Apparatus and method for treating containers under sterile conditions

Abstract

The invention relates to apparatuses and methods for treating containers under sterile conditions. The apparatus comprises a clean room having a surrounding clean-room housing (37). The apparatus also comprises a transport device and a treatment device. The transport device and the treatment device are arranged and designed such that, in the treatment mode of the apparatus, containers can be guided from the transport device, through the clean room, along a transport path and, in the process, treatment of the containers can be performed by the treatment device at least intermittently during transportation thereof through the clean room. The apparatus comprises a supply device for a sterile gas (80), which is arranged outside the clean room and can be brought into fluidic connection with the clean room via a supply line, wherein, in the treatment mode of the apparatus, the sterile gas can be applied to the clean room in order to apply the sterile gas against the ingress of germs. The apparatus comprises a connection means for connecting a sterilising device, wherein the connection means and the sterilising device are designed and configured to apply a hydrogen peroxide gas mixture (H2O2 gas mixture) to the clean room. The sterilising device is detachably attached to the apparatus and is designed as an advanceable H2O2 gas mixture generator which provides a H2O2 gas mixture that has low reactivity to condensation.

Description

[0001] Device and method for treating containers under sterile conditions

[0002] The invention relates to a treatment device according to the preamble of claim 1, in particular, the invention relates to a forming device for forming preforms. The invention further relates to a treatment method according to the preamble of claim 8.

[0003] It is known to carry out the treatment of containers, in particular a forming process in which preforms are formed into containers, under sterile conditions. This typically involves using a clean room, within which the treatment of the containers takes place, e.g., their production by forming.

[0004] A container is understood not only to mean a finished container, but also a preform from which the finished container is manufactured. For the purposes of this application, the term "container" therefore refers equally to preforms and to finished containers manufactured from them.

[0005] In addition to the aforementioned forming of preforms, which are also understood as containers, the treatment of containers also includes, for example, filling, closing, labelling, sterilizing, cleaning, etc. The term treatment does not mean the mere transport of a container without any influence on this container during transport. This influence required for treatment does not have to be accompanied by a change to the container, but this influence can, for example, also be inspecting a container to decide whether the container should be rejected. This influence can also be measuring the container, e.g. in order to use the measured values ​​obtained for control or evaluation.

[0006] The invention is particularly directed to methods and devices relating to the forming of preforms into containers. Forming is the treatment of the containers as claimed. For this reason, but without limiting the generality, such forming processes will be discussed below as representative of other treatments.

[0007] The production of containers by blow molding from preforms made of a thermoplastic material, for example, from PET (polyethylene terephthalate) preforms, is known. The preforms are fed to various processing stations within a blow molding machine. Typically, a blow molding machine comprises a heating device for tempering or thermally conditioning the preforms, as well as a blow molding device with at least one blow molding station, in which the previously temperature-conditioned preform is expanded into a container.

[0008] Options for tempering preforms are explained, for example, in DE 23 52 926 A1. Tempering or thermal conditioning involves heating the preform to a temperature suitable for forming and, if necessary, imprinting a temperature profile on the preform in the longitudinal and / or circumferential directions. This tempering of a preform represents a treatment of a container.

[0009] The expansion into the finished container takes place, for example, using a compressed gas, in particular compressed air, as a pressure medium, which is introduced into the preform to be expanded at a forming pressure. The process sequence for this type of preform expansion is explained in DE 43 40 291 A1. The basic structure of a blow molding station is described in DE 42 12 583 A1. According to a typical further processing method, the containers produced by blow molding are fed to a downstream filling device and filled there with the intended product or filling material. However, it is also possible to produce containers from preforms and simultaneously fill them with a liquid filling material, which is fed as a hydraulic pressure medium to expand the preform or to shape the container with a forming and filling pressure, so that the respective preform is formed into the container simultaneously with the filling.The forming of containers from preforms with the additional use of a stretching rod is also known. Regardless of the forming medium used and regardless of the use of a stretching rod, these manufacturing processes and the corresponding devices are hereinafter referred to as forming processes and forming devices.

[0010] It is also already known that forming can be carried out under sterile conditions by performing the forming process within a cleanroom. It is fundamentally conceivable, for example, to locate a blow molding machine, including an upstream heater and downstream transfer equipment, entirely within a cleanroom. This would result in a very large cleanroom that can be sterilized with considerable effort and the use of large quantities of sterilizing agent, and maintained sterile with equally great effort.

[0011] Sterilization is understood here to mean, for example, a germ-killing treatment using chemical sterilizing agents. Sterilization is understood here to mean that processes are carried out and / or devices are provided to prevent re-contamination of a previously sterilized area. Such devices and methods for maintaining sterility can, for example, consist of the cleanroom being surrounded by a housing that is designed to be as sealed as possible from the non-sterile environment in order to prevent the penetration of germs. For this purpose, seals can be provided at the cleanroom boundaries, for example, or locks for the entry and exit of containers into and out of the cleanroom. An alternative or additional measure can be, for example, the exposure of the cleanroom surrounded by the housing to a sterile gas, e.g.with sterile air in order to create an overpressure in the cleanroom compared to the non-sterile environment, so that the sterile gas from the cleanroom is pushed towards the environment and thereby prevents the penetration of germs. Keeping sterile also means, for example, that the cleanroom is regularly or continuously exposed to and / or by germicidal agents. These agents can be chemical in nature, for example, but can also include UV lamps or other emitters of radiation with a strong germicidal effect. The radiant heaters typically used for temperature conditioning of preforms are not understood as means of keeping sterile, since these radiant heaters are not used to kill germs, but to heat preforms.

[0012] It is also conceivable that the blow molding machine itself, i.e., the unit performing the forming process, especially excluding any upstream heating device for controlling the temperature of the preforms, could be converted into a cleanroom, for example, by converting the housing walls of the blow molding machine into cleanroom walls. This would at least partially avoid the disadvantages of a large-volume cleanroom described above.

