KR20190122268A - Method for preparation of a vaccinating agent - Google Patents

Abstract

The present invention relates to a kit of a vaccine for immunization against swine circovirus disease and / or pandemic pneumonia in pigs, to the use of said vaccine, and to a method of making said vaccine, wherein the first container is merely a first vaccine. Partially filled and the second container is filled with a second component, the second vaccine is delivered into the first container by first and / or only once through the closure device by an adapter device and the vaccine is transferred to the first container Manufactured in a container, this allows simple, less error prone and more hygienic operation with reduced material use.

Description

Method of Preparation of Vaccine Formulations {METHOD FOR PREPARATION OF A VACCINATING AGENT}

The present invention relates to a kit for preparing a vaccine formulation, to a use for a kit for preparing a vaccine formulation, to the use of two or more starting materials for preparing a vaccine formulation, and to a method of providing a vaccine formulation.

The present invention relates in particular to the preparation and provision of vaccine formulations, in particular vaccine formulations in the veterinary field. Basically, the present invention is directed to pigs with a pig circovirus, in particular type 2 (also known as Porcine Circovirus Disease or PCVD) and / or strain Mycoplasma hyopneumoniae. It relates to vaccine formulations for immunizing (also known as Enzootic Pneumonia or EP).

The diseases mentioned above are known to be preventable by immunization with vaccines. Vaccine formulations are generally provided for infusion and should be sterilized correspondingly. Moreover, each individual infusion stresses the organism to be treated and for this reason the number of vaccination processes should be kept to a minimum.

One known possible way of reducing the number of vaccination processes is so-called combined vaccination, whereby immunization against different diseases can be provided in a period of very few or even only one. However, combined vaccinations are often not possible because different vaccines or components thereof are incompatibility with each other. Although at least short compatibility can be achieved, these combination vaccines must be prepared on site. Especially in the field of veterinary medicine, the vaccine must be prepared and / or administered outdoors. The challenge here is that the combination vaccine can be contaminated by, for example, pathogens, especially if the mixing vessel has to be drilled several times.

It is an object of the present invention to provide a kit for preparing a vaccine formulation, the use of such a kit for preparing a vaccine formulation, the use of two starting materials for preparing the vaccine formulation, and a method of providing a vaccine formulation (accordingly, A) from starting materials that are stable with one another only for a short time, which can be produced by the simplest possible method which is hygienic and at the same time free of errors.

The problem is solved by a kit for preparing a vaccine formulation, the use of a kit for preparing a vaccine formulation, the use of two or more starting materials for the preparation of a vaccine formulation, or a method of making a vaccine formulation. Advantageous aspects are the subject of the dependent claims.

In a first aspect, the present invention provides a kit for preparing a vaccine formulation, in particular immunization against swine circovirus disease "PCVD" and / or pandemic pneumonia "EP" which is a disease or swine circovirus, in particular type 2 and / or mycoplasma A kit for preparing a vaccine formulation for use in immunization against infection by hypnosis.

The kit according to the invention comprises a first starting material and a second starting material different from the first starting material. Starting materials suitable for the purpose of the present invention are preferably any raw material, in particular vaccines, raw materials comprising vaccines and / or components or ingredients for vaccine preparations, preferably antigens or compositions containing antigens.

Moreover, the kit comprises a first container which is only partially filled with the first starting material and a second container which holds the second starting material.

Containers suitable for the purposes of the present invention are preferably structures, particularly vessels, bottles or bags, etc., which enclose a particular volume, preferably configured to receive a liquid.

The kit further includes an adapter device for establishing a fluid connection, wherein the fluid connection can be established between the first container and the second container. It is also preferred that the adapter device must be configured to establish a fluid connection between the interior of the first container and the interior of the second container.

Moreover, in the proposed kit, one or more of the containers are sealed by a factory-provided closure device. Preferably, the containers are both sealed by a factory-supplied closure device. Preferably, an airtight and / or sterile seal is provided. In particular, the closure device may be a seal, a rubber stopper or the like, wherein the closure device is preferably penetrated and / or perforated, in particular reversibly penetrated and / or perforated. . In this way, the containers, ie one or more of the containers, can be sealed in a sterile manner.

The second container, when the closure device is perforated for the first time and / or only once so that the second starting material enters the first container and in particular is moved to the first container, where the first starting material and the vaccine formulation are formed. It is envisioned that the adapter device can be connected to the first container. Thus, the closure device or closure devices are preferably embodied as being penetrated or perforated by the adapter device. The adapter device is preferably configured to be able to penetrate and / or puncture the closure device or closure devices. In this way, a fluid connection can be provided between the first container and the second container.

Using the kit according to the invention, only two containers and adapter devices are used to immunize from two starting materials, in particular against diseases caused by infection by porcine circovirus and / or mycoplasma hyonneumoniae. Vaccine formulations can be prepared for use, preferably for immunization against diseases caused by infection with porcine circoviruses and mycoplasma hyopneumoniae. The kit also prevents the use of other inappropriate starting materials, in particular by providing the starting materials and container in kit form.

Advantageously, the vaccine formulation may be formed only in a partially filled first container, so no additional container and / or additional adapter device may be needed. This makes the application as simple as possible. In addition, the use of materials is minimized as the number of components required is reduced to a minimum.

It is also particularly advantageous that the vaccine formulation can be sufficiently produced by simply penetrating or puncturing the closure device for the first time or only once. Indeed, this makes it possible to avoid foreign substances or pathogens from entering the vaccine formulation during multiple penetrations or punctures of the closure device.

In the present invention, for reasons of clarity, vaccines as possible components of one or more starting materials are distinguished from vaccine preparations as products prepared from said starting materials.

Thus, the term "vaccine formulation" refers to the final product, preferably even when it represents a vaccine, preferably produced or prepared from said two starting materials and / or used for said treatment. Particularly preferably, the vaccine preparation preferably comprises two or more vaccines which differ from one another or two or more antigens which differ from one another or two compositions containing antigens, wherein the compositions containing said antigens are present in an antigen present. At least different). The term "vaccine" also preferably refers to a starting agent or component thereof, in particular an antigen or an antigen-containing composition. “Antigen” or “antigen-containing composition” preferably means a substance or a composition containing the substance that can induce an immune response in an animal or enhance an existing immune response after administration. Thus, the differentiation between the terms "vaccine agent" and "vaccine" is provided primarily only to distinguish or distinguish the product from the possible components of one or more starting materials. As a result, the term "vaccine formulation" may be replaced by "vaccine", and it is also possible when the term "vaccine" is replaced by "vaccine formulation".

