Patent Publication Number: US-6668526-B2

Title: Web centering system

Description:
TECHNICAL FIELD 
     The present invention relates generally to a mechanism for adjusting the direction of a web of material in a packaging machine, and more specifically to an assembly for centering or tracking a web of film in an aseptic environment of a form-fill-seal packaging machine. 
     BACKGROUND OF THE INVENTION 
     One type of packaging machine is a form-fill-seal packaging machine. Form-fill-seal packaging machines are typically utilized to package a product in a flexible container. To this end, form-fill-seal packaging machines are used to seal pharmaceuticals, foods, liquids, magazines, cosmetics, pre-boxed goods, and numerous other items in flexible containers. The form-fill-seal packaging machine provides an apparatus for packaging these and many other products in an inexpensive and efficient manner. 
     Pursuant to FDA requirements, certain pharmaceuticals packaged in form-fill-seal packages are traditionally sterilized in a post-packaging autoclaving step. The post-packaging step includes placing the sealed package containing the pharmaceutical in an autoclave and steam sterilizing or heating the package and its contents to a required temperature, which is often approximately 250° F., for a prescribed period of time. This sterilization step operates to kill bacteria and other contaminants found inside the package, whether on the inner layer of film or within the pharmaceutical itself. 
     Certain packaged pharmaceuticals, however, cannot be sterilized in such a manner. This is because the intense heat required to kill the bacteria in the autoclaving process destroys or renders useless certain pharmaceuticals. As such, a different method of sterilization must be employed when packaging these types of pharmaceuticals. 
     One method of packaging heat sensitive pharmaceuticals is to first sterilize the pharmaceutical with a means other than intense heat, often through filtering, and then to package the pharmaceutical in an aseptic environment. 
     To date, the assignee of the present invention has developed several improvements in aseptic form-fill-seal packaging. Such improvements include at least: U.S. Pat. No. 4,761,197 (directed to an apparatus for sealing a web of film); U.S. Pat. No. 4,695,337 (directed to an apparatus and method for attaching a fitment to a web of film); U.S. Pat. No. 4,829,746 (directed to an apparatus for placing a web of film under tension); U.S. Pat. No. 4,888,155 (directed to an apparatus for sterilizing film and like packaging material); U.S. Pat. No. 4,744,845 (directed to an apparatus for splicing film together); and, U.S. Pat. No. 4,783,947 (directed to an apparatus for removing liquid and residue from a web of film). 
     Web tracking assemblies utilized in conventional form-fill-seal packaging machines (i.e., form-fill-seal packaging machines that do not include an aseptic packaging environment) are generally not suitable for use in an aseptic environment. For example, two conventional web tracking means are disclosed in U.S. Pat. No. 3,680,446, issued to James et al., and U.S. Pat. No. 5,833,106, issued to Harris. The &#39;446 patent issued to James et al. discloses a tracking system including a shiftable web guide roller having adjustable air cylinders mounted at its opposite ends for independently adjusting the ends of the roller (see FIG. 1 of the &#39;446 patent). The &#39;106 patent issued to Harris discloses an equalizing roll utilizing a common-axis shaft mounted horizontally on two bearings at its end for support, and a roller or sleeve mounted on the shaft. The sleeve has a single bearing mounted in the center of the sleeve with convex and concave portions that allows the sleeve to laterally rotate on the central bearing (see FIG. 5 of the &#39;106 patent). Such web tracking devices of the &#39;446 and &#39;106 patents are likely not appropriate for aseptic environments because of the number of moving parts and the areas for gathering particulate bacteria matter. 
     Thus, improvement in tracking the web of film as it enters the former in aseptic form-fill-seal packaging machines would be useful. To date, form-fill-seal packaging machines designed for aseptic packaging utilize a tracking assembly located adjacent the unwind, and outside the aseptic environment. This tracking assembly, however, is not located adjacent the former, but rather is located upstream of the ultimate package forming process. Thus, occasionally difficulties are encountered in attempting to track the film within the aseptic environment. As a result of this web-tracking limitation, much waste, inefficiency, and increased manufacturing costs are encountered by packagers in this industry. Specifically, when the web tracking is not balanced, and the web is not aligned through the former, each package that is created generally must be discarded due to improper overlap of the layers of film in the seal area. This may result in wasted film and wasted pharmaceutical material. It also may result in increased operator expense to observe the misaligned film, to select and discard the poorly formed packages, and to attempt to re-align the film. Further, severe cases of misaligned film may result in down time for the machine. All of the above increases the manufacturing costs of packaging such pharmaceuticals. 
