Product and process for packaging a powder

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.

1 . A process for enabling the packaging of a powder comprising the steps of:
 a) providing a first bag ( 9 ) from a flexible packaging material,   b) fixing the opening ( 19 ) of the first bag ( 9 ) to a lower outlet ( 11 ) of a DCS (drum containment system) glove box ( 1 ),   c) inside the DCS 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 ),   d) filling the second bag ( 16 ) with the powder ( 32 ) through an upper opening of the DCS glove box ( 1 ),   e) closing the second bag ( 16 ) by disconnecting the continuous liner ( 14 ),   f) closing the first bag ( 9 ) and removing the first and second bags ( 9 ,  16 ) from the DCS glove box ( 1 ).   
     
     
         2 . The process according to  claim 1 , including the providing of a low-pressure or a high-pressure environment inside the DCS glove box ( 1 ) outside the continuous liner ( 14 ). 
     
     
         3 . The process of one of  claim 1 , including the providing of a over-pressure environment inside the continuous liner ( 14 ) and/or outside the first bag ( 9 ), more particularly outside the continuous liner ( 14 ) in a lower section ( 3 ) of the DCS glove box ( 1 ) designed for holding a drum ( 8 ). 
     
     
         4 . The process in accordance with  claim 1 , wherein the first bag ( 9 ) is initially fixed in an upper position ( 20 ), more particularly an upper groove ( 22 ) on the lower outlet ( 11 ) by means of an O-ring, and that a remainder ( 24 ) of the first bag ( 9 ) left after closing the first bag ( 9 ) is moved into a lower position ( 23 ), more particularly a lower groove ( 26 ) in order to clear the upper position ( 20 ) for attaching the next bag ( 9 ). 
     
     
         5 . The process in accordance with  claim 1 , wherein the closing of the second bag ( 16 ) takes place manually by way of the gloves ( 6 ) of the DCS glove box ( 1 ). 
     
     
         6 . The process in accordance with  claim 1 , wherein in order to close the second bag ( 16 ) the continuous liner ( 13 ) closed at two points ( 45 ,  46 ) at a distance from each other and the continuous liner ( 14 ) is manually cut through in an area between these points ( 45 ,  46 ) via the gloves ( 6 ) of the DCS glove box ( 1 ). 
     
     
         7 . The process in accordance with  claim 1 , wherein in order to close the first bag ( 9 ) it is closed at two points at a distance from each other and the first bag ( 9 ) is manually cut through in an area between these points. 
     
     
         8 . The process in accordance with  claim 1 , wherein before filling of the second bag ( 16 ) a drum ( 8 ) with the first bag ( 9 ) is moved from a lower position ( 23 ) into an upper position ( 20 ) at which the drum ( 8 ) is in contact with a partition wall ( 4 ) between the upper section ( 2 ) and the lower section ( 3 ). 
     
     
         9 . The process in accordance with  claim 1 , wherein in order to insert a new continuous liner ( 14 ), the liner is introduced into a first bag ( 9 ) in the lower section ( 3 ) of the DCS glove box ( 1 ), the first bag ( 9 ) is connected to the lower outlet ( 11 ) and the continuous liner ( 14 ) is attached to an upper outlet ( 12 ) within the upper section ( 2 ) and the remainder ( 49 ) of the preceding continuous liner ( 14 ) is manually placed in the second bag ( 16 ) formed by the new continuous liner ( 14 ) and transferred with this into the first bag ( 9 ). 
     
     
         10 . The process in accordance with  claim 1 , wherein the powder ( 32 ) is supplied via a dosing unit ( 34 ) with a low pressure connection ( 35 ) and a high pressure connection, in such a way that at least a partial quantity of the powder ( 32 ) is transported by way of the vibrations generated by a vibrator ( 39 ). 
     
     
         11 . An apparatus for executing the process of  claim 1 , comprising a DCS (drum containment system) glove box ( 1 ), with an upper section ( 2 ) provided with gloves ( 6 ) and a lower section ( 3 ) for held holding a first bag ( 9 ), particularly arranged in a drum ( 8 ). 
     
     
         12 . The apparatus in accordance with  claim 11 , wherein an upper outlet ( 12 ) opens into the upper section ( 2 ) from a powder dosing device ( 34 ) and into the lower section ( 3 ) and lower outlet ( 11 ) from the upper section ( 2 ), whereby the continuous liner ( 14 ) attachable in the upper section ( 2 ) can be passed through the lower outlet ( 11 ). 
     
     
         13 . The apparatus in accordance with  claim 11 , further comprising at least one of means of generating over pressure and/or under pressure in the upper section ( 2 ), means for generating high pressure in the continuous liner ( 14 ), and means for generating over pressure and/or under pressure in the lower section ( 3 ) outside the continuous liner ( 14 ). 
     
     
         14 . The apparatus in accordance with  claim 11 , wherein in the lower section ( 3 ) a lift mechanism ( 10 ) is provided to move a drum ( 8 ) between a lower position ( 23 ) and an upper position ( 20 ) in which the drum ( 8 ) is in contact with a partition wall ( 4 ) between the upper section ( 2 ) and the lower section ( 3 ). 
     
     
         15 . The apparatus in accordance with  claim 11 , wherein on each of two different sides of the upper section ( 2 ) at least one detachably fixed glove is arranged. 
     
     
         16 . The apparatus in accordance with  claim 11 , wherein at least one volatile particle filter ( 54 ,  55 ) is provided in order to filter air flowing into the apparatus and/or air flowing out of the apparatus. 
     
     
         17 . Use of an apparatus according to  claim 11  as a packaging machine for performing the process according to  claim 1 . 
     
     
         18 . The process in accordance with  claim 1 , wherein the powder is a pharmaceutical product powder. 
     
     
         19 . The process according to  claim 2 , wherein the low pressure or high pressure environment is provided in an upper section ( 2 ) of the DCS glove box ( 1 ) with the glove ( 6 ). 
     
     
         20 . The process in accordance with  claim 4 , wherein the first bag ( 9 ) is initially fixed in an upper groove ( 22 ) on the lower outlet ( 11 ) by means of an O-ring. 
     
     
         21 . The process according to  claim 4 , wherein the remainder ( 24 ) of the first bag ( 9 ) left after closing the first bag ( 9 ) is moved into a lower groove ( 26 ) in order to clear the upper position ( 20 ) for attaching the next bag ( 9 ). 
     
     
         22 . The process in accordance with  claim 9 , wherein the liner has an O-ring for fastening the continuous liner ( 14 ).