Integrated device comprising multiple environmental monitoring instruments

Abstract

The present invention relates to devices for monitoring environmental contamination. The present invention relates, in particular, to a device that integrates at least two environmental monitoring instruments, which may be identical or different from each other.

Description

[0001] INTEGRATED DEVICE COMPRISING MULTIPLE ENVIRONMENTAL MONITORING INSTRUMENTS

[0002] DESCRIPTION

[0003] Field of the Invention

[0004] The present invention relates to devices for monitoring environmental contamination. More specifically, the present invention relates to a device that integrates at least two environmental monitoring instruments, identical or different.

[0005] Background of the Invention

[0006] Continuous particle monitoring is a well-known methodology used in various sectors, from pharmaceutical and electronic device manufacturing to healthcare and aerospace industries, to continuously monitor cleanliness levels of contamination- controlled areas.

[0007] The purpose of monitoring is to detect any potential adverse events, even of short duration or impulsive nature, that could jeopardize the quality and safety of the particular product being processed and / or the health of the patient / operator.

[0008] Particle monitoring relies on optical instruments, typically called Optical Particle Counters (OPCs), which sample a defined air volume within an observation interval (T), count the particles it contains, and classify them based on specific size ranges. The size ranges are identified according to a granulometric size value (number of particles with an optical diameter greater than or equal to the granulometric size value).

[0009] Detailed descriptions of this type of known instruments and their operational principles can be found, for example, in Italian Patent No. 102020000012256, registered by the same applicant, which is incorporated herein by reference.

[0010] Other environmental monitoring instruments commonly used in contamination-controlled environments (so-called cleanrooms), spaces used for chemical, mechanical, and / or electronic laboratories characterized primarily by the presence of very pure air, are those designed to control microbiological contamination by sampling ambient air. These instruments, the microbiological samplers, are also well-known. An example is the RI4001 HEBAS - IVS (Internal Vacuum Source), marketed by the same applicant (https: / / w w.rigellifesciences.com / ri4001 / ), which employs a suction system paired with an inertial impact capture system, in the form of a perforated plate (also known as an impactor).

[0011] Summary of the Invention

[0012] According to this invention, a device is now proposed which, through a new configuration, provides an effective response to all those operators who, in the above-mentioned context, need systems more versatile than those available and which also meet, without penalising the functionality and the measurement quality, the requirements of reduced available space that are often encountered in cleanrooms and that today force choices and compromises in the instrumental equipment actually used.

[0013] The integrated environmental monitoring device according to this invention achieves the above-mentioned objectives and has the essential characteristics set forth in the first of the appended claims. Additional features of the present invention are covered by the corresponding dependent claims.

[0014] In general terms, the invention consists of having effectively integrated at least two distinct and independently usable monitoring instruments, in a single compact device, specifically and preferably two different instruments such as an OPC optical detector and an IVS microbiological sampler, but more generally also two identical instruments such as two IVS microbiological samplers.

[0015] Brief description of the drawings

[0016] The invention will now be illustrated in greater detail through the following description of one of its embodiments, provided by way of example and without any limitation, with reference to the accompanying drawings, in which: - Figure 1 is a perspective view of the device according to a first embodiment;

[0017] - Figure 2 shows again a perspective view of the device of Figure 1 , without the covering, to show the main internal components;

[0018] - Figure 3 is a top plan view of the uncovered device of Figure 2;

[0019] - Figure 4 is a partial schematic representation indicating some dimensional parameters of the device of the previous figures;

[0020] - Figure 5 is a basic schematic circuit diagram of the device of the previous figures;

[0021] - Figure 6 is a perspective view, again without the covering, of the device according to a second embodiment;

[0022] - Figure 7 is another schematic representation, such as the one in Figure 4, referring here to the device according to the second embodiment of Figure 6.