     Thus, a means for tracking the web of film in the aseptic environment of a packaging machine is essential. 
     SUMMARY OF THE INVENTION 
     The web-centering apparatus of the present invention provides an assembly for tracking a web of material within an internal aseptic area of a form-fill-seal packaging machine. Generally, the web-centering apparatus comprises a support member, a tracking assembly, and an alignment mechanism. While the web-centering apparatus is located within the aseptic area of the packaging machine, certain components of the web-centering assembly are sealed off from the aseptic area in order to maintain the integrity of the aseptic environment. 
     According to one aspect of the present invention, the packaging machine has a former, a filler and a sealer located within the internal aseptic area of the packaging machine. The former forms bags from a web of material; the filler fills the bags with a substance; and, the sealer seals the bags to enclose the substance within the bags. 
     According to another aspect of the present invention, the support member is fixed to the form-fill-seal packaging machine within an interior aseptic environment of the form-fill-seal packaging machine, and the tracking assembly is rotatedly mounted to the support member in the aseptic environment of the form-fill-seal packaging machine. To provide for the mounting engagement between the support member and the tracking assembly, one of either the support member or the tracking assembly has a shaft member depending therefrom, and the other of either the support member or the tracking assembly has an engaging receptacle for the shaft member. The shaft member is seated in the engaging receptacle and pivots within the engaging receptacle. The pivoting of the shaft member provides angular displacement of the tracking assembly. 
     According to another aspect of the present invention, an engagement surface of each of the shaft member and the receptacle is sealed off from the aseptic environment of the form-fill-seal packaging machine. 
     According to another aspect of the present invention, a portion of the engaging surfaces between the shaft member and the receptacle are sealed off from the internal aseptic environment of the form-fill-seal packaging machine with a first gasket. A second gasket member seals off a second end of the receptacle. 
     According to another aspect of the present invention, the web tracking apparatus has a bearing surface between the pivot shaft and the receptacle. The bearing surface is sealed off from the aseptic environment with gaskets. 
     According to another aspect of the present invention, the tracking assembly comprises an engaging member and a roller member connected to the engaging member. The roller member is adapted to contact the web of material, and the engaging member pivots about the support member. 
     According to another aspect of the present invention, the tracking assembly is positioned at an angle with respect to the support member. The angle of the tracking assembly is modified when the tracking assembly is pivoted about the support member. Modification of the angle of the tracking assembly adjusts the flow path of the web of material. 
     According to another aspect of the present invention, the alignment mechanism comprises a first adjustment member, a mating second adjustment member, and an operator shaft. The first adjustment member is connected to the operator shaft, the second adjustment member is fixed to the tracking assembly, and the first and second adjustment members engage each other. The operator shaft controls any movement of the first adjustment member. Through movement of the first adjustment member, which engages the second adjustment member, the tracking assembly is pivoted. 
     According to another aspect of the present invention, the first adjustment member comprises a worm gear connected to the operator shaft, and the second adjustment member comprises a mating spur gear fixed to the tracking assembly. The spur gear is driven by the worm gear to effectuate pivotal rotation of the tracking assembly about the support member. 
     According to another aspect of the present invention, a clutch mechanism is removably connected to the alignment mechanism. The clutch mechanism engages the operator shaft and allows an operator outside of the aseptic interior environment of the form-fill-seal packaging machine to rotate the operator shaft and pivot the tracking assembly to adjust the tracking of the web of material. 
     According to another aspect of the present invention, the roller member of the tracking assembly comprises a shaft and a roller. The shaft is secured to the engaging member, and the roller is capable of rotating about the shaft. The roller member pivots with the tracking assembly about the support member when the tracking assembly is pivoted thereabout. Further, the roller member contacts the web of material. 
