A device for remote monitoring of the biological activities within a process chamber

Abstract

Described is a device (1, 101, 201 ) for remotely monitoring the biological activities of a process chamber (CP) which comprises a sterile container (3, 103, 203) for a Petri dish, suitable for being removably connected to a process chamber (CP). This connection is actuated by means (5, 105, 205) for adjusting the flow of air to be sampled coming from the process chamber (CP) and by means of a secondary valve (6, 106, 206), positioned downstream of the container (3, 103, 203), for adjusting the flow of air towards a suction device (A). The adjusting means (5, 105, 205) can be positioned between at least two configurations: a first configuration in which the container (3, 103, 203) is hermetically isolated from the process chamber (CP), and a second configuration in which the container (3, 103, 203) is in communication with the inside of the process chamber (CP).

Description

[0001] A device for remote monitoring of the biological activities within a process chamber DESCRIPTION

[0002] Technical field

[0003] This invention relates to a device for monitoring the biological activities inside a process chamber, preferably sterilisable by steam, a container for a Petri dish and the process for monitoring the biological activities inside a process chamber, preferably sterilisable by steam.

[0004] Background Art

[0005] According to the prior art, in the isolators sanitised with VHP and maintained in grade A used for filling and capping sterile elements such as vials, syringes, carpules, etc., after sanitising it is necessary to monitor the particles present in the environment where the sterile process has been performed. These particles are divided into two types: dead and alive. In the first case, reference is made to generic particles and they are simply distinct on the basis of their size.

[0006] More interesting is the screening of live particles.

[0007] Generally speaking, a “viable detector” system is used which consists of a device or instrument used to detect the presence of biological activity.

[0008] This instrument comprises the insertion in the process chambers of some small discs which contain a Petri dish; inside these containers there is a broth culture, that is to say, a liquid which helps the viruses and the bacteria to evolve and grow.

[0009] In isolators sanitised with VHP and maintained at grade A, Petri dishes are normally placed over intake ducts where the intake flow is maintained consistently throughout the drug production.

[0010] At the end of production, the Petri dishes are transported outside the isolator to observe an incubation period for any micro-organisms present.

[0011] After the incubation period, which varies according to the reproduction liquid, the viable detector is applied to the culture. This can be done in several ways, but a common method is the addition of a chemical compound or indicator that is metabolized only by live and active microorganisms.

[0012] After a specified period of time, the culture media is observed for the presence of signs of active metabolism. These signs may include discolouration, formation of precipitates or other visible chemical reactions. The microorganisms that are able to metabolize the added compound are considered alive and viable. Those that show no reaction are considered non-viable or unable to actively grow.

[0013] As mentioned, this method is useful for determining the quantity of live micro-organisms in a culture and for assessing their capacity for growth and metabolism.

[0014] Therefore, if, following a probabilistic calculation, the presence of microorganisms in the process area is determined at the end of a session for filling the ampoules, all that has been processed during that session must be rejected.

[0015] In these isolators, the operator intervenes manually from the outside using gloves inside the isolator, since, at the end of the production process, the Petri container is closed and this device is moved inside an incubator. After the necessary incubation period, the number of colonies of microorganisms born inside the broth culture are counted. If there are none, the production batch of all the drugs is declared good and compliant, otherwise, if at least one culture is detected, everything that was produced during that session is declared to be rejected.

[0016] According to this prior art, everything is based on the possibility for the operator to access inside the process chamber; the objects are brought inside and outside the isolator, generally by means of doors which maintain the isolation between the inner part and the outer zone (known as “Rapid Transfer Port”), so that the products are transferred aseptically from the inside to the outside.

[0017] All of this is not compatible with sterilisable containers which relate to patent application No. 1020230000A198. This patent application describes a double-container system, both of which can be sterilised by superheated steam, which - by means of an automatic and autonomous process for sterilising the process instruments - greatly limits or eliminates the need for intervention by the operator during normal operation of the system, without a supporting autoclave or gloves, since there are no preparation operations in an aseptic condition.

[0018] In this context, the sterilisation therefore occurs with the injection of superheated steam inside the process chamber according to alternating vacuum-steam cycles and it is therefore impossible to access with rubber gloves, which would not guarantee withstanding the pressure variations.

[0019] Currently, some solutions involve the use of robots inside the isolators which prevent or reduce the use of flanges and gloves for moving the Petri dishes. However, the robots, although they can be used in light overpressure environments and for moving Petri dishes, cannot be sterilised by steam due to high sterilisation pressures and temperatures.

