|Publication number||USRE38747 E1|
|Application number||US 10/023,394|
|Publication date||Jun 28, 2005|
|Filing date||Dec 17, 2001|
|Priority date||Mar 2, 1994|
|Publication number||023394, 10023394, US RE38747 E1, US RE38747E1, US-E1-RE38747, USRE38747 E1, USRE38747E1|
|Inventors||Theodore W. Jagger|
|Original Assignee||Robert Bosch Packaging Technology, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (74), Non-Patent Citations (2), Referenced by (1), Classifications (10), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is an application for reissue of U.S. Pat. No. 5,673,535 entitled “VIAL FILLING APPARATUS.” issued on Oct. 7, 1997 which is a continuation of Ser. No. 08/205,041, filed Mar. 2, 1994 (now abandoned), and a continuation of application Ser. No. 09/414,913, currently copending which will issue as U.S. Pat. No. RE 37,471, which is also a reissue of U.S. Pat. No. 5,673,535.
The invention broadly relates to container filling apparatus and is specifically directed to an improved apparatus for rapidly filling containers in a sterile environment.
Many pharmaceutical preparations produced by the pharmaceutical industry are dispensed in relatively small containers. Among these are injectable drugs and medicines which, by the nature of their use must be dispensed with a high level of sterility assurance. Elaborate techniques and apparatus are employed to maintain this high level of sterility.
To limit contamination, current container filling apparatus, which tends to be quite large, is placed in a clean room environment with the apparatus operators required to wear sterile attire, including gowns, gloves, headwear, masks and the like. The clean room itself must be maintained in a low contamination level, with conventional precautions taken as the operating personnel enter, observe and make adjustments to the equipment, and leave. The apparatus itself must be periodically sterilized by steam cleaning and/or washed down with decontaminating liquid cleaners. It is difficult, time consuming and expensive to maintain the container ruling apparatus and the clean room in a low level contamination.
This is particularly true with respect to the filling apparatus itself. A typical filling machine includes a number of operating stations; e.g., a container accumulator that dispenses empty (usually pre-sterilized) containers onto a lengthy container conveyor in sequential order through the use of a container transfer mechanism, a pre-fill check weigh station, a filling station which consists of a series of dispensing nozzles each of which is connected to a precision metering pump with associated control apparatus, a post-fill check weigh station, a stoppering or plugging mechanism (if required for the particular container configuration) including appropriate stopper feeder apparatus, and an eject and outfeed station that transfers the filled and sealed containers to an outfeed conveying system. Each component of the container package must be maintained in a sterile state throughout each of these operations. Conversely, the contamination of any single component may cause the finished package to become contaminated and unusable.
The primary source of contamination in a clean room environment is from individuals within the room who operate and/or monitor the filling apparatus. The air inside the room is brought in at a high rate thorough special filters that remove virtually all of the contaminants. Any liquids brought into the room such as cleaners or the drug product itself are filtered through high quality filters that again remove virtually all of the contaminants. Contamination is considered to be anything foreign to the drug product itself. This includes not only living microorganisms that are removed through filtration, steam sterilization, chemical sterilants, or other techniques, but also any particle matter that may enter the product container. Including particles that carry no living organisms. An example of sources for organism free or “sterile” particles are particles of matter that enter the air when two sterile containers or two sterile machine parts rub together.
Equipment operators or other people that may enter the sterile environment contribute high levels of contaminants to the environment both in the form of microorganisms and particles. Because of this, elimination of the entry of people into the sterile zone is a significant improvement.
The subject invention is the result of an effort to produce apparatus that is less difficult as well as less costly to operate and maintain, including the ease of contamination control. Specifically, it has been found that the apparatus itself can be designed in such a way that it includes a smaller isolation or sterile zone including only those components which are directly essential to the filling and sealing process with all other components as well as equipment operators disposed outside the zone. By creating such a sterile zone and providing it with operator access ports, the need for a clean room is obviated, as is the need for the apparatus operators to be in sterile attire.
