WO2013118154A1

WO2013118154A1 - Incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like

Info

Publication number: WO2013118154A1
Application number: PCT/IT2012/000044
Authority: WO
Inventors: Manuele MORINI
Original assignee: Bhi S.R.L.
Priority date: 2012-02-09
Filing date: 2012-02-09
Publication date: 2013-08-15

Abstract

An incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, which comprises a cabin (2) whose walls (3) delimit an enclosed space which is isolated from the outside environment. The cabin (2) has an entry door (4) and an exit door (5), respectively for introducing and extracting the products (P), and an environmental parameter control and management assembly (6). The assembly (6) makes it possible to regulate and equalize the temperature and the humidity inside the cabin (2) and to reduce the bacterial load and the concentration of microparticles.

Description

INCUBATOR, PARTICULARLY FOR THE PHARMACEUTICAL INDUSTRY, FOR TREATING PRODUCTS SUCH AS EGGS, ORGANIC COMPOUNDS, AND THE LIKE

The present invention relates to an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like.

Currently, the same incubators used in the poultry sector are used in the pharmaceutical sector for the production of vaccines starting from the amniotic liquid of an egg.

In particular, the process for producing vaccines consists in collecting a suitable predefined quantity of fertilized and partially incubated eggs and inoculating the virus in them.

After this, the eggs are transferred into an incubator.

One of the main limitations of using incubators of the poultry type to perform this process is that they do not meet the standard currently in use in pharmaceutical industries and contained in the Good Manufacturing Practice (GMP) Guide.

This Standard in fact prescribes, for the production of sterile drugs, four environmental classes (A, B, C, D) which are defined according to the maximum number of microparticles allowed per unit volume.

On this basis, the environments that comply with the Standard are termed classified environments.

Therefore, to obviate the fact that poultry incubators are not classified environments, the eggs, before being introduced in the incubator, are passed through a classified intermediate environment.

This environment acts as a buffer between the classified environment, inside which the virus is inoculated in the eggs, and the incubator, which is a non-classified environment.

Inside the incubator, the eggs are stored for approximately 3 days at a temperature generally comprised between 32 °C and 38 °C, with a humidity generally comprised between 65% and 80%.

The eggs are then transferred into a cold chamber, where they remain for at least three hours at a temperature comprised between 2 °C and 7 °C, so that the growth of the embryo in the eggs is interrupted.

The eggs are then transferred into a collection room, passing again through a further intermediate environment, which is classified as well.

The amniotic liquid is then collected from the eggs; the vaccine is obtained from said liquid by means of subsequent processes.

For the embryo to grow correctly, the temperature and the percentage of humidity must remain uniform inside said incubator for the entire duration of the treatment.

This requirement in practice limits the maximum size of incubators and accordingly limits their capacity.

One should also consider that the incubator has a single door and therefore the eggs are inserted and removed through said door.

This entails a workflow that does not conform to the standards in force in pharmaceutical plants, since the eggs, i.e., the processed product, pass through the same path as the eggs being processed, in practice exposing said eggs to a high risk of contamination.

The aim of the present invention is to solve the problems described above, proposing an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that allows the adoption of high hygiene and sanitary standards.

Within the scope of this aim, an object of the invention is to propose an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that makes it possible to reduce space occupation with respect to devices of the known type.

Another object of the invention is to propose an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that reduces the risk of product contamination.

A further object of the present invention is to provide an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that allows a unidirectional physical flow of the product within the production cycle.

Another object of the invention is to propose an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that allows keeping the temperature and the humidity percentage uniform inside it.

Another object of the present invention is to provide an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that ensures a high production capacity in terms of the number of products contained within said incubator.

Another object of the invention is to propose an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, that makes it possible to reduce production costs.

This aim and these objects are achieved by an incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, comprising a cabin whose walls delimit an enclosed space which is isolated from the outside environment, characterized in that said cabin has an entry door and an exit door, respectively for introducing and extracting the products, and an environmental parameter control and management assembly, said assembly regulating and uniforming the temperature and the humidity inside said cabin, and reducing the bacterial load and the concentration of microparticles.

Further characteristics and advantages of the invention will become more apparent from the description of a preferred but not exclusive embodiment of the incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, according to the invention, illustrated by way of non-limiting example in the accompanying drawings, wherein:

Figure 1 is a perspective view of an incubator according to the invention;

Figure 2 is a flowchart of the production process performed by using the incubator according to the invention;

Figure 3 is a flowchart of a different sequence of execution of the production process provided by using the incubator according to the invention;

Figure 4 is a flowchart of a further sequence of execution of the production process provided by using the incubator according to the invention.