Kits within the term of the present invention are in particular combinations and / or systems comprising a first container, a second container and preferably an adapter device forming the parts of the kit. The parts of the kit are preferably sold as a set, in particular as a combined package or the like. However, the parts specified above may form a loose combination for common use. Joint or connecting parts, eg, joint instruction manuals, use recommendations, caption references, etc., for one or more parts of the kit may be provided.

Another aspect of the invention that may also be practiced independently is immunization against, or / or infection with, swine circoviruses against the disease (s) swine circovirus disease “PCVD” and / or pandemic pneumonia “EP”. Immunization against swine circovirus disease "PCVD" and / or pandemic pneumonia "EP" for immunization against infection by bacteria of the mycoplasma strain, in particular mycoplasma hyopneumoniae, or swine circovirus Preferably, for the preparation and / or provision of vaccine preparations for immunization against infection by porcine circovirus type 2 and immunization against infection of bacteria of the mycoplasma strain, in particular mycoplasma hyopneumoniae. It relates to the use of the kit.

Another aspect of the invention which can also be carried out independently is, in particular, for simultaneous immunization against swine circovirus disease "PCVD" and / or pandemic pneumonia "EP" which are disease (s), preferably swine circus which is particularly diseases Simultaneous immunization against viral disease "PCVD" and pandemic pneumonia "EP" or simultaneous immunization against infection by porcine circovirus, in particular porcine circovirus type 2 and / or bacteria of mycoplasma strains, especially mycoplasma hyopneumoniae The use of two or more starting materials for preparing a vaccine formulation for simultaneous immunization against infection by the vaccine formulation is made using the starting materials in containers and adapter devices. Kits can be used as suggested.

In addition, the first starting material is used in the first container only partially filled with the first starting material, and the second starting material different from the first starting material is used in the second container having the second starting material, It is envisioned that an adapter device configured to establish a fluid connection between the first vessel and the second vessel is used. At least one of the containers is sealed by a factory-supplied closure device. In order to deliver a second starting material through the adapter device and the closure device into the first container to produce a vaccine formulation in the first container, the fluid connection between the first container and the second container is such that And / or created by the adapter device when penetrated only once.

Another aspect of the invention which can also be carried out independently is, in particular, for simultaneous immunization against the swine circovirus disease "PCVD" and / or pandemic pneumonia "EP" which is a disease, preferably the swine circovirus disease " For simultaneous immunization against PCVD "and pandemic pneumonia" EP ", the present invention relates to a method for preparing a vaccine formulation from a first starting material and a second starting material different from the first starting material. The vaccine formulation can be prepared using a kit as proposed.

A fluid connection between the first container only partially filled with the first starting material and the second container holding the second starting material is established by the adapter device so that the fluid connection between the first container and the second container is preferably Preferably, the at least one of the containers is sealed and the at least one factory-supplied closure device is established by the adapter device when it is first penetrated or perforated by the adapter device for the first time and / or only once. The second starting material is transferred or conveyed into the first container through the adapter device and the closure device. In a first container, the vaccine formulation is formed from the first starting material and the second starting material.

Preferably, the first starting material and / or the second starting material are or comprise a vaccine, antigen and / or antigen containing composition. Moreover, the first starting material may be different from the second starting material. Thus, the first starting material may be or include a first vaccine, a first antigen and / or a first antigen-containing composition, and the second starting material may be different from the second vaccine, the first antigen, which is different from the first vaccine. Or may comprise an antigen-containing composition containing a second antigen and / or an antigen different from the antigen of the first antigen-containing composition. Preferably, the first vaccine and the second vaccine, or the composition comprising the first and second antigens, or the various antigens above, are in particular, for example, the swine circovirus disease "PCVD" and the pandemic pneumonia, for example. For simultaneous immunity against various diseases or pathogens, such as EP "or for immunity against swine circoviruses, preferably swine circovirus type 2 and mycoplasma, preferably mycoplasma hyonneumoniae will be. This can produce a combination vaccine. The starting material may contain the vaccine and other substances separate from it, in particular water, adjuvants and / or excipients.

It is particularly preferred that the first starting material comprises only components of each of the components mycoplasma vaccine or mycoplasma antigen and each of the circovirus vaccine or circovirus antigen (and optionally other substances). Thus, the first starting material may comprise a mycoplasma vaccine or one or more mycoplasma antigens or may comprise a circovirus vaccine or one or more circovirus antigens. In particular, when the first starting material and the second starting material are not stable together for a long time, the first starting material is preferably stored separately from the second starting material. The second starting material preferably comprises only the other components of the components mycoplasma vaccine or one or more mycoplasma antigens and the circovirus vaccine or one or more circovirus antigens (and optionally other substances). Thus, when the first starting material contains a mycoplasma vaccine or one or more mycoplasma antigens, the second starting material contains a circovirus vaccine or one or more circovirus antigens, or the first starting material comprises a circovirus vaccine or one or more If it contains a circovirus antigen, the second starting material contains a mycoplasma vaccine or one or more mycoplasma antigens.

Mycoplasma vaccines may include attenuated and / or inactivated bacteria, bacterial fragments or recombinantly generated portions of Mycoplasma hypneumoniae, but may comprise one or more Mycoplasma hypneumoniae antigens. . Preferably, Mycoplasma hyopneumoniae strain J, or Mycoplasma hyopneumoniae antigens derived from inactivated mycoplasma hyopneumoniae bacteria, are antigens of said strain J. Moreover, the mycoplasma vaccine may be one of the following vaccines, and the mycoplasma hyopneumoniae antigen may be the antigen (s) contained in one of the following vaccines: Ingelvac® MycoFlex from Boehringer Ingelheim Bettmedica Incorporated (Boehringer Ingelheim Vetmedica Inc), St. Joseph, Missouri, USA, Porcilis M. hyo, Myco Silencer® BPM, Myco Silencer® BPME, Myco Silencer® ME, Myco Silencer® M, Myco Silencer® Once , Myco Silencer® MEH (all of which are manufactured by Intervet Inc., Millsboro, USA), Stellamune Mycoplasma (Pfizer Inc., New York, USA) New York), Suvaxyn Mycoplasma, Suvaxyn M. hyo, and Suvaxyn MH-One (all of which were based in Overland Park, Kansas, USA, were formerly Fort Dodge Animal Health and now Pfizer Animal) Scan is available from the manufacturer (Pfizer Animal Health)).

