WO2016138976A1

WO2016138976A1 - Metering valve for pharmaceutical liquids

Info

Publication number: WO2016138976A1
Application number: PCT/EP2015/081299
Authority: WO
Inventors: Olga Brandt; Markus Lasser; Michael Bratz
Original assignee: Robert Bosch Gmbh
Priority date: 2015-03-03
Filing date: 2015-12-28
Publication date: 2016-09-09
Also published as: DE102015203728A1

Abstract

The invention relates to a metering valve (10) for pharmaceutical liquids, comprising a valve element (25) which, in particular, takes the form of a valve needle, is arranged in a valve housing (11), can be actuated by means of a solenoid coil (45) and to which, when said solenoid coil (45) is not being supplied with current, a force is applied at least indirectly against a sealing seat (22) in said valve housing (11), by means of a spring element (40). According to the invention, the solenoid coil (45) is arranged in a coil housing (50) that is separate from the valve housing (11), said valve housing (11) being detachably connected to said coil housing (50).

Description

description

Dosing valve for pharmaceutical liquids

State of the art

The invention relates to a metering valve for pharmaceutical fluids according to the preamble of claim 1. Such a metering valve is already known from practice and designed in the form of a solenoid valve. For this purpose, the metering valve has a valve housing in which a valve member in the form of a

Valve needle is arranged to lift. The actuated by means of a solenoid valve member is arranged at unbestomter magnetic coil of the spring force of a compression spring against a valve housing in the or

formed seal seat to avoid leakage of pharmaceuticals from the valve body. The problem with such, known from the prior art metering valve is that due to the

Material use or construction of the metering valve for use according to clean room class A (according to GMP Guide) is only partially suitable.

As a result, for example, a relatively long production break is required if such a metering valve must be cleaned or sterilized.

Disclosure of the invention

Based on the illustrated prior art, the invention has the object, a metering valve for pharmaceutical fluids according to the preamble of claim 1 such that the use in areas of clean room class A is possible. This requires in particular a low-particle formation of the metering valve and the possibility of a particularly simple cleanability of the metering valve. Such a good cleanability can be achieved on the one hand by a corresponding construction of the metering valve, and on the other hand by the possibility of a particularly simple and fast assembly or disassembly, so that possibly required times for the Cleaning of such metering valves, during which no filling of

Pharmaceuticals is possible to be minimized.

This object is achieved with a metering valve for

pharmaceutical liquids with the features of claim 1, characterized in that the magnetic coil is arranged in a separate from the valve housing coil housing, wherein the valve housing with the

Coil housing is releasably connected. This makes it possible according to the invention, the components required for the actuation of the valve member in a separate from the valve housing, with respect to the particle number uncritical

To arrange the coil housing, which can be easily separated from the valve body. This in turn has the consequence that the coil housing with the components arranged therein does not have to be involved in the sterilization process, whereby the particularly simple and fast cleaning or

Sterilizability of potentially coming into contact with the product components of the metering valve in the valve housing is made possible.

Advantageous developments of the metering valve according to the invention for pharmaceutical liquids are listed in the subclaims. Within the scope of the invention, all combinations of at least two of those disclosed in the claims, the description and / or the figures fall within the scope of the invention

Features.

A structurally preferred embodiment of the metering valve provides that the coil housing has a receiving opening in which the valve housing is received at least partially. Such a receiving opening in particular allows a particularly simple assembly and disassembly of the valve housing or the coil housing, since only an axial joining or moving apart of the mentioned components is required to allow assembly or disassembly.

In a further development of the proposal made last, it is provided that the receiving opening is formed in the coil housing as a through hole, and that the valve housing in the installed state, the coil housing with respect to the longitudinal axis of the through hole projects axially on both sides. This makes it possible, in particular, the valve housing with respect to its axial To be able to design length such that the valve housing, for example, has a coil housing axially projecting portion for forming a magnetic core. This in turn has the consequence that in particular the coil housing can be made relatively short in relation to its axial length and still sufficiently high opening forces are made possible for the valve member to lift the valve member against the spring force of the spring element of the sealing seat in the valve housing.

In turn, structurally preferred embodiment, it is provided that in the valve housing in the arranged in the receiving opening of the bobbin case an area connected to the valve member and with the

Magnet coil cooperating anchor portion is arranged.

A particularly simple and reliable cleaning or sterilization of the relevant components of the metering valve is achieved when the valve housing and the valve member at least partially made of magnetizable stainless steel. Under stainless steel in the context of the invention are doing for

For pharmaceutical purposes approved or suitable, sterilizable materials understood.

A particularly simple connection between the valve housing and the coil housing is achieved when the valve housing is designed to be inserted into the receiving opening of the coil housing and received in a clamping manner in the receiving opening. As a result, in particular no additional fastening elements between the valve housing and the coil housing are required.

