MIXING APPARATUS AND SINGLE-USE APPARATUS FOR SAID MIXING APPARATUS
20170312712 · 2017-11-02
Inventors
Cpc classification
B01F2101/44
PERFORMING OPERATIONS; TRANSPORTING
B01F33/4531
PERFORMING OPERATIONS; TRANSPORTING
B01F35/5312
PERFORMING OPERATIONS; TRANSPORTING
B01F33/4532
PERFORMING OPERATIONS; TRANSPORTING
B01F35/513
PERFORMING OPERATIONS; TRANSPORTING
B01F33/452
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A mixing apparatus includes a mixing tank configured to receive substances, a rotor arranged in the mixing tank capable of driving a vane to rotate about an axial direction, a stator arranged outside the mixing tank and capable of driving the rotor to contactlessly magnetically rotate about the axial direction and capable of magnetically supporting the rotor with respect to the stator, and a security against tilting device that includes a bar extending in the axial direction and rotationally fixedly connected to the rotor, the security against tilting device having a limiting element fixed with respect to the mixing tank and cooperating with the bar, the security against tilting device being configured such that the bar is capable of rotating with respect to the limiting element and tilting of the rotor is limited by physical contact between the bar and the limiting element.
Claims
1. A mixing apparatus for mixing or stirring substances, comprising: a mixing tank configured to receive the substances to be mixed or to be stirred; a rotor arranged in the mixing tank by which at least one vane configured to mix or stir the substances is capable of being driven to rotate about an axial direction; a stator arranged outside the mixing tank and by which the rotor is capable of being driven to contactlessly magnetically rotate about the axial direction in the operating state and capable of being supported magnetically with respect to the stator and a security against tilting device for the rotor that comprises a bar extending in the axial direction and that is rotationally fixedly connected to the rotor, the security against tilting device having a limiting element fixed with respect to the mixing tank and cooperating with the bar, the security against tilting device being configured and arranged such that the bar is capable of rotating with respect to the limiting element and with tilting of the rotor being limited by physical contact between the bar and the limiting element.
2. The mixing apparatus in accordance with claim 1, wherein the stator is a bearing and drive stator configured to contactlessly magnetically drive the rotor in the operating state and is contactlessly magnetically support the rotor at least radially with respect to the stator.
3. The mixing apparatus in accordance with claim 2, wherein the rotor is configured to be passively magnetically stabilized with respect to the axial direction in the operating state.
4. The mixing apparatus in accordance with claim 1, wherein the security against tilting device is configured such that, when the rotor tilts, the bar comes into contact with the limiting element before the rotor comes into physical contact with a wall surrounding the rotor.
5. The mixing apparatus in accordance with claim 1, wherein the limiting element is inwardly disposed at one of the two axial limiting surfaces of the mixing tank.
6. The mixing apparatus in accordance with claim 1, wherein the limiting element is disposed opposite the rotor such that the bar extends substantially through the entire mixing tank.
7. The mixing apparatus in accordance with claim 1, wherein the bar is secured so as to prevent separation from the limiting element.
8. The mixing apparatus in accordance with claim 1, wherein the bar extends through the limiting element in the axial direction.
9. The mixing apparatus in accordance with claim 1, wherein the bar has, at an end remote from the rotor, a terminating element configured to be received by the limiting element.
10. The mixing apparatus in accordance with claim 8, wherein the terminating element can be is configured to be introduced into the limiting element via a snap-in connection.
11. The mixing apparatus in accordance with claim 8, wherein the terminating element is spherical or frustoconical.
12. The mixing apparatus in accordance with claim 8, wherein the limiting element comprises a pin extending in the axial direction and configured to be introduced into an end of the bar.
13. The mixing apparatus in accordance with claim 1, wherein the at least one vane is a plurality of vanes configured to mix or stir the substances, and the plurality of vanes are disposed on the bar.
14. The mixing apparatus in accordance with claim 1, the mixing tank, the rotor, the at least one vane, and the security against tilting device are a single-use apparatus, the mixing tank is being plastic and flexible, and the stator and a support container configured to receive the mixing tank are a reusable apparatus.