With reference to the figures, the numeral 1 generally designates an incubator, particularly for the pharmaceutical industry, for treating products P such as eggs, organic compounds, and the like, which comprises a cabin 2, the walls 3 of which delimit an enclosed space which is isolated from the outside environment.

According to the invention, the cabin 2 has an entry door 4 and an exit door 5, respectively for introducing and extracting the products P, and an environmental parameter control and management assembly 6.

The presence of the two doors 4 and 5 prevents the insertion and extraction of the products P from being performed through the same door.

This entails a production flow that complies with the standards in force in pharmaceutical plants and a reduction of the risk of contamination of the product P, also due to the fact that there are fewer exposed mechanical parts inside the cabin 2.

The assembly 6 makes it possible to regulate and homogenize the temperature and the humidity inside the cabin 2 and to reduce the bacterial load and the concentration of microparticles.

The assembly 6 (and all its components with it), by regulating the internal temperature of the incubator 1 , allows said incubator to work both as an incubator and as a cold chamber, consequently using a single machine to provide two different steps of the vaccine production process.

According to a specific constructive solution, the cabin 2 can be heated thanks to the presence of at least one resistor 7 arranged on at least one wall 3 of the cabin 2.

In this scope, the cooling of the cabin 2 can be achieved by means of at least one cooling coil 8, also arranged on a wall 3 of the cabin 2.

Conveniently, the environmental parameter control and management assembly 6 comprises an internal air treatment unit 9 and ventilation means 10.

The unit 9 produces a suitable air recirculation, which is required for the effective operation of the incubator 1, and also makes it possible to eliminate the phenomenon of condensation by means of a dehumidification process of a known type.

Advantageously, the ventilation means comprise at least one rotating element 1 1 , which is arranged inside the cabin 2 and is connected to a drive unit 12 arranged outside the cabin 2.

The rotating element 1 1 can rotate about a shaft which is rotated by the drive unit 12.

Said shaft is coupled rotatably and accommodated hermetically within a respective through opening of a wall 3 of the cabin 2.

These constructive solutions prevent the internal environment from coming into contact with the outside and therefore from being contaminated.

According to a solution of unquestionable interest in practice and in application, the rotating element 1 1 is constituted by at least one fan, which is arranged at the ceiling 13 of the cabin 2 and can rotate about its own axis, which is perpendicular to the floor 14, so as to provide a ventilation of the type known in the field as horizontal.

More particularly, the incubator 1 according to the invention comprises an access control device, which is connected to the entry door 4 and to the exit door 5, for the alternating opening of one of said doors at a time.

In this manner it is possible to manage the circulation of the products P according to a FIFO (First In First Out) logic, without having to resort to product recognition and traceability systems, which are difficult to manage.

In particular, the walls 3 can be constituted by a panel of expanded material interposed between two sheets of material preferably selected from stainless steel, other metallic materials, polymers, composites and the like.

The sheets have a uniform surface and a high resistance to disinfectants and the like, making the internal environment suitable for disinfection and sanitization.

Moreover, the unit 9 has a series of filtering elements which are suitable for separating and retaining the particles and microparticles that are suspended in the air, such as for example dust, and thus preventing them from being deposited on the product P.

This factor, together with the smaller number of exposed mechanical parts inside the cabin 2, allows reducing the bacterial load that is present on the surface of the products P.

One should in fact consider that according to the provisions of the Standard contained in the Good Manufacturing Practice (GMP) Guide, the environments used for the production of sterile drugs are divided into four environmental classes (A, B, C and D), which are defined according to the maximum number of microparticles allowed per unit volume.

This solution, therefore, allows turning the cabin 2 of the incubator 1 into a classified environment according to this Standard.

The method for treating products P of the type of eggs, organic compounds and the like consists of a first step a) of transferring the products P inside an incubator 1 of the type comprising a cabin 2 whose walls 3 delimit an enclosed space which is isolated from the outside environment.

The cabin 2 has an entry door 4 and an exit door 5, respectively for introducing and extracting the products P, and an environmental parameter control and management assembly 6.

The assembly 6 regulates and equalizes the temperature and humidity inside the cabin 2 and reduces the bacterial load and the concentration of microparticles.