     According to another aspect of the present invention, the tracking mechanism is located in the internal aseptic area of the packaging machine immediately upstream of the former. The tracking mechanism contacts the web of material and pivots within the aseptic area of the packaging machine. Further, the tracking mechanism is connected to an external control unit that controls the pivoting of the tracking mechanism. And, the pivoting of the tracking mechanism alters an angle of contact between the tracking mechanism and the web of material to center the web of material entering the former. 
     According to another aspect of the present invention, a container for holding a pharmaceutical is manufactured in an aseptic form-fill-seal packaging machine having a web centering system made in accordance with the present invention. 
     According to yet another aspect of the present invention, a process for centering a web of material in an aseptic environment of a form-fill-seal packaging machine is provided utilizing the web centering system made in accordance with the present invention. 
     Accordingly, a web centering system made in accordance with the present invention provides an inexpensive, easily manufactured, and efficient assembly which eliminates the drawbacks associated with aseptic form-fill-seal packaging machines. 
     Other features and advantages of the invention will be apparent from the following specification taken in conjunction with the following drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     To understand the present invention, it will now be described by way of example, with reference to the accompanying drawings in which: 
     FIG. 1 is a perspective view of a form-fill-seal packaging machine having a web centering apparatus of the present invention; 
     FIG. 2 is a perspective view of the web centering apparatus of the present invention; 
     FIG. 3 is a top plan view of the web centering apparatus of FIG. 1; 
     FIG. 4 is a cross-sectional side elevation view taken along line A—A of FIG. 3; 
     FIG. 5 is a front elevation view taken along line B—B of FIG. 3; 
     FIG. 6 is a partial side view of the alignment mechanism of the web centering apparatus of the present invention; 
     FIG. 7 is a front elevation view of a container made in a form-fill-seal packaging machine having a web centering apparatus of the present invention; and, 
     FIG. 8 is a schematic view of the process for centering the web of material in a form-fill-seal packaging machine. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     While this invention is susceptible of embodiments in many different forms, there is shown in the drawings and will herein be described in detail a preferred embodiment of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiment illustrated. 
     Referring now in detail to the Figures, and specifically to FIGS. 1 and 2, there is shown an aseptic form-fill-seal packaging machine  10  in FIG. 1, a schematic of the web-centering and forming processes in FIG. 8, and a web tracking assembly  12  for the aseptic form-fill-seal packaging machine in FIG.  2 . The aseptic form-fill-seal packaging machine  10  generally includes an unwind section  14 , a film sterilizing section  16 , a film drying section ( 17 ), an idler roller/dancer roller section  18 , a nipped drive roller assembly section (not shown), a fitment attaching assembly section ( 20 ), a forming assembly section  24 , a fin seal assembly section ( 25 ), a filling assembly section ( 26 ), an end sealing/cutting assembly section  30 , and a delivery section (not shown). Each of these assemblies downstream of the unwind section  14  is contained within the internal aseptic environment of the form-fill-seal packaging machine  10 . 
     The function of the various assemblies of the form-fill-seal packaging machine  10  is as such: the forming assembly  24  is provided to form tubes from the web of material that ultimately becomes the flexible container or bag  28 ; the fin seal assembly  25  provides the longitudinal seal on the flexible container, thereby longitudinally sealing the formed tube; the filling assembly  26  includes a filler that fills the flexible containers with a substance, that being a liquid pharmaceutical in the present preferred application; and, the end sealing/cutting assembly  30  contains a cutting and sealing head that seals the ends of the flexible containers to enclose the filled substance within the flexible container. 
     In the preferred embodiment of the present invention, the web tracking or centering apparatus  12  comprises a support assembly  34 , a tracking assembly  36 , and an alignment mechanism  38 . The web tracking apparatus  12  is provided to be assembled and operational within an existing internal aseptic area of an aseptic packaging machine  10 . In the preferred embodiment, the web tracking apparatus  12  is located in the aseptic area immediately upstream of the former assembly  24  to provide the most effective tracking for the web of film as it enters the former. 