The circovirus vaccine may comprise attenuated and / or inactivated porcine circoviruses, preferably type 2, especially type 2 ORF2 protein. Particular preference is given to using ORF2 protein, preferably expressed in vitro in cell culture and expressed by recombination of porcine circovirus type 2 obtained from said cell culture. Examples of ORF2 proteins of porcine circovirus type 2 are described in particular in international patent application WO 2006-072065. They have proven to be particularly advantageous for effective vaccination. Moreover, the circovirus vaccine may be one of the following vaccines, or the circovirus antigen may be an antigen or antigens contained in one of the following vaccines: Ingelvac®CircoFLEX, manufactured by Boehringer Ingelheim-Vetmedica Inc. , Based in St. Joseph, Missouri, USA CircoVac® (Merial SAS, Lyon, France), CircoVent® (Intervet Inc., Millsboro, Delaware, USA) ), Or Suvaxyn PCV-2 One Dose® (Fort Dodge Animal Health, Kansas, Kansas, USA).

If the circovirus vaccine contains the ORF2 protein, the circovirus vaccine is preferably from 2 μg to 150 μg, preferably from 2 μg to 60 μg, more preferably from 2 μg to 50 μg, more preferably per dose administered. More preferably 2 µg to 40 µg, more preferably 2 µg to 30 µg, more preferably 2 µg to 25 µg, more preferably 2 µg to 20 µg, more preferably 4 µg to 20 µg, more preferably Preferably 4 μg to 16 μg of ORF2 protein. The circovirus vaccine is preferably prepared or designed such that 1 ml of the vaccine corresponds to a dose of 1 and / or one (single) dose. In particular, the circovirus vaccine has an ORF2 protein greater than 2 μg / ml, preferably greater than 4 μg / ml and / or less than 150 μg / ml, preferably 60 μg / ml, 50 μg / ml, 40 μg / ml, It may contain an amount of less than 30 μg / ml or less than 25 μg / ml, in particular less than 20 μg / ml. This helps to ensure reliable dosing.

If the mycoplasma vaccine contains inactivated mycoplasma bacteria, preferably inactivated mycoplasma hyopneumoniae bacteria, the mycoplasma vaccine is preferably 10 ³ to 10 ⁹ colony forming units per dose to be administered. forming unit) (CFU), preferably 10 ⁴ to 10 ⁸ (CFU), more preferably 10 ⁵ to 10 ⁶ (CFU), and the corresponding CFU is selected before the bacteria are inactivated. Mycoplasma vaccines are preferably prepared or designed such that 1 ml of the vaccine corresponds to a dose of 1 and / or one (single) dose. In particular, the mycoplasma vaccine is in particular above 10 ³ CFU / mL, preferably above 10 ⁴ CFU / mL, especially above 10 ⁵ CFU / mL and / or below 10 ⁹ CFU / mL, preferably before the bacteria are inactivated. May contain less than 10 ⁸ CFU / ml, in particular less than 10 ⁷ CFU / ml or 10 ⁶ CFU / ml of inactivated mycoplasma bacteria, preferably inactivated mycoplasma hyonneumoniae bacteria.

One or more of the starting materials and / or the vaccine preparation may contain an adjuvant, preferably a polymeric adjuvant, in particular a carbomer. Preferably, at least one or exactly one of the two starting materials, preferably both starting materials, is between 500 μg and 5 mg, preferably between 750 μg and 2.5 mg, more preferably about 1 mg per dose to be administered. The adjuvant contains the adjuvant. The starting materials are preferably prepared or designed such that 1 ml of each starting material corresponds to a dosage of 1 and / or one (single) dosage. The use of an adjuvant, preferably a polymeric adjuvant (eg carbomer), has proved advantageous in terms of the efficiency of immunization or its duration of effect. However, the use of alternative and / or additional adjuvants is not excluded.

Furthermore, if the total volume of the first container exceeds the volume of the first starting material at least by the volume of the second starting material, in particular it is more than 2%, preferably more than 5%, in particular more than 8% It turned out to be advantageous. This ensures that the first container has a sufficient capacity for the second starting material. In addition, the volume of the first container that exceeds the sum of the volumes of the first starting material and the second starting material is determined by the volume of the starting material, in particular when the first container is moved after the second starting material has been delivered into the first container. Ensure effective mixing

Thus, on the one hand it is preferred that the total volume of the first vessel should not exceed the sum of the volumes of the starting materials. On the other hand, the first vessel is moved to achieve or accelerate homogeneous mixing and / or reaction during and / or after the second starting material is delivered to the first vessel.

According to another aspect of the invention, the first container may be used for installation in or in conjunction with an injection device. In particular, the infusion device is a multi-use infusion device such as, for example, an injection gun, a press injector and / or a self-filled syringe, for example used to provide a vaccine to a larger number of animals. . In this way, the number of times of penetration of the closure device of the first container can be minimized. In particular, the number of penetrations can be reduced to two, that is, one penetration for the manufacturing process and one second penetration for making the vaccine formulation. Particularly advantageously, the adapter device can be used for connection to the injection device, reducing the number of penetrations by one.

The kit according to the invention may comprise or be associated with an injection device. In particular, the opening, flange or other connecting member or closure member of the first container, and / or the adapter device may be configured to allow for use directly in or with the injection device. In addition, the opening, flange or other connecting member and / or closure member may be specially designed to be connected to a particular injection device. Once again, this reduces the possibility of misuse, in particular the wrong amount of active substance or the wrong method of administration.

One or more of the containers may contain gases, in particular protective gases, in addition to the respective starting materials, to improve the long term stability of each starting material. Moreover, the adapter device can be implemented to deliver the gas from the first vessel to the second vessel, in particular when the second starting material is transferred from the second vessel into the first vessel under the exclusion of the ambient atmosphere. Thus, in particular, it is ensured that the effect on one or more of these starting materials and / or vaccine preparations as a result of oxidation or the like is excluded and / or pressure equalization becomes possible.

The present invention provides a method for preparing a combination vaccine for simultaneous immunization against swine circovirus disease and pandemic pneumonia in a hygienically simple manner.

Further aspects, details, features, characteristics, and advantages of the invention will be apparent from the following description of the preferred embodiments of the proposed kit for the manufacture of vaccine formulations as well as claims and graphs. In the drawing:
1 shows a first vessel partially filled with a first starting material.
2 shows a second container holding a second starting material.
3 shows an adapter device for fluidly connecting the containers.
4 shows a second container with an adapter device inserted.
5 shows a first container and a second container connected by an adapter device.
6 shows a first container holding a vaccine formulation.
7 shows an injection device with a first container attached.

In the drawings, like reference numerals are used for identical or similar parts where corresponding or comparable properties and advantages are obtained even if the description is not repeated.

