Claims for Patent: 4,553,677

Summary for Patent: 4,553,677

Title:	Dilution bottle
Abstract:	A dilution bottle for mixing a sample material with a sterile diluent solution. The bottle comprises side wall portions of synthetic polymeric material formed around the central axis of the bottle, a bottom wall of polymeric material closing off one end of the bottle, and the opposite end of the bottle including an opening. At least one side wall portion of the bottle is formed with one or more concave protrusions extending into the interior of the bottle, the protrusions being dimensioned so as not to obstruct the introduction of insertion means along said axis. The bottle also includes means for sealing the opening of the bottle so as to maintain aseptic conditions within the bottle.
Inventor(s):	Shuster; Herbert V. (Waban, MA)
Assignee:	Aseptic Technologies, Inc. (Quincy, MA)
Application Number:	06/618,832
Patent Claims:	1. A dilution bottle for mixing sample material with a sterile diluent solution, said bottle comprising, in combination: side wall portions of blow-moldable, synthetic polymeric material formed around the longitudinal axis of said bottle, a bottom wall of said polymeric material closing off one end of said bottle, and the opposite end of said bottle including an opening, at least one side wall portion of said bottle being formed with a protrusion extending into the interior of said bottle; and means for sealing said opening of said bottle so as to maintain aseptic conditions within said bottle, said means for sealing said bottle comprising an ancillary sterile stopper emplaced in said opening, and a seal formed of said plastic material integrally with said bottle and spaced from and encapsulating said stopper, said stopper being shaped as an extended closed cylinder surrounded coaxially at one end thereof by a hemi-torus which in turn is surrounded coaxially by a disc-shaped rim, said cylinder, hemi-torus and rim being formed integrally of a resilient, liquid-impermeable material. 2. A bottle according to claim 1, wherein said protrusion is conical-like in shape. 3. A bottle according to claim 2, wherein said bottle includes at least two of said protrusions formed as integral parts of diametrically-opposed side portions of said bottle. 4. A bottle according to claim 3, wherein said protrusions are axially-offset from one another with respect to said longitudinal axis. 5. A bottle according to claim 3, wherein the apices of said protrusions are spaced from said central axis so as not to obstruct the introduction of insertion means along said axis. 6. A bottle according to claim 1, wherein said seal includes a groove positioned so that said seal, upon the application of mechanical force thereto, will fracture to provide access to said stopper. 7. A bottle according to claim 1, wherein a side wall portion of said bottle includes at least one fiducial mark for indicating a fill level for said sterile diluent solution.

Details for Patent 4,553,677

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23