In order to enable the desired requirements with regard to the sterilisability of the components of the metering valve, it is particularly necessary that the components of the metering valve can be sterilized particularly simply and effectively. Contribute for this purpose, for example, a non-undercut training as well as geometrically simple shapes as possible, which can be sterilized by a suitable sterilizing medium (for example, sterile air) particularly simple and effective. Against this background, it is provided in a preferred embodiment of the invention that the valve housing consists of at least two valve housing elements, a first valve housing member disposed in the receiving opening of the bobbin case, and a second valve housing member having a

Product storage space for the pharmaceuticals forms, the two

Valve housing elements are releasably connected together. In other words, this means that due to the detachable arrangement or design of the two valve housing elements, they can be sterilized particularly easily in the released state, since the areas coming into contact with pharmaceuticals are particularly simple and readily accessible.

In a further preferred embodiment of the proposal made last, it is advantageous for the same reasons, if the second

Valve housing element is closed on the side facing away from the first valve housing element side of a third valve housing element formed an outlet opening for the pharmaceuticals, wherein the second and the third valve housing element are detachably connected to each other in particular via a screw connection.

A further improvement of the sterilizability as well as the possibility of being able to separately form and thus replace the component that is particularly critical with regard to possible wear, which forms the sealing seat on the valve housing, provides that the sealing seat in the valve housing is separated by a valve body separate from the second valve housing element the second and / or third valve housing element insertable, in particular cylindrical

trained and a through hole for the pharmaceuticals

comprising sealing element is formed.

A further preferred embodiment of the metering valve, which allows sterilization of the interior of the metering valve during operation or during a batch or product change, provides that the valve housing is at least indirectly connected to a storage element for the pharmaceuticals via a product inlet connection, and that the Product inlet port for sterilizing the valve housing is additionally connectable to a sterile air source. Further advantages, features and details of the invention will become apparent from the following description of preferred embodiments and from the drawing.

This shows in:

Fig. 1 is a perspective view of a metering valve according to the invention and

2 shows a longitudinal section through the metering valve according to FIG. 1.

The same elements or elements with the same function are provided in the figures with the same reference numerals.

The dosing valve 10 according to the invention shown in the figures is used for dispensing or dosing of pharmaceutical liquids in containers, not shown, in particular in the form of ampoules, vials or the like. The metering valve 10 has a multi-part valve housing 1 1, whose components are at least partially made of magnetizable and approved for pharmaceutical applications stainless steel materials. The valve housing 1 1 comprises a first valve housing element 12, in which a blind hole-shaped recess 13 is formed. In the axial direction with respect to a

Longitudinal axis 14 of the metering valve 10 connects to the first

Valve housing member 12 a releasably connected to the first valve housing member 12 second valve housing member 15 at.

The sleeve-shaped second valve housing element 15 has on its side facing away from the first valve housing element 12 side a blind hole-shaped receptacle 16 for receiving a sealing element 18. The axial movement of the sealing element 18 in the direction of the first valve housing element 12 in the receptacle 16 is by an axial stop surface 19 in the first

Valve housing element 12 limited. The sealing element 18 has in the

Longitudinal axis 14 on a through hole 21 for the pharmaceuticals and forms on the valve housing elements 12, 15 side facing a sealing seat 22 which cooperates with one end of a valve member designed as a valve member 25. The second valve housing element 15 is on the the side facing away from the first valve housing element 12 by a third valve housing element 28 having a through hole 26 closed.

The two valve housing elements 15, 28 are preferably by means of a in

Single threaded connection, not shown in the manner of a

Union nut connection releasably connected together. Furthermore, the through hole 26 is aligned in the third valve housing member 28 with the

Through hole 21 in the sealing element 18. In the through hole 26 is on the second valve housing member 15 side facing away from the third valve housing member 28, preferably via a threaded connection, a discharge nozzle element 30 can be used. The outlet connection element 30 is connected, for example, to a fluid hose or a needle, via which the pharmaceuticals can be dispensed into a container.

Between the valve member 25 and the second valve housing member 15 is formed within the second valve housing member 15, a product storage space 31 for the pharmaceuticals. Further, perpendicular to the longitudinal axis 14 in the product storage space 31, a product inlet pipe 32 connected to the second valve housing element 15 opens.

The product inlet nozzle 32 is connected as shown in FIG. 1 either with a product memory 35 for the pharmaceuticals, or with a sterile air source 36, wherein the connection between the

Product inlet nozzle 32 and the product memory 35 and the sterile air source 36 takes place for example via a switching valve 38.