[0020] Summary of the Invention

[0021] The aim of the invention is to overcome the above-mentioned drawbacks and provide for the monitoring of the biological activities inside a process chamber, without the direct intervention of the operator or the use of robots. In the context of the above-mentioned purpose, an aim of the invention is to provide a device for monitoring biological activities inside a hermetic process chamber which guarantees the maximum reliability.

[0022] Another aim of the invention is to provide a device for monitoring biological activities inside a hermetic process chamber which is quick and easy to use. Yet another aim of the invention is to provide a device for monitoring biological activities inside a hermetic process chamber which, whilst guaranteeing the maximum quality and sterility, is also economically competitive.

[0023] This purpose, as well as these and other aims, which are described in more detail below, are achieved, according to the invention, comprising the technical features described in one or more of the appended claims. The dependent claims correspond to possible different embodiments of the invention.

[0024] In particular, according to a first aspect, the invention relates to a device for monitoring biological activities in a hermetic process chamber which is sterilisable by steam, the device being internally sterile and hermetically isolatable.

[0025] The device comprises firstly a sterile container for a Petri dish, of per se known type, and which will hereafter be referred to simply as “container”.

[0026] The container is suitable for being removably connected to a process chamber, using means for adjusting the flow of air to be sampled coming from the process chamber. In this way, the Applicant allows the hermetic closing of the entrance to the container during the installation, transport and sterilisation steps of the connection with the process chamber, preserving the integrity of the Petri broth.

[0027] The connection is also carried out by a secondary valve, positioned downstream of the container, for adjusting the flow of air towards a suction device.

[0028] For this reason, the adjusting means and the secondary valve constitute removable couplings, respectively upstream and downstream of the container, for the aseptic disconnection of the device, in such a way as to be able to transport the container to the analysis laboratory with confidence and safely, but also to allow operation in parallel with several containers.

[0029] The Applicant has in fact understood that by preparing several containers for the monitoring, arranged in parallel, it would have been possible to cover a much longer time than the duration of the monitoring of the individual broth culture, which is just a few hours.

[0030] For this reason, this solution allows both the steam sterilisation of the inside of the connector and of the duct, but also the possibility of changing the device from the outside, without the use of gloves and avoiding the intervention of robots.

[0031] The adjusting means are suitable for being positioned between at least two configurations: a first configuration in which the container is hermetically isolated from the process chamber, and a second configuration in which the container is, on the other hand, in communication with the inside of the process chamber.

[0032] Advantageously, the container comprises a base and a cap suitable for mutually engaging for forming a hermetic closure: the base is provided with a suction pipe suitable for being removably connected with the suction device by means of the secondary valve; the cap has an inlet pipe for conveying the flow from the process chamber to the container.

[0033] According to a first embodiment, the adjusting means 5 comprise a singleuse three-way valve, which has an inlet suitable for being connected to the process chamber, a first outlet at the container and a second outlet suitable for being connected to a discharge. The single-use valve is suitable for being movable between the first configuration, in which there is the direct connection between the inside of the process chamber and the external discharge, for the escape of the steam to the outside, and the second configuration, in which the container communicates with the inside of the process chamber for sampling the flow.

[0034] For this reason, in the case of use of a single-use valve, there is a double configuration: in the first configuration, the single-use valve places in communication the sampling means with an external discharge to allow saturated steam to be received for sterilising the communication routes coming from the process chamber; in the second configuration, on the other hand, the single-use valve places in communication the process chamber with the container (and therefore with the suction device) to allow the monitoring of the flow to be sampled.

[0035] The assembly consisting of the single-use valve (in the first configuration), container and secondary valve downstream of the container, must be prepared inside a standard isolator before being connected, by means of clamp connections, or so-called “tri-clamp” connections, to the process chamber for sterilisation of the connections and subsequent monitoring.

[0036] According to another embodiment, the adjusting means comprise a first and a second portion, forming a multi-use two-way system. The first portion is suitable for being integrally associated with the process chamber, becoming in practice a fixed body associated with the machine which contains the process chamber, whilst the second portion is suitable for being removably connected to the first portion by a separating partition interposed between the first portion and the second portion and which separates them hermetically.

[0037] Advantageously, the first portion has a first inlet suitable for being connected to the process chamber, a second inlet suitable for being connected to a steam generator and an outlet suitable for being connected with the external discharge. The second portion is, on the other hand, connected to the container in such a way that, in the first configuration the second portion is associated with but not in communication with the first portion and therefore the container is hermetically isolated from the process chamber, whilst in the second configuration the first and the second portions are associated with and in communication, favouring the internal communication between the container and the process chamber, so as to allow the passing through of the adjusting means by the flow to be sampled.

