Patent Publication Number: US-9849432-B2

Title: Method for preparation of pharmaceutical products

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation patent application that claims priority benefit to a co-pending non-provisional patent application entitled “Machine for the Preparation of Pharmaceutical Products,” which was filed on Jun. 5, 2014, and assigned Ser. No. 14/362,980, which in turn claims the benefit of PCT/IB2012/056998, which was filed on Dec. 5, 2012, which in turn claims the benefit of European Application No. 11192020.3, which was filed on Dec. 5, 2011, all of which are herein incorporated by reference in their entireties. 
    
    
     TECHNICAL FIELD 
     The present invention relates to a machine for the preparation of pharmaceutical products. 
     BACKGROUND ART 
     A machine is known in the field of the preparation of pharmaceutical products, in particular of the preparation of toxic pharmaceutical products, such as, for example, cytostatic drugs used for chemotherapy, comprising a store for a plurality of containers, e.g. infusion bags, bottles and syringes; a dosing station for the preparation of a pharmaceutical product obtained by mixing, by means of a syringe, at least one pharmaceutical substance contained in a bottle and at least one diluent contained in an infusion bag; a weighing station of the containers; and a robotized arm for gripping and transporting the containers themselves. 
     The store, the dosing station, the weighing station and the robotized arm are accommodated within a containment chamber limited by a protective casing provided with an access opening adapted to allow personnel to load and/or unload the various types of containers into/from the store itself. 
     In order to protect the health of personnel and to avoid the diffusion of toxic substances outside the containing chamber, the machine normally comprises a pneumatic ventilation device for feeding an air flow through the containing chamber itself. 
     The pneumatic ventilation device is selectively controlled so that the pressure existing in the containing chamber is lower than the pressure existing in the environment outside the containing chamber itself. 
     The known machines for the preparation of pharmaceutical products of the type described above have some drawbacks mainly deriving from the fact that the various pressures existing in the containing chamber and in the environment outside the containing chamber prevent the diffusion of toxic substances from the containing chamber into the outside environment, but do not prevent the diffusion of contaminating agents from the outside environment into the containing chamber. 
     DISCLOSURE OF INVENTION 
     It is an object of the present invention to provide a machine for the preparation of pharmaceutical products which is free from the above-described drawbacks, and which can be simply and cost-effectively implemented. 
     According to the present invention, a machine for the preparation of pharmaceutical products is provided as claimed in the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will now be described with reference to the accompanying drawings, which show a non-limitative embodiment thereof, in which: 
         FIG. 1  is a diagrammatic front view, with parts removed for clarity, of a preferred embodiment of the machine according to the present invention; 
         FIG. 2  is a diagrammatic side view, with parts in section and parts removed for clarity, of the machine in  FIG. 1 ; 
         FIG. 3  is a diagrammatic perspective view, with parts in section and parts removed for clarity, of the machine in  FIG. 1 ; 
         FIG. 4  is a diagrammatic plan view, with parts in section and parts removed for clarity, of the machine in  FIG. 1 ; and 
         FIG. 5  diagrammatically shows the operation of a pneumatic ventilation device fitted in the machine in  FIG. 1 . 
     
    
    
