Abstract:
The invention is directed at a process for enabling the packaging of a powder ( 32 ), in particular a pharmaceutical product powder, including the steps of: providing a first bag ( 9 ) from a flexible packaging material; fixing the opening ( 19 ) of the first bag ( 9 ) to a lower outlet ( 11 ) of a DCS (drum containment system) glove box ( 1 ); inside the DSC glove box ( 1 ) pulling a continuous liner ( 14 ) at a closed end of the liner ( 14 ) and inserting the liner ( 14 ) into the first bag ( 9 ), thus providing a second bag ( 16 ) inside the first bag ( 9 ); filling the second bag ( 16 ) with the powder ( 32 ), in particular through an upper opening of the DCS glove box ( 1 ); closing the second bag ( 16 ) by disconnecting the continuous liner ( 14 ); closing the first bag ( 9 ) and removing the first and second bags ( 9, 16 ) from the DSC glove box ( 1 ). Furthermore the invention is directed at an apparatus for performing the process.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention concerns a process as well an apparatus/system for enabling the packaging of a powder, in particular an API, in a contained and GMP manner, without the requirement of a clean room around the filling area. Furthermore, the present invention concerns the use of an apparatus, and process, for pharmaceutical powders and/or for specific pharmaceutical packaging processes. 
         [0002]    The aim of the invention is to set out a process and an apparatus, with which powder, preferably pharmaceutical powder, can be packaged in at least approximately clean room conditions, without the need to set up the proposed apparatus in a clean room. 
       SUMMARY OF THE INVENTION 
       [0003]    With regard to the process and apparatus, these aims are achieved with the features disclosed herein. Advantageous further embodiments of the invention are set out herein as well. The framework of the invention includes all combinations of at least two of the features disclosed herein. In order to avoid repetition, features disclosed in relation to the process should also apply and be claimable in relation to the apparatus. Equally, features disclosed in relation to the apparatus should also apply and be claimable in relation to the process. 
         [0004]    More particularly, a process is claimed which can be read in connection with the enclosed process description. While the disclosure recites a set of steps, this does not limit the scope of the invention, rather, protection is sought for each combination of two or more process steps that may become obvious from the enclosed process description. 
         [0005]    The full disclosure (description, claims and figures) of the European patent application with the application reference number EP 0 801 793 2.8, the priority of which is being claimed, should apply as forming part of the disclosure of the present application, in particular in that at least any one feature of the present application should be combinable and claimable with any one feature of the present application and/or EP 0 801 793 2.8. Thus, EP 0 801 793 2.8 is incorporated herein by reference. 
         [0006]    The invention is based on the concept of using a DCS (drum containment system) glove box, also claimed as an apparatus, for filling a powder with a mean particle diameter in a range between around 10 μm and around 1000 μm. This is taken to mean an apparatus which has a lower section for holding a drum comprising a first bag, and an upper section, which can be reached into manually with the aid of at least one, preferably with the aid of four, more particularly detachable sealed gloves in order, as will be explained later, to close a second bag and the first bag surrounding the second bag. Ideally the powder to be filled is exclusively in contact with the second bag and the first bag forms a second protective covering, where by the first bag and the second bag are surrounded by the apparatus, which then forms an overall protective covering and/or barrier, preferably exposed to an under pressure (negative pressure) and/or an over pressure (positive pressure). 
         [0007]    The process and device are particularly suitable for filling powder, more particularly API powder, with a particle size of between 1 and 1000 μm. Preferably the density of the poured powder is between 0.1 and 1 kg/dm 3 . 
         [0008]    It is particularly preferable if a dosing device forms part of the apparatus, as described, for example in WO 2007/088022 A1 by the applicant. The dosing device is preferably arranged in such a way that from it, emerging more particularly as a result of vibration, powder within the DCS glove box can flow into the second bag formed by the hose-like continuous liner. The content of the disclosure of WO 2007/088022 A1 is incorporated herein by reference and should, with regard to possible advantageous embodiments of the dosing device, apply as disclosed as part of the subject matter of the present application. 