[0038] For this reason, even in the case of use of a multi-use connector, there is always at least a double configuration.

[0039] According to the first configuration the second portion is associated with the first portion so that the duct does not communicate to allow the sterilisation of the separating partition between the two portions.

[0040] According to the second configuration the second portion is connected to the first portion so that the flow to be sampled flows from the process chamber to the container of the Petri dish.

[0041] According to a variant, the first portion comprises a fixed half-valve, provided with the partition and associated integrally with the process chamber. The second portion comprises a removable half-valve. The two half-valves constitute a two-way multi-use valve.

[0042] According to this configuration there is also a complementary half-valve, suitable for being removably associated, on one side, with the fixed halfvalve, by means of the above-mentioned partition, and connected, on the other side, to a discharge outlet positioned downstream of the complementary half-valve. In this way, when the adjusting means are in the first configuration, the steam generator is in direct communication with the external outlet and the sterilising steam is suitable for passing through the fixed half-valve and the complementary half-valve for escape.

[0043] According to a second variant of the multi-use device, the first portion comprises a group of valves interconnected with each other and associated integrally with the process chamber. In this case, the second portion comprises a movable valve and the partition consists of a duct interposed between the valve unit and the movable valve.

[0044] Another aspect of the invention is that of having formed a container for a Petri dish which comprises a base provided with an intake pipe and a cap which has a duct for conveying air from the outside. The special feature of this container is due to the fact that the base and the cap are suitable for engaging together to form a hermetic closure.

[0045] This hermetic seal is preferably achieved by a clamp connection, also called “tri-clamp”.

[0046] A further protection is required for a kit for sampling the biological activities of a process chamber, which comprises a series of devices for the remote monitoring of the biological activities of the process chamber according to the invention. These monitoring devices each have their own container for a respective Petri dish and are suitable for being connected in parallel with the process chamber, in such a way as to be able to sample a process cycle with a duration greater than the operating period of each single Petri dish (on average two / three hours).

[0047] In this way, with an adequate number of devices, it will be possible to sample the atmosphere of the process chamber for a very long period of time.

[0048] The Applicant also requests protection for a process for monitoring the biological activities inside a hermetic process chamber which is sterilisable by steam.

[0049] The process is different depending on the adjusting means used.

[0050] A first process for monitoring biological activities inside a process chamber connected with the device which uses a single-use valve comprises the following steps.

[0051] Before the sterilisation, the monitoring device, previously prepared, is connected to the process chamber, to the suction device and to the discharge, by means of connections preferably of the tri-clamp type.

[0052] The device has the secondary valve closed to prevent connection between the container and the suction device, and the single-use valve in the first configuration. The connecting duct between the single-use valve and the process chamber is sterilised by introducing steam coming from the process chamber using sampling means positioned inside it.

[0053] In this regard, the sampling means may be an isokinetic cone, of known type, used for measuring the speed of the air and the concentration of particulate in environments in which it is important to obtain accurate measurements and which are representative of the real conditions.

[0054] When the sterilisation is completed, the discharge valve is closed disconnecting the device and the discharge, whilst the secondary valve is opened for enabling the suction by the suction device, in such a way as to introduce a flow of air into the container. The single-use valve is positioned in the second configuration to allow the communication between the process chamber and the container and the sampling is performed, which occurs during the production cycle inside the process chamber.

[0055] At the end of the sampling period, the single-use valve is changed to the first configuration to hermetically close the connection between the container and the process chamber. The secondary valve is also closed for hermetically isolating the container from the suction device and the device 1 is removed by means of the connections, preferably of the tri-clamp type, to perform the known incubation activities on the Petri dish.

[0056] The process for monitoring the biological activities inside a process chamber connected with the multiuse device according to the first variant, that is to say, with the fixed and removable half-valve, comprises the following steps.

[0057] Before the sterilisation, the fixed half-valve is associated integrally to the process chamber, for example fixing it to the machine containing the process chamber, and the complementary half-valve, which communicates with the discharge outlet, is associated with the fixed half-valve.

[0058] The adjusting means are moved to the first configuration to allow the connection between the process chamber and the condensate discharge outlet; therefore, the connecting duct is sterilised between the fixed halfvalve and the process chamber, injecting steam coming from the process chamber using sampling means (isokinetic cone).