15. A single-use apparatus for a mixing apparatus including a reusable apparatus that is designed for multiple use, the resuable apparatus a stator and a support container configured to receive a plastic flexible mixing tank, the single-use apparatus is designed for single use and comprising: the plastic flexible mixing tank configured to receive substances to be mixed or stirred; a rotor disposed in the mixing tank and by which the at least one vane configured to mix or stir the substances is capable of being driven to rotate about an axial direction; and a security against tilting device for the rotor that comprises a bar extending in the axial direction and rotationally fixedly connected to the rotor; and the security against tilting device comprising a limiting element fixed with respect to the mixing tank and cooperating with the bar, the security against tilting device being configured and arranged such that the bar is capable of rotating with respect to the limiting element and a tilting of the rotor is limited by physical contact between the bar and the limiting element, the single-use apparatus being configured to cooperate with the reusable apparatus and being insertable into the support tank of the reusable apparatus, with the rotor being drivable about the axial direction by the stator of the reusable device contactlessly through a magnetic rotational field and being magnetically supportable with respect to the stator.
16. The mixing apparatus in accordance with claim 3, wherein the rotor is passively magnetically stabilized against tilting with respect to the axial direction.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The invention will be explained in more detail hereinafter with reference to the drawings.
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0039]
[0040] In the first embodiment shown in
[0041] The mixing tank 2 has two axial limiting surfaces, namely a base 22 (at the bottom in the representation in
[0042] A disk-shaped or ring-shaped rotor 3 is arranged in the mixing tank 2, at the base 22 thereof, and a plurality of vanes 6 can be driven by it to rotate about an axial direction A and mix or stir the substances in the mixing tank 2. A stator 4 having a plurality of coil cores 41 that carry the coils or windings 42 is disposed outside the mixing tank and the rotor 3 can be contactlessly magnetically driven thereby in the operating state. The stator 4 is preferably designed as a bearing and drive stator by which the rotor 3 can be contactlessly magnetically driven in the operating state and can be contactlessly magnetically supported with respect to the stator 4. The stator 4 and the rotor 3 thus form an electromagnetic rotary drive that is preferably designed in accordance with the principle of a bearingless motor.
[0043] In a bearingless motor, the rotor 3 is contactlessly magnetically drivable and is contactlessly magnetically supportable with respect to the stator 4. For this purpose, the stator 4 is designed as a bearing and drive stator by which the rotor 3 can be driven contactlessly magnetically about a desired axis of rotation in the operating statethat is it can be set into rotationand can be supported contactlessly magnetically with respect to the stator 4. That axis is called the desired axis of rotation about which the rotor 3 rotates in the operating state when the rotor 3 is in a centered and non-tilted position with respect to the stator 4. This desired axis of rotation defines the axial direction A, i.e. the axial direction A is the direction of the desired axis of rotation. The desired axis of rotation fixing the axial direction A typically coincides with the central axis of the stator 4. A direction perpendicular to the axial direction is called a radial direction.
[0044] The bearingless motor has in the meantime become sufficiently well-known to the skilled person so that a detailed description of its function is no longer necessary. The term bearingless motor means that the rotor 3 is supported completely magnetically, with no separate magnetic bearings being provided. The stator 4 is configured for this purpose as a bearing and drive stator; it is therefore both the stator of the electric drive and the stator of the magnetic support. The stator 4 in this respect comprises the windings 42 by which a magnetic rotational field can be generated which, on the one hand, exerts a torque on the rotor 3 which effects its rotation and which, on the other hand, exerts a shear force on the rotor 3 which can be set as desired so that its radial positionthat is its position in the radial plane perpendicular to the axial direction Acan be actively controlled or regulated. At least three degrees of freedom of the rotor 3 can thus be actively regulated. The rotor 3 is at least passively magnetically stabilized, that is cannot be controlled, by reluctance forces with respect to its axial deflection in the axial direction A. The rotor 3 can also likewise be stabilizeddepending on the embodimentpassively magnetically with respect to the remaining two degrees of freedom, namely tilts with respect to the radial plane perpendicular to the desired axis of rotation.