The valve member 25 is subjected to a force in the direction of the sealing seat 22 by means of a spring element 40 designed as a compression spring. The valve member 25 projects with an area serving as anchor portion 41 in a reduced diameter portion 42 of the recess 13 of the first valve housing member 12 in. On the spring element 40 opposite side of the

Anchor portion 41, the first valve housing member 12 is preferably formed of solid material. The valve member 25 and the anchor portion 41 can be actuated by means of a magnetic coil 45. The magnet coil 45 is arranged within a block-shaped in the embodiment coil housing 50, which has a concentric with the longitudinal axis 14 arranged through hole 51, preferably with a constant diameter. In the through hole 51 acting as a receiving opening, the first valve housing portion 12 of the

Valve housing 1 1 inserted, wherein between the through hole 51 and the outer diameter of the first valve housing member 12 a

According to the representation of FIG. 1, the coil housing 50 moreover has a connection 52 for electrically contacting the magnetic coil 45, which is not shown in detail.

In order to spatially separate the coil housing 50 with the magnetic coil 45 therein from the valve housing 1 1, it is sufficient to pull the valve housing 1 1 from the through hole 51 of the coil housing 50. The individual parts of the valve housing 1 1 turn, in particular the three valve housing elements 12, 15, and 28, can be particularly easily separated from each other on the above-mentioned releasable connections and have in the disconnected state, especially if the sealing element 18 and the valve member 25 are removed, simple geometric shapes without undercuts, which are particularly easy to clean or sterilize. In addition, there is also the possibility with mounted metering valve 10, when energizing the

Magnetic coil 45, which causes a lifting of the valve member 25 from the sealing seat 22 on the sealing element 18, by connecting the metering valve 10 with the

Sterilluftquelle 26 a cleaning of the product-carrying areas of the

Make metering valve 10.

The dosing valve 10 described so far can be modified or modified in many ways, without departing from the spirit of the invention

departing.

Claims

claims

1 . Dosing valve (10) for pharmaceutical liquids, with a solenoid (45) operable, in a valve housing (1 1) arranged valve member (25), in particular in the form of a valve needle, which in de-energized magnetic coil (45) by means of a spring element (40) at least indirectly against a sealing seat (22) in the valve housing (1 1) is subjected to force, characterized in that the magnetic coil (45) in one of the valve housing (1 1) separate coil housing (50) is arranged, wherein the valve housing (1 1) is releasably connected to the coil housing (50).

Dosing valve according to claim 1,

characterized,

that the coil housing (50) has a receiving opening (51), the valve housing (1 1) is received at least partially.

3. metering valve according to claim 2,

characterized,

that the receiving opening (51) in the coil housing (50) as

Through hole is formed, and that the valve housing (1 1) in the installed state, the coil housing (50) with respect to a longitudinal axis (14) the receiving opening (51) projects axially on both sides.

4. metering valve according to claim 2 or 3,

characterized,

in that in the valve housing (1 1), in the region arranged in the receiving opening (51) of the coil housing (50), there is connected to the valve member (25) connected and cooperating with the magnetic coil (45)

Anchor portion (41) is arranged.

Dosing valve according to one of claims 1 to 4,

characterized,

that the valve housing (1 1) and the valve member (25) at least

partially made of magnetizable stainless steel.

Dosing valve according to one of claims 1 to 5,

characterized,

that the valve housing (1 1) in the receiving opening (51) of the

Spool housing (50) can be inserted and in the receiving opening (51) is preferably received by clamping.

Dosing valve according to one of claims 1 to 6,

characterized,

in that the valve housing (1 1) consists of at least two valve housing elements (12, 15), a first valve housing element (12) which is arranged in the receiving opening (51) of the bobbin housing (50), and a second valve housing element (15) which has a Product memory space (31) forms for the pharmaceuticals, wherein the two valve housing elements (12, 15) are releasably connected to each other.

Dosing valve according to claim 7,

characterized,

that the second valve housing element (15) on the first

Valve housing element (12) facing away from a one

Outlet opening (26) for the pharmaceuticals forming third

Valve housing element (28) is closed, wherein the second and the third valve housing element (15, 28) are releasably connected to one another, in particular via a screw connection.

Dosing valve according to claim 7 or 8,

characterized,

that the sealing seat (22) in the valve housing (1 1) by a separate from the second valve housing element (15), in the second and / or Valve housing element (15, 28) insertable, in particular cylindrically shaped and a through hole (21) for the pharmaceuticals exhibiting sealing element (18) is formed.

10. dosing valve according to one of claims 1 to 9,

characterized,

in that the valve housing (11) is at least indirectly connected to a storage element (35) for the pharmaceutical via a product inlet connection (32), and that the product inlet connection (32) for sterilizing the valve housing (11) can additionally be connected to a sterile air source (36) is.