WO2022064078A1

WO2022064078A1 - Device for the preparation of pharmaceutical products

Info

Publication number: WO2022064078A1
Application number: PCT/ES2020/070568
Authority: WO
Inventors: Manuel Garcia Sanchez; Javier RUBIO AGUILERA; Asier LIZARRITURRI MARTIARENA
Original assignee: Grifols, S.A.
Priority date: 2020-09-22
Filing date: 2020-09-22
Publication date: 2022-03-31

Abstract

Device for the preparation of pharmaceutical products Device for the preparation of pharmaceutical products which comprises a medicine compounding area (70) and an air recirculation system (9, 90), said air recirculation system comprising an air recirculation area and at least one fan to drive the air from the recirculation area to the compounding area, which also comprises a drying system connected to the air recirculation area (9) by a conduit (5), said drying system comprising an air heater (30) and an intake (100) for air from outside controlled by a valve (40).

Description

DEVICE FOR THE PREPARATION OF PHARMACEUTICAL PRODUCTS

DESCRIPTION

This application refers to a device for the preparation of pharmaceutical products (PCD, for its acronym in English, "pharmacy compounding device', in particular for the preparation of drugs used in chemotherapy.

More specifically, the present invention discloses a device for the automatic preparation of drugs, which can be used for the preparation of oncological products, either by dosing and/or by mixing.

Known devices allow mixing and/or accurately dosing the desired dose of one or more pharmaceutical compounds in a container for use in patients. In the case of cancer chemotherapy, these compounds are usually toxic products. These devices comprise a window, normally guillotine, through which the necessary materials are loaded and unloaded to make the mixtures inside. After loading the materials, the device uses a syringe to draw a set amount of medication from a bag with the syringe as the final container or to inject the medication into a container, which may be a bag, a vial, or others. These devices also allow, among other functions, to add a predefined volume of diluent in a vial by means of a peristaltic pump to a vial containing a lyophilized substance and shake said vial until the drug is completely dissolved before dosing it into a final container, being this process especially useful of wanting to dispense a lyophilized drug.

Typically, pharmaceutical preparation devices have two modes of operation. The first operating mode is an "open mode" in which the loading and unloading processes of the mixer are carried out, this "open mode" being carried out with said window open. The second mode of operation is a "closed mode" in which the automatic mixing process is carried out, this "closed mode" being carried out with said window closed in order to increase the safety of the users to the movements carried out inside the device. .

After finishing the operation of the device, it is necessary to eliminate the chemical components that may have remained inside it, cleaning the inside of the device. To this end, pharmaceutical product preparation devices are known that comprise means for their automatic cleaning. This automatic cleaning or self-cleaning process usually consists of several steps, including a cleaning step, a rinsing step, and a drying step. During the drying process, the device is not operational, which affects the productivity of a high cost device.

It is an objective of the present invention to provide a device for the preparation of pharmaceutical products whose drying time during the self-cleaning process is shorter than the drying times of the devices of the state of the art, so that it considerably decreases the time between device operation processes. More specifically, the present invention discloses a device for the preparation of pharmaceutical products comprising a drug preparation zone and an air recirculation system, said air recirculation system comprising an air recirculation zone and at least one fan to drive air from the recirculation zone to the preparation zone, with the particularity that it further comprises a drying system connected to the air recirculation zone by means of a duct, said drying system comprising an air inlet controlled by a valve. Preferably, said valve controls a sealed gate arranged after the air heater.

With the device of the present invention, which includes a rapid drying system, it is possible to avoid the risk of accumulation of contaminants and a possible growth of microorganisms in the area or zone of preparation of the device during the automatic self-cleaning process, achieving thus avoiding the need to manually clean areas of the mixer that are difficult to access, in addition to avoiding the exposure of operators to dangerous or toxic drugs.