[0045] With a bearingless motor, unlike with classical magnetic bearings, the magnetic support and the drive of the motor is implemented via electromagnetic rotational fields whose sum, on the one hand, generates a drive torque on the rotor 3 as well as a transverse force that can be set as desired and with which the radial position of the rotor 3 can be regulated. These rotational fields can be generated either separatelythat is using different coilsor the rotational fields can be generated by superposition by calculation of the required currents and then with the aid of a single coil system.
[0046] To position the rotor 3 in the mixing tank 2, the mixing tank 2 has at its base 22 a substantially cylindrical bucket 21 that extends outwardly as a bulge with respect to the mixing tank 2 and is arranged at the center of the base 22. The cylindrical bucket 21 is preferably stable in shape and produced from a plastic. The rotor 3 is arranged in the bucket 21.
[0047] The stator 4 is arranged such that it completely surrounds the bucket 21 in the peripheral direction so that the rotor 3 is arranged centrally between the stator poles 43 formed by the coil cores 41.
[0048] The rotor 3 comprises a magnetically effective core 31 that interacts with the stator 4 via magnetic fields to magnetically drive and support the rotor 3. In the present embodiment, the magnetically active core 31 of the rotor 3 is an annular permanent magnet whose magnetization is indicated in
[0049] In the following the magnetic center plane of the magnetically effective core 31 of the rotor 3 is called the magnetic rotor plane C. It is that plane perpendicular to the axial direction A in which the rotor 3 or the magnetically effective core 31 of the rotor 3 is supported in the operating state when the rotor 3 is not tilted. As a rule, the magnetic rotor plane C is the geometrical center plane of the magnetically effective core 31 of the rotor 3 that is disposed perpendicular to the axial direction A. That plane in which the rotor 3 is supported in the operating state is also called the radial plane. The radial plane defines the x-y plane of a Cartesian coordinate system whose z axis extends in the axial direction A. If the rotor 3 is therefore not tilted, the radial plane coincides with the magnetic rotor plane C.
[0050] The bucket 21 has a depth in the axial direction that is somewhat larger than the extent of the magnetically effective core 31 of the rotor 3 in the axial direction A. The rotor 3 can thus be raised from the base of the bucket 21 by the magnetic forces on the activation of the electromagnetic rotary drive and can be brought into a centered position between the stator poles 43 where the rotor 3 can then rotate contactlessly with respect to the bucket 21.
[0051] The stator 4 is arranged in a substantially cylindrical separating can 5 that has a centrally arranged cut-out 51 that is likewise cylindrical at its upper side in accordance with the representation and that is dimensioned such that it can receive the bucket 21. In the assembled state, the bucket 21 of the mixing tank 2 is arranged coaxially with the separating can 5 or with the recess 51. The dimensions of the separating can 5 and of the bucket 21 are adapted to one another in this respect such that the separating can 5 tightly surrounds the bucket 21 in the assembled state and its jacket surface contacts the jacket surface of the bucket 21.
[0052] The separating can 5 is an integral component of a stator housing 52 or is fixedly connected to the stator housing 52 that receives the stator 4. The stator 4 in this embodiment is molded by a thermally conductive compound in the separating can 52 and is thus fixed in the separating can 52.
[0053] In the embodiment described here, the rotary drive formed by the stator 4 and the rotor 3 is designed as a so-called temple motor. What is characteristic in a design as a temple motor is that the stator 4 comprises a plurality of separate coil cores 41 of which each comprises a bar-shaped longitudinal limb that extends from a first end in the axial direction A up to a second end, with all the first endsthey are the lower ends in accordance with the representation in
[0054] It is a further feature of the temple motor that the windings 42 of the stator 4 are each arranged around the longitudinal limbs of the coil cores 41 and are thus arranged outside the magnetic rotor plane C; beneath the magnetic rotor plane C in accordance with the representation. The windings 42 are preferably arranged beneath the magnetically effective core 31. The windings 42 are therefore not arranged in the plane in which the rotor 3 is driven and supported in the operating state. Unlike other electromagnetic rotary drives in which the windings of the stator are arranged such that the coil axes each lie in the magnetic rotor plane, that is in the plane in which the rotor is driven and supported, in the temple motor, the windings 42 of the stator 2 are arranged such that the axes of the windings 42 stand perpendicular on the magnetic rotor plane C and are thus aligned in parallel with the axial direction A.