[0013] It is also known to convert only a portion of a blow molding machine into a clean room, with this portion being limited as far as possible to those areas in which the containers are guided and treated. Such prior art is disclosed, for example, in WO 2010 / 020529 A2, which relates in particular to blow molding machines addressed by the present invention, particularly those using a stretching rod, i.e. stretch blow molding machines, and particularly rotating machines. Due to this rotating design, there are stationary clean room walls and clean room walls that move with the blow molding wheel, as well as seals arranged in between. This prior art also describes providing a sterile gas within the clean room to maintain sterility, and wherein said sterile gas is under a pressure higher than the pressure outside the clean room.It is also mentioned that, optionally, an antimicrobial agent is continuously supplied to the clean room to maintain sterility. It is also mentioned there that said clean room extends as far as a filling machine arranged downstream of the blow molding machine and preferably into the area of ​​a closing device for closing the filled containers. This WO 2010 / 020529 A2 also describes options for sterilizing the preforms. The present invention is not concerned with special features of preform sterilization, but rather with special features of sterilizing and maintaining sterility in a clean room. However, with the present devices and methods, preform sterilization prior to its forming can also advantageously be provided for all described embodiments, or, more generally, sterilization of the container prior to its treatment.

[0014] The present invention should be viewed from the perspective that, for example, germ-sensitive beverages must be filled under aseptic or sterile conditions in order to achieve the desired shelf life. This requires, for example, that the containers into which the beverages are filled also meet these sterile conditions. In this regard, it is known in the prior art to sterilize finished containers before filling or to sterilize preforms before they are converted into containers and subsequently prevent re-contamination of the containers. It is also known to sterilize both the preforms and later the containers produced from them. Sterilizing the preform has the advantage over sterilizing the container made from it that a much smaller surface area needs to be sterilized, so that the amount of sterilizing agent to be used can be lower.

[0015] In addition to the disclosure of WO 2010 / 020529 A2, generic methods and devices comprise a sterilization device for sterilizing the cleanroom. This sterilization device, which should not be confused with a possible sterilization device for the preforms, is connected to connecting means, e.g., the forming device, and the cleanroom is exposed to a sterilizing agent. It is also generally known to use a hydrogen peroxide gas mixture (H2O2 gas mixture) as a sterilizing agent, e.g., for preforms. For this purpose, an aqueous H2O2 solution is usually evaporated.

[0016] It is considered a disadvantage that the known sterilization devices are often not required for extended periods, e.g., because the treatment device operates trouble-free over an extended period and the clean room can be kept sterile for an extended period, or because the treatment device does not require the treatment of containers under sterile conditions because, for example, containers are being treated into which, for example, no germ-sensitive beverage is being filled. It is also considered a disadvantage that the commonly used H2O2 gas mixtures also attack surfaces and sensitive machine elements, e.g., seals or electronic components, which can lead to failures and malfunctions.

[0017] The invention is therefore based on the object of providing an improved solution that addresses the aforementioned problems. In particular, the object of the present invention is to provide a device of the type mentioned above in such a way that advantages are achieved in the treatment of containers under sterile conditions, e.g., in the sterilization of the clean room and / or in the maintenance of the clean room.

[0018] According to a first aspect, the object is achieved according to the invention by a device having the features of claim 1. Advantageous developments of the device are specified in subclaims 2-7.

[0019] As is the case with the prior art, the treatment device according to the invention comprises a clean room with a surrounding clean room housing. This clean room is preferably essentially limited to the area in which the treatment of the containers takes place and the transport of these containers. However, the advantages according to the invention are also achieved if the treatment device is designed as a clean room as a whole and not just a part of it. The treatment device further comprises a transport device and a treatment device. This transport device and this treatment device are arranged and designed such that, during treatment operation of the device, containers can be guided by the transport device through the clean room along a transport path and the containers can be treated by the treatment device at least temporarily during this transport.A rotating blow molding machine can be considered as an exemplary embodiment. The blowing wheel, on which blowing stations rotating with the blowing wheel are arranged at a circumferential distance, represents one such transport device. In this example, a stretching rod would be a treatment device; the treatment would consist of stretching the preform. A treatment device would also be the blowing nozzle, through which, for example, blowing gas is introduced into a preform held in the blowing station. In this example and according to the claim, the clean room would have to include the area in which the preform would be stretched by the stretching rod during its rotation on the blowing wheel and / or exposed to the blowing gas by the blowing nozzle. The stretching rod itself and the blowing nozzle themselves do not have to be located, at least not entirely, inside the clean room, but could also be located or run at least partially outside the clean room.According to the claim, it is only necessary that the treatment itself takes place within the clean room, so that in any case the preform must be arranged within the clean room and is guided within the clean room.

[0020] Furthermore, the treatment device should have a supply device for a sterile gas. This sterile gas is usually sterile air. This supply device is located outside the cleanroom and supplies the cleanroom with the sterile gas when the treatment device is in operation. The supply is via a supply line, via which a fluid connection can be established between the supply device and the cleanroom, e.g. by opening appropriate valves, throttles or flaps. When the treatment device is in operation, the cleanroom is pressurised with the sterile gas. The purpose of this is to prevent the penetration of germs, since this pressurisation of the cleanroom, which is surrounded by a housing, allows overpressure conditions to be set within this cleanroom.Depending on the sealability of the cleanroom, the flow rate of sterile gas should be adjusted to create an overpressure compared to the surrounding non-cleanroom area, thus providing protection against the ingress of germs. The sterile gas and the sterile gas supply system described here should not be confused with blow gas, which is used, for example, in the bias-forming production of containers. In this case, we are talking about sterile gas that is fed into the cleanroom to keep it sterile, while the blow gas is introduced into the preform to expand it into a container.

[0021] The supply device does not have to be permanently connected to the treatment device or to the clean room, but can also be provided as a detachable and deliverable unit, which is advantageous for transport and assembly of the treatment device.