         [0009]    Preferably the dosing device operates on a low pressure basis in order to attract powder by way of suction. The unloading of the powder/filling of the second bag preferably takes place by way of vibration, which allows precise dosing of the powder. It is particularly preferable if a dryer is arranged upstream of the dosing device, from which the powder is transferred into a mill, more particularly an online conical mill, which is preferably arranged above the PTS feeder. From the mill the powder is then sucked in by the dosing device. The core of the process is that the powder is filled into a continuous liner, from which the second bag, surrounded by the first bag, is formed by the closing and separation of the remaining continuous liner. It is particularly preferable if the device comprises at least one inlet and/or at least one outlet volatile particle filter, more especially an HEPA particle filter, in order to avoid contamination of the surrounding area and/or the interior of the apparatus. 
         [0010]    The process in accordance with the invention comprises the following steps: 
         [0011]    Initially a first bag of flexible packaging material is provided, preferably within a drum, more particularly through insertion of the drum into the lower section of the DCS glove box. It is particularly expedient if doors corresponding to this are provided and the lower section of the DCS glove box is closed on all four sides after closing the doors. Alternatively the lower section is realized without doors, preferably with the front side open. Preferably, after opening the drum the first bag is attached on a lower outlet, which projects into the lower section of the DCS glove box starting from the upper section. For this the operating gloves of the upper section of the apparatus are used. 
         [0012]    Thereafter, the continuous liner, closed at its lower end, is passed from the upper section of the DCS glove box through the lower outlet thereof into the first bag so that a second bag is provided within the first bag preferably located within the drum. The second bag is then filled with the powder, very particularly preferably via an upper outlet in the upper section of the DCS glove box. Placing the second bag into the first bag preferably takes place manually by way of the gloves, but alternatively can take place automatically through starting the filling procedure. Particularly preferably a dosing device, as described in said PCT application, is used for filling/dosing. After the filling procedure the second bag is closed and separated from the remaining continuous liner, which preferably has already been closed again at its lower end. The first bag, which fully surrounds the second bag, is then closed, and preferably closing of the optionally provided drum in the lower section of the DCS glove box takes place before the first bag and the second bag, preferably together with the drum, are removed from the lower section of the DCS glove box, preferably through a, preferably lateral, outlet door which differs from the inlet door. Preferably, for facilitated removal of the drum, a roller mechanism is provided. 
         [0013]    The invention also relates to an apparatus, i.e. a DCS (drum containment system) glove box, for implementing the process described above. The apparatus is characterised by an upper section, comprising at least one pair of gloves, in which by way of the at least one pair of gloves, which is preferably permanently, but in a replaceably connected in a sealing manner with a housing, intervention can take place, and a lower section, in which a first bag, preferably arranged within a drum, can be accommodated. It is particularly expedient if the apparatus comprises a dosing device as described in the previously cited PCT application. It is particularly expedient if the lower connection, to which the first bag can be attached, is the only connection between the upper section and the lower section, with the continuous liner being passable from the upper section through the lower connection into the lower section. Preferably, the, more particularly, tubular lower connection is within a partition wall which isolates the upper section from the lower section. 
         [0014]    In the event of a fault or damage to a continuous liner forming the second bag the DCS glove box prevents contamination of the product and allows the continuous liner to be replaced. The proposed apparatus, more particularly at least the upper section, preferably exclusively the upper section of the DCS glove box is, in a further development of the invention, connected to an air circulating system, which is designed so as to guarantee a high rate of air exchange. Preferably the air flows through volatile particle filters, more particularly HEPA filters, and particularly preferably at a volumetric flow of 100 Nm 3 /hour, which preferably corresponds to a gas exchange rate of 5 to 10 times per minute (depending on the volume of the upper section). The high rate of gas exchange also prevents powder remaining in and being contaminated in the upper section and thereby guarantees additional product protection. 
         [0015]    It is particularly expedient if, at least during the filling procedure, there is a slight over pressure within the upper section of the DCS glove box, which prevents air entering the system from outside, as a result of which the product is optimally protected. 
         [0016]    Especially in the case of filling highly toxic products, instead of bringing about a positive pressure, it can, however, be preferable to implement a negative pressure, in relation to the atmosphere, within the upper section in order to thereby rule out contamination of the surrounding area and endangering operating personnel. 