[0055] It is naturally understood that the invention is not restricted to such embodiments as temple motors. Numerous other designs of the stator 4 are also possible. It is only essential that the rotor 3 can be contactlessly magnetically be driven to rotate about the axial direction in the operating state.
[0056] In accordance with the invention, the mixing apparatus 1 has a security against tilting device 7 by which the tilt of the rotor 3 can be limited in the operating state. It is in this respect meant by a tilt of the rotor 3 that the magnetic center plane C of the rotor no longer stands exactly perpendicular on the axial direction A, but rather includes an angle different than 90 with it. This is equivalent to the fact that the magnetic rotor plane C and the radial plane in which the rotor 3 is supported are no longer congruent and are no longer parallel with one another, but rather include an angle different from zero with one another.
[0057] An axial tilt of the rotor 3 means that the non-tilted rotor 3 is displaced in the axial direction A without being tilted in so doing. In this case, the magnetic rotor plane C is parallel with the radial plane, but is no longer congruent therewith.
[0058] The security against tilting device 7 comprises a bar 8 that extends in the axial direction A and that is rotationally fixedly connected to the rotor 3 and comprises a limiting element 9 that is fixed with respect to the mixing tank 2 and that cooperates with the bar 8. In this respect, the security against tilting device 7 is designed and arranged such that the bar 8 can rotated with small clearance with respect to the limiting element 9 and a tilt of the rotor 3 is limited by a physical contact between the bar 8 and the limiting element 9.
[0059] In the first embodiment shown in
[0060] The rotor 3 is passively magnetically stabilized, i.e. not controllable, in the stator 4. This means that if a tilt of the rotor 3 occurs in the operating state, magnetic restoring forces are thereby invoked that effect a torque with respect to the axial direction A on the rotor 3 that moves the rotor 3 back into its non-tilted position. These magnetic restoring forces are typically reluctance forces that are generated by the tilt of the rotor 3. This passive magnetic stabilization of the rotor 3 against tilts should also not be influenced by the limiting element 9. The rotor 3 rotates contactlessly in the stator 4 in the operating state and the bar 8 also rotates contactlessly in the limiting element 9 with a tilt-free rotor 3. If a tilt of the rotor 3 occurs in operation, it is first compensated by the passive magnetic stabilization of the rotor 3 that moves the rotor 3 back into its non-tilted position without there being any physical contact between the bar 8 and the limiting element 9.
[0061] Only when the tilt of the rotor 3 becomes too great or too strong does a physical contact occur between the limiting element 9 and the bar 8 that then limits the maximum tilt of the rotor 3. If the rotor 3 is tilted to much in operation, the bar 8 comes into physical contact with the limiting element 9, whereby a further increase in the tilt of the rotor 3 is prevented.
[0062] It is essential in this respect that the bar 8 can rotate contactlessly in the limiting element 9 with a non-tilted rotor 3 and on tilts of the rotor 3 that can be reversed by its passive magnetic support. Only when the tilt of the rotor 3 could become too large does the physical contact between the bar 8 and the limiting element 9 prevent a further increase in the tilt of the rotor 3.
[0063] The security against tilting device 7 is thus not a full-fledged bearing for the rotor 3, but rather only a limit for the tilt of the rotor 3.
[0064] The clearance S between the bar 8 and the limiting element 9 is preferably dimensioned such that the bar 8 comes into contact with the limiting element 9 before the rotor 3 comes into physical contact with the wall of the bucket 21.
[0065] A further criterion for the determination of a suitable clearance S between the bar 8 and the limiting element 9 is that a physical contact between the rotor 3 and the wall surrounding it or the base of the bucket 21 is to be avoided. How much the rotor 3 can be tilted before such a contact with the bucket 21 comes about can be determined in a simple manner. The clearance S can then be selected such that a contact between the rotor 3 and the bucket 21 is reliably avoided.
[0066] The bar 8 is preferably also manufactured from plastic and can either be molded to the jacket 32 of the rotor 3 as an integral component oras the representation in
[0067] In the first embodiment shown in
[0068] Unlike the embodiment shown in
[0069]
[0070] The second embodiment shown in
[0071] The limiting element 9 is fixed opposite the center of the rotor 3 at the base 22 of the mixing tank 2 such that the limiting element 9 can receive the end of the bar 8.