     BEST MODE FOR CARRYING OUT THE INVENTION 
     With reference to  FIGS. 1, 2, 3 and 4 , reference numeral  1  indicates as a whole a machine for the preparation of pharmaceutical products comprising a dosing chamber  2  limited, in the case in point, by a front wall  3  and by a rear wall  4 , substantially vertical and parallel to each other, by two substantially vertical side walls  5 , perpendicular to the walls  3  and  4 , by a substantially horizontal bottom wall  6 , and by a substantially horizontal upper wall  7 , parallel to the wall  6  itself. 
     Chamber  2  accommodates therein a pocket drum  8  for storing infusion bags (not shown); a robotized gripping and transporting device  9 , which is fitted in the drum  8 , comprises a plurality of articulated arms  10  hinged to each other, and is provided with a gripping member  11  fitted on the free end of the arms  10 ; a weighing device  12  of the infusion bags (not shown); and a dosing station  13  for the preparation of a pharmaceutical product. 
     Furthermore, the machine  1  has a store  14 , which allows the storage of a plurality of containers  15  (in the case in point, bottles and syringes which can also be weighed on the device  12 ), and comprises a parallelepiped-shaped box-like body  16  coupled to the front wall  3  so as to protrude downwards from chamber  2 . 
     Store  14  accommodates therein two pocket conveyor devices  17  (only one of which is shown in  FIGS. 2 and 3 ), each of which is shaped to store a given type of container  15 , and has a plurality of pockets  18  fitted between a pair of belt conveyors  19 . 
     The containers  15  of each device  17  are loaded into and/or taken from the respective pocket  18  through a first opening  20  obtained through a front wall  16   a  of body  16  and normally closed by a first access door (not shown) and through a second opening (not shown) obtained through the wall  3  and normally closed by a second access door (not shown). 
     The mentioned infusion bags (not shown) are transferred to and from the drum  8  by means of a linear conveyor (known and not shown), which is engaged in sliding manner by an adapter member fitted on each infusion bag (not shown), communicates with the environment outside the machine  1  through an opening  21  obtained through the wall  16   a  and normally closed by an access door (not shown), and further communicates with chamber  2  through an opening (not shown) obtained through the wall  3  and normally closed by an access door (not shown). 
     Furthermore, store  14  comprises a vibration distribution plate (not shown) for a plurality of closing caps (not shown) of the mentioned syringes (not shown). 
     The vibrating distribution plate (not shown) is accommodated within body  16 , is loaded by the personnel with closing caps (not shown) through an opening  22  obtained through the wall  16   a  and normally closed by an access door (not shown), and communicates with chamber  2  by means of an opening (not shown) obtained through the wall  3  and normally closed by an access door (not shown). 
     Furthermore, the machine  1  comprises a chamber  23  for collecting the machining waste of the machine  1  itself. 
     Chamber  23  is obtained under chamber  2 , is limited by a box-like body  24  fitted under the wall  6 , and communicates with chamber  2  through an opening  25  obtained through the wall  6  and normally closed by an access door (not shown). 
     Chamber  23  accommodates therein a container  26  for collecting the machining waste of the machine  1  adapted to be extracted from chamber  23  through a hatch (not shown) defining part of the body  24  after having been closed and sealed automatically with a lid (not shown) within chamber  23  itself. 
     Store  14  and therefore body  16  jointly define with chamber  23 , and thus with the body  24 , part of a containing liner  27  of chamber  2 . 
     The liner  27  further comprises a rear wall  28  substantially superimposed on the wall  4  and two side walls  29  substantially superimposed on walls  5 . 
     The walls  4 ,  28  and the walls  5 ,  29  mutually define a gap  30  closed at the bottom by wall  6  and at the top by wall  7 . 
     The machine  1  is provided with a pneumatic ventilation device  31  comprising a main filtering unit  32  and a first feeding circuit  33  for feeding an air flow through chamber  2 . 
     Circuit  33  comprises an inlet branch  34  for feeding the air from chamber  2  into the unit  32 , and an outlet branch  35  for feeding the air from the unit  32  firstly through a secondary filtering unit  36  fitted over the wall  7 , and thus into chamber  2 . 
     In this regard, it is worth noting that the bottom wall  6  of chamber  2  is shaped as a double wall adapted to divide chamber  2  itself into an upper chamber  2   a  and a lower chamber  2   b  connected to each other by means of a peripheral intake grille  37  which facilitates the direction of the air flow from chamber  2   a  to chamber  2   b.    
     Circuit  33  is further provided with a variable flow rate impeller  38  arranged along the branch  34 , two adjustable flow rate impellers  39  arranged along the branch  35 , and an on-off valve  40  arranged along the branch  35  between the two impellers  39 . 
     The device  31  further comprises a discharge pipe  41  of at least part of the air from the unit  32  into the outside environment. 
     The pipe  41  is connected to the branch  35  between the two impellers  39  and upstream of the valve  40  in a direction of advancement of the air along the branch  35 , and has a filtering unit  42 , an adjustable flow rate impeller  43 , and a flow rate adjustment valve  44  arranged in sequence and in order along the pipe  41  itself. 
     The device  31  further comprises a second feeding circuit  45  for aspirating an air flow from chamber  23  and from gap  30 . 
