Abstract:
An assembly and a method for providing a sterile connection between a vessel and a bag. The assembly includes a previously sterilized bag connected to tubing which is clamped closed. The tubing is connected to the vessel. The vessel and the tubing distally of the clamp are sterilized together. The clamp is then opened to allow material to pass from the vessel to the bag in a sterile environment.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    This invention relates to the provision of a sterile connection between vessels which may be used in pharmaceutical manufacturing.  
           [0002]    During the manufacture of a pharmaceutical product, it is often required to transfer the product from a stationary vessel to a bag, which can then be transported to some other location. Before being used, the vessel, the bag, and the connection therebetween must be sterilized. The bag and connection tubing are typically sterilized at the place of manufacture and are placed within individual packaging which protects their sterility during shipment. However, when the packaging is opened at the location where the bag is to be filled, unless this is done in a sterile environment, the bag and the connection tubing lose their sterility. Usually, clamps are applied to the bag and the tubing so that the interiors thereof remain sterile, but the interiors distally of the clamps lose their sterility when the packaging is opened. These interiors then have to be re-sterilized before the bag can be filled. It would therefore be desirable to have a method for providing a sterile connection between a vessel and a bag, as well as an assembly which can be used with such a method.  
         SUMMARY OF THE INVENTION  
         [0003]    According to the present invention, there is provided a sterilized assembly adapted to provide a sterile connection between a vessel and a bag. The assembly comprises the bag and collapsible tubing having three arms connected at a central manifold. A first of the arms is secured to the bag with the interior of the tubing in communication with the interior of the bag. The assembly further comprises a first selectively tightenable clamp member on the first tubing arm and a second selectively tightenable clamp member on a second of the tubing arms.  
           [0004]    According to the present invention, a method for providing a sterile connection between a first vessel and a second vessel, wherein each of the first and second vessels has a respective connection port, comprises the steps of providing a collapsible connecting tube having first and second ends, providing a first selectively tightenable clamping member on the connecting tube between the first and second ends, securing the first end of the connecting tube to the connection port of the first vessel, tightening the first clamping member to collapse the connecting tube, sterilizing the first vessel and the connecting tube, securing the second end of the connecting tube to the connection port of the second vessel, sterilizing the interior of the second vessel and the interior of the connecting tube from its second end to where it is collapsed by the first clamping member, and loosening the first clamping member to dilate the connecting tube.  
           [0005]    In accordance with an aspect of this invention, the step of sterilizing the interior of the second vessel and the interior of the connecting tube comprises the step of utilizing steam to perform the sterilization. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]    The foregoing will be more readily apparent upon reading the following description in conjunction with the drawings in which like elements in different figures thereof are identified by the same reference numeral and wherein:  
         [0007]    [0007]FIG. 1 is a plan view of an embodiment of the assembly according to the present invention;  
         [0008]    [0008]FIG. 2 is a view of the assembly shown in FIG. 1 connected to the vessel and to a steam trap;  
         [0009]    [0009]FIG. 3 is a flow chart of a sterilization method according to the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0010]    Referring now to the drawings, FIG. 1 shown an assembly, designated generally by the reference numeral  10 , which may be utilized in practicing the present invention. The assembly  10  includes a bag  12  connected to collapsible connection tubing  14 . The tubing  14  has three arms  16 ,  18 , and  20  connected at a T-shaped central manifold  22 . Fittings  24 ,  26  are secured to the distal ends of the tubing arms  18 ,  20 , respectively, to allow for connection to corresponding fittings, as is conventional in the art. A first selectively tightenable clamp member  28  is provided on the tubing arm  16  and a second selectively tightenable clamp member  30  is provided on the tubing arm  20 . It is preferred that the clamps  28 ,  30  be as close to the manifold  22  as possible. Specifically for the clamp member  28  this limits the intrusion of steam, as will be described hereinafter. Preferably, the bag  12  and the tubing  14  are both made of silicone and the interior of the bag  12  is in communication with the interior of the tubing  14 . With the clamp member  28  tightened to collapse the tubing arm  16  and provide a seal thereat, the assembly  10  is sterilized, illustratively by radiation, and placed in a sealed package (not shown), so that it can be transported while remaining sterile.  
         [0011]    When the assembly  10  arrives at the location where the bag  12  is to be filled, the first clamp member  28  remains closed and the assembly  10  is removed from its sterile package. The fitting  24  at the end of the tubing arm  18  is secured to a corresponding fitting  32  at the end of a connection port  34  of the vessel  36 . A clamp, not shown, is used to secure the fitting  24  to the fitting  32 . The fitting  26  is secured by a clamp, not shown, to a fitting  38  of a steam trap  40 . After making sure that the second clamp member  30  is opened, steam is utilized to sterilize the interior of the vessel  36 . This steam passes through the connection port  34  to the interior of the tubing arm  18  and the interior of the tubing arm  16  up to the first clamp member  28 , thereby sterilizing this interior. The steam passes through the tubing arm  20 , sterilizing its interior as well, and is collected in the steam trap  40 . After this sterilization process, the second clamp member  30  is closed to seal off the tubing arm  20 . Material may then be placed in the vessel  36  and the first clamp member  28  may be opened to allow the material to fill the bag  12 . After the bag  12  is appropriately filled, the first clamp member  28  is closed to seal the material within the bag  12 . The clamps on the fittings  24 ,  26  may then be removed so that the steam trap  40  can be removed and the now-filled bag  12 , along with the tubing  14 , is separated from the vessel  36 .  
         [0012]    The aforedescribed sterilization method is illustrated in FIG. 3. As shown in the box  50 , the bag  12  and the tubing  14  are sterilized with the first clamp  28  closed. Then, as shown in the box  52 , the tubing  14  is connected to the vessel  36  and the tubing arm  20  is connected to the steam trap  40 , with the second clamp  30  being open. As shown in the box  54 , steam is applied to the vessel  36 . As shown in the box  56 , the second clamp  30  is closed. As shown in the box  58 , the first clamp  28  is opened.  
         [0013]    While the aforedescribed sterilization method has disclosed the use of steam for sterilizing the vessel  36  and the tubing  14 , there may be other ways of sterilizing the vessel  36  and the tubing  14 . In this case, the steam trap  40  would be unnecessary and the tubing  14  can be constructed as a straight tube without the manifold  22  or the tubing arm  20 . The clamp member  28  would still be required and the assembly of the bag and tubing would be sterilized and then shipped in its sealed packaging with the clamp member  28  closed. In this case, the clamp member  28  would be as far from the bag  12  as possible.  
         [0014]    Accordingly, there has been disclosed an improved method for providing a sterile connection between two vessels, along with an assembly that can be utilized in practicing the method. While an illustrative embodiment of the present invention has been disclosed herein, it is understood that various modifications and adaptions to the disclosed embodiment are possible, and it is intended that this invention be limited only by the scope of the appended claims.