1 shows a first container 1 with a wall 2 defining a specific volume. The container 1 comprises an opening region 3 which may have a flange 4, for example an annular shoulder. Preferably, the container 1 is sealed by the closure device 5, in particular in a sterile and / or airtight manner. For this purpose, it can be envisaged that the sealing device 5 is tightly adjoining on the flange 4, more particularly against the flange 4.

For example, a clamping member 6, in particular a clamping ring, may be provided which presses the closure device 5 against the flange 4. The clamping member 6 may be metal and in particular contain aluminum or stainless steel. Alternatively or in addition, the clamping member 6 may comprise or consist of plastic. The clamping member 6 is preferably embodied so that the first container 1 is in particular sealed from the environment and / or the atmosphere by pressing the closure device 5 against the flange 4.

In the embodiment shown, the closure device 5 seals or seals the first container 1. The closure device 5 may preferably be penetrated or perforated, for example with spikes, needles, hollow needles, double spikes and the like. Particularly preferably, the closure device 5 is configured to penetrate or puncture in such a way as to achieve a reversible closure, ie the closure device 5 is particularly hermetic and / or sterile even after penetration or puncture and removal of the corresponding formulation. Sealing can be obtained. The closure device 5 contains rubber, in particular halobutyl type 1 rubber, and / or may be in the form of a rubber stopper. However, the sealing device 5 may also consist of or contain other materials, in particular those used in the wall 2.

The wall 2 of the first container 1 is preferably a sterilizable material, preferably glass, polyethylene, high density polyethylene (HDPE), ethylenevinylacetate (EVA), halobutyl type 1 rubber and / or siliconization Chlorobutyl. Wall 2 may be of rigid or flexible structure. The first container 1 may in particular be embodied as a bottle, bag, can or the like. In particular, the first container 1 may be a cartridge, insert, or installation or attachment device for the injection device 22 (see FIG. 7) as discussed in more detail below.

In the embodiment shown in FIG. 1, the container 1 is only partially filled with the first starting material 7. The container 1 is, for example, said first start in an amount of less than 70%, preferably less than 50%, in particular less than 45% and / or more than 10%, preferably more than 20% and in particular more than 30% It is filled with the material.

In addition to the first starting material, the first vessel 1 may contain a gas 8, in particular a protective gas, a rare gas, an inert gas and the like. In this way, the shelf life of the first starting material 7 can be improved.

Preferably, the sum of the volumes of the first starting material 7 and the gas 8 is the total volume of the first container 1, preferably in particular the wall of the first container 1 with the closure device 5. Provide a volume enclosed by (2), or less.

2 shows a second container 9 holding a second starting material 10. The second container 9 comprises a wall 11, an opening area 12, a flange 13, a sealing device 14 and / or a clamping member 15, which preferably comprises the first container 1. May have the same or similar properties as the corresponding members of, and for this reason the description will not be repeated at this point. Therefore, only possible differences between the second container 9 and the first container 1 will be mentioned below.

The second vessel 11 is preferably configured with a wall 11 which is preferably at least partially flexible, in particular the pressure may be applied to the second starting material 10 by pressing the wall 11. This may help to facilitate the removal or delivery of the second starting material 10.

Preferably, the volume of the gas 8 corresponds to or exceeds the volume of the second starting material 10. In particular, the volume of gas 8 in the first vessel 1 is greater than 2%, preferably greater than 5%, in particular greater than 8% and / or less than 80%, preferably greater than the volume of the second starting material 10. Is less than 50%, in particular by less than 40% or 30%. This allows the preparation of the vaccine preparation 21 (see FIG. 5) in the first container 1 while at the same time allowing the first container 1 to take a minimum space. In particular, a sufficient volume of gas 8 remains in the first vessel 1, allowing homogeneous mixing by the movement of the first vessel 1.

In the embodiment shown in FIG. 2, the second container 9 is at least substantially filled with a second starting material 10. Alternatively or additionally, however, the second container 9 may also be completely filled with the second starting material 10 or only partially filled with the second starting material 10. If the second container 9 is only partially filled with the second starting material 10, a gas 6, in particular a protective gas, may be provided, which is preferably a wall, in particular with a closure device 14. A second volume 9 of specific volume surrounded by 11 is filled with a second starting material 10.

It is particularly preferred if the total volume of the first container 1 exceeds the volume of the first starting material 7 at least by the volume of the second starting material 10. Thus, the volume of the first container 1 preferably exceeds the sum of the volume of the first starting material 7 and the volume of the second starting material 10.

3 shows an adapter device 17 for providing a fluid connection between the first container 1 and the second container 9. The adapter device 17 may comprise one or more, preferably two, but also more than two adapter members 18, in particular needles, hollow needles, spikes, wedges and the like.

The adapter device 17 preferably comprises a fluid channel 19, in particular a fluid channel 19 for fluidly connecting the container 1 and the interior of the container 9. The adapter device 17 is in the form of double spikes or hollow needles in the illustrated embodiment.

The adapter device 17 allows gas 8 or protective gas to pass from the first vessel 1 into the second vessel 9 or more particularly while delivering the second starting material 10 into the first vessel 1. It may be configured to be moved. For this purpose, the adapter device 17 may comprise a venting and / or exhaust device 20. The ventilation and / or exhaust device 20 is preferably in the form of a channel, in particular a channel at least substantially parallel to the fluid channel 19. However, other solutions are possible.

Preferably, the adapter device 17 comprises a channel as the ventilation and / or exhaust device 20, the opening of which is when the second starting material 10 flows out of the second container 9 under the influence of gravity. The gas 8 is arranged to allow backflow from the first vessel 1 into the second vessel 9. In particular, the opening of the ventilation and / or exhaust device 20 facing the first container 1 is in the longitudinal axis direction of the adapter device 17 with respect to the opening of the fluid channel 19 facing the first container 1. It may be concave or arranged on the opening side of the fluid channel 19 remote from the open end of the adapter device 17. On the other hand, the opening of the ventilation and / or exhaust device 20 facing the second container 9 is preferably in connection with the opening of the fluid channel 19 facing the second container 9. It is arranged close to the open end of.

In the embodiment shown in FIG. 3, the adapter device 17 is integrally formed. Alternatively or additionally, however, a hose, tube or some other flexible or hard transition may be provided between the adapter members 18. Preferably, the fluid channel 19 and / or the ventilation and / or exhaust device 20 connect the adapter members 18 without interruption. In particular, a hose or tube or the like can be provided between the adapter members 18, in particular can be molded over the adapter members 18. This allows for flexible handling and / or extension of the adapter device 17.