         [0017]    It is particularly expedient if the lower section of the DCS glove box is surrounded by three side walls, more particularly arranged perpendicularly to each other, whereby in at least one side wall, preferably in the front wall, doors are provided. Alternatively the front side is open permanently. It is very particularly expedient if the rear side of a perforated plate, connected to a fan with volatile particle filters, more particularly HEPA filters, is sealed, whereby the fan is arranged and designed so that at least during removal of the drum lid and the connection of the first bag with a lower connection of the DCS glove box, an high pressure predominates. An over pressure is also preferred when dividing/separating the first bag. Particularly preferably the air flows at a maximum rate of 0.5 m/sec. Alternatively the lower section can be realized without means for providing over pressure or under pressure. 
         [0018]    Particularly preferably the system is CIP-capable and can therefore be cleaned by means of a CIP. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    Advantageous further developments of the method and apparatus are set out in the following description of preferred examples of embodiment as well as the drawings. The figures, with the accompanying descriptions, should not only form the entirety of the disclosure content, but individual figures with the accompanying description should also serve as independent disclosure sources. 
           [0020]    The figures show in 
           [0021]      FIG. 1  to  FIG. 23  Process steps of a preferred form of embodiment of a process in accordance with the concept of the invention. 
           [0022]      FIG. 24  to  FIG. 43  A preferred method (process) for replacing and/or renewing a continuous liner. 
           [0023]      FIG. 44  A variant of embodiment of the apparatus in which both within the continuous liner as well as within the upper and lower section of the DCS glove box a high pressure is produced. 
           [0024]      FIG. 45  An alternative embodiment variant in which there is a high pressure in the continuous liner and in the lower section of the DCS glove box, and a low pressure in the upper section outside the continuous liner (each in relation to atmospheric pressure). 
           [0025]      FIG. 46  A table setting out the advantages resulting for a combination of any two barrier features for the form of embodiment in accordance with  FIG. 44 . 
           [0026]      FIG. 47  A table analogue to  FIG. 46  for the form of embodiment in accordance with  FIG. 45 . 
           [0027]      FIGS. 48   a  to  48   c  Various views and details of a partially incompletely illustrated DCS glove box. 
           [0028]      FIG. 49  An overall system, comprising a DCS glove box for filling powder. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    In the figure the same elements and elements with the same function are marked with the same reference symbol. 
         [0030]    In  FIG. 2  a DCS glove box (hereinafter apparatus  1 ) is shown. This comprises an upper section  2  and a lower section  3  adjoining it. The lower section  3  is isolated/hermetically sealed off from the upper section  2  by means of an essentially horizontally orientated partition wall. Within the upper section  2  there is a schematically shown waste container  5 . In the upper section  2 , gloves  6  (operating gloves), which are only partially shown, project into openings provided in the housing and are detachably arranged on the housing  7 . In the illustrated example of embodiment on each of two sides facing away from each other there is a pair of such gloves, which are made of flexible material. 
         [0031]    On the front of the apparatus in the plane of the drawing there are two pivoting doors for opening and closing the lower section  3  so that a drum  8  with a first bag  9  can be inserted into the lower section  3  from the front side, using a lift mechanism  10  for lifting the drum  8  with the first bag  9 . Alternatively there are no doors on the front side. Preferably then the front side is permanently open. 
         [0032]    Passing through the partition wall  4  is a lower outlet  11  (connection) to the outer circumference of which the first bag  9  can be attached. The lower outlet  11  is the only connection between the upper and the lower section  2 ,  3 . 
         [0033]    At a distance from the lower outlet  11  is an upper outlet  12  (connection), which projects into the upper section  2 . Via the upper connection  12  the powder to be filled can be supplied, preferably by a dosing device, which is not shown, more particularly a PTS feeder. 
         [0034]    The free end  13  of the upper outlet  12  is surrounded by a continuous liner  14  which is closed at the bottom. To close the continuous liner  14  a clip  15  or a cable binder is provided. By closing the continuous liner  14  a second bag  16  is formed from the continuous liner  14  in a lower section into which the upper outlet  12  projects. 
         [0035]    The upper outlet  12  is surrounded by a tubular bearing structure  17  on the outer circumference of which the folded continuous liner, which preferably when unfolded is of a length of between 10 and 50 m, preferably around 30 m, is held by means of a, more particularly elastic, clamping ring. 
         [0036]    In order to fill the first bag  9 , the drum  8  is initially inserted from the front side into the lower section  3 , which is delimited by three side walls, a base and the partition wall  4 . A lid  18  of the initially closed drum  8  is opened within the lower section  3 , as indicated in  FIG. 1 , and parked in a corresponding holder, which is not shown. 