[0022] The treatment device further comprises a connection means for connecting a sterilization device. The connection means and the sterilization device are designed and configured to supply the cleanroom with a hydrogen peroxide gas mixture (H2O2 gas mixture). This supply of the cleanroom, namely with the H2O2 gas mixture, is carried out for the purpose of sterilizing the cleanroom. The previously described supply of the cleanroom with a sterile gas serves to maintain the cleanroom in a sterile state after this sterilization. Conceptually, therefore, the terms "maintenance of sterile gas" and "sterile gas" belong together, as do the supply device for the sterile gas on the one hand, and sterilization, the sterilization device, the connection means for connecting the gas, and the hydrogen peroxide gas mixture on the other.

[0023] In other words, the connection means are designed as an interface for the detachable connection of the sterilization device, which is supplied when required in order to provide the low-condensation H2O2 gas mixture and feed it via the interface to the treatment device or clean room. Interface and connection means are to be regarded as synonymous terms. The requirement arises when the sterilization of at least the clean room is to be carried out, e.g. before production begins under sterile conditions; e.g. after an interruption in production and after the clean room is opened due to the need to resolve a problem; e.g. after a certain production period has been reached for which sterilization is specified as necessary and to be carried out, e.g. in the machine control system of the treatment device. The requirement can also arise when an operator wishes to carry out sterilization.

[0024] The prior art frequently states that hydrogen peroxide should not reach the area of ​​blowing stations, heating devices, or other equipment on a blow molding or straight blow molding machine, because H2O2 has damaging effects on many materials and attacks materials and their surfaces on which H2O2 precipitates. For example, seals or electrical components are attacked by H2O2.

[0025] However, it is known from other areas of application that hydrogen peroxide gas mixtures can be produced that exhibit little or no such damaging effect. Such hydrogen peroxide gas mixtures are also suitable for use in container treatment devices of the generic type. According to the invention, an H2O2 gas mixture generator is used as the sterilization device, which provides or can provide a low-condensation H2O2 gas mixture. Furthermore, it is provided that the sterilization device is detachably connected to the treatment device and is designed to be adjustable, i.e., it can be added and connected as needed, and after the clean room has been sterilized, it can be removed again and used elsewhere, e.g., on another device. This mobile generator therefore has the advantage of being usable in multiple systems, thus reducing investment costs.A further advantage is that existing machines can also be retrofitted or sterilized with it.

[0026] Deliverability means that the generator can be moved from the delivery position to the delivery position. The generator can be delivered, for example, by a forklift truck. Deliverability can also be advantageously achieved by designing the generator on wheels and pushing it into the delivery position, possibly supported by a self-propelled drive that assists movement or completely takes over the movement of the generator.

[0027] The term H2O2 gas mixture generator is representative and synonymous for all devices that can generate and provide an H2O2 gas mixture that, in contrast to conventional H2O2 gas mixtures, such as those used for sterilizing containers, does not condense significantly on surfaces, hereinafter referred to as a low-condensation H2O2 gas mixture. Whether condensation of an H2O2 gas mixture occurs depends on the prevailing temperature and the moisture concentration (moisture from water plus moisture from H2O2). The H2O2 concentration, the temperature and the exposure time are decisive for the sterilization effect. If, for example, the H2O2 concentration in an H2O2 gas mixture is not to exceed a certain value to prevent condensation, then the exposure time and / or exposure temperature must be increased to achieve the same sterilization effect.In summary, and in relation to the present invention, this means: In the H2O2 gas mixture generator, very dry air and a vaporized aqueous H2O2 solution are mixed together. The dry air minimizes the moisture from the water in order to simultaneously achieve the highest possible H2O2 concentration without exceeding the condensation point. If the condensation point is not exceeded, the H2O2 gas mixture is slow to condense, and no significant condensation occurs. A claimed, slow-condensation H2O2 gas mixture is therefore a gas mixture of vaporized H2O2, vaporized water, and air, preferably heated air, with a low water and high H2O2 concentration. The mixture is calculated so that the condensation point is not exceeded at a given temperature.The given temperature is considered to be in the range 10 °C to 35 °C, because these are typical temperatures in which treatment devices are operated.

[0028] The term H2O2 gas mixture generator, which provides or can provide a condensation-inert H2O2 gas mixture, should be understood in the context of the present invention as a device in which an aqueous H2O2 solution with an H2O2 concentration greater than 5%, preferably greater than 15%, more preferably greater than 30% and finally preferably between 30 and 35%, is evaporated in particularly dry air, i.e., for example, has an evaporator for this purpose. The device has, for example, a container for the aqueous H2O2 solution to be evaporated. Between the container and the evaporator, for example, there is a connecting line to supply the aqueous H2O2 solution to the evaporator, preferably in a metered manner, in that the connecting line has switching means for opening and closing and / or throttling means for adjusting the flow rate. The humidity of the dry air in which the evaporation takes place should be less than or equal to 5%, i.e., the device has, for example,a drying device for the appropriate drying of the air in which the evaporation takes place, or, for example, a supply line through which this dry air is fed to the generator. This dry air is preferably heated, so that the generator, for example, preferably has the necessary heating device for this purpose or receives the dry air already heated. The aqueous H2O2 solution can be fed to the evaporator, for example, in atomized form by atomizing the H2O2 solution with the dry air in an atomizer in a conventional manner and then introducing it into the evaporator.

[0029] The percentage for H2O2 concentration refers to the concentration of hydrogen peroxide in the aqueous solution. A 35% aqueous hydrogen peroxide solution contains 350 g of hydrogen peroxide per liter. The percentage for air humidity refers to the relative humidity: the ratio of the actual mass of water vapor present in the air to the maximum possible mass; or, in other words, the ratio between the absolute humidity and the maximum humidity.