     Circuit  45  comprises an inlet branch  46  for feeding air from liner  27  into unit  32 , and an adjustable flow rate impeller  47  fitted along the branch itself  46 . 
     Furthermore, the device  31  has a feeding circuit  48  for feeding an air flow through store  14  and thus body  16 . 
     The circuit  48  comprises an inlet branch  49  for feeding air from the outside environment into body  16 , an outlet branch  50  for feeding air from body  16  into the unit  32 , a filtering unit  51  fitted along the branch  49 , and two adjustable flow rate impellers  52  fitted along branch  49  and branch  50 , respectively. 
     Furthermore, each branch  34 ,  35 ,  46 ,  50  is provided, similarly as, the pipe  41 , with a device  53  for measuring the air flow rate fed along the branch  34 ,  35 ,  46 ,  50  or along the pipe  41 . 
     The operation of the impellers  38 ,  39 ,  47 ,  52 , and thus the air flow feed through chamber  2  and store  14  and the air flow aspirated through the gap  30 , are selectively controlled by means of an electronic control unit  54  as a function of the signals coming from the devices  53  and by further measuring devices (not shown) of the pressures existing within chamber  2 , store  14 , gap  30 , and the outside environment so that the pressure within the liner  27  is lower than the pressure within chamber  2  and the pressure in the outside environment and the pressure in chamber  2  is higher than the pressure in the outside environment. 
     In other words, the pressure within the liner  27  on one hand allows the possible diffusion of toxic substances from chamber  2  into liner  27  but prevents the diffusion thereof from liner  27  into the outside environment, and on the other hand allows the possible diffusion of contaminants from the outside environment into liner  27  but prevents the possible diffusion from liner  27  into chamber  2 . 
     From the above, it derives that the toxic substances present inside chamber  2  cannot jeopardize the health of personnel and that the contaminants present in the outside environment cannot compromise the correct preparation of the pharmaceutical products in chamber  2  itself. 
     When the front wall  3  of chamber  2  is opened to allow cleaning and/or maintenance operations of chamber  2  itself, the on-off valve  40  fitted along the branch  35  is closed, and the impeller  43  is activated to discharge the air fed along branch  35  into the outside environment and make the pressure in chamber  2  substantially equal to the pressure in liner  27  and lower than the pressure in the outside environment. 
     When one of the access doors (not shown) obtained through front wall  3  of chamber  2  is opened to allow the robotized device  9  to load/unload containers  15  or the mentioned closing caps (not shown) of the syringes to/from store  14 , the pressure in chamber  2 , being higher than the pressure in body  16 , diverts part of the air flow fed along the branch  35  from chamber  2  into body  16  itself. As the mentioned access doors are mainly arranged at an upper zone of chamber  2 , the air diverted from chamber  2  into body  16  thus comes from the filtering unit  36  without coming into contact with the possible contamination zones. 
     When the access door (not shown) obtained through the front wall  3  of chamber  2  is opened to allow the introduction/removal of the infusion bags into/from chamber  2 , the pressure in chamber  2 , being higher than the pressure in body  16 , diverts part of the air flow fed through chamber  2  in body  16  itself. As the mentioned access door (not shown) is arranged at a lower zone of chamber  2  and between the two conveyor devices  17  of containers  15 , the air diverted from chamber  2  in body  16  is thus immediately taken from branch  50  of the feeding circuit  48  without coming into contact with containers  15 . 
     When one of the access doors (not shown) obtained in the wall  16   a  is opened to load/unload containers  15  or the mentioned infusion bags (not shown) or the mentioned closing caps (not shown) of the syringes into/from store  14 , the entrance of contaminants present in the outside environment into store  14  is obstructed by a feeding flow  55 , which feeds an air flow along the wall  16   a , and defines part of the device  31 . 
     Circuit  55  comprises a shelf  56  fitted underneath the openings  20  and  22 , and an adjustable flow rate impeller  57  fitted over the openings  20  and  22  for feeding an air flow taken from the outside environment firstly through a filtering unit  58  and thus to shelf  56 . 
     The air flow generated by the impeller  57  is fed to shelf  56  in substantially vertical direction, and thus taken in by a frame  59  fitted about opening  21 , diverted by frame  59  in substantially horizontal direction, fed on opening  21 , and finally discharged downwards again into the outside environment. 
     As the pressure in body  16  is lower than the pressure in the environment outside the machine  1 , the air flow fed along the wall  16   a  defines, on one hand, an air barrier adapted to obstruct the introduction of contaminants inside store  14 , and on the other is diverted in part inside store  14  through the access door (not shown) opened each time. 
     Consequently, the activation of circuit  55  obstructs the introduction of air coming from the outside environment into body  16  allowing the introduction into body  16  of filtered air coming from unit  58 . 
     According to some variants (not shown): 
     feeding circuit  45  is eliminated and replaced with a feeding circuit similar to circuit  33  and adapted to feed an air flow through the gap  30 ; 
     containing liner  27  is shaped so as to fully envelop dosing chamber  2  at the front wall  3 , the rear wall  4  and the side walls  5 , both at the bottom wall  6  and the upper wall  7 .