         [0037]    Thereafter, as shown in  FIG. 3 , an opening  19  of the first bag  9  is attached to the lower outlet  11 , namely in an upper position  20  (cf.  FIG. 3 ) by means of an O-ring  21 , with which the first bag  9  is attached to an upper circumferential groove  22 . The upper position  20  is above the lower position  23  on the lower outlet  11 , to which a remainder  24  of an already re-closed first bag is attached by means of an O-ring  25  in a lower circumferential groove  26 . The new first bag  9  therefore also surrounds the remainder  24  of the preceding first bag. 
         [0038]    After attaching the new first bag  9  to the outer circumference of the lower, tubular outlet  11 , more specifically in an upper position  20 , even more specifically in an upper circumferential groove  22  by means of the O-ring  21 , the situation as shown in  FIG. 4  is achieved. 
         [0039]    In the next step of the process the drum  8  and with it the first bag  9  are moved by means of the lift mechanism  10  upwards in the plane of the drawing in the direction of the partition wall until an upper circumferential edge  27  of the drum  8  is in contact with the lower side of the partition wall  4 . The previously described process is shown in both  FIGS. 5 and 6  jointly. Preferably the, not shown, front doors are only closed now so that the lower section  3  is screened off from the outside environment. Alternatively the lower section is provided without front and/or side doors. 
         [0040]    Joint consideration of  FIGS. 7 and 8  shows that the remainder  24  of the preceding first bag  9  is removed with the aid of the gloves through the lower outlet  11  upwards into the upper section  2  and then transferred to the waste container  5 , so that there is now a direct connection via the lower section  11  between the upper section  2  and the first bag  9 . 
         [0041]    As can be seen in  FIG. 9 , in a lower section the continuous liner  14  is pressed from outside against the bearing structure  17  by means of an inflatable gasket  28 . The upper end  29  of the folded continuous liner  14  is pressed against the bearing structure  17  by means of an O-ring sealing. In the process step in accordance with  FIGS. 9 and 10 , gas, more particularly air, is released from the inflatable gasket  28  so that the continuous liner  14  can, by means of the gloves within the upper section  2 , as shown by the arrow  31 , be pulled downwards and inserted into the first bag  9  through the lower outlet  11 , which is in axial alignment with the upper connection  12 . A second bag  16  is therefore provided within the first bag  9 , as can be seen directly in  FIG. 12 . After the second bag  16  has been transferred into the first bag  9  the inflatable gasket is inflated again whereby the inflatable gasket  28  again presses from outside on the continuous liner  14  forcing it against the bearing structure  17 , as a result of which contamination of an area above the inflatable gasket  28  can be reliably prevented. 
         [0042]    In a next step of the process, shown in  FIG. 13 , the first bag  9  is filled with powder  32 . Below the lift mechanism  10  there are scales  33  which are connected with a control unit of the dosing device  34  in such a way that the dosing unit  34  feeds powder through the upper connection  12  until the required target weight is achieved. The dosing device  34  is connected to a low pressure line  35  for attracting powder through suction. Via a filter element  36  contamination of the low pressure line  35  is prevented. Preferably the filter element  36  can be cleaned by means of surge pressure. The dosing device  34  comprises a pump chamber  37  which emerges into an oblique pipe  28  on which a vibrator  39  is arranged in order to be able to dose the powder  32  accurately. The dosing device  34  also comprises a closing mechanism  40 , preferably designed as a slide, to regulate the filling quantity and/or to stop the filling process, preferably depending on the filling weight measured by the scales. 
         [0043]    Preferably during the filling procedure there is an over pressure in the lower section of the drum  8 , related to atmospheric pressure, and within the upper section  2  outside the continuous liner  14  alternatively a low pressure or high pressure related to atmospheric pressure. Preferably, within the continuous liner  14  there is a certain high pressure, also related to atmospheric pressure, during the filling procedure. 
         [0044]    From  FIG. 13  a roller mechanism  41  can be seen, which is arranged within and to the side of the lower section  3 , the rollers of which may be driven by an electric motor. The roller mechanism  41  is for unloading the first bag  9 /the drum  8  from the lower section  3 .  FIG. 13  also shows that the apparatus  1  has two operating positions  42 ,  43  on opposite sides. Providing two operating positions  42 ,  43  facilitates the renewal of the continuous liner  14 , which will be explained later. Preferably there is a sliding door  44  before the roller mechanism  41 . 