[0030] Such H2O2 gas mixtures, which are referred to in this application as condensation-inert H2O2 gas mixtures in contrast to the above-described H2O2 gas mixtures with damaging effects, have the advantage that they exert a sterilizing effect on surfaces without causing lasting damage to these surfaces or materials. Due to the very dry production of the H2O2 gas mixture, there is no significant condensation on surfaces at normal room temperatures, e.g., in the range of 10°C to 35°C. Due to its condensation inertia, the H2O2 gas mixture spreads as a reactive gas mixture throughout the entire fumigated space, including all surfaces, and decomposes into radicals, so that germs and other biological material are attacked and destroyed by the radicals.Due to this fine dispersion, the decomposition into radicals after the fine dispersion, and the negligible precipitation as condensate, the H2O2 gas mixture does not attack surfaces. Thus, there is no corrosion, for example, of metal parts, but the surfaces and the entire gassed space are reliably decontaminated. This distinguishes the low-condensation H2O2 gas mixtures described here from the conventional mixtures previously used in sterilization, which deliberately cause condensation on the preform, container, or the respective element to be sterilized (forceps, blow nozzle, rake rod, etc.).An advantage of using the low-condensation gas mixture prepared as described above, in addition to the protection of the materials and the fine distribution, is that machine surfaces do not need to be heated above 20°C or higher to prevent condensation of H2O2 gas mixtures that cannot be described as low-condensation. For conventional vaporous H2O2, a surface temperature of >40°C is advisable to inhibit condensation. This involves considerable energy expenditure.

[0031] There are commercially available devices and processes that generate and use such low-condensation H2O2 gas mixtures, known, for example, under the designation VHP® (Vaporized Hydrogen Peroxide, Steris, Basingstoke, UK). In particular, the company Steris, e.g., STERIS Deutschland GmbH, offers such commercially available H2O2 gas mixture generators for the generation of low-condensation H2O2 gas mixtures under the product names VHPIOOi and VHP1000L.

[0032] The treatment device according to the invention is preferably of a rotating design. This means that the containers to be treated are transferred to a treatment wheel that is driven in continuous rotation, and the treatment takes place while the container rotates on this treatment wheel. After treatment is complete, the containers are then removed from the treatment wheel and fed for further use. Such rotating devices allow a high number of treatments per unit of time. The invention is particularly suitable for forming machines for forming preforms into containers, since the invention makes it possible to sterilize a preform and keep it sterile during forming. Such a forming machine is known, for example, as a blow molding machine or - when using a stretch rod - also as a stretch blow molding machine.Furthermore, forming machines are known in which the material to be filled into the container is used as a forming fluid, i.e. the forming and filling of the container takes place simultaneously.

[0033] Advantages can be achieved by arranging the connection means or interface on the supply line and / or on the supply device for the sterile gas. In this way, the hydrogen peroxide gas mixture fed in via the connection means is also passed through the supply line and / or the supply device for the sterile gas from the connection point or interface and can also effect sterilization in these areas of the line and / or device. Preferably, the connection is made on the supply device, ensuring complete sterilization of the supply line.

[0034] The supply device often has a conditioning device for the sterile gas. Such a conditioning device could, for example, be designed as a HEPA or ULPA filter in the flow path of the sterile gas and, for example, carry out filtration. Such a conditioning device could, alternatively or additionally, have heating and / or cooling means for the sterile gas and carry out temperature control of the sterile gas. Drying of the sterile gas would also be a conditioning process, and accordingly the supply device could have drying means for the sterile gas. Several or combinations of the aforementioned conditioning devices are also conceivable. If such conditioning devices are available, it is advantageous for the connection means or interface for the H2O2 gas mixture to be arranged upstream of the conditioning device in the flow direction of the sterile gas, i.e. on the side of the conditioning device facing away from the clean room.In this way, the H2O2 gas mixture also flows through the conditioning unit, sterilizing it in the process. Due to its condensation inertia, it is not damaged. This allows, for example, filter change intervals to be extended, such as those for sterile filters such as HEPA or ULPA filters. Fundamentally, this proposed approach improves the sterility of the device, as the introduction of new germs from the supply unit is reduced or prevented.

[0035] Due to the condensation inertia of the H2O2 gas mixture according to the invention, the clean room could be exposed to the gas at least temporarily during production operations, e.g., at specific time intervals during production operations. However, the sterilization of the treatment device is preferably carried out outside of its production operations by the inventive exposure to the low-condensation H2O2 gas mixture, while the exposure of the clean room to a sterile gas for the purpose of maintaining the previously sterilized clean room sterile has so far only taken place during production operations of the treatment device. Production operations are understood to mean the operation of the device in which the intended treatment of the containers is carried out, i.e., in the case of a container manufacturing device, containers are manufactured. In operating modes to be distinguished from this, e.g.,In a sterilization mode or a standby mode, no containers are treated but the device is operated for other purposes, e.g. it is kept in a ready state (= standby) in order to be able to resume production quickly after an interruption, e.g. due to a malfunction. Startup or shutdown mode, which is used to start the device up from a standstill to production mode or to shut it down from a production mode to a standstill, is also not a production mode, because in these modes, no containers are treated. As a rule, production mode can be distinguished from these other modes of operation in that workpieces to be treated, e.g. preforms or containers, are fed to the treatment device in treatment mode and not in the other modes of operation.

[0036] It is advantageously proposed that a control unit controls the H2O2 gas mixture generator in such a way that the cleanroom can only be supplied with the low-condensation H2O2 gas mixture outside of the treatment operation of the device. Preferably, the supply device should be controlled to supply the cleanroom with the sterile gas at least partially simultaneously with this H2O2 supply. The sterile gas flowing into the cleanroom thus ensures a good and uniform distribution of the low-condensation H2O2 gas mixture and the H2O2 contained therein, thus promoting good and uniform sterilization of the cleanroom, particularly if the connection means or interface for the H2O2 gas mixture is arranged on the supply device and / or on the supply line for the sterile gas.It is particularly preferred if the simultaneous exposure is carried out over the predominant duration of the sterilization treatment, in particular that the exposure to the sterile gas also takes place during the entire sterilization treatment.

[0037] Said control unit could be integrated into a control device of the treatment device. Preferably, however, this control unit is located in the H2O2 gas mixture generator, thus forming part of the generator, and is communicatively connected to the control device of the device. This improves the possibility of using such an H2O2 gas mixture generator with existing treatment devices and facilitates the sequential use of the generator in different treatment devices as needed.