Preferably, the air recirculation zone comprises at least one fan and at least one extractor. More preferably, said at least one fan is arranged in the upper part of the air recirculation zone. Even more preferably, said at least one extractor is arranged in the upper part of the air recirculation zone. Preferably, the at least one fan comprises a High Efficiency Particulate Air (HEPA) filter. More preferably, the at least one extractor comprises a HEPA filter.

Preferably, the drying system comprises at least one filter, said at least one filter being located at the air inlet of the drying system. More preferably, the drying system comprises at least two filters. Even more preferably, the filter is a filter box, said filter box being located at the air inlet of the drying system.

Preferably, the drying module comprises an air heater. More preferably, said air heater is a resistance. Preferably, the air heater is arranged between the at least one filter and the valve.

Preferably, the drying system is connected to the air recirculation zone by means of a duct located behind the valve.

Preferably, the valve is controlled by a servomotor. More preferably, the servomotor is controlled by means of an analog card installed in the device. Even more preferably, the servomotor further comprises a spring. This spring ensures that the valve remains closed when power to the device is turned off. More preferably, the servomotor comprises a position control system to control the opening state of the valve, thus controlling the flow of air entering the air recirculation zone. Preferably, the drying system is arranged in a removable module of the device. More preferably, the drying system is arranged in a removable module of the device, said module being coupled to said device.

The present invention also discloses a drying module for a pharmaceutical product preparation device as described above, with the particularity that it comprises:

- a casing;

- means for joining the module to said device;

- an air inlet controlled by a valve; and

Preferably, the drying module comprises an air heater. More preferably, said air heater is a resistance. Preferably, the means for joining the module to the device is a conduit. More preferably, the module comprises at least one filter, said at least one filter being located at the air inlet of the drying system. Preferably, the valve is controlled by a servo motor.

Preferably, the module comprises an access door to said module.

For better understanding, by way of explanatory but not limiting example, some drawings of an embodiment of the present invention are attached.

Figure 1 shows a first perspective view of a device for the preparation of pharmaceutical products according to an embodiment of the present invention.

Figure 2 shows a perspective view of the rear part of the device of figure 1 .

Figure 3 shows the drying system of the device of figures 1 and 2.

Figure 4 shows a diagram of the air recirculation system without the drying system of the invention.

Figure 5 shows a schematic of the air recirculation system of the device in figures 1, 2 and 3.

Figure 1 shows a device 1 for the preparation of pharmaceuticals. The device of the present invention is a device 1 for pharmaceutical products (PCD) that comprises a drug preparation area, which is an area inside the device where the preparation, mixing and/or dosing of drugs is carried out. The device 1 is preferably arranged in a clean room that is a sterile area, preferably in accordance with ISO 7 or ISO 8 standards. The device 1 also comprises a guillotine window 7 that allows hermetically closing said preparation area of the device 1 .

The device 1 of the present embodiment comprises an air recirculation system, said system air recirculation comprising an air recirculation zone, an air outlet duct 6 and a quick-drying system connected to said air recirculation zone of the device.

In the example shown, the quick-drying system is arranged inside a module 2 separate from the device 1. Figure 2 shows the module 2 as a structure located at the rear of the device 1, and coupled to it. Module 2 may comprise a door 8 or fairing that prevents free access to the elements inside module 2. In this way, access to said quick-drying system is limited. Module 2 further comprises an opening in its lower part through which outside air can access the air inlet 100 of the drying system. An advantage of the presence of the door 8 or fairing is that the entry of external elements such as dust into the quick-drying system is prevented, also facilitating its cleaning and protection. Another advantage of this module 2 is that it allows its coupling to already known devices, its application being in existing low-cost devices. Alternatively, the fast drying system can be integrated in the same device 1 .