         [0045]    Once the required filling weight has been reached, the continuous liner  14  is closed with a clip  15  at each of two points  45 ,  46  at distance from each other, as can be seen in  FIGS. 14 and 15 , and then cut through in an area between points  45 ,  46 . This therefore results in a closed second bag  16  within the first bag  9 , which in turn is arranged in the drum  8 . 
         [0046]    In a following step of the process, the result of which can be seen in  FIG. 17 , the drum  8  is returned back down into its original position by means of the lift mechanism as shown in  FIG. 16 . The first bag  9  it then closed at two points at a distance from each other, preferably with one clip at each point and then cut through between the two points. This results in a closed second bag  16  within the closed first bag  9 . 
         [0047]      FIGS. 18 and 19  show that by cutting through the first bag  9  the remaining section  24  is moved from the upper position  20  to the lower position  23  at the lower connection  11  in order to make space for the next first bag of the next filling procedure. 
         [0048]    In a following step which is illustrated in  FIGS. 20 and 21  the drum  8  is closed by way of the lid  18  being put on. 
         [0049]    Thereafter, as shown in  FIGS. 22 and 23 , the drum  8  with the first and second bag  9 ,  16  is removed laterally via the roller mechanism  41  with the sliding door  44  open. 
         [0050]    Below, with the aid of  FIGS. 24 to 42 , a preferred method of renewing the continuous liner  14  is described. 
         [0051]    In order to do this a (new) continuous liner  14  within a first bag  9 , in which an O-ring seal  30  is also contained, is moved to the lower section  3  of the apparatus  1  through the front doors. As can be seen in  FIG. 24  the first bag  9  is closed and the contents are sterile. 
         [0052]    As can be seen in  FIGS. 26 and 27 , the first bag  9  is fixed in the upper position  20  by means of an O-ring  21  after the remainder  24  of the preceding first bag has been moved to the lower position  23 . 
         [0053]    The remainder  24  is then taken to the waste container  5  using the gloves so that a connection is created between the upper section  2  and the first bag  9  and so that the O-ring seal  30  and the new continuous liner  13  can be removed through the lower connection  11  and/or moved into the upper section  2 . From  FIG. 30  it can be seen that the continuous liner  14  is contained in an additional external packaging  47  within the first bag  9 , whereby this external packaging is now opened. The continuous liner  14  was produced and packed under clean room conditions. 
         [0054]    Then, as shown in both  FIGS. 32 and 33 , gas is released from the inflatable gasket  28  and a carrier structure  48  which bears the inflatable gasket  28 , is removed from the tubular bearing structure  17  together with the inflatable gasket  28  (cf.  FIG. 32 ). Prior to this the new continuous liner  14  is parked within the upper section  2  to the side of the upper connection  12 . 
         [0055]    In a following step, shown in  FIG. 34 , the upper end  29  of the new continuous liner  14  is attached to the bearing structure  17  by means of an O-ring  30 , after an upper end of a remainder  49  of the used continuous liner has been moved into a lower position. Inside, a lower end  50  of the continuous liner is passed down through the carrier structure  48  past the inflatable gasket  28 . Preferably the above operating steps are carried out by two persons, located on opposite sides of the apparatus  1 , each using a pair of gloves, and preferably also the following step in which the inflatable gasket with its carrier structure  48  is moved upwards and the carrier structure  48  is attached in the lower section of the tubular bearing structure  17 . 
         [0056]    In a subsequent step shown in  FIGS. 36 and 37 , the new continuous liner  14  is closed by means of a clip  15  so that consequently the remainder  49  is within the new continuous liner forming the new, second bag. 
         [0057]    In a following step shown in  FIGS. 38 and 39  the remainder  49  of the previous continuous liner together with its O-ring is removed from the bearing structure  17  and transferred in full into the second bag  16  formed by the continuous liner  14 , whereupon the continuous liner is, as shown in  FIGS. 40 and 41 , is closed with a clip  15  at two points at a distance from each other and the second bag  16  is separated from the continuous liner  14  in an area between the two points. The second bag  16 , incorporating the remainder  49 , can now fall into the first bag  9 , whereupon, as shown in  FIG. 42 , the first bag  9  is closed, whereby previously the contents of the waste container  5 , i.e. the remainders  24  of the preceding first bags are transferred from the waste container  5  into the first bag. Then only the first bag  9 , filled with waste and the second bag, can be removed. The apparatus  1  is then ready for further filling procedures. 