[0038] It is advantageously proposed that the clean room, the clean room housing and the generator are dimensioned and designed such that an H2O2 concentration of at least 100 ppm H2O2 in the room air, preferably several hundred ppm, preferably more than 500 ppm, more preferably more than 1000 ppm can be set or is set in the clean room. In this way, the required duration of a sterilization cycle can be kept short until the desired degree of germ-freeness is achieved. The treatment device can therefore begin production under sterile conditions as quickly as possible. The aforementioned dimensioning and design of the elements mentioned means in particular that the generator output would have to be adjusted depending on the size of the clean room and the tightness of the clean room housing, i.e. the amount of low-condensation H2O2 gas mixture introduced into the clean room per unit of time.In general, this amount should be larger the larger the cleanroom and the less sealed the cleanroom enclosure is. It is understood that the specified concentration is not reached immediately upon beginning the addition of the H2O2 gas mixture, but rather only after a time delay. Therefore, this concentration should be understood as the equilibrium concentration of H2O2, i.e., when the addition of H2O2 and the removal of H2O2 occur in equilibrium.

[0039] It is also advantageously proposed that an extraction device be provided which is connected to the clean room for extraction, wherein the extraction device preferably has an H2O2 filter and / or an H2O2-degrading catalyst. This prevents a critical amount of H2O2 from occurring outside the clean room and / or outside the treatment device. The extraction capacity of the extraction device is preferably selected such that the above-mentioned H2O2 concentrations are achieved, but at the same time no critical H2O2 quantities occur outside the clean room and outside the treatment device. H2O2 quantities which exceed legal limits are considered critical. Currently, such a limit is 0.5 ppm in Germany and 1 ppm in the EU and other countries, e.g. the USA. If the gas extracted by the extraction device is, for example,If the wastewater is released into the open air via the roof of a factory hall, a filter and / or catalyst is generally not required because there is no danger whatsoever.

[0040] A further object of the present invention is, in particular, to provide a method of the type mentioned above that addresses the problems mentioned. It is, in particular, the object of the present invention to provide a method of the type mentioned above in such a way that advantages are achieved in the treatment of containers under sterile conditions, e.g., in the sterilization of the clean room and / or in the maintenance of the clean room.

[0041] According to a further aspect of the invention, this object is achieved by a method having the features of claim 8. Advantageous developments of the method are specified in subclaims 9-13.

[0042] The features of the method according to the invention and the resulting advantages correspond in mirror image to the features and advantages mentioned for the device, so that, to avoid repetition, reference can be made to the above description of the features of the device according to claim 1 and to the advantageous developments according to claims 2-7. The method according to the invention and the advantageous developments specified in the method subclaims can be carried out in particular on the devices according to the claims.

[0043] The invention is explained in more detail below using preferred embodiments and the accompanying figures. The drawings are not necessarily to scale. The figures depict identical or essentially functionally equivalent components.

[0044] -similar elements are designated by the same reference numerals. They show:

[0045] Fig. 1 is a schematic representation of a device for treating containers under sterile conditions using the example of a treatment device for producing finished containers from preforms;

[0046] Fig. 2 is a side view of a device shown in principle in Fig. 1 in a sectional view; and

[0047] Fig. 3 is a schematic representation of a method for treating containers under sterile conditions using the example of producing finished containers from preforms.

[0048] In the illustration in Fig. 1, a device for treating containers 2 under sterile conditions is shown in a schematic representation using the concrete example of a device for producing containers 2 from thermally conditioned preforms 1. The device comprises a container production plant 30, which in the embodiment shown here is a forming device 30 of rotating design with a forming wheel 32 and with a plurality of forming stations 31 arranged circumferentially spaced thereon for forming the preforms 1 into containers 2.

[0049] Via a feed 40a, e.g. designed as a feed rail or as an air conveyor, preforms 1 are transferred to a separating wheel 40, which rotates as indicated by arrow 400, driven by a drive not shown. The preforms 1 are transferred by means of the separating wheel 40 to a tempering device 50, which has heating devices 51 for thermally conditioning the preforms 1. The preforms 1 are guided in the direction of rotation indicated by arrow 500 along the heating devices 51 and then transferred to the rotationally driven transfer wheel 60, which rotates in the direction of arrow 600. From the transfer wheel 60, the preforms 1 are transferred to the forming device 30. By means of the forming stations 31, finished containers 2 are formed from the preforms 1. After the finished containers 2 have been formed from the preforms 1, they are transferred to an output wheel 70 which rotates in the direction of arrow 700.The containers 2 are then removed by means of a discharge line 70a. In a known manner (not shown), the transport of the preforms 1 through the tempering device 50 can be carried out by a mandrel chain with transport mandrels connected to form an endless chain. The structure of the tempering device 50 is also generally known and therefore will not be described in detail here.

[0050] For the continuous conveyance of the preforms 1 or the containers 2 along a transport path through the overall device of Figure 1, the aforementioned orbital movements of the aforementioned wheels 40, 60, 70, the forming device 30, and the tempering device 50 are coordinated with one another, e.g., by synchronization and / or by a common drive. The transport path of the preforms 1 or the containers 2 is defined by the transport path along a partial circumference of the aforementioned plurality of wheels, along a partial circumference of the forming device 30, and along a partial circulation area of ​​the mandrel chain.The sequence of the spaced-apart preforms 1 and containers 2 shown in Figure 1, starting from the separating wheel 40 via the tempering device 50, further via the transfer wheel 60, continuing via the forming device 30, while the preforms 1 are transformed into containers 2 on the forming wheel 32, continuing further onto the output wheel 70 and finally ending at the discharge 70a, corresponds to this transport path through the overall arrangement shown.