[0059] At the end of sterilisation, the complementary half-valve is disconnected from the fixed half-valve. Therefore, the removable half-valve, connected to the container, is associated with the fixed half-valve keeping the secondary valve closed, using connections preferably of the tri-clamp type, and the hermetic separation partition is sterilised by introducing steam from the steam generator connected to the fixed half-valve, preferably using an injection valve.

[0060] After performing this second sterilisation, a flow of air is sucked from the inside of the container by means of the secondary valve which is opened to allow the active connection with the suction device.

[0061] The adjusting means are then positioned in the second configuration, to allow the direct connection between the inside of the process chamber and the container and perform the sampling during the production cycle inside the process chamber.

[0062] At the end of the sampling period, adjusting means are moved to the first configuration in such a way as to hermetically close the connection between the container and the process chamber. The outlet valve is also closed to hermetically prevent the connection between the container and the intake duct, and the monitoring device may be disconnected by separating the movable half-valve from the fixed half-valve and disconnecting the connection (preferably of the tri-clamp type) with the suction device.

[0063] The process for monitoring the biological activities inside a process chamber connected with a device which uses multipurpose adjusting means with a fixed valve unit and a movable valve, comprises the following steps. The valve unit is associated with the process chamber, for example fixing it to the machine for containing the process chamber, before the sterilisation.

[0064] The connecting duct between the valve unit and the process chamber is sterilised by using steam coming from the sampling means inside the process chamber and activating the respective valves.

[0065] The movable valve is associated, preferably through tri-clamp type connections, to the valve unit and the secondary valve is associated to the suction device.

[0066] The partition is then sterilised by introducing steam injected by the steam generator, opening the other related valves.

[0067] The suction unit extracts the flow of air from the inside of the container thanks to the opening of the secondary valve.

[0068] The adjusting means are positioned in the second configuration to allow the connection between the process chamber and the container and thereby perform the sampling during the production cycle inside the process chamber.

[0069] At the end of the sampling period, the adjusting means are returned to the first configuration, in such a way as to hermetically close the connection between the container and the process chamber.

[0070] The outlet valve is closed to hermetically prevent the connection between the container and the suction device and the monitoring device is disconnected by means of the connections preferably of the tri-clamp type.

[0071] Description of the drawings

[0072] Further features and advantages of the invention are more apparent in the detailed description below, with reference to a preferred, non-limiting embodiment of the device for monitoring biological activities inside a hermetic process chamber illustrated byway of example and without limiting the scope of the invention, with the aid of the accompanying drawings, in which:

[0073] Figure 1 schematically shows an example embodiment of the device 1 for monitoring biological activities inside a process chamber CP, comprising a single-use valve 5;

[0074] Figure 2A schematically shows the device 1 of Figure 1 during the sterilising (SIP) or cleaning (CIP) cycle, with the single-use valve 5 in the sterilising configuration, that is, in the first configuration, where the arrows indicate the direction of the flow of saturated steam;

[0075] Figure 2B schematically shows the device 1 of Figure 1 during the sampling cycle, with the single-use valve 5 in the sampling configuration, that is, in the second configuration, where the arrows indicate the direction of the flow to be monitored (and the flow of air);

[0076] Figure 3 schematically shows a first variant of the device 101 for monitoring the biological activities inside a process chamber CP, wherein the adjusting means 105 are multi-use, formed by a fixed half-valve 105a and a removable half-valve 105b;

[0077] Figure 4A schematically shows the device 101 of Figure 3, wherein the removable half-valve 105b and the secondary valve 106 have been replaced by a complementary half-valve 1 15b, during the first configuration of the adjusting means 105 (cleaning step CIP and sterilising step SIP);

[0078] Figure 4B schematically shows the device 101 of Figure 3 during the process cycle, wherein the adjusting means 105 are again formed by the fixed half-valve 105a and by the removable half-valve 105b;

[0079] Figure 5 schematically shows a second variant of the device 201 for monitoring the biological activities inside a process chamber CP, wherein the adjusting means 205 are multipurpose, formed by a valve unit 205a and a movable valve 205b;

[0080] Figure 6A schematically shows the device 201 of Figure 5, during the step of sterilising (SIP) and cleaning (CIP) of the process chamber CP, with the movable valve 205b disconnected from the valve unit 205a;

[0081] Figure 6B schematically shows the device 201 of Figure 5 during the sampling process, with the movable valve 205b associated with the valve unit 205a.

[0082] Figure 7 shows a side view of an embodiment of the container 3, 103 and 203 for the Petri dish (not illustrated), with a partial cross section.

