister pack formed of a prescribed polymeric material suitable for use in a sterilization procedure without melting, a closure lid placed along the open side of said blister pack and formed from a non-woven textile material having the characteristics of being permeable, said closure lid being sealed to said polymeric material around the open side thereof, and capable of remaining sealed during said sterilization procedure. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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Specification