Pipe joints or couplings – Materials – Nonmetallic
Reexamination Certificate
2001-08-06
2004-01-20
Bochna, David (Department: 3679)
Pipe joints or couplings
Materials
Nonmetallic
C285S915000, C285S003000, C604S905000
Reexamination Certificate
active
06679529
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of Invention
The present invention relates generally to a method and apparatus to form sterile connections, and more particularly, a method and apparatus for inexpensively creating sterile connections in non-sterile environments.
2. Background of the Invention
Presently, the pharmaceutical industry is comprised of two manufacturing systems. The first manufacturing system is the traditional system that uses clean rooms, stainless steel reactors, holding tanks, and piping to maintain sterile conditions during manufacture. The second manufacturing system is state-of-the-art biotechnology manufacturing that uses an assortment of disposable plastic bags and flexible sterile tubing. With the traditional manufacturing methods, clean-in-place and steam-in-place systems are required to assure that the stainless steel reactors and piping remain clean and sterile. A sterile clean room is also required during traditional manufacturing processes so that when necessary connections are made that breach the sterile piping, the environment does not contaminate the fluid flow. Maintaining a clean room is time consuming and difficult to validate. In contrast, the state-of-the-art biotechnology methods use plastic bags and tubing sets that can be sterilized prior to implementation in the manufacturing process and are completely disposable. Biotechnology manufacturing methods require significantly less capital because no initial investment in expensive stainless steel reactors or piping is required.
The tubing in biotechnology manufacturing is used between process containers and equipment that require sterile connections. A sterile tube welding machine can be used to weld the thermoplastic tubing in a sterile manner without the need for a laminar flow cabinet or similar environmental control device. The tube welder sterilizes a cutting blade or wafer then moves the blade through the two ends of the tubing to be joined. Once both ends of the tubing have been cut, the machine aligns the ends of the tubes while maintaining a high temperature. After the thermoplastic tubes cool, a sterile weld is formed. Another system utilizes a self contained HEPA system and a sterile plastic connector to create the union; still using the heated blades.
The various types of sterile tubing welders have disadvantages in that there is a limited range of the size of tubing that can be welded by one particular tube welding machine. A tube welding machine is also usually limited in applicability to specific tube materials such as thermoplastic. Furthermore, tube welding machines are typically large, heavy, lack versatility, and expensive.
The biotechnology approach, out of necessity, requires large amounts of disposable flexible tubing. This tubing is used to convey the sterile contents of one bag to another. Each time a connection is made to add or remove contents of a bag, only one of four systems noted below can be used; each system has significant shortcomings.
TABLE 1
Cost per
Device
Connection
Comments
Terumo Sterile
US $ 3.00 to
Clean room required one-quarter inch
Connection
5.00
O.D. maximum size; lab scale and
Device
R&D applications only. Requires
thermoplastic elastomer (herein “TPE”)
for tube material.
Wave Ree-
US $ 4.00 to
Clean room required; tubing up to ¾″
welder
7.00
O.D. in size; requires TPE material;
new and unproven design; expensive
at US $ 35,000.00 per typical
application.
CPT Aseptic
US $ 7.00 to
½ by ¾ and ⅜ by ⅝ inch tubing;
Connection
10.00
heavy and large; expensive at
Device
US $ 35,000.00 per typical application;
uses only C-Flex TPE tubing.
Manual System
US $ 10.00 to
Manual method requires clean room and
25.00
clean hood utilizing sterile
utensils and connections; training in
sterile technique required.
All of the systems listed above require the use of thermoplastic tubing (no silicone) except the manual system. The ideal aseptic/sterile connection system would have the following characteristics:
1. Applicability to a wide array of tubing materials and sizes;
2. Inexpensive to assemble and maintain;
3. Requires no capital equipment;
4. Operates without a clean room;
5. Disposable;
6. Reliable and repeatable; and
7. Operator independent.
The current systems in use presently fall short of meeting the ideal criteria. Thus, there is a need for a disposable aseptic connection system that does not require a tube welding machine. A disposable aseptic connection system that does not employ a tube welding machine could be used regardless of the tubing material, size or location, at a competitive cost. Additionally, once a company commits to this type of connector, all pre-sterile bags and tube sets can be supplied with the appropriate disposable aseptic connection system fittings already in place. Therefore, connections are simple, repeatable and validatable.
Prior art describes varying apparatus for accomplishing sterile connections using a disposable aespetic connection system. By way of example, U.S. Pat. No. 4,418,945 to Kellog describes sterile connectors having strips that are withdrawn to expose the ends of conduits attached to cooperating connectors. U.S. Pat. No. 4,149,534 to Tenczar describes sterile connectors for joining conduits having an adhesive release positioned on adjoining faces of the connectors. U.S. Pat. No. 4,030,494 to Tenczar describes sterile fluid connectors having cooperating heat penetratable and fusible plastic barriers for coupling two conduits. U.S. Pat. No. 4,022,205 to Tenczar describes sterile fluid connectors having cooperating adhesive surfaces that are jointly punctured upon coupling two conduits. U.S. Pat. No. 4,019,512 to Tenczar describes an adhesively sterile connector having a protective member that is progressively pulled away. U.S. Pat. No. 3,865,411 to Rowe et al. describes a sterile connector having an adhesive release and two connectors are used to make a connection. Rowe et al. teaches to align the adhesive portions; then the free ends of the adhesive are pulled thereby exposing the free ends of the connectors to form a sealed, sterile fluid passage.
Notwithstanding the existence of such prior art disposable aseptic connection systems, there is a need for an improved and more efficient apparatus and method for using a disposable aseptic connection system that can be used as either a temporary or permanent connection.
An objective of the present invention is to provide a disposable aseptic connection system that is a temporary and disposable connection.
Another objective of the present invention is to provide a disposable aseptic connection system that is adaptable to a permanent connection.
Another objective is to provide a connection that is reliable and repeatable.
Still another objective is to provide a disposable aseptic connection system that is operator independent.
Another objective is to provide a connection system that is applicable to a wide array of tubing materials and sizes.
Another objective is to provide a disposable aseptic connection system that is inexpensive to assemble and maintain and requires no expensive equipment.
Another objective is to provide an aseptic connection system that can operate without a clean room.
Another objective is to provide a connection means that is compatable with the standard sanitary fittings common to the biotechnology industry.
It is, therefore, to the effective resolution of the aforementioned problems and shortcomings of the prior art that the present invention is directed.
However, in view of the prior art at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how the identified needs could be fulfilled.
SUMMARY OF INVENTION
The present invention solves significant problems in the art by providing an apparatus for establishing an aseptic/sterile connection comprising a substantially flexible, substantially transparent sterile barrier enclosing a terminal end of a conduit, a resilient, deformable support card fixed to the sterile barrier having an outer face disposed
Boley-Johnson Robin M.
Johnson Theodore D.
Bochna David
Hopen Anton J.
Smith & Hopen , P.A.
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