Abstract:
The invention relates to a disposable packaging item capable of being sterilised and/or depyrogenated. The invention in particular relates to the packaging of products and/or devices in the fields of medicine, pharmaceutics, chemistry, biology, food or electronics. The invention in particular relates to a disposable packaging item ( 1 ) at least partially produced with at least one thermoplastic film ( 10 ) that can withstand sterilisation and/or depyrogenation, said disposable packaging item ( 1 ) defining at least one inner enclosure ( 5 ) for receiving one or more elements ( 50 ) to be packaged, said inner enclosure ( 5 ) being under vacuum ( 40 ) and preferably sterile and/or depyrogenated, said packaging item ( 1 ) including one or more packaged elements ( 50 ).

Description:
[0001]    The invention relates to a primary or secondary disposable packaging product that can be sterilized and/or depyrogenized. 
         [0002]    The invention relates in particular to a packaging for products and/or devices of the medical, pharmaceutical, chemical, biological, alimentary, or electronic domains. 
       STATE OF THE ART 
       [0003]    In the domain of heat sterilization and/or depyrogenation of packaged products or devices, the practice is to place these products or devices in the chamber of an oven with positive pressure gradient in order to keep the product and the packaging sterile and/or depyrogenized during the cooling phases. The oven must therefore be specialized for this type of operation, which in general requires continuous sterilizing filtration of the air inside the oven and a laminar flow at the exit of the oven chamber, in particular to isolate the inside of the oven chamber from the exterior atmosphere and to guarantee that the sterilization is maintained at the exit. 
         [0004]    Very recently, the company DISPOSABLE-LAB (France) has invented a new valve applicable to packaging for such products. This product is currently the subject of an international patent application PCT/EP2010/053617. The presence of this valve eliminates the need for laminar flow at the exit of the sterilization and/or depyrogenation chamber. However, the oven must be under sterile atmosphere and in over-pressure during the sterilization and/or depyrogenation operation. 
       GOALS OF THE INVENTION 
       [0005]    The main goal of the invention is to resolve the new technical problem of providing a packaging that can be used in all types of ovens or sterilization and/or depyrogenation chambers. The goal of the invention is therefore to introduce the use of a sterilization and/or depyrogenation chamber not requiring a laminar flux at the exit, or a sterile over-pressure atmosphere, which are not advantageous operational conditions. 
         [0006]    The goal of the invention is also to resolve the technical problem of providing a packaging which keeps the product sterile and/or depyrogenized during its storage and up to its use. 
         [0007]    The goal of the invention is also to resolve the technical problem of providing a sterilization and/or depyrogenation method for a disposable packaging, which is easier to produce and/or less costly. 
         [0008]    The goal of the invention is also to resolve the technical problem of providing a sterilization and/or depyrogenation method for a disposable packaging that can be used in all types of sterilization or depyrogenation devices, in particular by heating and holding at a certain sterilization and/or depyrogenation temperature. 
         [0009]    The goal of the invention is to provide a solution to all of the aforementioned technical problems in a simple, industrial manner, and at low cost. In particular, the invention aims at providing an easy to use disposable sterile packaging. 
       DESCRIPTION OF THE INVENTION 
       [0010]    The invention relates to a packaging that can be sterilized and/or depyrogenized, in other words freed of pyrogenic agents. A pyrogenic agent is an agent that can provoke fever in humans or animals. The expression “freed of pyrogenic agents” means that pyrogenic agents are not present or that their quantity is smaller than the acceptable standards for the use of the subject product or device. The term “depyrogenation” refers in particular to the removal of pyrogenic agents from the devices or products, and more particularly from injectable pharmaceutical products, sterile creams, or pharmaceutical, medical or surgical devices. 
         [0011]    The present invention covers in particular a disposable packaging ( 1 ) made at least partially from at least one thermoplastic film ( 10 ) resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa, said item of disposable packaging ( 1 ) defines at least one interior space ( 5 ) intended to receive one or more elements ( 50 ) to be packaged, whereby said space ( 5 ) is under vacuum ( 40 ) and sterile and/or depyrogenized, and said packaging ( 1 ) is containing one or more packaged elements ( 50 ). 
         [0012]    The term “thermoplastic” refers to a polymeric material obtained by polymerization of monomers comprising at least one atom of carbon, and susceptible of being softened by heating and hardened by cooling, in repeatable manner. 
         [0013]    By vacuum is understood a pressure in the interior space that is lower than the exterior pressure on the packaging in storage conditions. By preference, the vacuum is a pressure between 1 and 500 hPa, by preference between 1 and 400 hPa, and for instance approximately 300 to 350 hPa. 