[0083] Detailed description of the invention

[0084] The above-mentioned drawings show a preferred embodiment of a device for monitoring biological activities inside a process chamber sterilisable by steam, according to the invention, which is denoted in its entirety with the reference numerals 1 , 101 and 201 and which comprises a sterile container 3, 103 or 203, for a Petri dish, connectable to a process chamber CP using means 5, 105 or 205 for adjusting the flow of air to be sampled. The flow of air to be sampled comes from the process chamber CP and the adjusting means 5, 105 or 205 hermetically close the infeed pipe during the steps for installation, transporting and sterilising the connection with the process chamber CP.

[0085] The connection is also achieved by a secondary valve 6, 106 or 206, positioned downstream of the container 3, 103 or 203, which allows the adjustment of the air flow towards a suction device A and is necessary to hermetically close the contact with the suction device A during the installation and transport steps.

[0086] The adjusting means 5, 105 and 205 can be positioned between at least two configurations: a first configuration in which the container 3, 103 or 203 is hermetically isolated from the process chamber CP, and a second configuration in which the container 3, 103 or 203 is in communication with the inside of the process chamber CP.

[0087] In particular, the container 3, 103 and 203 comprises a base 31 , provided with an suction pipe 32 suitable for being removably connected with the suction device A by means of the secondary valve 6, 106 or 206, and a cap 35 which has an inlet pipe 36 for conveying the flow from the process chamber CP to the container 3, 103 or 203. The base 31 and the cap 35 are designed for being engaged with each other in order to form a hermetic closure. For example, by means of a tri-clamp connection or with internal threads of mutual engagement (a thread 33 on the base 31 and a counterthread 37 on the cap 35, as shown in Figure 7).

[0088] With reference to Figures 1 , 2A and 2B, according to a first embodiment a single-use valve 5 is used, that is to say, a device of per se known type, designed for being used only once and then disposed of, thus avoiding cross contamination between samples or products.

[0089] In this device 1 , the isokinetic cone C, inserted inside the process chamber CP, is connected to the single-use valve 5 by a duct C1 . The single-use valve 5 has two outlets: a first outlet towards the container 3, through a first outlet duct 51 , associated with the inlet pipe 36 of the container 3, and a second outlet towards the discharge E, by means of a second outlet duct 52.

[0090] Advantageously, the two outputs can be switched remotely or automatically, by means of the button 50, selecting between the first configuration, in this case for sterilisation, and the second configuration, which can be called monitoring or sampling.

[0091] In particular, in the sterilising configuration (Figure 2A), the single-use valve 5 is connected, on one side, to the isokinetic cone C and, on the other side, to the discharge E; by means of the dust C1 , the superheated steam arrives from the process chamber CP at a high pressure which sterilises the duct C1 and the single-use valve 5, and then escapes towards the discharge E passing through the second outlet duct 52.

[0092] This configuration is used both for the SIP (“Sterilisation In Place”) phase, that is, the sterilisation of production plants without prior disassembly operations, and CIP (“Cleaning In Place”) phase, that is to say, the process for cleaning the inside of the machine without the removal or disassembly of its parts.

[0093] According to the second configuration (Figure 2B), on the other hand, the particles inside the process chamber CP, move from the isokinetic cone C, passing through the first inlet duct C1 and passing from the single-use valve 5, arrive at the container 3 depositing inside the Petri broth. The latter is connected, by means of the duct A1 , to the suction device A through the valve 6.

[0094] After sampling the particles of the Petri dish, the single-use valve 5 returns to the first configuration, the valve 6 is closed and the container 3 is replaced with another container in which a new Petri dish is positioned (whilst the one previously used is taken to the laboratory for the analysis).

[0095] According to the variant wherein the adjusting means 105 are multi-use and substantially composed of two half-valves, fixed 105a and removable 105b (Figures 3, 4A and 4B), the sterilisation of the adjusting means 105 is required before use, since the aseptic nature of the component is not guaranteed as in the case of single-use.

[0096] This type of adjusting means 105 has a fixed half-valve 105a, which is associated with the machine M which contains the process chamber CP and is made integral with the isokinetic cone C, which is always located inside the process chamber CP, and which can be removably associated with a removable half-valve 105b.

[0097] The fixed half-valve 105a is connected, by an inlet duct G1 , to a steam generator G: the steam is introduced for the sterilising through a first inlet of the fixed half-valve 105a. There is also a second inlet which connects the fixed half-valve 105a to the isokinetic cone C by means of a duct C1 and an outlet towards the discharge E of the condensate to the outside.