A preliminary approach to the problem was to build an isolation barrier around the upper “clean” portion of an existing filling apparatus. This resulted in a number of problems, the primary of which were inaccessibility to and extreme difficulty in cleaning and sterilizing the zone interior including the housed components, and the sealing of the components that pass from the inside to the outside of the sterilize zone.
The existing filling machine used for this preliminary approach is constructed in a manner with a large flat horizontal table top to which clean zone devices are mounted in the upward direction and to which the mechanical drive components are mounted in a downward direction from the horizontal table top. A stainless steel sheet metal cover is placed on the top side of the horizontal table top plate and serves as the division between the upper clean area and the lower mechanical space. When the concept was proposed to surround the upper clean space with an isolation barrier, several problems arose. First, the horizontal table top was relatively wide and, when surrounded by a barrier, would not allow for access to all points within the clean space with conventional techniques using glove port access. Second, since the significant amount of water and/or chemical may be used in a process to clean and/or sterilize the interior sterile zone, a simple and clean drainage system would be required. Because the conventional horizontal table top was large and flat, not allowing for good drainage, and since many mechanical devices pass through from the upper clean zone, now the sterile zone inside the isolator, to the lower mechanical space, the problems of drainage and sealing of the bottom of the sterile zone became a major problem.
In the subject invention an apparatus has been created the frame and main mounting plate of which are oriented vertically, defining sterile and non-sterile zones in side-by-side relation. Those components which are directly essential to the actual processing of the containers are disposed on one side of the plate (sterile zone) with the supporting components disposed on the opposite side (non-sterile zone). The plate, together with sterile cabinetry, encloses the essential components and defines the sterile zone. For example, the dispensing nozzles are disposed within the sterile zone, whereas the pumping devices are located within the non-sterile zone and connected to the nozzles by tubes that pass through the plate or barrier in sealed relation. The container conveyor itself, which of necessity is located in the sterile zone, also has been oriented from horizontal to vertical to significantly reduce its width. The drive means for the conveyor; however, is located in the non-sterile zone.
The result is a sterile zone that is of significantly reduced size, and an apparatus which is much more easily operated and maintained. The smaller sterile zone and the internally disposed components are easily accessed through glove ports and, since the zone is much smaller, it is easily cleaned. In addition, the absence of any mechanical devices passing through the bottom of the sterile zone enclosure allows for an extremely clean and drainable collection pan without the associated sealing problems.
With initial reference to
With reference to
The vials 14 are sequentially carried by conveyor 17 to a pre-fill check weigh mechanism 27, a filling apparatus 28 consisting of a plurality of nozzles connected to a like number of pumps 29, a post-fill check weigh mechanism 31, a stoppering head 32 supplied by a stopper feeder 33, and a vial eject station 34.
Prior art vial filling apparatus 11 is open to the surrounding environment, and is conventionally disposed in a large clean room the environment of which is maintained in a decontaminated or sterile state as is known in the art. Conventional techniques are also used to prevent contamination as operating personnel enter and leave the room, including the wearing of sterile attire such as gowns, gloves, headwear and masks.
With reference to
With particular reference to
Conveyor 45 sequentially moves the vials 14 to a pre-fill check weigh station 46 that randomly removes a vial to establish a reference pre-fill weight. The vials are then carried by conveyor 45 through a filling station 47 which comprises a plurality of nozzles 49. Nozzles 49 are supplied by a plurality of pumps 51 described in further detail below.
After filling, the vials 14 are moved by conveyor 45 past a post-fill check weigh station 52, which removes each of the randomly selected empty vials previously weighed at pre-fill check weigh station 46. This comparative weighing ensures that the specific amount of pharmaceutical preparation has been metered and dispensed into each vial.
Conveyor 45 then moves the vials through a stoppering station 53 at which each of the filled vials is closed and sealed with a stopper. Vials 14 then move into an eject and outfeed station 54, where the vials are removed from conveyor 45 and carried by means not shown to a packing station.