     As shown in FIGS. 2-4, the support assembly  34  of the present invention comprises a support member  40  which is internally fixed within the internal aseptic area of the form-fill-seal packaging machine  10 . In the preferred embodiment, the support member  40  is a “V” shaped stainless steel plate and is attached to a pair of side members  42  with stainless steel screws. A gusset member  44  is secured to both the support member  40  and each of the side members  42 , respectively, to provide additional rigidity to the support member  40 . The side members  42  are internally secured to the frame  50  of the packaging machine  10  with the use of two existing support shafts  46 ,  48  that span between the internal walls of the packaging machine frame  50 . The lower support shaft  46  also operates as an idler roller  52  for the film as the film enters the tracking assembly  12 . 
     As best shown in FIG. 4, the support member  40  has an engaging receptacle  54  depending therefrom. In the preferred embodiment, the receptacle  54  is a tubular member having an internal cavity  55  that is welded to the support member  40 . The cavity  55  is cylindrical in shape and thus has an internal diameter associated therewith. As will be described in greater detail herein, the engaging receptacle  54  operates to mate with a member of the tracking assembly  36 . 
     Referring now to FIGS. 2-4, the tracking assembly  36  of the web centering apparatus  10  is rotatedly mounted to the support member  40 , and generally comprises an engaging member  56 , and a roller member  58  depending from the engaging member  56 . The engaging member  56  is generally a stainless steel plate. In the preferred embodiment, the engaging member  56  has four arms  60   a - 60   d  in the form of an “X” shape (see FIG.  3 ). The preferred embodiment of the engaging member  56  also has two apertures  62  through the body of the engaging member  56 . The arms  60   a - 60   d  and the apertures  62  allow for decreased surface area and increased air flow about the tracking assembly  36  during the hydrogen peroxide fog sterilization process for the internal aseptic area of the packaging machine. Without the allowance for such air flow capabilities, either contaminants may remain in the aseptic area after sterilization, or an absolute cleansing of the hydrogen peroxide remnants may not be possible in a timely manner. 
     In the preferred embodiment shown in the Figures, first and second roller members  58   a,    58   b  are utilized. The roller members  58  are adapted to contact the web of material, and are also identified as contact members  58 . While in the preferred embodiment the roller members  58  spin about the shaft  64 , it is understood that the roller members  58  may be stationary members, and in fact do not have to have a circular cross-section. A piece of flat stock or any other geometric member that can contact the web of material is understood to be within the meaning of a roller member  58  of the present invention. The first roller member  58   a  is connected to the engaging member  56  adjacent a first end of the engaging member  56 , and the second roller member  58   b  is connected to the engaging member  56  adjacent a second end of the engaging member  56 . The first end of the engaging member  56  is located at the downstream end of the engaging member  56 , while the second end of the engaging member  56  is located at the upstream end of the engaging member  56 . Each roller member  58   a,    58   b  comprises a shaft  64  and a roller  66 . The roller  66  is capable of rotating about the shaft  64  through the use of plastic bushings. The plastic bushings are non-lubricated and are capable of withstanding the corrosive elements of hydrogen peroxide during the daily sanitization process. Additionally, the plastic bushings are open to allow the hydrogen peroxide fog to enter all of the areas for cleaning. The shaft  64  is secured to a roller support  68  at each end of the shaft  64  with set screws. Further, the roller supports  68  depend from and are secured to the engaging member  56  at approximately the end of each arm  60   a - 60   d  of the engaging member  56 , respectively (see FIG.  3 ). Thus, the roller supports  68  secure the roller members  58   a,    58   b  to the engaging member  56 . While the use of two roller members  58  provides increased tracking capabilities for the web, it has been found that one roller member  58  may suffice. When the engaging member  56  rotates within the engaging receptacle  54 , both roller members  58   a,    58   b  of the present invention pivot or rotate simultaneously with the engaging member  56 . Thus, both a first upstream roller and a second downstream roller are utilized to track the film. 
     With reference to FIG. 3, the web-centering apparatus  12  is located in-line with the web of film material as it passes through the form-fill-seal packaging machine  10 . Further, the web-centering apparatus pivots substantially about a centerline of the packaging machine, the centerline of the packaging machine approximately being a centerline of the web of film material being fed into the former. 