[0023] Detailed description of the Invention

[0024] With reference to said figures, a device according to the invention comprises a box-shaped housing 1 , for example in the shape of a parallelepiped, with side walls 11 extending between a base 12 and a cover wall 13. The device serves as a housing for at least two environmental monitoring instruments, which, according to the first embodiment (Figures 1 to 5), are, for example, and preferably, an optical particle counter 2 and a microbiological sampler 3. These two instruments are well-known per se - see also and for example, what is mentioned in the introductory part - and will not be described in detail, except for their main components, which include for the optical OPC 2, following the direction of the pneumatic flow, an inlet with an isokinetic probe 21 extending, preferably vertically, from the cover 13 and, inside the box-shaped housing 1 ; a particle counter 22; a detector pump 23; and a detector outlet with a filter 24 facing sideways. Similarly, for the IVS sampler 3, the components include an inlet with a plate impactor 31 , a sampler pump 32 a sampler outlet with a filter 33. Both pumps are preferably brushless blower pumps. Also visible, mounted on the sidewalls 11 , are power supply, control, and data connection components, functional for both instruments, and configured to allow their management independently of each other, as is obvious to a skilled person in the art. These components include a power supply 4 for receiving power from the mains (100-230 VAC) and transforming it into 24 VDC and 12 VDC power supplies, a control unit 5, typically in the form of a microprocessorbased board PCB (Printed Circuit Board), a board 6 for the wireless data connection. These components are also identifiable in the exemplary circuit diagram in Figure 5, in which one can also see, in addition to the pump blocks 23 and 32 with their respective drive controllers 23a, 32a, a particle sensor 25 associated with the OPC, temperature sensors 71 , 72 for the pneumatic flows, a sensor 73 for measuring external temperature and humidity, an LED (Light Emitting Diod) block 8 to monitor the functionality of the device. Other sensors, not shown, may also be provided, such as sensors to monitor the flow rate of the two air flows in the respective instruments. A PoE (Power over Ethernet) board, indicated as block 9, is also visible, with its connection to the global data network to supply power in parallel or as an alternative to the mains power supply 4 and to also ensure Ethernet communication. The PoE board 9 and the mains power supply 4 thus function, individually or in combination, as a single power supply unit 4, 9, common to the different instruments.

[0025] According to an important aspect of the invention, the device is therefore configured to allow the instruments to operate with two separately managed air flows through the use of two distinct pumps controlled by a single microprocessor-based board. In this regard, it is important to note that the arrangement of the instruments is in any case such as to prevent interference between the flows, thus ensuring full efficacy and reliability of their operation. In this sense, the compactness of the device, surprisingly, does not compromise efficiency or safety, offering a structure that allows the independent and programmable use of both functionalities.

[0026] With specific reference to Figure 4, and taking as a reference an OPC probe 21 with a typical diameter <T>1 of about 30 mm, it was found that a distance D1 of approximately 65 mm between the edge of the probe 21 and the nearest peripheral hole of the plate 31 , essentially, the minimum distance between the air passage openings of the respective inlets, is already sufficient to ensure substantially undisturbed operating conditions for each of the two instruments, even when both are active at the same time.

[0027] Clearly, by adopting two distinct circuits for the two air flows, the device architecture is scalable, and the same device can also accommodate two identical instruments, such as two IVS samplers 3’ and 3”. In this alternative embodiment, shown in Figures 6 and 7, components similar to those already mentioned in relation to the first embodiment are assigned similar reference numbers and are not described again. In this case, assuming holes 02 of 0.4 mm spaced by a distance D3 of approximately 5 mm (minimum distance in the innermost ring), it was again found that, by placing the two instruments side by side, their regular functionality is not mutually affected, provided that the distance D2 between the nearest peripheral holes of the two different instruments is greater than approximately 40 mm.

[0028] In this embodiment, the operation of the two biological samplers can be programmed in a sequential manner to comply with the latest regulations regarding the production of sterile pharmaceuticals. These regulations require continuous monitoring throughout the duration of certain critical processes, and thus, in this case, one instrument can alternate with the other to cover a longer time window without the need to intervene to replace the plate inside the sampler, as is currently necessary when using a single sampler. In general, the independent programming of the two sampling lines makes the device particularly versatile for integration into multiple environmental monitoring systems.