         [0014]    According to a variant, the item of the invention comprises at least one entry and/or exit opening for one or more elements to be packaged in the interior space of the item, said at least one entry and/or exit opening is closed by at least one closing means after introduction of the elements to be packaged in the interior space of the item, such as for instance by means of welding and/or mechanical pinching of the film of a thermoplastic resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa. 
         [0015]    By preference, the entry and/or exit opening is formed by the thermoplastic film. 
         [0016]    By polymeric material resistant to sterilization and/or depyrogenation is understood a material that is not degrading, or not in appreciable manner, during sterilization and/or depyrogenation. In particular, this material should not partially assume a liquid or gaseous state, or be the subject of degradation caused by the form of the item and/or products or devices to be conditioned. Typically the melting temperature of this material is higher than 225° C. at 10 5  Pa. 
         [0017]    Advantageously, a vacuum is drawn in the interior packaging space, by preference before or simultaneously to the closing, by at least one closing means, of the entry and/or exit openings, such as for instance closing by at least one weld or a mechanical action. 
         [0018]    According to one implementation mode, the disposable packaging is a disposable bag, for instance a single or multiple bag made from one or several films of at least one thermoplastic. Advantageously, the external edges of the thermoplastic film(s) forming the periphery of the introduction opening are welded. 
         [0019]    According to one implementation mode, the disposable packaging has walls formed from at least one thermoplastic film resistant to sterilization and/or depyrogenation, and resistant to a temperature higher than 225° C. at 10 5  Pa. 
         [0020]    Advantageously, said item comprises at least one introduction opening for one or more elements to be packaged in the interior space of the item, the entry and/or exit openings are closed by welding or by a mechanical pinching mechanism of the thermoplastic film. 
         [0021]    By preference, only one thermoplastic is used, but the invention covers also the use of several polymeric materials in order to associate their properties and to improve the properties of the packaging. Among the preferred polymers, one or more polymers are used selected among: PE (Polyethylene), PP (Polypropylene), PFA (Perfluoroalkoxy), Polyaryletherketone, FEP (fluoro ethylene propylene), PEEK (Poly(ether ether ketone)) (PEEK MT or ST), PAI (polyamide imide), PI (Polyimide), PPSU (Polyphenylene sulfon), PES (Polyether sulfon), PPP (Polyparaphenylene), POM (Polyoxymethylene), and the analog polymers. PEEK is a preferred polymer. 
         [0022]    The item of the invention is made, at least partially, and by preference completely, by preference, from PEEK or PFA. 
         [0023]    According to an advantageous implementation mode, the pressure of the interior space is between 1 and 500 hPa, by preference between 1 and 400 hPa, and for instance approximately 300 to 350 hPa. The vacuum is created in such manner as to limit to the maximum the expansion of the interior space of the packaging. According to a particular implementation mode, enough gas is left behind (air, oxygen, nitrogen or other inert gas, or gas necessary for the packaged product or device) to expand the interior space so that the products or devices are in the presence of the same gas, and in order to validate the sterilization and/or depyrogenation, at least from the point of view of quality. 
         [0024]    Advantageously, the item of the invention comprises, by preference close to an introduction opening, means of easy opening by ripping of the thermoplastic film. Typically, a V shaped notch is provided. 
         [0025]    According to a variant, the easy opening means consist of a notch, for instance “V” shaped, made in the thermoplastic film. By preference the notch is made in directional manner for easy ripping of the plastic film if the thermoplastic opposes a resistance which is mainly directional. 
         [0026]    Advantageously, the item of the invention comprises as vacuum packaged element, one or more recipients for one or more products, and in particular chemical, pharmaceutical, biological, or alimentary products, or one or more medical, surgical or electronic devices. 
         [0027]    According to one implementation mode, the interior space is sterile and/or depyrogenized with one or more products and/or devices packaged in the interior space. 
         [0028]    According to a variant, the packaging is made of at least one thermoplastic film resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa, and by preference is made of PEEK or PFA, said thermoplastic film has a tubular form closed in its extremities to define said interior space. 
         [0029]    Advantageously, the item comprises one or more flasks or vials containing chemical, pharmaceutical or biological products to be sterilized and/or depyrogenized. 
         [0030]    According to an implementation mode of the invention, the flasks or vials are placed on a tray or support with separators for the flasks or vials. The tray including flasks or vials is placed in the interior space for sterilization and/or depyrogenation. 
         [0031]    According to a preferred implementation mode of the invention, the flasks and vials are positioned by means of one or more flask or vial separating elements. The assembly of flasks/vials and separating elements is placed in the interior space for sterilization and depyrogenation. In this implementation mode, the packaging has no support or tray and only one or more separating elements of flasks and vials. 