     As best shown in FIG. 4, the engaging member  56  has a shaft member  70  depending from the bottom of the engaging member  56 . The shaft member  70  operates as a first rotating member  70 . In the preferred embodiment, the shaft member  70  is a cylindrical member made of stainless steel round stock that is welded to the engaging member  56 . Further, in the preferred embodiment, a projection  72  extends from the engaging member  56 . The projection  72  extends the bottom surface of the engaging member  56  upward a distance from the generally planar bottom surface of the engaging member  56 . FIG. 4 illustrates that the projection  72  further creates a cavity within the engaging member  56 . The projection  72  of the preferred embodiment is manufactured utilizing a cylindrical member  72  welded to the planar surface of the engaging member  56 . The cylindrical member  72  has an internal diameter. In this embodiment, the shaft member  70  depends from the bottom of the projection  72  and partially extends within the cavity of the projection  72 . A cylindrical gap  74  extends between the shaft member  70  and the internal wall of the projection  72 . 
     As explained above, in the preferred embodiment the shaft member  70  depends from the engaging member  56 , and the engaging receptacle  54  depends from the support member  40 . Conversely, however, the shaft member  70  may depend from the support member  40  and the engaging receptacle  54  may depend from the engaging member  56 . As such, one of either the support member  40  or the tracking assembly  36  has a shaft member  70  depending therefrom, and the other of either the support member  40  or the tracking assembly  36  has an engaging receptacle  54  for the shaft member  70 . 
     Irrespective of the specific depending member for each of the shaft member  70  and the engaging receptacle  54 , to form the web tracking apparatus  12  of the present invention the tracking assembly  36  is mounted to the support assembly  34  via the shaft member  70  being seated in the engaging receptacle  54 , and with the shaft member  70  being capable of pivoting within the receptacle  54 . Such engagement between engaging surfaces of the tracking assembly  36  and the support assembly  34  provides rotational or pivoting capabilities of the tracking assembly  36  about the support assembly  34 . Initially, the tracking assembly  36  is positioned at an angle (α) with respect to the support assembly  34 . When the tracking assembly  36  is pivoted or rotated about the support assembly  34 , the angle (α) of the tracking assembly  36  is modified. Modification of the angle (α) of the tracking assembly  36  provides angular displacement of the tracking assembly  36 , thereby adjusting the angle of the roller members  58  which contact the web of material, and ultimately adjusting the flow path of the web of material entering the former assembly  24  to allow the film to be centered as it enters the former assembly  24 . As explained further herein, the alignment mechanism  38  controls the angle of rotation (α) between the support member  40  and the tracking assembly  36 . 
     In the seating of the shaft member  70  in the engaging receptacle  54  of the support assembly  34 , a plastic bushing  76  operating as a bearing surface is placed between the shaft member  70  and the inner wall of the engaging receptacle  54 . The bushing  76  also has a flange to properly seat and locate the surfaces between the inner wall of the cavity of the projection  72  of the engaging member  56 , and a top surface of the tubular member of the receptacle  54 . Because only slight movement of the tracking assembly is effectuated, a bushing is not critical, and the surfaces of the engaging receptacle and the shaft member may be manufactured to operate as bearing surfaces. 
     The engaging receptacle  54  also has a groove  78  machined in its outer diameter. A first gasket member  80  is seated in the groove  78 . In the preferred embodiment, the first gasket  80  is an silicon rubber O-Ring. When the engaging member  56  engages the engaging receptacle  54 , the first gasket  80  extends between the engaging member  56  and the support member  40 . Specifically, the O-Ring  80  in the groove  78  of the engaging receptacle  54  engages the inner wall of the cavity of the projection  72  to seal a first end of the receptacle  54 . Thus, a portion of the mating area of the engaging surfaces between the pivot shaft  70  and the receptacle  54  adjacent a first end of the receptacle is sealed off from the internal aseptic environment of the form-fill-seal packaging machine  10 . 
     After the shaft  70  is seated in the opening of the engaging receptacle  54 , a retainer  82  is secured to the shaft  70  to prevent the shaft  70  from disengaging from the receptacle  54 . In the preferred embodiment, the retainer  82  is a retaining ring. The retainer  82  vertically fixes the support assembly  34  to the tracking assembly  36 , but the retainer  82  does not prevent pivotal or rotational displacement between the two assemblies. 