[0029] From the above, it is clear that the invention offers the possibility of a complete and versatile functional setup for various environmental monitoring needs, with compact dimensions, allowing use even when space is limited, and moreover at a reduced cost, with the user having to purchase a single device that fully performs the functions of (at least) two instruments. Additionally, not to be overlooked is the ease of installation, which benefits from a significant simplification of cabling. In particular, in the solution with PoE power supply only, a single cable is sufficient compared to the four needed for two separate instruments in a standard configuration. For example, in sterile pharmaceutical production environments (ISO 5 classification), a monitoring point is, in most cases, characterized by a particle counter and a biological sampler, but with the present device, only one installation is required. This is particularly useful in complex systems such as isolators and RABS (Restricted Access Barrier Systems), where limited physical space is often a constraint in the technical compartment.

[0030] In one embodiment, the device is operable via a control software configured to allow remote control of the parameters of the instruments. In particular, diagnostic control via remote access enables the supplier to provide technical assistance on the instrument at any time and from anywhere. This promptness is critical, considering that continuity in this type of monitoring is essential for bringing pharmaceuticals to market in full compliance with current regulations and patient health.

[0031] As mentioned, the inclusion of sensors is also advantageously provided, allowing the collection of environmental parameters to achieve greater flow and volume measurement accuracy, as well as complete metrological traceability.

[0032] The invention is not limited to the embodiments described and illustrated above but encompasses any additional execution variants.

Claims

CLAIMS1. Environmental monitoring device comprising a box-shaped housing (1 ) containing at least two identical or different instruments chosen from an optical particle counter (2) and a microbiological sampler (3), the device being configured to allow said instruments (2, 3) to operate with respective air flows separately managed through the use of distinct pumps (23, 32), powered by a single power supply unit (4, 9) controlled by a single control unit (5).

2. Device according to claim 1 , wherein said box-shaped housing (1 ) comprises a cover wall (13) in which respective inlets of the at least two instruments (21 , 31 ) are located.

3. Device according to claim 2, wherein said instruments comprise an optical particle counter (2) comprising air passage openings of the optical particle counter inlet (21 ) and a microbiological sampler (3) comprising air passage openings of the microbiological sampler inlet (31 ), the air passage openings of said optical particle counter inlet (21 ) and the air passage openings of said microbiological sample inlet (31 ) being separated by a distance (D1 ) greater than approximately 65 mm.

4. Device according to claim 2, wherein said instruments include two microbiological samplers (3), comprising air passage openings of respective microbiological sampler inlets (131 ’, 131 ”), the air passage openings of said microbiological sampler respective inlets (131 ’, 131 ”) being separated by a distance (D1 ) greater than approximately 40 mm.

5. Device according to claim 4, wherein said two microbiological samplers (3) are programmable to operate in a sequential manner.

6. Device according to any one of the preceding claims, wherein said power supply unit (4, 9) includes a power supply (4) for receiving AC power from the mains and converting it into DC power for said instruments.

7. Device according to any one of the preceding claims, wherein said power supply unit (4, 9) includes a PoE (Power of Ethernet) board (9) and corresponding data network connection.

8. Device according to any one of the preceding claims, wherein said control unit (5) comprises a microprocessor-based board (PCB).

9. Device according to any one of the preceding claims, comprising means for wireless data connection.

10. Device according to any one of the preceding claims, comprising one or more of the following accessory components: at least one particle sensor (25) associated with the possible optical particle counter, at least two temperature sensors (71 , 72) for the pneumatic flows in the instruments, at least one sensor for measuring external temperature and humidity (73), at least one LED (Light Emitting Diod) (8) for monitoring the functionality of the device, at least one air flow sensor in at least one of the two instruments.

11. Device according to any one of the preceding claims, wherein said pumps (23, 32) are brushless blower pumps.

12. Device according to any one of the preceding claims, wherein the device is operable via a control software configured to allow remote control of parameters of the instruments.

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