         [0058]      FIG. 44  shows a perspective view of a device  1  with a dosing unit  34 . A positive air pressure can be seen within the continuous liner  14  during the filling procedure, a positive air pressure within the upper section  2  and a positive air pressure within the lower section  3 . This configuration provides optimum product protection. The table in accordance with  FIG. 46  summarises the result of the interaction of the various barriers. 
         [0059]      FIG. 45  shows the identical apparatus as in  FIG. 44 , but the air circulation in the uppers section  2  is such that within the upper section  2  outside the continuous liner  14  a low pressure predominates. In the lower section  3  as well as within the continuous liner  14  there is a slight high pressure. The effects of the interaction of two different barriers are shown in the table in accordance with  FIG. 47 . 
         [0060]    The views in accordance with  FIGS. 48   a  to  48   c  show a possible embodiment variant of an apparatus  1  with a dosing unit  34 . The outer walls have not been shown. Lateral openings  51  in the housing of the upper section  2  can be seen, which can be used to operate the apparatus  1  via integral system gloves, which are attached in a detachable sealed manner on the outside of the openings  51 . A drum  8  can be seen, which can be moved between a lower and an upper position within the upper section  2  by means of a lift mechanism  10 . The lift mechanism  10  stands on a separate weighing mechanism  52  which is connected in a signal-conducting manner to the control system of the dosing unit  34 . 
         [0061]      FIG. 48   b  shows a section of the dosing unit  34  with a powder supply line  53 , pump chamber  37 , low pressure connection  35 , filter element  36 , oblique pipe  38 , vibrator  39  and closing mechanism  40  and/or valve. 
         [0062]      FIG. 48   c  shows the arrangement of a preferably provided roller mechanism  41  for facilitated removal of a drum  8 . 
         [0063]      FIG. 48   c  shows the position of two volatile particle filters, namely an inlet air volatile particle filter  54  and an outlet air volatile particle filter  55 , preferably both HEPA filters, by means of which air circulation in the upper section  2  of the apparatus  1  is brought about. 
         [0064]      FIG. 49  shows an apparatus  1  (DCS glove box) with an upper section  2  and a lower section  3  in an overall system. It shows the dosing device  35 , to which powder is supplied from a mill  56 , which is turn is supplied by a dryer  57 . To the side there is a sample removing device  58  from which or with which or automatically, product samples can be taken during filling. 
       List of Reference Symbols 
       [0000]    
       
           1 . Apparatus 
           2 . Upper section 
           3 . Lower section 
           4 . Partition wall 
           5 . Waste container 
           6 . Gloves 
           7 . Housing 
           8 . Drum 
           9 . First bag 
           10 . Lift mechanism 
           11 . Lower outlet 
           12 . Upper outlet 
           13 . End 
           14 . Continuous liner 
           15 . Clip 
           16 . Second bag 
           17 . Bearing structure 
           18 . Lid 
           19 . Opening 
           20 . Upper position 
           21 . O-ring 
           22 . Upper circumferential groove 
           23 . Lower position 
           24 . Remainder of the preceding first bag 
           25 . O-ring 
           26 . Circumferential groove 
           27 . Circumferential edge 
           28 . Inflatable gasket 
           29 . End 
           30 . O-ring seal 
           31 . Arrow 
           32 . Powder 
           33 . Scales 
           34 . Dosing device 
           35 . Low pressure connection/low pressure line 
           36 . Filter element 
           37 . Pump chamber 
           38 . Oblique pipe 
           39 . Vibrator 
           40 . Closing mechanism 
           41 . Roller mechanism 
           42 . Operating position 
           43 . Operating position 
           44 . Sliding door 
           45 . Point 
           46 . Point 
           47 . External packaging 
           48 . Carrier structure/carrying structure 
           49 . Remainder of the preceding continuous liner 
           50 . End 
           51 . Housing opening 
           52 . Weighing mechanism 
           53 . Powder supply line 
           54 . Inlet air volatile particle filter 
           55 . Outlet air volatile particle filter 
           56 . Mill 
           57 . Dryer 
           58 . Product removal devices/sample-taking device