With reference to
A vertically disposed mounting plate 59 is secured to the several frame support members 58, extending longitudinally over the length of the apparatus 41 (see also FIG. 4). A portion of vertical mounting plate 59 extends above the upper cross rail members 57. A thin stainless steel sheet 61 corresponding in size to vertical mounting plate 59 is mounted thereto in spaced relation, defining an air gap 62. The stainless steel sheet 61 defines the elongated barrier or back plate of a stainless steel cabinet bearing general reference numeral 63, which in turn defines an internal sterile zone 64. The area outside cabinet 63 (i.e., that portion on the left side of barrier plate 61 as viewed in
With continued reference to
The primary inlet to sterile zone 64 is the sterile tunnel 42 as discussed above. The stoppering station 53 also includes a stopper inlet or docking port 53 a through which sterilized stoppers are admitted in a sterile manner as is known in the art. The sole outlet from sterile zone 64, is the eject and outfeed station 54, which in the preferred embodiment comprises a plurality of conventional star wheels, the first of which is disposed within sterile zone 64 and the second of which is disposed outside zone 70. Vials 14 are transferred between these first and second star wheels through a small opening in cabinet 63. Sterile zone 64 is preferably maintained at a pressure higher than that of the ambient surroundings to cause an outflow of air through the vial outlet between the star wheels, thus resisting contaminant entry. The means for maintaining such pressure, which is not shown, is conventional and typically includes a supply of air that is filtered to remove contaminants.
Preferably, cabinet 63 includes a plurality of conventional glove ports 80 or other conventional means for permitting sealed access to the sterile zone 64. Preferably, glove ports 80 are disposed at spaced points to permit operators of the apparatus 41 to have access at all points along the line of vial movement.
With reference to
With reference to
Each of the pumps 51 has an inlet 81 to which or an inlet tube 82 is connected. The several inlet tubes 82 are commonly, connected to a manifold that supplies the liquid to be dispensed and filled into the vials 14.
Each of the pumps 51 has an outlet 83 from which the precise amount of liquid is dispensed or pumped. Each pump outlet 83 has an outlet tube 84 connected thereto that leads to one of the nozzles 49. The series of nozzles 49 are mounted on a walking beam 85 that linearly reciprocates in a timed sequence relative to the moving vials 14. The apparatus which controls the walking beam 85 bears general reference numeral 86 and is known in the art.
With reference to
With continued reference to
The upper body 94 of each of the cleats 92 is offset relative to the lower body 93 to permit a vial 14 to rest in centered relation on the lower body 93. Upper body 94 defines lower and upper lateral supports which respectively define V-shaped recesses 100, 102, respectively. The recesses 100, 102 are centered relative to the lower body 93, and in the preferred embodiment are farmed at a 90 degree included angle. This angle, coupled with the size of platform 98, permits each of the cleats 92 to accept vials 14 having a range of diameters. For vials having diameters that do not fall within such range, cleats 92 of a different size or a different included angle may be substituted. -With reference to
In comparing the prior art conveyor 17 of
With reference to
More specifically, the drive sprocket wheel 89 is carried by a mounting bracket 104 which in turn is carried by an annular mounting flange 105. Mounting flange 105 is secured to a telescoping adjustment tube 106 that projects through stainless steel sheet 61 and mounting plate 59. Telescoping adjustment tube 106 is carried for such telescopic movement by a stationary mounting tube 107 that is secured to an annular mounting collar 108. An annular ring 109 and annular seal 110 disposed in the air gap 62 in encircling relation to mounting collar 108 serve to maintain the sterile zone 64 in a decontaminated state.
Bearings 111, 112 disposed between adjustment tube 106 and mounting tube 107 permit relative telescoping movement of the tube 106, and a flexible bellows 113 extends between stationary tube 107 and mounting flange 105 to permit such relative movement while sealing against contamination.