The adapter device 17, in particular one or more of the adapter members 18, may in particular be configured for the first container 1 and / or for the second container 9. This is particularly true for each one of the containers 1, 9, in particular by means of a particular thread 3, 12, a particular protrusion, undercut, a particular lug or other structure, for example. It can be achieved by mechanically configuring one or more of the adapter members 18 for one of the containers 1, 9 associated with 18). In this way, materials other than the first starting material 7 and / or the second starting material 10 can be prevented from entering the first container 1 and / or the second container 9. In addition, the opening area of one or more or both of the containers 1, 9 is specifically configured for the adapter device 17, in particular for the adapter member 18.

In addition, the connection is preferably provided only between the containers 1, 9, excluding the ambient atmosphere. For the purposes of the present invention, it is preferred that the atmosphere is already excluded even if there is only a small volume of the remaining air source remaining in the adapter device 17, for example less than 10 ml or 5 ml.

The first starting material 7 and / or the second starting material 10 preferably comprises a vaccine. In addition, the starting materials 7, 10 should be different, in particular containing different vaccines.

As shown in FIGS. 4 and 5, the adapter device 17 can be used to provide a fluid connection between the first vessel 1 and the second vessel 9, where the second starting material 10 ) Forms the vaccine formulation 21 with the first starting material 7 to the second starting material 10 with the aid of gravity and / or through the wall 11 of the second container 9. It can be preferably moved into the first vessel 1 by applying pressure. Preferably, the vaccine preparation 21 is intended to prevent pigs from becoming infected with mycoplasma hyopneumoniae and / or swine circovirus, in particular type 2, preferably pigs are mycoplasma hyopneumoniae. And infection with porcine circovirus type 2 (ie, in the embodiments shown, this is a combination vaccine).

The first container 1, the second container 9 and preferably the adapter device 17 preferably form a kit or a set, and thus preferably have one or more connected common features suitable for the purposes of the present invention. Have This common feature may be that the first container 1, the second container 9 and / or the adapter device 17 are packaged together. Alternatively or in addition, the first container 1, the second container 9 and / or the adapter device 17 may have the same operating instructions, the same in-pack leaflets, the same manufacturer's recommendations, and the like. It is also possible for the captions, label labels, symbols or other information for the containers 1, 9 to cross-reference each other and the like.

The kit may optionally also include other components. Examples of these are one or more injection devices 22, an adapter device for connecting the first container 1 to the injection device 22, some other device or another container.

The kit is preferably for the prevention of diseases caused by infection with porcine circovirus type 2 and / or mycoplasma hyonneumoniae, preferably in swine circovirus type 2 and / or mycoplasma in pigs. To prepare a vaccine preparation 21 for preventing a disease caused by infection by Hi pneumoniae. However, different uses are not excluded. In particular, in the alternative, advantages may be obtained for the use of substances or mixtures of substances other than the specific vaccine or starting materials 7, 10 and / or for ease of handling and reduction of the likelihood of entry of foreign substances or pathogens. It can be expected to obtain. In particular, the alternative starting material may be one or more antigens of the following pathogens: Actinobacillus pleuropneumonia (A1); Adenovirus (A2); Alphaviruses such as the Eastern Equine Encephalomyelitis Virus (A3); Bodetella bronchiseptica (A4); Brachyspira spp. (A5), preferably B. hyodysenteriae (A6); B. piosicoli (A7), Brucella suis, preferably biovar 1, 2 and 3 (A8); Swine cholera virus (Classical Swine Fever Virus) (A9); Clostridium spp. (A10), preferably Cl. Difficile (A11), Cl of type A, B and C. Perfringen (A12), Cl. Novyi (A13), Cl. Septicum (A14), Cl. Tetani (A15); Coronavirus (A16), preferably Porcine Respiratory Corona Virus (A17); Eperythrozoonosis suis (A18); Erysipelotrix rhusiopathiae (A19); Escherichia coli (A20); Haemophilus parasuis, preferably types 1, 7 and 14 (A21); Hemagglutinating Encephalomyelitis Virus (A22); Japanese Encephalitis Virus (A23); Lawsonia intracellularis (A24); Leptospira spp. (A25), preferably Leptospira australis (A26), Leptospira canicola (A27), Leptospira gripfora (28) Leptospira icterohaemorrhagicae (A29), Leptospira interrogans (A30), Leptospira pomona (A31), Leptospira hardjo (Leptospira hardjo) Leptospira tarassovi) (A33); Mycobacterium spp. (A34), preferably M. avium (A35) and M. intracellulare (A36); Pasteurella multocida (A37); Porcine Cytomegalovirus (A38); Porcine Parvovirus (A39); Porcine Reproductive and Respiratory Syndrome (PRRS) virus (A40); Pseudorabies Virus (A41); Rotavirus (A42); Salmonella spp. (A43), preferably S. thyphimurium (A44) and S. choleraesuis (A45); Staphylococcus spp. (A46), preferably Staph. Hicus (A47); Streptococcus spp. (A48), preferably Streptococcus suis (A49); Swine herpes virus (A50); Swine influenza virus (A51); Swine pox virus (A52); Vesicular Stomatitis Virus (A53); Vesicular exanthema (A54) of porcine virus; And Mycoplasma hyosynoviae (A55). Preferably, the starting materials 7, 10 are different antigens of the pathogens listed herein, so that two of the pathogens listed herein, using the vaccine preparation 21 after mixing the different starting materials, are used. Diseases caused by dog abnormalities can be prevented.

In order to produce the vaccine formulation 21, in particular, as shown in FIG. 4, the adapter device 17 having the adapter member 18 is connected to the second container through the closure device 14 of the second container 9. 9) can be pushed into the interior. Thus, the closure device 14 is preferably penetrated by the adapter device 17, in particular its adapter member 18.

Moreover, in particular, as shown in FIG. 5, the combination of the second container 9 and of the adapter device 17, in particular with another adapter member 18 of the adapter device 17, is the first container 1. It can be pushed into the inside of the first container 1 through the sealing device (5). Preferably, the adapter device 17 or the adapter member 18 penetrates the closure device 5 of the first container 1. In this way, the adapter device 17 can provide a fluid connection 20 between the interior of the first container 1 and the interior of the second container 9.

4 and 5, the details of the opening areas 3, 12 of the containers 1, 9 and the adapter device 17 are not shown for reasons of clarity. See FIGS. 1-3 for this subject.