[0072] The mixing tank 2 is arranged in a foot 10 that gives the mixing tank 2 a secure standing.
[0073] Further components of the mixing apparatus that can e.g. be provided in an embodiment as a bioreactor are now also shown with an exemplary character in
[0074]
[0075] The third embodiment essentially differs from the first two embodiments in that the bar 8 does not extend through the total mixing tank 2 with respect to the axial direction A, but rather ends within the mixing tank 2, that is considerably spaced apart from its top 23.
[0076] The limiting element 9 is here provided at and fixed to the base 22 of the mixing tank 2. For better understanding,
[0077] The limiting element 9 furthermore comprises a plurality of arms 92, four here, that start, equidistantly distributed, in each case at the radially outer margin of the ring 91 and extend from there first in the radial direction and then in the axial direction A up to the base 22 of the mixing tank 2 where they are each fixed. Depending on how long the bar 8 is, the arms 92 of the limiting element 9 can also be fixed to the top 22 of the mixing tank 2.
[0078] It is naturally also possible in such embodiments in which the bar 8 does not extend through the whole mixing tank 2 with respect to the axial direction A to design the limiting element 9 such that it receives an end of the bar 8 and is not fully penetrated by the bar 8.
[0079]
[0080] The fourth embodiment of the mixing apparatus 1 in accordance with the invention is specifically designed for applications with a single use. To ensure the purity or the sterility of those components of the mixing apparatus 1 which come into contact with the substances to be mixed or stirred, the fourth embodiment comprises a single-use apparatus which is designated as a whole by the reference numeral 20 and is configured for a single use and comprising a reusable apparatus which is designated as a whole by the reference numeral 60 and which is configured for permanent use, that is for multiple use. In this respect, the single-use apparatus 20 comprises those components which come into contact with the substances to be mixed during the mixing process. That is in particular the mixing tank 2, the rotor 3, all the vanes 6 and the security against tilting device 7.
[0081] In this respect those components or parts are meant by the term single-use apparatus and other compound words having the element single-use such as single-use part, single-use component, etc. which are configured for single use, that is which are used only one single time as intended and are then disposed of A new, previously unused single-use part then has to be used for a new application. In the design or configuring of the single-use apparatus 20, essential aspects are therefore that the single-use apparatus 20 can be manufactured as simply and economically as possible, causes few costs and can be manufactured from materials which are available as inexpensively as possible. Another important aspect is that the single-use apparatus 20 can be assembled in as simple a manner as possible with the reusable apparatus 60 to form the mixing apparatus 1. The single-use apparatus 20 should therefore be able to be replaced in a very simple manner without a high installation effort being required for this purpose. The single-use apparatus 20 should particularly preferably be able to be assembled with or separable from the reusable apparatus 60 without using tools.
[0082] It is also an important aspect that the single-use apparatus 20 can be disposed of as simply as possible after its use. Those materials are therefore preferred which bring about environmental pollution which is as low as possible, in particular also during their disposal.
[0083] In the design of the single-use apparatus 20, the mixing tank 2 is designed as a flexible mixing tank 2 that is manufactured from a plastic. The mixing tank 2 is preferably a flexible pouch, for example a plastic sack or a sack of a synthetic material, which can be folded together so that it takes up as little space as possible during storage. The mixing tank 2 in the fourth embodiment has a plurality of inlets or outlets 11 that, as described above, can be used, for example, for feeding and draining substances and gases or for the reception of probes or measurement sensors. In this respect, for example, hoses or hose-like continuations are provided at some of the inlets or outlets 11 in a manner known per se; they are manufactured from plastic and are welded to the mixing tank 2 such that substances can be fed or drained through these hoses. Other inlets or outlets 11 can also be designed as self-sealing passages in a manner known per se.
[0084] So-called sampling ports 111 can in particular be adhesively bonded or welded to the mixing tank 2. They are in this respect short hose-like plastic structures through which, for example, samples can be removed from the mixing tank 2. Each sampling port 111 is in this respect typically secured in a manner known per se by a clamp at its end projecting from the mixing tank 2 such that no unwanted substances can move through these sampling ports 111 into the interior of the mixing tank 2.