         [0032]    Advantageously, the separating element is an element comprising partitions defining contiguous pockets for receiving, by preference at regular intervals, the flasks, vials or other product to be packaged. 
         [0033]    By preference, in packaged form, the separating element is held in place solely by the reduced pressure applied in the interior space acting through progressive compression of the thermoplastic film. In other terms, when, for instance, flasks or vials are used, the separating element can be held at a height between the lower part and the upper part of the flasks, essentially thanks to the reduced pressure (the vacuum) existing in the interior space. In practice, the creation of the vacuum causes progressive displacement of the separating element from a position “at rest” corresponding, by preference, with the lower part of the flasks to a “vacuum” position corresponding, by preference, with a median position located between the lower part and the upper part of the flasks. 
         [0034]    According to another implementation mode, the invention does not comprise a tray or support, or separating elements. In other words, the interior space of the packaging according to the invention contains only, for instance, the products, the recipients, the flasks or vials to be packaged. 
         [0035]    According to a particular implementation mode, the item of the invention encloses in the interior space of the packaging one or more disposable packagings as defined previously, for instance to constitute at least a double pocket. This double pocket, triple pocket, or multiple pocket, allows for the sterilization and/or depyrogenation of the exterior of the first pocket. 
         [0036]    According to a preferred implementation mode, different thermoplastics are used to make the different films of a double pocket, triple pocket or multiple pocket. According to one variant, a different thermoplastic is used for each layer. Advantageously, the double pocket, triple pocket or multiple pocket comprises a PEEK film forming the layer closest to the elements to be packaged, and a PFA film for the layer farthest away forming the exterior layer of the packaging. In this way, different properties of thermoplastics are combined, avoiding in particular the phenomenon of adhesion of one film against the other films of the same thermoplastic during a temperature rise, such as during a sterilization and/or depyrogenation phase. 
         [0037]    In general, the thickness of the thermoplastic film of the invention is between 25 and 500 microns, by preference between 300 and 50 microns and often approximately 200 microns. 
         [0038]    According to an implementation mode, the packaging is a partially or totally flexible bag. The flexibility can be conferred in particular by varying the nature of the thermoplastic and/or the film thickness. It is also possible to make one part of the packaging with lateral walls and a bottom in order to receive products, devices, flasks or vials, and to close the entry or exit opening (the surface above the bottom) by means of a thermoplastic film welded to the periphery of the edges of the lateral walls. The lateral walls and bottom can be made of rigid material. The film can be withdrawn. The bottom of the item can constitute a support surface for the products, devices, flasks and vials. Each of the products, devices, flasks or vials can be placed in an individual compartment. 
         [0039]    The invention relates also to an under partial vacuum sterilized and depyrogenized product and/or device, ready to use, contained in a packaging as defined above and here after. The packaged product and/or device of the invention can be removed from its packaging by a simple motion of ripping the thermoplastic film, in particular at the location of the easy opening means. 
         [0040]    The invention relates also to a method for sterilizing and/or depyrogenating a disposable packaging, by preference such as previously defined, characterized in that it comprises:
       the introduction of one or more products and/or devices inside the interior space of a disposable packaging made at least partially from a thermoplastic film resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° at 10 5  Pa, and by preference with walls made of a thermoplastic film resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa, said introduction takes place by means of at least one introduction opening defined in said item;   applying a vacuum to the disposable packaging; and   the closing, by preference by welding or mechanical pinching of the thermoplastic film, and of the introduction opening(s); and   the sterilization and/or depyrogenation of the disposable packaging enclosing in its interior space, under vacuum, one or more products and/or devices.       
 
         [0045]    The packaging contains in this way one or more sterilized and/or depyrogenized products and/or devices. 
         [0046]    The European Pharmacopoeia, 5.1.1 “methods for preparing sterile products” defines sterilization methods among which sterilization by dry heat. The vacuum in the interior space can be drawn through the intermediary of a system for aspirating the gas in the interior space. The aspiration system can be connected to a tube ending in the interior space. Once the vacuum is drawn, the tube is retracted operculating the space left by the retracted tube, then before the total retraction of the tube, the opening is closed rendering the interior space impermeable. 
         [0047]    According to a variant, the closing phase includes welding of the thermoplastic film. A typical weld consists of a continuous double linear weld rendering impermeable the interior space from the atmosphere outside the packaging. 
         [0048]    Advantageously, the method comprises the introduction in a closed space, such as for instance an oven, of the disposable packaging under vacuum, then the sterilization and/or depyrogenation of the disposable packaging, then the removal of the disposable packaging from the closed space. 