As shown in FIG. 5, the second starting material 10 is produced through the adapter device 17 by compression of the second container 9, preferably using gravity and / or preferably flexibly formed. 1 can be delivered into the container (1). Alternative and / or additional methods or processes for delivering the second starting material 10 into the first container 1 are also possible.

In another example, not shown, first, the adapter device 17 is used to penetrate the closure device 5 of the first container 1. Subsequently, in the second step, the second container 9 is mounted on or connected to the adapter device 17 already inserted into the first container 1 so that the fluid connection 20 is connected to the first. It is formed between the container 1 and the second container 9. In each case, after inserting the adapter device 17 into the first of the containers 1, 9, one of the containers 1, 9 that is not yet attached to the adapter device 17, the adapter device 17 ) And the vertically arranged combination of the other of the containers 1, 9 is preferred. This prevents one of the starting materials 7, 10 from leaking out.

In one aspect, the invention relates to one or more of the closure devices 5, 14 penetrating first and / or only once by the adapter device 17. Particularly preferably, the containers 1, 9 both contain closure devices 5, 14, which are penetrated, pierced or perforated for the first time and / or only respectively. This is made possible by the fact that in the illustrated embodiment, the first container 1 is only partially filled with the first starting material 7. Advantageously, this makes it possible to produce the vaccine preparation 21, in particular combination vaccines, without necessarily using multiple adapter devices 17 or two or more containers 1, 9. As a result, the vaccine preparation 21 is manufactured using only one adapter device 17, thereby enabling a simple, reliable and clear operation that effectively prevents mixing with other starting materials and introduction of impurities or pathogens. .

These positive characteristics indicate that the first container 1, optionally with the adapter device 17, is used in the injection device 22, in particular in the injection gun, in the pressure injector and / or in the self-filling syringe (see FIG. 7) or It can be further improved if it is configured to be used directly with these devices. Thus, the first container 1 can preferably be used in the multi-use injection device 22 or in conjunction with the multi-use injection device 22. This means that the respective closure devices 5, 14 must be drilled or penetrated only once for the first time. This allows for a high level of safety, ease of handling and hygiene.

The first container 1 is in the neck or mouth region, in particular in the opening region 3, in the injection device 22 or together with the injection device 22, in particular to the multi-use injection device 22. You can expect to be configured to use for the connection. The injection device 22 can have a reservoir 23 for the first container 1. It may be provided that the length and / or diameter of the first container 1 is configured for use in an injection device 22, especially designed for multiple use. For example, the first container 1 may have a diameter of more than 1 cm, preferably more than 2 cm, in particular more than 3 cm and / or less than 10 cm, preferably less than 8 cm, in particular less than 6 cm. Alternatively or additionally, the first container 1 may have a length of more than 3 cm, preferably more than 5 cm, in particular more than 6 cm and / or less than 30 cm, preferably less than 25 cm, in particular less than 20 cm.

As soon as the second starting material 10 passes through the adapter device 17 into the first container 1, a vaccine preparation 21 may be formed. Vaccine preparation 21 by mixing the starting materials 7, 10 and / or by dissolving the starting materials 7, 10 with each other and / or by reacting the starting materials 7, 10 or a portion thereof with each other. Can be prepared. Preferably, as indicated by the arrows in FIG. 6, the first container 1 holding the starting materials 7, 10 is configured to move, in particular to be shaken, tilted, rotated or the like. This ensures or assists in homogeneous and / or faster mixing, reaction and / or dissolution.

In the embodiment shown above, the first starting material 7 and / or the second starting material 10 preferably contain more than 30% by weight, preferably more than 40% by weight, in particular more than 50% by weight, and / or Less than 90% by weight, preferably less than 80% by weight, in particular less than 70% by weight. Moreover, the first starting material 7, the second starting material 10, and / or the vaccine preparation 21 formed therefrom, preferably contain more than 30% by weight of the vaccine and / or insoluble protein, preferably Preferably a suspension having an amount of more than 40% by weight, in particular more than 50% and / or less than 90% by weight, preferably less than 80% by weight, in particular less than 70% by weight. This ensures efficacy with a small amount of vaccine formulation while ensuring a sufficiently low viscosity to aid administration.

The second starting material 10 preferably comprises only the other of the components mycoplasma vaccine or mycoplasma antigen and the circovirus vaccine or circovirus antigen. Furthermore, if the first starting material 7 comprises a mycoplasma vaccine or one or more mycoplasma antigens, it is preferred that the first starting material 7 does not comprise a circovirus vaccine or a circovirus antigen, but for this purpose. The second starting material 10 comprises a circovirus vaccine or one or more circovirus antigens but no mycoplasma vaccine or mycoplasma antigen. However, in any of the starting materials 7, 10 it is not excluded that the particular starting material should not contain further materials. These may be water, excipients, adjuvants, preservatives and the like.

In one embodiment, the volume ratio of the first starting material 7 to the second starting material 10 is 3: 1 to 1: 3, preferably 2: 1 to 1: 2, especially about 1: 1. The viscosity of the first starting material 7 and / or the second starting material 10 and / or the vaccine preparation 21 measured at 5 ° C. in accordance with EN ISO 2555 is preferably less than 10000 mPa · s, preferably It may be less than 1000 mPa · s, in particular less than 500 mPa · s and / or more than 5 mPa · s, preferably more than 10 mPa · s, in particular more than 20 mPa · s. Preferably, the first starting material 7 and / or the second starting material 10 are liquid at 2 ° C. to 8 ° C., and / or have a melting point of less than 1 ° C., preferably less than 0 ° C., in particular -0.2 ° C. Less than and / or above -1.5 ° C, preferably above -1 ° C, in particular above -0.8 ° C.

According to another aspect of the invention, the vaccine preparation 21 preferably has a different characteristic color than the two starting materials 7, 10. The specific color of the vaccine formulation can be formed, for example, by mixing different colors of starting materials 7, 10. For example, mixing the yellow starting material 7 with the red starting material 10 produces an orange colored vaccine preparation 21. The dye components in the starting materials 7, 10 may produce characteristic colors by reaction or other interactions during the manufacture of the vaccine formulation 21. Alternatively or in addition, the vaccine preparation 21 may have one color or be colorless, unlike one or more of the starting materials 7, 10. As a result, the characteristic color can ensure that the vaccine formulation 21 has been successfully manufactured. This also enables one or more of the starting materials to have one color, but once prepared, the vaccine formulation 21 has no color.