[0085] The gas drainage line 24 having the gas filter can also be provided at the mixing tank 2, with the gas filter also being configured for single use.
[0086] The cylindrical bucket 21 for the reception of the rotor 3 is preferably of stable shape and is produced from a plastic. However, it can also, for example, be designed in the form of a flexible hose or pouch composed of a plastic film. The security against tilting device 7 as well as all the vanes 6 are designed as stable in shape and are preferably produced from a plastic. The shape-stable parts that are fixed to the mixing tank 2, that is in particular the bucket 21 and the limiting element 9, can be connected to the flexible mixing tank 2 in a fluid-tight manner by adhesive bonding or welding. It is naturally also possible in the design for single use to manufacture the security against tilting device 7 fully or partly from a metal material. The limiting element 9 can thus, for example, be a metal sleeve, e.g. of aluminum. The bar 8 can also comprise a metal material in the design for single use to ensure a greater stability, for example. Since both the limiting element 9 and the bar 8 are components of a very simple design, in particular with respect to their geometry, they can also be manufactured very inexpensively.
[0087] The reusable apparatus 60 comprises a stable-shape support tank 61 for receiving the mixing tank 2 and comprises the stator 4. The support tank 61 has a plurality of feet 62 on which the support tank 61 stands at its base. At least one opening 12 is furthermore disposed in the base so that substances can be drained out of the mixing tank 2 or can be introduced into it. The substantially cylindrically designed support tank 61 is open at its upper side or optionallyas shown in
[0088] The substantially cylindrically designed separating can 5 and the stator housing 52 having the sensor 4 contained therein are centrally arranged at the base of the support tank 61. The separating can 5 is integrated in the stator housing 52 or is fixed thereto. The separating can 5 extends downwardly in accordance with the illustration in the direction of its cylinder axis such that it can coaxially receive the bucket 21 in the assembled state. The dimensions of the separating can 5 and of the bucket 21 are adapted to one another in this respect such that the recess 51 of the separating can 5 tightly surrounds the bucket 21 in the assembled state and its jacket surface contacts the jacket surface of the bucket 21.
[0089] The stator housing 52 having the separating can 5 is preferably fixed to the base of the support tank 61 by screws.
[0090] The stator 4 is arranged in the separating can 52 and is designed as a bearing and drive stator by which the rotor 3, in the operating state, can be driven contactlessly and can be magnetically contactlessly supported with respect to the stator 3.
[0091] The assembly of the single-use apparatus 20 and of the reusable apparatus 60 to form the mixing apparatus 1 is extremely simple and can be carried out fast and in particular without tools. For this purpose, the mixing tank 2 that is typically folded together for storage or is wound around the bar 8 and that has the rotor 3 located thereat, the limiting element 9 and the vanes 6, is removed from its packaging and is placed into the support tank 61 and the bucket 21 having the rotor 3 is inserted into the separating can 5. If the bar 8 is not yet connected to the rotor 3, the bar 8 is inserted into the rotor 3 and is then brought into active connection with the limiting element 9. The cover 63 is optionally placed on to close the support tank 61. The mixing apparatus 1 is then already ready for use. After use, the mixing tank 2 having the bucket 21, the bar 8, the limiting element 9 and the rotor 3 is simply pulled out of the support tank 61. The bucket 21 in this respect simply releases from the separating can 5. This particularly simple and problem-free connection or separation of the single-use apparatus 20 to or from the reusable apparatus 60 thus takes account of a substantial aspect of the embodiment for the single use.
[0092] It can in particular be advantageous in the design of the mixing tank 2 as a flexible mixing tank 2 if the limiting element 9 comprises a fixing 90 by which the limiting element can be fixed with respect to the reusable apparatus 60. In the embodiment shown in
[0093] The rotor 3 canas shown in
[0094] In such embodiments in which the rotor 3 is designed without permanent magnets, it is particularly preferred if one or more permanent magnets are disposed in the stator 4 to generate a permanent magnetic premagnetization flux such that the total magnetic flux required for the drive and for the support does not have to be generated as an electromagnetic flux.