[0098] In this case, there is a complementary half-valve 1 15b itself connected to an outlet U towards the outside, which is also provided with valve systems 1 19 for adjusting the flows of CIP and SIP.

[0099] In the steps of CIP and SIP, the complementary half-valve 1 15b is associated with the fixed half-valve 105a.

[0100] For the sterilisation of the duct C1 steam is introduced coming from the process chamber CP by means of the isokinetic cone C and the condensate is discharged towards the outside from the outlet U by means of the outlet valve 1 16

[0101] The sterilisation of the partition 105’, on the other hand, occurs by associating the removable half-valve 105b, connected to the container 103, to the fixed half-valve 105a and keeping the secondary valve 106 closed, after - obviously - having removed the complementary half-valve 1 15b.

[0102] In this case, the sterile steam arrives from the steam generator G connected to the fixed half-valve 105a by means of an injection valve G2, through the respective inlet duct G1 .

[0103] For the sampling during the process, with regard to what is illustrated in Figure 4B, a flow of air is sucked from the inside of the container 103 by opening the secondary valve 106 communicating with the suction device A through the duct A1. The adjusting means 105 are placed in the second configuration implementing the direct connection between the inside of the process chamber CP and the container 103.

[0104] For this reason, the particles present in the process chamber CP, pass through the isokinetic cone C, along the first inlet duct C1 , arrive at the adjusting means 105, passing through it from the fixed half-valve 105a to the removable half-valve 105b, and leave by means of the outlet duct 151 , associated with the inlet pipe 36 of the container 103, up to the container 103. The suction device A, from the pipe 32, sucks a flow of air through the channel A1 , by means of the valve 106.

[0105] In practice, the complementary half-valve 1 15b is initially connected to the half-valve 105a, whilst the removable half-valve 105b is left apart, for the sterilisation of the duct from the process chamber CP to the condensation discharge outlet U, thanks to the steam generator G and the first configuration of the adjusting means 105.

[0106] Therefore, the complementary half-valve 1 15b is removed and the removable half-valve 105b is connected. The partition is sterilised and then the second configuration of the removable half-valve 105b is moved to which allows communication between the process chamber CP and the container 103 for sampling

[0107] Upon completion of the sampling, the device 101 is disconnected closing firstly the adjusting means 105 and then the valve 106.

[0108] A final variant of the multi-use device 201 (Figure 5) comprises a group of valves 205a interconnected with each other which are associated integrally with the process chamber CP contained in a machine M, whilst the second portion 205b comprises a movable valve 205b: the partition 205' is, in this case, a duct interposed between the valve unit 205a and the movable valve 205b.

[0109] In order to sterilise the duct C1 for connecting between the valve unit 205a and the process chamber CP, use is made of the steam coming from the process chamber CP through the isokinetic cone C positioned inside it and actuating the respective valves of the valve unit 205a, keeping closed the inlet valve G2, located on the inlet duct G1 for connecting between the valve unit 205a and a steam generator G (Figure 6A).

[0110] For sterilising the partition 205', on the other hand, the mobile valve 205b is associated with the valve unit 205a preferably through tri-clamp type connections; moreover, the secondary valve 206 is associated with a suction device A.

[0111] Through the inlet duct G1 , the sterile steam is injected by the steam generator G by means of the injection valve G2. The valve unit 205 is configured in such a way as to allow the steam to reach the partition 205’ without coming into contact with the container 203 (movable valve 205b closed) and opening the other relative valves of the valve unit 205a in such a way as to allow the condensate to reach the discharge E through the outlet duct E1 .

[0112] For monitoring the flow of air coming from the process chamber CP, a flow of air is sucked from the inside of the container 203 by opening the secondary valve 206 in communication with the suction device A through the duct A1. The adjusting means 205 are placed in the second configuration, implementing the direct connection between the inside of the process chamber CP and the container 203.

[0113] For this reason, the particles present in the process chamber CP, pass through the isokinetic cone C, travel along the first inlet duct C1 , arrive at the adjusting means 205, passing through the valve unit 205a and the movable valve 205b, and arrive at the inlet pipe 36 of the container 203. On the other hand, the suction device A sucks a flow of air through the channel A1 and the valve 206.

[0114] After sampling, the device 201 is disconnected after closing the valve 205b and the valve 206.

[0115] From the above description it may be seen how the invention achieves the preset purpose and aims and in particular it should be noted that a device is made for monitoring the biological activities inside a hermetic process chamber which prevents the intervention of operators inside the process chamber or the use of robots.