As already mentioned above, the mycoplasma vaccine may comprise attenuated and / or inactivated bacteria, fragments of bacteria, or portions produced by recombination of mycoplasma hyonneumoniae, Contains moniae antigens. Preferably, Mycoplasma hyopneumoniae strain J, or Mycoplasma hyopneumoniae antigens derived from inactivated mycoplasma hyopneumoniae bacteria, are antigens of said strain J. Moreover, the mycoplasma vaccine may be one of the following vaccines, and the mycoplasma hyopneumoniae antigen may be antigens contained in one of the following vaccines: Ingelvac® MycoFlex from Boehringer Ingelheim Bettmedica Inc. Tide, based in St. Joseph, Missouri), Porcilis M. hyo, Myco Silencer® BPM, Myco Silencer® BPME, Myco Silencer® ME, Myco Silencer® M, Myco Silencer® Once, Myco Silencer® MEH Manufactured by Intervet Inc., Millsboro, Stellamune Mycoplasma (Fiser Incorporated, New York, NY), Suvaxyn Mycoplasma, Suvaxyn M. hyo, Suvaxyn MH-One ( These are all based in Overland Park, Kansas, USA, formerly Fort Dodge Animal Health, and are now available from the manufacturer, Pfizer Animal Health).

The circovirus vaccine may comprise attenuated and / or inactivated porcine circoviruses, preferably type 2, especially type 2 ORF2 protein. Particular preference is given to using ORF2 proteins, preferably expressed in vitro in cell culture and expressed by recombination of porcine circovirus type 2 obtained from the upper cell culture. Examples of ORF2 proteins of porcine circovirus type 2 are described in particular in international patent application WO 2006-072065. They have proven to be particularly advantageous for effective vaccination. Moreover, the circovirus vaccine may be one of the following vaccines, or the circovirus antigen may be antigen (s) present in one of the following vaccines: Ingelvac®CircoFLEX (Beringer Ingelheim Bettmedica Inc.) , Based in St. Joseph, Missouri, USA, CircoVac® from Merial SAS, Lyon, France, CircoVent® from Intervet Inc., Millsboro, Delaware, USA Or Suvaxyn PCV-2 One Dose® from Fort Dodge Animal Health, Kansas, Kansas, USA.

If the circovirus vaccine contains the ORF2 protein, the circovirus vaccine is preferably from 2 μg to 150 μg, preferably from 2 μg to 60 μg, more preferably from 2 μg to 50 μg, more preferably per dose administered. More preferably 2 µg to 40 µg, more preferably 2 µg to 30 µg, more preferably 2 µg to 25 µg, more preferably 2 µg to 20 µg, more preferably 4 µg to 20 µg, more preferably Preferably 4 μg to 16 μg of ORF2 protein. The circovirus vaccine is preferably prepared or designed such that 1 ml of the vaccine corresponds to a dose of 1 and / or one (single) dose.

If the mycoplasma vaccine contains inactivated mycoplasma bacteria, preferably inactivated mycoplasma hyopneumoniae bacteria, the mycoplasma vaccine is preferably 10 ³ to 10 ⁹ colony forming units (CFU) per dose to be administered. ), Preferably 10 ⁴ to 10 ⁸ (CFU), more preferably 10 ⁵ to 10 ⁶ (CFU), wherein the corresponding CFU is adjusted before the bacteria are inactivated. Mycoplasma vaccines are preferably prepared or designed such that 1 ml of the vaccine corresponds to a dose of 1 and / or one (single) dose.

The mycoplasma vaccine preferably comprises attenuated and / or inactivated bacteria or bacterial fragments or corresponding antigens of the strain Mycoplasma hyopneumoniae, preferably greater than 30% by weight, preferably greater than 40% by weight, in particular 50 It may comprise in an amount greater than and / or less than 90% by weight, preferably less than 80% by weight, in particular less than 70% by weight.

The circovirus vaccine preferably contains attenuated and / or inactivated swine circovirus, preferably type 2, in particular swine circovirus type 2 ORF2 protein or corresponding antigens, preferably greater than 30% by weight, preferably 40% by weight. It may comprise more than%, in particular more than 50% and / or less than 90% by weight, preferably less than 80% by weight, in particular less than 70% by weight.

Furthermore, one or more of the starting materials 7, 10 and / or the vaccine preparation 21 may comprise one, preferably polymeric adjuvant, in particular carbomer. Preferably one or more preferably both of the two starting materials contain the adjuvant in an amount of 500 μg to 5 mg, preferably 750 μg to 2.5 mg, more preferably about 1 mg per dose to be administered. do. The starting materials are preferably prepared or designed such that 1 ml of each starting material corresponds to a dosage of 1 and / or one (single) dosage. Thus, in particular, at least one of the starting materials 7, 10 contains more than 500 μg / ml, preferably more than 750 μg / ml and / or less than 5 mg / ml, preferably 2.5 mg / ml of one or more adjuvants. It may comprise less than the total amount.

In addition, one or more of the starting materials 7, 10 and / or the vaccine preparation 21 contain more than 0.1% by weight, preferably more than 1% by weight, in particular more than 2% by weight and / or less than 20% by weight, Preferably in an amount of less than 10% by weight, in particular less than 5% by weight. In addition, polymeric adjuvants, in particular carbomers, may preferably be formed in the vaccine formulation 21.

One or more of the mycoplasma vaccines and / or circovirus vaccines or starting materials (7, 10) and / or the vaccine preparation (21) preferably contain less than 2.5 mg / m³, preferably less than 1.5 mg / m³ formaldehyde. And especially at a concentration of 0.74 mg / m³ or less. Alternatively or additionally, at least one of the starting materials 7, 10, preferably both starting materials 7, 10 are at least 20% by weight, preferably at least 30% by weight, in particular 40% by weight of water. It may be contained at a concentration of at least% and / or at most 80% by weight, preferably at most 70% by weight, in particular at most 60% by weight.

The first starting material 7, the second starting material 10 and / or the vaccine preparation 21 preferably contain at least 0.1% by weight, preferably 0.2 or more excipients, in particular preservatives, antioxidants and / or emulsifiers. It may comprise at a concentration of at least% by weight, in particular at least 0.3% by weight and / or at most 10% by weight, preferably at most 5% by weight, in particular at most 3% by weight.

A preferred use of the invention is in the preparation of vaccine preparation 21 from two vaccines, particularly preferably simultaneous immunization against swine circovirus disease "PCVD" and / or epidemic pneumonia "EP" or swine circovirus and Immunization or porcine circoviruses, particularly type 2 and mycoplasma bacteria, for use in the simultaneous immunization against infection by mycoplasma bacteria, preferably against said disease swine circovirus disease "PCVD" and pandemic pneumonia "EP" In particular, the present invention provides a vaccine preparation 21 for use in immunization against infection by Mycoplasma hyopneumoniae. Moreover, the present invention relates primarily to the manufacture of vaccine formulations for veterinary medicine, in particular for veterinary medicine for use in pigs.