[0095] Since the components of the single-use apparatus 20, that is the mixing tank 2, the rotor 3, all the vanes 6 and the security against tilting device 7, are configured for single use, the parts produced from plastic should be manufactured from a commercial plastic that is as inexpensive as possible. A further substantial aspect is that the single-use apparatus 20 or its components have to be able to be sterilized for certain fields of application. In this respect, it is particularly advantageous if the single-use apparatus 20 can be gamma sterilized. In this type of sterilization, the element to be sterilized is acted on by gamma radiation. The advantage of the gamma sterilization, for example in comparison with steam sterilization, in particular lies in the fact that the sterilization can also take place through the packaging. It is common practice, especially with single-use parts, that the parts are brought into the packaging after their manufacture and are then stored for some time before they are delivered to customers. In such cases, the sterilization takes place through the packaging, which is not possible with a steam sterilization or another method.
[0096] The single-use apparatus 20, on the other hand, offers the great advantage due to its only single usability that no value has to be placed on a good cleaning capability of the single-use apparatus 20 in the construction because the single-use apparatus does not have to be cleaned when used as intended. It is furthermore not necessary as a rule that the single-use apparatus 20 or its components have to be sterilized more than once. This is in particular a great advantage with the gamma sterilization because the application of gamma radiation to plastics can result in degradations so that a multiple gamma sterilization can make the plastic unusable.
[0097] Since as a rule a sterilization at high temperatures and/or at a high (steam) pressure can be dispensed with for single-use parts, less expensive plastics can be used, for example those which cannot withstand high temperatures or which cannot be exposed to high temperature values and high pressure values a multiple of times.
[0098] When taking all these aspects into account, it is therefore preferred to use those plastics for the manufacture of the single-use apparatus 20 which can be gamma sterilized at least once. The materials should in this respect be gamma-stable for a dose of at least 40 kGy to allow a single-time gamma sterilization. In addition, no toxic substances should arise in the gamma sterilization. It is additionally preferred for all materials which come into contact with the substances to be mixed to satisfy USP Class VI standards.
[0099] The following plastics are, for example, preferred for the manufacture of the flexible mixing tank 2: Polyethylenes (PE), low density polyethylenes (LDPE), ultra low density polyethylenes (ULDPE), ethylene vinyl acetates (EVA), polyethylene terephthalates (PET), polyvinylchloride (PVC), polypropylenes (PP), polyurethanes (PU), silicones.
[0100] The following plastics are, for example, preferred for the manufacture of the bucket 21, of the security against tilting device 7, of the vanes 6 and of the parts of the rotor 3 comprising plastic, that is e.g. the jacket 32. Polyethylenes (PE), polypropylenes (PP), low density polyethylenes (LDPE), ultra low density polyethylenes (ULDPE), ethylene vinyl acetates (EVA), polyethylene terephthalates (PET), polyvinylchloride (PVC), polyvinylidene fluorides (PVDF), acrylonitrile butadiene styrenes (ABS), polyacrylics, polycarbonates (PC).
[0101] These named plastics are inter alia also suitable for the manufacture of a shape-stable mixing tank 2 that is designed for multiple use.
[0102] Less suitable materials or even unsuitable materials for the manufacture of the plastic parts of the single-use apparatus 20 are, for example, the materials known under the trade name Teflon polytetrafluroethylenes (PTFE) and perfluooralkoxy polymers (PFA). There is namely the risk with these materials on gamma sterilization that hazardous gases arise such as fluorine which can then form toxic or harmful compounds such as hydrofluoric acid (HF).
[0103] If the mixing tank 2 is designed for multiple use, it can naturally also be manufactured from PTFE or PFA or also from a metal, for example from stainless steel or also from glass.
[0104] It is also preferred if the components comprising plastic can be manufactured by an injection molding process because this is a particularly inexpensive kind of manufacture.
[0105] Different variants for the design of the limiting element 9 that are suitable for all the above-described embodiments will be explained in the following by way of example with reference to
[0106] In the variants shown in
[0107] The variant of the limiting element 9 shown in
[0108] The variants for the limiting element 9 shown in
[0109] In the variant shown in
[0110] The variant shown in
[0111] The limiting element 9 that is preferably of stable shape canas shown in
[0112] The variants shown in