Figure 3 shows the rapid drying system of the invention. In the present embodiment, the quick-drying system comprises an outside air inlet 100, an air heater 30, a valve 40 that controls the air intake, and a duct 5 connecting the quick-drying system with a recirculation zone. from the back of the device, that is, the part of the device opposite the window 7. The drying system also comprises at least one filter, this filter being a filter drawer 3 or filter holder box located at the air inlet 100 of the system of recirculation. The valve 40, which is a gate valve or alternatively a sealed gate, controls the passage of the filtered air through the filter box 3 through the conduit 5 by controlling the passage of said air through the valve. In the example shown, the filter drawer 3 comprises two filters of different sizes.

Additionally, the valve 40 is controlled by a servomotor 4 installed after the air heater 30, this heater 30 being a resistance. When the valve 40 allows the passage of the air flow towards the conduit 5, the air that enters through the air inlet 100 is filtered in the filter holder box 3 and subsequently heated by the heater 30, the servomotor 4 allowing a controlled entry of the air. filtered and heated to the recirculation zone of the device. Said filtered and heated air will subsequently be blown into the device preparation area in order to dry said device preparation area, achieving more efficient drying than in devices without a rapid drying system.

In the example shown, the control of the servomotor 4 is carried out by means of an analog card installed in the device 1. The servomotor 4, which controls the valve 40, also comprises a spring that ensures that the valve 40 remains closed when the supply is closed. of the device, and a position control system to control the opening state of the valve 40.

Figure 4 shows a schematic of the air recirculation system of a device 10 without a quick-drying system, with the window 7 open in "open mode". Elements analogous to elements of the present invention are shown with the same numerals. In pharmaceutical preparation devices with an air recirculation system, approximately 70% of the air is recirculated during the "open mode of operation". In this mode of operation, ambient air from outside enters the preparation zone 70 inside the device, mixing together with the already filtered air during recirculation. The resulting air is directed to the recirculation zone 9, which is a room located at the rear of the device, through a filter 60c located in the lower part of said recirculation zone 9, said filter 60c being a HEPA filter ( H14) comprising a double filter. Said air rises through said recirculation zone 9 to its upper zone 90, where at least one fan 80a and at least one extractor 80b are arranged, each comprising two separate filters 60a, 60b HEPA (H14). In the upper zone 90, potentially contaminated air is separated by said fans 80a and extractors 80b.

The air that reaches the upper zone 90 is recirculated to the preparation zone 70 through a fan 80a and a supply HEPA filter 60a (H14) located in the lower part of the upper zone 90 of the recirculation zone 9 . This fan 80a, of lower power and larger than the extractor 80b, pushes the air below atmospheric pressure, and after passing through the filter 60a, it recirculates approximately 70% to the preparation area 70 inside the device 1. from air. The other approximately 30% of the air is discharged through an exhaust fan 80b and a H14 filter 60b. The extractor 80b, located in the upper part of the upper zone 90 of the recirculation zone 9, pushes the air above atmospheric pressure which, after passing through the filter 60b, is expelled through an outlet duct.

On the other hand, during the “closed mode” process without a quick dry system (not shown), 100% of the air is recirculated.

Figure 5 shows a diagram of the air recirculation system of the device 1 of the invention, which comprises a quick-drying system located in a module. Said rapid drying system is arranged in a removable module of the device, said module being coupled to said device. More specifically, the rapid drying system is connected to the recirculation zone 9 of the device (located at the rear of the device) by a conduit 5. In the diagram, device 1 is shown in "closed mode", while device 1 is module 2 is shown with an opening in its lower part so that outside air can enter module 2, said opening being located above the lower part of the device, further favoring said air entry.

The rapid drying system of the invention can operate in different processes of the device. During the self-cleaning process, in which the window 7 remains closed and the device 1 is in "closed mode" as shown in figure 5, the valve 40 is open, freeing the passage of air. . In this case, air from the outside enters through the air inlet 100 of the system, said inlet air being air coming from outside the device 1. Said air is filtered by the filters of the filter holder box 3 and subsequently introduced into the zone 9 of recirculation through conduit 5. In the present invention, the device is arranged in a clean room which is a sterile area, the air coming from outside the device being clean air.