However, the present invention is not limited to this combination. In particular, the proposed kit can be used with other starting materials, in particular vaccines or antigens (eg, antigens of the above-mentioned pathogens). Here too, similar advantages can be achieved at least in ease of use and in particular in hygienic applications. The same is true of the present invention, which provides a method for efficiently and simply and effectively checking whether the vaccine formulation 21 produced has a different color from the starting materials 7 and 10 so that the vaccine formulation 21 has been successfully manufactured. The same applies to the aspect. The specific color of the vaccine formulation can be produced, for example, by mixing different colors of starting materials 7, 10. For example, mixing the yellow starting material 7 with the red starting material 10 produces an orange colored vaccine preparation 21. The use of the first container 1 with the injection device 22 can also be applied successfully and advantageously in other fields, where similar advantages can be achieved, in particular in terms of improved hygiene and / or reduced use of the material. . However, it is particularly preferred to combine the proposed kit with the characteristic color of the prepared vaccine preparation 21 which is different from the color of the starting materials 7, 10. This causes unusual high certainty in use. However, the individual aspects of the present invention can also be combined in any other preferred manner.

1 first container
2 walls
3 opening area
4 flange
5 sealing device
6 clamping member
7 First starting material
8 gas
9 second container
10 Second starting material
11 walls
12 opening area
13 flange
14 sealing device
15 clamping member
16 gas
17 adapter unit
18 adapter parts
19 fluid channels
20 Ventilation and / or exhaust systems
21 Vaccine Preparation
22 injection device
23 storage
24 living creature

Claims (16)

For simultaneous immunization against swine circovirus disease and pandemic pneumonia, a combination vaccine is prepared from a first liquid starting material comprising a first vaccine and a second liquid starting material comprising a second vaccine different from the first vaccine. As a method,
The first liquid starting material comprises only one component of the mycoplasma vaccine component and the circovirus vaccine component, the second liquid starting material comprises only the other component of the mycoplasma vaccine component and the circovirus vaccine component,
A first container partially filled and sealed with the first liquid material in liquid form, the empty space remaining therein, the multi-use selected from the group consisting of one or more of an injection gun, a pressure injector and a self-filling syringe Providing a first container with a neck or mouth area specially configured for connection to an injection device,
A sealed second container that is smaller than the first container and contains the second liquid starting material in liquid form, the second volume of the provided second liquid starting material being less than the volume of the empty space in the first container Providing a container,
Perforating the first container and the second container with an adapter device, the adapter device having a pair of passages extending between the ends of the adapter located within the containers, the closure of each container being of the adapter; Perforated by each end, the first container and the second container connected by the adapter such that the second starting material is transferred into the first container and the second starting material enters the first container. Perforating, wherein gas from the empty space is transferred to the second vessel,
After the transfer of the second liquid starting material to the first container is completed, the combination vaccine is formed in the first container, and
At least one animal for swine circovirus disease and pandemic pneumonia, comprising directly connecting a specially configured neck or mouth region of the first container containing the combination vaccine to the multiple dose infusion device. A method of making a combination vaccine for inoculating. The combination vaccine of claim 1, wherein the first starting material comprises mycoplasma vaccine in an amount of greater than 30% by weight and the second starting material comprises an amount of greater than 30% by weight of the circovirus vaccine. How to. The method of claim 1, wherein the transfer of the second starting material to the first container is performed under the influence of gravity. The combination vaccine of claim 1, wherein the first vessel is moved during and / or after the transfer of the second starting material to the first vessel to achieve or accelerate homogeneous reaction, dissolution or mixing of the substances. How to manufacture. The method of claim 1, wherein the first container is disposed in or on a multiple-use infusion device, an injection gun, a pressure injector, or a self-filled syringe. The kit of claim 1, wherein a kit is used to prepare the combination vaccine, wherein the kit comprises the first container containing the first starting material and the second container containing the second starting material, and the first container. An adapter device providing a fluid connection between the container and the second container, wherein at least one of the containers is closed by a factory-provided closure device. The method of claim 1, wherein at least one of the starting materials comprises a polymeric adjuvant or carbomer. The method of claim 1, wherein at least one of the starting materials contains formaldehyde at a concentration of less than 2.5 mg / m³. The method of claim 1, wherein the first or second starting material contains water at a concentration of at least 20% by weight. The method of claim 1, wherein the first or second starting material contains one or more excipients, preservatives, antioxidants and emulsifiers. The method of claim 1, wherein the first vessel is filled with the first starting material in an amount of less than 70%, wherein the first vessel contains a gas and the volume of the gas is in the second vessel in the second vessel. A method of making a combination vaccine, at least corresponding to a volume of starting material. The method of claim 11, wherein the volume of the gas in the first container exceeds the volume of the second starting material by more than 5%. The method of claim 1, wherein a substance other than the first and / or second starting material is prevented from being introduced into the first and / or second container. The method of claim 1, wherein the adapter device forms a unique connection between the containers. The device of claim 1, wherein the adapter has pointed ends on both sides, each end having a rounded outer surface for providing a fluid connection between the first and second containers, wherein the adapter is provided for the second liquid starting material. A first through channel for the passage to the first vessel and a second through channel for the passage of the gas from the first vessel to the second vessel, the passages being from one side of the pointed end to the other of the pointed end. Extending diagonally to the opposite side, the end of the second through channel abutting against the first container is disposed farther from each pointed end of the rounded outer surface than the opening of the first channel inserted into the first container, An opposite end of the second through channel is each pointed end of the rounded outer surface than an opposite end of the opening of the first channel inserted into the second container; Method for producing a blended vaccines are disposed close together. 7. The adapter of claim 6, wherein the adapter has pointed ends on both sides, each end having a rounded outer surface for providing a fluid connection between the first and second containers, wherein the adapter is configured for the second liquid starting material. A first through channel for the passage to the first vessel and a second through channel for the passage of the gas from the first vessel to the second vessel, the passages being opposite of the one pointed end to the other The ends of the second through-channels diagonally extending in a plane and abutting the first container are disposed farther from each pointed end of the rounded outer surface than the opening of the first channel inserted into the first container, The opposite end of the second through channel is each pointed end of the rounded outer surface than the opposite end of the opening of the first channel inserted into the second container. Method for producing a blended vaccines are disposed close together.

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