[0116] In particular, the use of the innovative container for the Petri dish makes it possible to remove the biological culture from the process chamber, creating a sort of connected outer projection, in such a way as to be hermetically in communication, or disconnected, in such a way as to be fully isolated, from the process chamber, without intervening inside the process chamber.

[0117] Another advantage of the invention is to have provided a device for monitoring biological activities inside the hermetic process chamber which, thanks to the possibility of separating the paths of the steam injected and the flow to be sampled, guarantees the maximum reliability without adversely affecting the apparatuses.

[0118] Another advantage of the device for monitoring such biological activities is due to the extreme simplicity of use, avoiding the use of gloves, which are awkward to use, or robots, which are expensive.

[0119] Yet another advantage of the invention is due to the fact that the monitoring device designed in this way, using a large number of known components, is economically competitive. The invention described can be modified and adapted in several ways without thereby departing from the scope of the inventive concept.

[0120] Moreover, all the details of the invention may be substituted by other technically equivalent elements. In practice, the materials used, as well as the dimensions, may be of any type, depending on requirements, provided that they are consistent with their production purposes.

Claims

CLAIMS1 ) A device (1 , 101 , 201 ) for remotely monitoring the biological activities of a process chamber (CP) comprising: a sterile container (3, 103, 203) for a Petri dish suitable for being removably connected to a process chamber (CP) using means (5, 105, 205) for adjusting the flow of air to be sampled coming from the process chamber (CP); and by means of a secondary valve (6, 106, 206), positioned downstream of the container (3, 103, 203), for adjusting the flow of air towards a suction device (A), wherein the adjusting means (5, 105, 205) can be positioned between at least two configurations: a first configuration in which the container (3, 103, 203) is hermetically isolated from the process chamber (CP), and a second configuration in which the container (3, 103, 203) is in communication with the inside of the process chamber (CP).2) The device (1 , 101 , 201 ) according to claim 1 , wherein the container (3, 103, 203) comprises a base (31 ), provided with a suction pipe (32) suitable for being removably connected with the suction device (A) by means of the secondary valve (6, 106, 206), and a cap (35) having an inlet pipe (36) for conveying the flow from the process chamber (CP) to the container (3, 103, 203); the base (31 ) and the cap (35) being suitable for engaging each other for making a hermetic closure.3) The device (1 ) according to claim 2, wherein the adjusting means (5) comprise a single-use valve (5), having an inlet suitable for being connected to the process chamber (CP), a first outlet at the container (3) and a second outlet suitable for being connected to a discharge (E); the single-use valve (5) being suitable for being movable between the first configuration, in which the direct connection is formed between theinside of the process chamber (CP) and the discharge (E), for the escape of the steam to the outside, and the second configuration, in which the container (3) communicates with the inside of the process chamber (CP) for sampling the flow.4) The device (101 , 201 ) according to claim 1 or 2, wherein the adjusting means (105, 205) comprise a first portion (105a, 205a) suitable for being integrally associated with the process chamber (CP); and a second portion (105b, 205b) suitable for being removably connected to the first portion (105a, 205a) by means of a separating partition (105’) interposed between the first portion (105a, 205a) and the second portion (105b, 205b); the first portion (105a, 205a) having a first inlet suitable for being connected to the process chamber (CP), a second inlet suitable for being connected to a steam generator (G) and an outlet suitable for being connected with the discharge (E); and the second portion (105b, 205b) being connected to the container (103, 203), in such a way that, in the first configuration the container (103, 203) is hermetically isolated from the process chamber (CP), whilst in the second configuration the container (103, 203) is in communication with the inside of the process chamber (CP) and the flow to be sampled is suitable for passing through the adjusting means (105, 205) thanks to the connection between the first portion (105a, 205a) and the second portion (105b, 205b).5) The device (101 ) according to claim 4, wherein: the first portion (105a) comprises a fixed half-valve (105a) provided with the partition (105’) associated integrally with the process chamber (CP); and the second portion (105b) comprises a removable half-valve (105b);the device (101 ) also comprising a complementary half-valve (1 15b) suitable for being removably associated, on one side, with the fixed halfvalve (105a) by means of the partition (105’) and connected, on the other side, to a discharge outlet (U) positioned downstream of the complementary half-valve (1 15b), in such a way that, in the first configuration, the steam generator (G) is in direct communication with the outlet (U).6) The device (201 ) according to claim 4, wherein: the first portion (205a) comprises a valve unit (205a) interconnected with each other and associated integrally with the process chamber (CP); the second portion (205b) comprises a movable valve (205b); the partition (205') is a duct interposed between the valve unit (205a) and the movable valve (205b).7) A sterile container (3, 103, 203) for a Petri dish, particularly for monitoring biological activities inside a process chamber (CP) which can be sterilised by steam, comprising a base (31 ) provided with a suction pipe (32) suitable for being removably connected to a suction device (A) for feeding the Petri dish; and a cap (35) having an inlet pipe (36) for channelling the flow from the process chamber (CP) to the container (3, 103, 203); wherein the base (31 ) and the cap (35) are designed for being engaged with each other in order to form a hermetic closure.8) A kit for sampling the biological activities of a process chamber (CP) comprising a series of devices (1 , 101 , 201 ) for remotely monitoring the biological activities of the process chamber (CP) according to any one of claims 1 to 6, suitable for being connected in parallel with the process chamber (CP).9) A process for monitoring biological activities inside a process chamber (CP) connected with the device (1 ) according to any one of claims 1 to 3, comprising the following steps:- connecting the device (1 ) to the process chamber (CP) and to the suction device (A),- connecting the device (1 ) to the discharge (E) by opening the discharge valve (E2),- sterilising the connecting duct (C1 ) between the single-use valve (5) and the process chamber (CP) by introducing steam coming from the process chamber (CP) using sampling means (C) positioned inside it,- after sterilisation has been completed, closing the discharge valve (E2), opening the secondary valve (6) for enabling suction by the suction device (A), in such a way as to introduce a flow of air in the container (C),- positioning the single-use valve (5) in the second configuration to allow the communication between the process chamber (CP) and the container (3) and performing the sampling which occurs during the production cycle inside the process chamber (CP),- at the end of the sampling period, moving the single-use valve (5) to the first configuration so as to hermetically close the connection between the container (3) and the process chamber (CP),- closing the secondary valve (6) for hermetically isolating the container (3) from the suction device (A),- removing the device (1 ).10) A process for monitoring biological activities inside a process chamber (CP) connected with the device (101 ) according to claim 4 or 5, comprising the following steps:- integrally associating the fixed half-valve (105a) to the process chamber (CP),- associating the complementary half-valve (115b) communicating with the outlet (U) to the fixed half-valve (105a),- moving the adjusting means (105) to the first configuration to allow the connection between the process chamber (CP) and the outlet (U),- sterilising the connecting duct (C1 ) between the fixed half-valve (105a) and the process chamber (CP) injecting steam coming from the process chamber (CP) using sampling means (C),- at the end of the sterilisation, disconnecting the complementary half-valve (1 15b) from the fixed half-valve (105a),- associating the removable half-valve (105b), connected to the container (103), to the fixed half-valve (105a) keeping the secondary valve (106) closed,- sterilising the partition (105’) by introducing steam from the steam generator (G) connected to the fixed half-valve (105a),- sucking a flow of air from the inside of the container (103) by opening the secondary valve (106) in communication with the suction device (A),- positioning the adjusting means (105) in the second configuration to allow the direct connection between the inside of the process chamber (CP) and the container (103) and performing the sampling during the production cycle inside the process chamber (CP),- at the end of the sampling period, moving the adjusting means (105) to the first configuration in such a way as to hermetically close the connection between the container (103) and the process chamber (CP)- closing the outlet valve (106) to hermetically prevent the connection between the container (103) and the intake duct (A1 )- disconnecting the device (101 ).11 ) A process for monitoring biological activities inside a process chamber (CP) connected with a device (201 ) according to claim 6, comprising the following steps:- rigidly associating the valve unit (205a) with the process chamber (CP),- sterilising the connecting duct (C1 ) between the valve unit (205a) and the process chamber (CP) by using steam coming from the sampling means(C) inside the process chamber (CP),- associating the movable valve (205b) with the valve unit (205a) and associating the secondary valve (206) with the suction device (A)- sterilising the partition (205') by introducing steam injected by the steam generator (G),- sucking a flow of air from the inside of the container (203) by means of the suction device (A) opening the secondary valve (206),- positioning the adjusting means (205) in the second configuration to allow the connection between the process chamber (CP) and the container (203) and performing the sampling during the production cycle inside the process chamber (CP),- at the end of the sampling period, returning the adjusting means (205) to the first configuration, in such a way as to hermetically close the connection between the container (203) and the process chamber (CP), - closing the outlet valve (206) to hermetically prevent the connection between the container (203) and the suction device (A)- disconnecting the device (201 ).

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