The products P can be transferred into the incubator 1 by using trolleys with castors, whose supporting surfaces (shelves) for the products P can be inclined at 45° with respect to the floor 14 in both directions.

After this step a), one proceeds by performing the step b) of preserving, for a first preset time interval, inside the incubator 1 , the products P at a first predefined set of parameters.

After this step b), one proceeds by performing the step c) of reducing, by means of the environmental parameter control and management assembly 6, the temperature inside the incubator 1.

At this point one proceeds by performing the step d) of maintaining, for a second preset time interval, inside the cabin 2, the products P at a second predefined set of parameters.

In the subsequent step e), the products P are transferred to the collection room.

Conveniently, the products P are fertilized and partially incubated eggs, which are subjected, prior to at least one of step a) and step b), to a preheating step f), to a preliminary incubation step g) and to a step h) of inoculating a virus into them.

According to the background art, the fertilized eggs are preheated in an adapted room and then transferred into an incubator to be subjected to a preliminary incubation in order to allow the growth of the embryo contained inside them. Once the embryo has reached a growth of approximately 50% (after a time comprised between 10 and 18 days, depending on the type of egg and virus), it can be subjected to the virus inoculation step.

At this stage of growth, the embryo is in fact capable of developing correctly the antibodies against the injected virus.

After this virus inoculation step h), one proceeds by performing the step a) of transferring the products P into the incubator 1.

According to a different constructive solution, steps g), f) and h) can be performed after step a) and before step b): the incubator 1 can in fact perform the preheating step f) and the preliminary incubation g) of the eggs, without therefore having to transfer them beforehand into specific dedicated rooms, and thus is more efficient than the technical solutions of the known type.

The presence of the environmental parameter control and management assembly 6 in fact makes it possible to provide the suitable heat and humidity conditions to the eggs in order to allow and ensure the correct growth of the embryo.

In this manner it is possible to use a single device instead of three, consequently reducing time, costs and space occupation.

According to a constructive solution that is unquestionably effective, the first preset time interval is comprised between 2 and 7 days and the first predefined set of parameters is characterized by a temperature comprised between 30 °C and 40 °C, preferably between 32 °C and 37 °C, and a humidity comprised between 50% RH and 85% RH, preferably between 65% RH and 80% RH.

According to a solution of particular interest in practice and in application, the second preset time interval is comprised between 5 and 20 hours, preferably 8 hours, and the second predefined parameter set is characterized by a temperature comprised between 3 °C and 7 °C, preferably 5 °C. The incubator 1 , particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, according to the invention, therefore allows the adoption of high hygiene and sanitary standards.

This advantage is achieved mainly by the presence of the assembly 6, and in particular of the rotating element 1 1 , which allows regulating and equalizing the temperature and the humidity inside the cabin 2 and reducing the bacterial load and the concentration of microparticles.

In particular, the series of filtering elements allows separating and retaining the particles and microparticles that are suspended in the air, such as for example dust, ensuring an environment that is suitable for the production of products of the pharmaceutical type.

The possibility of treating the air by administering additives such as disinfectants, sanitizers and the like to ensure a more effective disinfection and purification of the environment of the cabin 2 is not excluded.

Moreover, the assembly 6, by means of a dehumidification process of a known type, facilitates the substantial elimination of the phenomenon of condensation.

The incubator 1 according to the invention also allows a reduction in space occupation with respect to devices of the known type.

The assembly 6 in fact makes it possible to make the incubator 1 work not only as an incubator but also as a cold chamber; in this manner it is possible to use a single device instead of two, which would obviously have produced twice the space occupation.

In addition to this, the high hygiene and sanitary standards achieved allow an elimination of the three classified intermediate environments, with a further reduction in space occupation.

These advantages allow a simultaneous reduction of the unit production costs for providing a single unit of product and a reduction in fixed costs, particularly of production equipment, since the cold chamber and the two classified intermediate environments are no longer needed to perform the process.

The presence of the two doors, the entry door 4 and the exit door 5, furthermore allows reducing the risk of product contamination, since it prevents performing the insertion and extraction of the products P through the same door, preventing the processed product from circulating in the same environments in which the unprocessed product circulates.

In this manner, a unidirectional physical flow of the product P within the production cycle is also ensured, allowing the circulation of the products P according to a FIFO (First In First Out) logic, without the need to resort to product recognition and traceability systems which are difficult to manage.