         [0049]    The thermoplastic film is welded in particular by a permanent assembly technique which ensures by fusion a continuity of the same nature of the surfaces to be joined, by approaching, making contact then holding until solidification of the mixture formed in this manner. Welding can take place in particular by means of hot air, friction, mirror, ultrasound, high frequency or laser. 
     
    
     
         [0050]    Other goals, characteristics and advantages of the invention will become clear by reading the explanatory description with reference to the implementation modes illustrated by the attached drawings, in which: 
           [0051]      FIG. 1  illustrates an implementation mode in which a disposable packaging ( 1 ) is made at least partially, and here completely, from a thermoplastic film ( 10 ) resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa. This film is made of PEEK. Said disposable packaging ( 1 ) defines at least one interior space ( 5 ) intended to receive one or more elements ( 50 ) to be packaged. The film ( 10 ) comprises a first weld ( 20 ) closing one end of the packaging. This weld is also visible in the implementation modes of  FIGS. 2 and 3  ( 20 ,  320 ). 
           [0052]      FIGS. 2 and 3  illustrate a disposable packaging ( 1 ,  301 ) according to the implementation mode of  FIG. 1  in which the interior space ( 5 ,  305 ) of the item ( 1 ,  301 ) is under vacuum ( 40 ,  340 ) and sterile and/or depyrogenized, said packaging ( 1 ,  301 ) comprises one or more packaged elements ( 50 ,  350 ). The packaged elements ( 50 ,  350 ) are sterile and/or depyrogenized. This is obtained by introducing the elements ( 50 ,  350 ) to be packaged, then closing the thermoplastic film ( 10 ,  310 ), here by welding ( 30 ,  330 ) edge to edge at the location of the introduction opening ( 15 ,  315 ). The extraction of one or more packaged elements ( 50 ,  350 ) can take place through the introduction opening ( 15 ,  315 ) which serves then as exit opening, or by ripping the film ( 10 ,  310 ) in another place or in a predefined place, typically by means of a notch facilitating the ripping of the film ( 10 ). 
           [0053]      FIG. 3  illustrates a disposable packaging ( 301 ) in which the packaged elements ( 350 ) are under vacuum ( 340 ), sterile and/or depyrogenized in the interior space ( 305 ) and placed on a tray comprising separations ( 360 ). These elements ( 350 ) are here flasks which can contain a product of interest in chemistry, pharmacy, biology, biotechnology, or food industry; 
           [0054]      FIG. 4  illustrates an implementation mode of the invention in which a disposable packaging ( 401 ) is produced at least partially by means of a thermoplastic film ( 410 ) resistant to sterilization and/or depyrogenation, and resistant to a temperature greater than 225° C. at 10 5  Pa. This film is made of PEEK. Said disposable packaging ( 401 ) defines at least one interior space ( 405 ) intended to receive one or more elements ( 450 ) to be conditioned. The film ( 410 ) is welded by a weld ( 430 ) attaching the film ( 410 ) to the periphery of the upper surface of the interior space ( 405 ) of the packaging ( 401 ). The elements ( 450 ) are packaged under vacuum ( 440 ). 
           [0055]    In a preferred mode of the invention the interior space comprises a buffer volume or “dead” volume which limits the forces exercised on the closing means when the volume of the interior space increases. Typically, during the sterilization and/or depyrogenation procedure, the rise in temperature causes a volume increase of the interior space. The buffer volume serves therefore as expansion zone of the gas present in the interior space. A typical buffer zone comprises an extension of several centimeters of the thermoplastic film not facing the packaged elements, typically 5 to 10 cm. 
           [0056]      FIG. 5  shows a variant of the buffer volume ( 570 ). The other references are deduced by adding  500  to the references of  FIGS. 1 and 2 . 
           [0057]      FIG. 6  is a photo of an implementation mode of the invention. In this interior space comprising flasks, the vacuum is approximately 320 hPa. 
           [0058]      FIG. 7  illustrates a packaging ( 1 ,  701 ) in which the packaged elements ( 750 ) are under vacuum ( 740 ), sterile and/or depyrogenized in the interior space ( 720 ) and separated by separating elements ( 780 ). The other references are deduced by adding  700  to the references of  FIGS. 1 and 2 . 
           [0059]      FIG. 8  is a photo of an implementation mode of the invention. In this interior space, a separating element comprising partitions defining contiguous pockets is used to ensure the separation of the flasks. 
       
    
    
       [0060]    The examples which have been given are an integral part of the present invention and any characteristic appearing novel relative to the prior state of technology, starting from the description as a whole, including the examples, is an integral part of the invention in its function and generality. 
         [0061]    Each example has a general reach.