The opening of the valve 40 is carried out in such a way that the desired pressures are maintained in the areas preparation and recirculation, it being preferable that this opening is not complete to avoid increasing the pressure inside the device, while avoiding that the pressure in the preparation area is positive to increase the safety of the device.

The system of the invention also comprises a heater 30. In such a way that the air introduced into the recirculation zone 9 through the duct 5 is already filtered and heated. The presence of the heater 30 and this rapid drying system allows the drying time to be shorter, increasing the drying capacity of the device 1, being particularly relevant in the preparation area of the device 1.

Additionally, it is possible to further increase the airflow absorption ratio of the fans 80a and extractors 80b, allowing air recirculation to be higher than in other modes of operation.

Unlike devices without a quick-drying system, in which during the "closed mode" 100% of the interior air is recirculated, in device 1 of the invention, which comprises a quick-drying system, at least the amount of air that enters through the drying system, helping to dry the device preparation area. Specifically, the quick-drying system of the present invention manages to reduce the drying time of the preparation zone 70 by more than 50% with respect to the drying time of devices of the state of the art that do not include a quick-drying system, thus resulting in a clear advantage over them.

The fast drying system is also advantageous during the preparation, dosing, mixing or automatic compounding process, in which the window 7 is also closed. During this mode of operation, the valve 40 is partially open, allowing a partial passage of air to compensate for the intake air that has entered the device when said window or leaf 7 has been opened. In this case, the automatic drying system allows increase the rate of air renewal and reduce the negative pressure in the preparation zone 70 during the automatic composition in the closed mode. In this way, it is also possible to reduce the risk of the incidence of particles in the preparation area.

During the process of loading and unloading the materials, products or components in the device, in which the device 1 works in "open mode", the valve 40 remains closed, closing the drying system, and the system operating air recirculation of the device in a similar way to that of a device without the drying system, the presence of the rapid drying system not preventing the normal operation of the recirculation system.

Although the invention has been described and represented based on representative examples, it should be understood that said exemplary embodiment is in no way limiting to the present invention, so that any of the variations that are included directly or By way of equivalence in the content of the attached claims, they should be considered included in the scope of the present invention.

Claims

7 CLAIMS

1. Device for the preparation of pharmaceutical products comprising a drug preparation area and an air recirculation system, said air recirculation system comprising an air recirculation area and at least one fan to drive the air in the area recirculation to the preparation area, characterized in that it further comprises a drying system connected to the air recirculation area by means of a duct, said drying system comprising an outside air inlet controlled by a valve.

2. Device according to claim 1, characterized in that the drying system comprises at least one filter, said at least one filter being located at the air inlet of the drying system.

3. Device, according to claim 2, characterized in that the drying system comprises at least two filters.

4. Device according to any of claims 2 to 3, characterized in that the filter is a filter box.

5. Device according to any of the preceding claims, characterized in that the drying system comprises an air heater.

6. Device, according to claim 5, characterized in that the air heater is a resistance.

Device according to any of claims 5 to 6, characterized in that the air heater is arranged between the at least one filter and the valve.

8. Device according to any of the preceding claims, characterized in that the drying system is connected to the air recirculation zone by means of a conduit located behind the valve.

9. Device according to any of the preceding claims, characterized in that the valve is controlled by a servomotor.

Device according to any of the preceding claims, characterized in that the drying system is arranged in a module that can be separated from the device, said module being coupled to said device.

11. Drying module for a device for the preparation of pharmaceutical products according to any of the preceding claims, characterized in that it comprises

- a casing;

- means for joining the module to the device; and 8

- an air inlet controlled by a valve;

12. Module, according to claim 11, characterized in that it comprises an air heater.

13. Module, according to claim 12, characterized in that the air heater is a resistance.

14. Module according to any of claims 11 to 13, characterized in that it comprises at least one filter, said at least one filter being located at the air inlet of the drying system.

15. Module, according to any of claims 11 to 14, characterized in that it comprises an access door to said module.