For the embryo to grow correctly, the temperature and the humidity must remain uniform inside the cabin 2 throughout the duration of the treatment.

The presence of the assembly 6, and particularly of the rotating element 1 1 , ensures that this condition is met even in the case of cabins that are larger than those of the known type, ensuring in practice a high production capacity in terms of the number of products contained in the incubator 1.

In practice it has been found that the incubator 1 , particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like according to the invention fully achieves the intended aim, since it allows the adoption of high hygiene and sanitary standards.

The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the accompanying claims; all the details may furthermore be replaced with other technically equivalent elements.

In the examples of embodiment shown, individual characteristics, given in relation to specific examples, may actually be interchanged with other different characteristics that exist in other examples of embodiment.

In practice,^' the materials used, as well as the dimensions, may be any according to the requirements and the state of the art.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

1. An incubator, particularly for the pharmaceutical industry, for treating products such as eggs, organic compounds, and the like, comprising a cabin (2) whose walls (3) delimit an enclosed space which is isolated from the outside environment, characterized in that said cabin (2) has at least one entry door (4) and at least one exit door (5), respectively for introducing and extracting the products (P), and at least one environmental parameter control and management assembly (6), said assembly (6) regulating and equalizing the temperature and the humidity inside said cabin (2), and reducing the bacterial load and the concentration of microparticles.

2. The incubator according to claim 1 , characterized in that said assembly (6) comprises an internal air treatment unit (9) and ventilation means (10), said unit (9) determining a suitable air recirculation.

3. The incubator according to claim 2, characterized in that said ventilation means (10) comprise at least one rotating element (1 1), which is arranged in said cabin (2) and is connected to a drive unit (12) arranged outside said cabin (2), said rotating element (1 1) being able to rotate about a shaft which is turned by said drive unit (12), said shaft being accommodated hermetically within a respective through opening of a wall (3) of said cabin (2).

4. The incubator according to one or more of the preceding claims, characterized in that said rotating element (1 1) is constituted by at least one fan which is arranged at the ceiling (13) of said cabin (2) and can rotate about its own axis at right angles to the floor (14), for a substantially horizontal ventilation.

5. The incubator according to one or more of the preceding claims, characterized in that it comprises an access control device which is connected to said entry door (4) and to said exit door (5) for the alternating opening of only one of said doors at a time.

6. The incubator according to one or more of the preceding claims, characterized in that said walls (3) are constituted by a panel of expanded material which is interposed between two sheets of material preferably selected from stainless steel, other metallic materials, polymers, composites and the like, said sheets having a uniform surface and a high resistance to disinfectants and the like.

7. The incubator according to one or more of the preceding claims, characterized in that said unit (9) has a series of filtering elements which are suitable for separating and retaining the particles and the microparticles that are suspended in the air.

8. A method for treating products such as eggs, organic compounds and the like, comprising the steps of:

a) transferring said products (P) into an incubator of the type comprising a cabin (2) whose walls (3) delimit an enclosed space which is isolated from the outside environment, said cabin (2) having an entry door (4) and an exit door (5), respectively for introducing and extracting the products (P), and an environmental parameter control and management assembly (6), said assembly (6) regulating and equalizing the temperature and humidity inside said cabin (2) and reducing the bacterial load and the concentration of microparticles;

b) preserving, for a first preset time interval, inside said cabin (2), said products (P) at a first predefined set of parameters;

c) reducing, by means of said assembly (6), the temperature inside said cabin (2);

d) maintaining, for a second preset time interval, inside said cabin (2), said products (P) at a second predefined set of parameters;

e) transferring said products to the collection room.

9. The method for treating products such as eggs, organic compounds and the like according to claim 8, characterized in that said products (P) are fertilized and partially incubated eggs, said eggs having been subjected, prior to at least one of said steps a) and b), to a preheating step f) and to a step g) of inoculating a virus into them.

10. The method for treating products such as eggs, organic compounds and the like according to claims 8 and 9, characterized in that said first preset time interval is comprised between 2 and 4 days and said first predefined parameter set is characterized by a temperature comprised between 30 °C and 40 °C and a humidity comprised between 50% RH and 85% RH.

1 1. The method for treating products such as eggs, organic compounds and the like according to claims 8, 9 and 10, characterized in that said second preset time interval is comprised between 5 and 20 hours and said second predefined parameter set is characterized by a temperature comprised between 3 °C and 7 °C.