[0051] The forming stations 31 of the forming device 30, e.g., in a manner known per se and therefore not shown, consisting of multi-part outer molds against whose inner contour the preforms 1 are expanded, are arranged within a clean room 35, to which a radially inner and a radially outer boundary wall 35a, 35b is shown. A sterile air supply unit 36 ​​is fluidly connected to the clean room 35, wherein the sterile air supply unit 36 ​​and the clean room 35 are designed to cooperate in such a way that sterile air is provided in the clean room 35 and an overpressure is generated in the clean room 35. "Cooperating" is to be understood as stated in the general description, namely that in a clean room that is very well sealed against the environment, the quantity of sterile air to be supplied by the sterile air supply unit 36 ​​can be selected to be smaller than in the case of a less well-sealed clean room 35.The size of the cleanroom also influences the amount of sterile air to be supplied. The goal of this interaction is to achieve an overpressure in cleanroom 35 compared to the surrounding area, and the sterile air supply unit 36 ​​and cleanroom 35 work together to achieve this goal.

[0052] A machine housing 37a, 37b is indicated by dotted lines. In an alternative embodiment, corresponding approximately to the illustration in Fig. 2, the housing area 37a essentially surrounding the forming device 30 could be designed as a cleanroom housing, omitting the boundary walls 35a, 35b. In this alternative case, a larger cleanroom volume would be created within the housing 37a. In this respect, the limitation of the cleanroom 35 to the cleanroom boundary walls 35a, 35b shown in Fig. 1 is preferable.

[0053] The forming stations 31 of the forming device 30 are guided within the illustrated housing walls 35a and 35b of the clean room 35, in this case by the forming wheel 32 on a circular path. The forming of the preforms 1 into containers 2 in these forming stations 21 thus takes place within the clean room 35 defined by these housing walls 35a, 35b. For reasons of clarity, no upper boundary wall is shown. A floor boundary, for example, with respect to a support surface, is also not shown, but may be present.

[0054] The previously mentioned sterile air supply device 36 supplies the clean room 35 with sterile air. The supply line provided for this purpose between the supply device 36 and the clean room 35 is indicated in Figure 1 by arrow 38. In principle, it is also possible to supply areas outside the clean room 35 with sterile air in order to realize the beneficial effects of sterile air supply there as well.

[0055] An extraction device 45, which can be brought into extraction connection with the clean room 35, can extract clean room fluid from the clean room 35. Both the sterile air supply device 36 and the extraction device 45 can preferably be brought into operative connection with the clean room 35 via controllable switching means, e.g. valves, throttles or flaps, or the operative connection can be broken. If, for example, the clean room 35 is not to be supplied with sterile air, the connecting line 38 can be closed, e.g. by controlling a valve, a throttle and / or a flap suitably arranged in this line 38 from an open position to a closed position. If the clean room 35 is not to be extracted by the extraction device 45, a corresponding extraction line 47 can be closed, e.g. by controlling a valve, a throttle and / or a flap suitably arranged in the line 47 from an open position to the closed position.

[0056] The sterile air supply device 36 is connected to an H2O2 gas mixture generator 80. This H2O2 gas mixture generator 80 supplies the supply device 36 via connection means 82 with a low-condensation H2O2 gas mixture, the generation and properties of which are explained in the general description. This low-condensation H2O2 gas mixture is passed, together with the sterile air, from the sterile air supply device 36 through line 38 to the clean room 35. In the clean room 35, an atmosphere with a certain concentration of H2O2 is established, and the H2O2 unfolds its sterilizing effect in a manner known per se and therefore not to be described here. The clean room 35 is suctioned, preferably continuously, via the suction device 45. The suctioned gas with the H2O2 contained therein is, for example,through an H2O2 filter 48, which may alternatively be designed as an H2O2-degrading catalyst or may additionally have this, so that the suction device 45 leaves a substantially H2O2-free fluid in the blow-off direction 49.

[0057] A control unit 84 is arranged in the H2O2 gas mixture generator 80. This control unit 84 is in communication with, for example, a control unit 20 of the forming device 30. This control unit 20 could also control the heating devices 50 or other control functions of the overall device. However, it is also conceivable that additional control units are provided to perform these additional control functions. The extraction device 45 can also have a control unit; alternatively, the extraction device 45 can be controlled by the control unit 84 of the H2O2 generator 80 or by the control unit 20 of the forming device 30.

[0058] Figure 2 shows a cleanroom 35 with a larger installation space than Figure 1, which is enclosed by the housing walls 37a and 37b, thus forming the cleanroom housing. For reasons of illustration, no upper boundary wall and no lower boundary with respect to a support surface are shown, but they may be provided. The forming stations 31 are arranged entirely within this cleanroom 35, with even the entire forming device 30 being arranged within the cleanroom 35. In the illustrated embodiment, the output wheel 70 is also arranged within the cleanroom 35. Containers 2 to be conveyed away by the output wheel 70 are not shown. In a sterilization operation, there are preferably no containers 2 or preforms 1 in the cleanroom 35.

[0059] On the right side of Figure 2, a sterile air supply device 36 is shown, which was also explained in relation to Figure 1. This device has a fan that conveys air through sterile air filters 39 and via supply lines 42 and 43 to the clean room 35 in the direction of the arrow shown. The supply line 42 ends, controlled by a shut-off valve 46a, in the area of ​​the forming device 30, while the supply line 43 ends, controlled by a valve 46b, in the area of ​​the output wheel 70.

[0060] Figure 2 shows a first H2O2 gas mixture generator 80 with solid lines and a second H2O2 gas mixture generator 80' with dashed lines. This second generator 80' can be provided as an alternative to the first H2O2 gas mixture generator 80 or in addition to it, and both generators 80, 80' are fundamentally identical, so that only the generator 80 is described below.