Guide rail 103 is carried by a mounting bracket 114 that is mounted to a telescoping adjustment shaft 115. Shaft 115 telescopically slides within adjustment tube 106 relative to a pair of bearings 116, 117. A flexible bellows 118 is secured at one of its ends to the adjustment shaft 115 with the other end secured to the end of adjustment tube 106, also for the purpose of preventing the entry of contaminating matter into sterile zone 64.
A control plate 119 is mounted to the outer end of adjustment tube 106, and a similar mounting plate 121 is mounted to the outer end of adjustment shaft 115. Separate actuator means 122, 123 are respectively connected to the control plates 119, 121 to effect separate adjustment of the adjustment tube 106 and shaft 115. The actuator means 122, 123 may be interrelated for adjustment to vials of predetermined diameter, and may also include automated means to ensure centering of the vials 14 relative to the nozzles 49.
With reference to
Drive pulley 133 is connected through a drive belt 136 to a driven pulley 137, which in turn is mounted to a common drive shaft bearing the general reference numeral 138. Drive shaft 138 comprises a plurality of interconnected drive shaft segments 138 a-e.
Drive shaft segment 138 a is connected through a right angle gear drive 139 to a pulley/timing belt configuration. A drive connection 142 extends through the wall of cabinet 63, connecting the pulley/timing belt 141 to the oscillating belt infeed station 43. The seal in the wall of cabinet 63, which bears reference numeral 143, is of the same type as the seal consisting of components 108-110 used for the lateral conveyor belt/rail adjustment of FIG. 9.
Drive shaft segment 138 a is connected to shaft segment 138 b through a right angle drive 144. A right angle drive 145 is connected between drive shaft segments 138 b-c, the purpose of which is to drive the star wheel 44 through a pulley/belt configuration 146 and a drive connection 147. Drive connection 147 extends through mounting plate 59 of cabinet 63 through a seal of the same type as seal 143.
Drive shaft segment 138 c is connected through a pulley/belt configuration 148 to a right angle gear drive 149 having a drive pulley 151 (see also FIG. 5). Drive pulley 151 is connected to drive the walking beam 85 through actuators 86 as described above, each of which extends through the mounting plate 59 through a seal similar to seal 143.
The pre-fill check weigh station 46 and post-fill check weigh station 52 are separately driven by servomotors (no shown for purposes of charity), which are operated in synchronous relation to the primary drive motor 131. Pre-fill check weigh apparatus 46 includes a drive connection 152, and post fill check weigh apparatus 52 includes a drive connection 153.
Shaft drive segment 138 d is connected through a pulley/belt configuration 154 to a right angle gear drive 155 which in turn drives a pulley/belt configuration 156. This in turn is connected to a drive connection 157 that actuates a portion of the stoppering station 53. Other components of the stoppering station are driven by a separate variable speed motor.
Shaft drive segment 138 d is also connected through a gear drive 158 that drives a pulley/belt configuration 159. A drive connection 161 interconnects the configuration 159 through a seal, similar to seal 143, to the eject and outfeed station 54.
Shaft drive segment 138 e is connected to a right angle gear drive 162 which in turn drives a pulley/belt configuration 163. A drive connection 164 extends through a seal and mounting plate 59 and connects configuration 163 with drive sprocket wheel 89. Sprocket wheel 90 is a driven wheel and does not include a direct drive.
The lateral adjustment mechanism shown on
In this latter regard, and with particular reference to
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|U.S. Classification||53/282, 198/803.14, 53/284.6, 53/284.5, 53/167|
|Cooperative Classification||B65B55/025, B65B55/027|
|European Classification||B65B55/02D, B65B55/02C|
|Sep 6, 2005||FPAY||Fee payment|
Year of fee payment: 8
|Sep 6, 2005||SULP||Surcharge for late payment|
Year of fee payment: 7
|Mar 25, 2009||FPAY||Fee payment|
Year of fee payment: 12