Package making – Methods – Filling preformed receptacle and closing
Reexamination Certificate
2000-10-03
2001-06-26
Vo, Peter (Department: 3721)
Package making
Methods
Filling preformed receptacle and closing
C053S489000, C053S452000, C053S425000, C053S443000
Reexamination Certificate
active
06250052
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a method of partially assembling and packaging medical devices, such as syringe components and in particular prefillable syringe barrels in a clean, substantially particulate free area. More particularly, the invention is directed to a method for assembling, filling and packaging medical devices in a locally controlled environment which is clean and substantially free of airborne particulates.
BACKGROUND OF THE INVENTION
Syringes have been classified into several general types. The first type is assembled and placed in sterile packaging which can be shipped with a vial or ampoule of a drug or other injectable solution. The vial or ampoule is generally made of glass or other clear material that does not interfere with the stability of the drug during prolonged storage. The syringe is filled with the drug or other solution at the point of use and injected into the patient. Another type of syringe is packaged with a vial filled with a powdered or lyophilized drug which is dissolved in water or other suitable solvent prior to charging into the syringe.
These syringes have the disadvantage of increasing the time and difficulty of filling the syringe at the point of use with increased possibility of contamination of the syringe and/or drug solution. There is a further risk of glass particles from the ampoules contaminating the drug solution when the ampoules are opened.
Several of these disadvantages of syringes are overcome by providing prefilled syringes which can be filled with a suitable drug solution prior to use. Prefilled syringes as the term is known in the art are syringes that are filled by the drug manufacturer and shipped to the health care provider ready for use. The prefilled syringes have the advantage of convenience and ease of application with reduced risk of contamination of the drug solution. A difficulty in producing prefilled syringes, if they are made of plastic rather than glass, is selecting suitable materials that maintain their clarity for extended periods of time and do not contaminate or react with the drug solution.
Syringes and other medical appliances are generally produced and packaged in clean rooms to maintain proper cleanliness levels. The clean rooms are equipped with extensive filter assemblies and air control systems to remove particulates and pyrogens from the air in the room and to prevent particulates and pyrogens from entering the room. The operators and other personnel in the clean room are required to wear appropriate protective garments to reduce contamination of the air and the medical appliances being manufactured or assembled. As people and equipment enter and leave the clean room the risk of contamination and introduction of foreign particulates and pyrogens increases.
Accordingly, there is a continuing need in the industry for an improved system for manufacturing and assembling clean and sterile medical devices, as well as such filling devices, without the complexity and expense associated with clean rooms.
SUMMARY OF THE INVENTION
The present invention is directed to a method and apparatus for maintaining a clean environment for various assembly operations for medical devices and medical appliances. More specifically, the invention is directed to the use of a locally controlled environment for maintaining cleanliness levels for assembling medical devices, without the need for clean rooms. The medical devices can be filled with a suitable substance such as water, saline solutions, flush solutions, contrast agents, pharmaceutical agents, and vaccines in either a dry or liquid state.
Accordingly, a primary object of the invention is to provide at least one housing assembly to define a locally controlled environment for receiving medical devices or components where the components can be assembled within the housing assembly under controlled conditions.
Another object of the invention is to provide a method for assembling a syringe barrel and tip closure in a locally controlled environment.
A further object of the invention is to provide a method for filling a medical container, such as a syringe barrel, in a locally controlled environment.
A further object of the invention is to provide a method for assembling an array of medical containers, such as syringe barrels in a tray and packaging the array in a container while in a locally controlled environment.
A still further object of the invention is to provide a method for assembling tip closures to prefillable plastic syringe barrels in a locally controlled environment.
Another object of the invention is to provide a housing assembly to define a locally controlled environment where the housing assembly includes a HEPA filter and an air blower assembly to feed filtered air into the housing and maintain the housing assembly at predetermined cleanliness levels.
A further object of the invention is to provide a housing assembly to define a locally controlled environment for packaging an array of syringe barrels in closed containers and thereafter sterilizing the syringe barrels in the closed container.
The housing assembly defining the locally controlled environment can be a portable unit having a work surface for performing the desired operations manually or automatically. The work surface is enclosed by side panels which are preferably transparent to allow viewing by an operator. The assembly includes a top wall coupled to the side panels to define an enclosure. The top wall includes a fan or blower assembly and a filter assembly to direct filtered air into the housing and maintain a clean environment. The blower assembly can be operated to maintain a positive pressure in the housing assembly to prevent the infiltration of unfiltered air. An optional exhaust fan can also be provided to draw air downwardly through the housing assembly and exhaust the air without causing a negative pressure in the housing assembly.
Medical containers such as syringe barrels are placed in the housing assembly where they are cleaned by streams of clean filtered air or ionized air. The clean air removes substantially all particulates that are adhered to the inner and outer surfaces of a syringe barrel to attain the desired cleanliness level. A vacuum can be provided in the area of the barrel to carry the particulates away from the barrel and out of the housing assembly. Tip closures or syringe needles with their associated needle sheaths are also supplied to the housing assembly where they can be cleaned with filtered air or ionized air. The tip closure is coupled to the syringe barrels. A lubricant is then applied to the inner surface of the syringe barrel, and the syringe barrels are placed in a grid or tray which then is placed in a container such as a tub. A plastic sheet is placed over the tray and the tub is closed with a sheet of flexible material which generally is heat sealed to the tub. The tub is then enclosed in an outer wrap such as a plastic bag which is heat sealed. The tub, outer wrap and contents are sterilized by a sterilizing gas or radiation. These operations can be conducted in a single housing assembly or in a plurality of housing assemblies coupled together.
A method of producing a prefillable syringe in accordance with the present invention comprises the steps of supplying a plurality of syringe barrels to a first housing assembly having an air filtering device to maintain a predetermined cleanliness level therein, supplying a plurality of tip closures to the first housing assembly and assembling the tip closure on the syringe barrels. A stream of filtered air is directed to the syringe barrels and tip closures to remove particulates therefrom and clean the outer surfaces thereof. The syringe barrels and tip closures are conveyed to a second housing assembly having a filtering device for maintaining a predetermined cleanliness level, cleaning the inner surface of the syringe barrel, and applying a lubricant to an inner surface of the syringe barrels. In a third housing assembly, the syringe barrels and tip closures are fo
German Mark A.
Kropatsch James C.
Odell Robert B.
Porfano Donald J.
Becton Dickinson and Company
Huynh Louis K.
Vo Peter
Wark Allen W.
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