[0061] This generator 80 has the control unit 84 already mentioned in relation to Figure 1, as well as a container 85 into which an aqueous H2O2 solution can be poured. This aqueous H2O2 solution is evaporated in an evaporator 88. In the example shown, the generator is additionally designed to provide dry air with an air humidity of less than or equal to 5%, so that evaporation takes place in a dry environment and a condensation-inert H2O2 gas mixture is formed. To avoid repetition, reference is made to the additional explanations regarding an H2O2 gas mixture generator according to the invention in the general description section. The aqueous H2O2 solution held in container 85 preferably has an H2O2 content of 30-35%; this content can also be selected differently, e.g., to 25%, as stated in the claims.The H2O2 gas mixture generator 80 is connected to the sterile air supply device 36 via connection means 90, which in the illustrated example are designed as interconnected connection pieces and can also be referred to as an interface. In the illustrated case, the connection 90 is preferably selected such that the condensate-inert H2O2 gas mixture fed from the generator 80 into the supply device 36 must flow through the filter 39 and then reach the clean room 35 via the supply lines 42 and / or 43. This filter 39 can be designed, for example, as a HEPA or UPLA filter. Alternative conditioning means to these filters are specified in the claims and in the general description.

[0062] Alternative connection options or interface arrangements are shown by the generator 80', shown with dashed lines, which can, for example, also be connected directly to the clean room 35 via connection means 90' and can therefore supply it with an H2O2 gas mixture without running via the supply lines 42 or 43. Further alternatively or in addition to the connection means 90', connection means 90" can be provided to feed the condensate-inert H2O2 gas mixture into the supply lines 42 and 43, so that the mixture is not passed through the conditioning device 39. A control device 84' (not shown) for the generator 80' can, for example, enable or stop the flow of H2O2 gas mixture via the connection means 90' and / or 90", by controlling flaps, throttles, or valves provided in the connection lines. Corresponding switching means are not shown in Figure 2.It is also conceivable to connect the generator to a central distributor, from which the flow is distributed to the connection devices 90, 90', and 90". This way, the generator would only have to be connected to an interface once. The flow through the connection devices 90, 90', and 90" could occur simultaneously or sequentially. A sensible sequence for at least partially staggered or consecutive, i.e., completely staggered flow would be connection device 90, then connection device 90', and finally 90".

[0063] Fig. 3 shows a schematic representation of a method 100 for treating containers 1, 2, explained without loss of generality using the specific example of the forming of preforms 1 into finished containers 2. In a first step 110, a clean room 35 with a surrounding clean room housing is provided. Corresponding clean rooms 35 with corresponding clean room housings 35a, b and 37a, b were shown in Figures 1 and 2. In a second step 120, a transport device and a treatment device are provided. In Figures 1 and 2, forming stations 31 were shown as an example of such a treatment device. The temperature control devices 50 would also be an example of such a treatment device because the temperature control devices act on preforms, which absorb heating energy as they pass through the temperature control devices and thereby change their temperature.Figures 1 and 2 show different transport devices, wherein in the example of the forming device 30 this was designed as a forming wheel 32, so that this rotating forming wheel 32 represents a transport device.

[0064] In a next method step 130, containers are transported by means of the transport device 32 through the clean room 35 along a transport path which, in the case shown in Figure 1, corresponds to the partial circumference of the rotating forming wheel 32, which extends from the input area of ​​the preforms 1 on the forming wheel 32 to the removal area of ​​the finished containers 2 on the output wheel 70. On this partial circumference of the forming wheel 32, the preforms 1 are formed into a finished container 2.

[0065] In a next method step 140, a supply device 36 for a sterile gas is provided and this supply device 36 is connected to the clean room 35 by means of a supply line, shown in Figure 2 by way of example using supply lines 42 and 43 and indicated in Figure 1 by the arrow 38. The clean room 35 can be supplied with sterile air via these supply lines with the aim of creating an overpressure in the clean room 35 and thereby preventing the penetration of germs. This therefore serves to keep a previously sterilized clean room 35 sterile. In a next method step 150, the clean room 35 is supplied with the sterile gas in a treatment operation of the treatment device, e.g. in a treatment operation of the forming device 30.As just explained, this serves to maintain the clean room 35 sterile by creating an overpressure within the clean room 35 relative to the ambient air, thereby preventing germs from penetrating the clean room 35. In a further method step 160, a connection 90, 90', 90" is provided on the device, and a sterilizing device 80, 80' is connected to it. In a further method step 170, the clean room 35 is then pressurized with a low-condensation hydrogen peroxide gas mixture provided by the sterilizing device 80, 80'. This takes place outside of the treatment operation of the treatment device.

[0066] The method described so far is characterized by the fact that the sterilization device 80, 80' is detachably connected to the treatment device, meaning that the sterilization device can be detached and removed without impairing the remaining device functions. Furthermore, the method is characterized by the fact that the sterilization device 80, 80' is designed as a deliverable H2O2 gas mixture generator. This is representative of all generators that can provide a low-condensation H2O2 gas mixture. Reference is made to the explanations regarding this and the resulting advantages in the general description.

[0067]