     Once the tracking assembly  36  is rotatedly fixed to the support assembly  34  with the retaining ring  82 , a cover  84  and a second gasket member  86  are used to seal the second end of the receptacle  54 . Specifically, in the preferred embodiment the second gasket member  86 , preferably made of silicon rubber, is fitted between a bottom surface of the support member  40  and the cover  84  to seal off the mating areas of the pivotal engagement surfaces between the pivot shaft  70  and a second end of the receptacle  54  from the internal aseptic environment of the form-fill-seal packaging machine  10 . Sealing off the first and second ends of the cavity areas between the pivot shaft and the mating receptacle creates a sealed off area for the pivotal engagement surfaces separate from and within the aseptic environment of the packaging machine. To maintain the aseptic environment of the packaging machine, the pivotal engagement bearing surfaces between the pivot shaft and engaging receptacle must be located within that sealed-off area. 
     As shown in FIGS. 2,  3 ,  5  and  6 , the web tracking apparatus  12  of the present invention further comprises an alignment mechanism  38  contained within the aseptic area of the form-fill-seal packaging machine  10 . The alignment mechanism is connected to the tracking assembly  36  and is utilized to control and effectuate pivotal rotation of the tracking assembly  36  about the support assembly  34 . The alignment mechanism  38  comprises a first alignment or adjustment member  88 , a mating second alignment or adjustment member  90 , and a means for manipulating the first alignment member. The alignment mechanism  38  further comprises an operator shaft  94  connected to the first adjustment member  88 . As shown in FIGS. 2 and 6, because of the length of the operator shaft  94  in the preferred embodiment, it is formed of two pieces connected by a coupling  96 . The operator shaft  94  is fixed in place with the use of shaft guides  98  and shaft collars  100 , and thus is only capable of rotational movement. The shaft guides  98  operate to prevent transverse movement of the operator shaft  94 , while the shaft collars  100  prevent lateral movement of the operator shaft  94 . The rotational movement of the operator shaft  94  controls rotational movement of the first adjustment member  88 . 
     In the preferred embodiment, the first alignment member  88  comprises a first gear member connected adjacent a distal end of the operator shaft  94 . The first gear member is preferably a single-threaded, 16 pitch, stainless steel precision worm gear having a lead of 0.1963 inch, a lead angle of 5°-43′, and a pressure angle of 14-½°. The second alignment member  90  comprises a second gear member that mates with the worm gear  88 . The second gear member is made of from a mating spur gear having 180 teeth about its circumference, however, the spur gear utilized in the preferred embodiment is a partial spur gear of the identified gear, and only has approximately 18 of the 180 teeth. The partial spur gear  90  is fixed to a bracket  96  connected to the engaging member  56  of the tracking assembly  36 . The first gear member  88  is manipulated by rotation of the operator shaft  94 . Further, the worm gear  88  drives the spur gear  90  to effectuate rotation of the tracking assembly  36  about the support assembly  34  via the pivot shaft  70 . Use of a worm gear to manipulate a spur gear provides increased control and precision in adjusting the tracking assembly  36  in fine increments. This is because the ratio between the worm gear and the spur gear should be at least 100 to 1, and in the preferred embodiment is approximately 180 to 1. However, a ratio of less than 100 to 1 will not destroy the intent of the invention. Additionally, use of the worm gear in combination with the spur gear provides a positive locking mechanism that is able to overcome any force provided by the film on the roller member. As such, the film will not cause movement of the tracking assembly. 
     The alignment mechanism  38  further has a first clutch member  102  connected adjacent a proximal end of the operator shaft  94 , and opposite the worm gear  88 . The first clutch member  102  cooperates to removably secure the alignment mechanism  38  to a controller  104  located outside the aseptic area of the form-fill-seal packaging machine. The first clutch member  102  has a plurality of fingers  106  which allow it to engage the controller  104 . In the preferred embodiment, the alignment mechanism  38  is maintained within the aseptic environment and is sealed from a portion of the controller  104 , which is located outside the aseptic environment. 
