Method of packaging and sterilizing a pharmaceutical product
First Claim
1. A method of preparing and sterilizing a pharmaceutical package comprising a squeeze-type bottle containing a selected pharmaceutical liquid product, said method including the steps of:
- (a) filling a resilient polymeric bottle with the selected pharmaceutical product to the point that said bottle is filled to capacity so as to eliminate any residual air in the bottle or the bottle neck, said bottle formed of a material that will withstand sterilizing temperatures without deforming and with substantially no leakage of vapor through the wall thereof;
(b) inserting a plug-type cannula adapter in the neck of each bottle while forcing out excess liquid and maintaining the bottle completely filled, said adapter being of the type used for connecting the pharmaceutical package to a cannula or other such medical apparatus;
(c) capping the bottles with a cap and providing a seal between the inner surface of the top wall of the cap and the rim of the bottle to absorb pressures developed by expansion of said bottle and prevent deformation of the cap and bottle during subsequent sterilization, thus eliminating leakage therebetween;
(d) forming a package by inserting said bottle into an individual blister pack formed of a prescribed polymeric material suitable for use in a sterilization procedure and sealing said blister pack along the open side thereof with a closure lid made from a non-woven textile material having the characteristics of being permeable and capable of withstanding and remaining sealed to said polymeric material during the sterilization procedure; and
(e) sterilizing said package.
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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.
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Citations
11 Claims
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1. A method of preparing and sterilizing a pharmaceutical package comprising a squeeze-type bottle containing a selected pharmaceutical liquid product, said method including the steps of:
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(a) filling a resilient polymeric bottle with the selected pharmaceutical product to the point that said bottle is filled to capacity so as to eliminate any residual air in the bottle or the bottle neck, said bottle formed of a material that will withstand sterilizing temperatures without deforming and with substantially no leakage of vapor through the wall thereof; (b) inserting a plug-type cannula adapter in the neck of each bottle while forcing out excess liquid and maintaining the bottle completely filled, said adapter being of the type used for connecting the pharmaceutical package to a cannula or other such medical apparatus; (c) capping the bottles with a cap and providing a seal between the inner surface of the top wall of the cap and the rim of the bottle to absorb pressures developed by expansion of said bottle and prevent deformation of the cap and bottle during subsequent sterilization, thus eliminating leakage therebetween; (d) forming a package by inserting said bottle into an individual blister pack formed of a prescribed polymeric material suitable for use in a sterilization procedure and sealing said blister pack along the open side thereof with a closure lid made from a non-woven textile material having the characteristics of being permeable and capable of withstanding and remaining sealed to said polymeric material during the sterilization procedure; and (e) sterilizing said package. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification