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US 6,805,170 B2Granted
Method for filling a vial
AssigneeMedical Instill Technologies, Inc.
InventorDaniel Py
Life of this patent
Estimating the term…
Abstract
A resealable cap for a medicament vial has a base portion formed of vulcanized rubber or like material known for providing a stable environment for the medicament contained within the vial, and a resealable portion overlying the base portion. The resealable portion is made of low-density polyethylene or like material, and can be punctured by a needle or like injection member for dispensing medicament into the vial. Prior to filling, the cap is assembled to the vial and the cap/vial assembly is sterilized. Then, a needle is inserted through the cap and medicament is introduced through the needle and into the vial. Upon withdrawal of the needle, the penetrated region of the cap is fused by laser or direct heat sealing to hermetically seal the needle hole in the cap.
Claims28
A method of filling a vial with a predetermined medicament, comprising the following steps:
- providing a vial;
- a resealable stopper including a body defining a predetermined wall thickness in an axial direction thereof, wherein the body defines a needle penetration region that is pierceable with a needle to form a needle aperture therethrough, and is heat resealable to hermetically seal the needle aperture by applying laser radiation from a laser source at a predetermined wavelength and power thereto;
- a locking member for securing the stopper to the vial;
- and a laser source that transmits laser radiation;
- selecting a predetermined wavelength and power of the laser source;
- selecting a predetermined color and opacity of the needle penetration region of the resealable stopper that substantially absorbs laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period;
- selecting the predetermined wall thickness of the body of the resealable stopper to substantially absorb the laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness of the body;
- prior to filling the vial with medicament, assembling the stopper and locking member to the vial and forming a substantially gas-tight seal between the stopper and vial;
- sterilizing the empty assembled stopper, locking member and vial;
- penetrating the needle penetration region of the body with a needle coupled in fluid communication with a source of the predetermined medicament;
- introducing the predetermined medicament through the needle and into the interior of the vial;
- withdrawing the needle from the needle penetration region of the body and forming a needle aperture therein;
- applying laser radiation from the laser source at the predetermined wavelength and power to the needle penetration region of the body;
- substantially absorbing within the needle penetration region of the body the laser radiation at the predetermined wavelength and substantially preventing the passage of radiation through the predetermined wall thickness of the body;
- and
- causing the laser radiation at the predetermined wavelength and lower to hermetically seal the needle aperture formed in the needle penetration region of the body within the predetermined time period to form a substantially gas-tight seal between the penetrated region and the interior of the vial.
13 more elements
A method of filling a container with a predetermined substance, comprising the following steps:
- providing a container;
- providing a laser source that transmits laser radiation at a predetermined wavelength and power;
- providing a resealable stopper including a body defining a predetermined wall thickness in an axial direction thereof that substantially absorbs the laser radiation at the predetermined wavelength and power and substantially prevents the passage of such radiation therethrough, and a needle penetration region that is pierceable with a needle to form a needle aperture therethrough and that defines a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture therein in a predetermined time period;
- providing a locking member for securing the stopper to the container;
- prior to filling the container with the substance, assembling the stopper and locking member to the container and forming a substantially gas-tight seal between the stopper and container;
- penetrating the needle penetration region of the body with a needle coupled in fluid communication with a source of the predetermined substance;
- introducing the predetermined substance through the needle and into the interior of the container;
- withdrawing the needle from the needle penetration region of the body and forming a needle aperture therein;
- applying laser radiation from the laser source at the predetermined wavelength and power to the needle penetration region of the body;
- substantially absorbing within the needle penetration region of the body the laser radiation at the predetermined wavelength and power and substantially preventing the passage of radiation through the predetermined wall thickness of the body;
- and
- causing the laser radiation at the predetermined wavelength and power to hermetically seal the needle aperture formed in the needle penetration region of the body within the predetermined time period to form a substantially gas-tight seal between the penetrated region and the interior of the container.
9 more elements
Dependencies are inferred from the claim text.