     As shown in FIG. 6, the controller  104  has a knob  108 , a shaft  110 , a first controller gasket  112 , a second controller gasket  114 , a bushing  116 , a second clutch member  118 , and a pin  120 . In assembly of the controller  104 , the bushing  116  has a hollowed out cylindrical portion and a flange portion. The hollowed out cylindrical portion is fitted through an aperture in the frame of the packaging machine  10 , and the flange portion is located against the outside of the frame of the packaging machine, with the first controller gasket  112  being located between the bushing  116  and the packaging machine  10 . The frame of the packaging machine separates the aseptic environment from the non-aseptic environment. The controller shaft  110  is fitted within the hollowed out cylindrical portion of the bushing  116 . Next, the knob  108  is engagingly fitted on one end of the shaft  110 , and is fixed to the shaft  110  with a set screw  124 . The outer portion of the knob  108  also engages the first controller gasket  112  in a sealing manner. 
     The shaft  110  and the cylindrical portion of the bushing  116  extend inside the aseptic environment of the packaging machine  10 . Along with the first controller gasket  112 , the second controller gasket  114  prevents external contaminants from entering the internal aseptic environment. Specifically, the second controller gasket  114  is preferably a silicon O-Ring located between the internal diameter of the hollowed out portion of the bushing  116  and the controller shaft  110  within the bushing  116 . A portion of the second end of the controller shaft  110  extends beyond an outer limit of the bushing  116  and is connected to the second clutch member  118  with a set screw. The second clutch member  118  has a pin  120  which is adapted to engage the first clutch member  102  to turn the operator shaft  94 . The controller assembly  104  is removably connected to the alignment mechanism, and allows an operator to rotate the operator shaft to effectuate rotation of the tracking assembly. 
     The container  28  produced by the form-fill-seal packaging machine  10  having the web tracking assembly  12  is shown in FIG.  7 . The container  28  is made from a web of polymeric film material that is formed in the packaging machine. The container  28  has a cavity  126  enclosed by a first wall  128 , an opposing second wall  130 , and seals  132 ,  134 ,  136  about a periphery of the first and second walls  128 ,  130 . The longitudinal seal  132  at the top of the container  28  opposes the fold area  138  at the bottom of the container  28 . The joined seals  132 ,  134 ,  136  and the fold  138  create a fluid-tight chamber within the cavity  126  of the container  28 . As explained later herein, a quantity of a pharmaceutical is stored within the fluid-tight chamber  126  of the container  28 . With the use of the web tracking assembly  12 , the peripheral edge of the first wall  128  and the second wall  130  are located substantially adjacent one another to form the longitudinal seal  132 . 
     The container  28  also has a fitment  140 . The fitment  140  is connected to the container  28  at the fold area  138 , and has a passageway that cooperates with the fluid-tight chamber  126  of the container  28 . 
     As shown in FIG. 8, a schematic is illustrated of the process for creating a container  28  in an aseptic environment of a form-fill-seal packaging machine  10  having a web centering apparatus  12 . The overall process includes providing a web of material in the unwind section  14 , and passing the material through a series of subassemblies in the aseptic packaging machine  10  to form the finished container  28  that is filled with the pharmaceutical. The various subassemblies of the packaging machine  10  include the film sterilization section  16 , film drying section  17 , dancer roller section  18 , drive roller section, web centering section  12 , forming section  24 , fin seal section  25 , fitment attaching section  20 , filling section  26 , end sealing section  30 , and delivery section. These subassemblies have been fully disclosed herein. 
     Prior to usage, the internal aseptic area of the packaging machine must be sterilized each day. This is accomplished with a hydrogen peroxide fog which is passed through the aseptic area of the packaging machine. Because of the sterilization process, and the need to maintain an aseptic environment, the present invention, including the sealed off areas specifically for the moving parts is required. 
     Currently, three different sizes of flexible containers  28  are capable of being filled in the aseptic form-fill-seal packaging machine: 50 ml, 100 ml, and 200 ml. However, the tracking assembly of the present invention can be utilized for larger or smaller size bags. 
     While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection is only limited by the scope of the accompanying claims.