[0068] 1 preform

[0069] 2 finished containers

[0070] 1, 2 together containers

[0071] 20 Control unit

[0072] 30 Container treatment device, in particular forming device

[0073] 31 forming stations

[0074] 32 forming wheel

[0075] 35 cleanroom

[0076] 35a, b Cleanroom enclosure walls

[0077] 36 Sterile air supply device

[0078] 37a, 37b Housing walls

[0079] 38 supply line

[0080] 39 sterile air filters

[0081] 40 Separation wheel

[0082] 40a feeder

[0083] 45 Extraction device

[0084] 46a, b butterfly valve

[0085] 47 Suction line

[0086] 48 H2O2 filter / catalyst

[0087] 49 Blow-off direction

[0088] 50 Tempering device

[0089] 51 heating elements

[0090] 60 Transfer wheel

[0091] 70 Output wheel

[0092] 70a Transfer

[0093] 80, 80' H2O2 generator for condensation-inert hydrogen peroxide

[0094] 82 connecting cable

[0095] 84 Generator control unit

[0096] 85 containers for aqueous H2O2 solution

[0097] 86 aqueous H2O2 solution

[0098] 88 Generator evaporator

[0099] 90, 90', 90“Connectors

[0100] 100 Methods for discharging rejected preforms and / or

[0101] containers

[0102] 110-170 process steps

[0103] 300 Direction of rotation of the forming wheel of the forming device

[0104] 400 Direction of rotation of the separating wheel

[0105] 500 Direction of rotation of the transport chain of the tempering device

[0106] 600 Direction of rotation of the transfer wheel

[0107] 700 Direction of rotation of the output wheel

Claims

Claims 1. Device (30) for treating containers (1, 2) under sterile conditions, wherein the device (30) has a clean room (35) with a surrounding clean room housing (35a, 35b; 37a, 37b), wherein the device (30) further has a transport device (32) and a treatment device (31), wherein this transport device (32) and this treatment device (31) are arranged and designed such that, during treatment operation of the device (30), containers (1, 2) can be guided by the transport device (32) through this clean room (35) along a transport path and, in the process, a treatment of the containers (1, 2) can be carried out by the treatment device (31) at least temporarily during their transport through the clean room (35), wherein the device (30) has a supply device (36) for a sterile gas, which is arranged outside the clean room (35) and is connected via a supply line (38, 42, 43) can be brought into fluid communication with the clean room (35),wherein the clean room (35) can be supplied with the sterile gas during treatment operation of the device (30) in order to protect it from the penetration of germs with the sterile gas, wherein the device (30) has a connection means (90, 90', 90") for connecting a sterilizing device (80, 80'), wherein the connection means (90, 90', 90") and the sterilizing device (80, 80') are designed and configured to supply the clean room (35) with a hydrogen peroxide gas mixture (H2O2 gas mixture), characterized in that the sterilizing device (80, 80') is detachably connected to the device (30) and is designed as an adjustable H2O2 gas mixture generator (80, 80') which provides a condensation-inert H2O2 gas mixture.

2. Treatment device (30) according to claim 1, characterized in that the device (30) is designed as a rotating machine and in particular as a forming machine for forming preforms (1) into containers (2).

3. Treatment device (30) according to claim 1 or claim 2, wherein the connection means (90, 90") is arranged on the supply line (42, 43) for the sterile gas and / or on the supply device (36).

4. Treatment device (30) according to one of the preceding claims, characterized in that the supply device (36) has a conditioning device (39) for the sterile gas, in particular a HEPA or ULPA filter, through which the sterile gas flows to the device (30), wherein the connecting means (90) is arranged in the flow direction of the sterile gas upstream of the conditioning device (39), i.e. on the side of the conditioning device (39) facing away from the clean room (35).

5. Treatment device (30) according to one of the preceding claims, characterized by a control unit (84) which controls the H2O2 gas generator (80, 80') in such a way that a supply can only be carried out outside of the treatment operation of the device (30), wherein preferably at least partially simultaneously with this H2O2 supply the supply device (36) is controlled to supply the clean room (35) with the sterile gas, wherein the control unit (84) is preferably arranged in the H2O2 gas generator (80, 80') and is communicatively connected to a control device (20) of the device (30).

6. Treatment device (30) according to one of the preceding claims, characterized in that the clean room (35), the clean room housing (35a, 35b; 37a, 37b) and the generator (80, 80') are dimensioned and designed and controlled such that an H2O2 concentration of at least 100 ppm H2O2 in the room air, preferably of several hundred ppm, preferably more than 500 ppm, more preferably more than 1000 ppm, can be set in the clean room (35).

7. Treatment device (30) according to one of the preceding claims, characterized by a suction device (45) which is or can be brought into suction connection with the clean room (35), wherein the suction device (45) preferably has an H2O2 filter and / or an H2O2-degrading catalyst (48).

8. Process for treating containers (1, 2) under sterile conditions, comprising the following process steps: Providing a clean room (35) with a surrounding clean room housing (35a, 35b; 37a, 37b), Providing a transport (32) and a treatment facility (31), Transporting containers (1, 2) by means of the transport device (32) through the clean room (35) along a transport path and treating the containers (1, 2) at least temporarily during this transport along the transport path by means of the treatment device (31), Providing a supply device (36) for a sterile gas and connecting the supply device (36) to the clean room (35) by means of a supply line (38, 42, 43), Pressurising the clean room (35) in a treatment facility of the treatment device (30) with the sterile gas in order to protect it against the penetration of germs, Providing a connection (90, 90', 90") for connecting a sterilizing device (80, 80') to the clean room (35) and connecting the sterilizing device (80, 80'), Pressurizing the clean room (35) with a hydrogen peroxide gas mixture (H2O2 gas mixture) provided by the sterilizing device (80, 80') outside of the treatment operation, characterized in that the sterilizing device (80, 80') is detachably connected to the clean room (35) and is designed as an adjustable H2O2 gas mixture generator which provides a condensation-inert H2O2 gas mixture.

9. The method according to claim 8, wherein the sterilizing device (80, 80') is connected to the supply line (42, 43) for the sterile gas and / or to the supply device (36) and at least partially simultaneously with this H2O2 application, the supply device (36) applies the sterile gas to the clean room (35).

10. The method according to claim 8 or 9, characterized in that the supply device (36) has a conditioning device (39) for the sterile gas, in particular a HEPA or ULPA filter, through which the sterile gas flows to the clean room (35), and the sterilizing device (80') in the flow direction of the sterile gas is connected in front of the conditioning device (39) so that sterilizing agent flows through the conditioning device (39) towards the clean room (35).

11. Method according to one of the preceding claims 8-10, characterized in that the H2O2 gas mixture generator (80, 80') is controlled by a control unit (84) in such a way that the sterilizing agent is only applied outside of the treatment operation of the treatment device (30), wherein the control unit (84) is preferably arranged in the H2O2 gas mixture generator (80, 80') and communicates with a control device (20) of the device (30).

12. Method according to one of the preceding claims 8-11, characterized in that when the clean room (35) is supplied with the sterilizing agent in the clean room (35), an H2O2 concentration of at least 100 ppm H2O2 in the room air, preferably of several hundred ppm, preferably more than 500 ppm, more preferably more than 1000 ppm is set.

13. Method according to one of the preceding claims 8-12, characterized by providing a suction device (45), establishing a suction connection of the suction device (45) with the clean room (35), wherein preferably an H2O2 filter and / or an H2O2-degrading catalyst (48) is arranged in the suction device (45).

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