Method for transferring objects from a lock into the working chamber of a containment under aseptic conditions

Abstract

The present invention relates to a method for transferring objects (4) under aseptic conditions from a lock (3) into the process chamber (21) of a containment (2), which process chamber is surrounded by a housing (20), and which containment, together with the lock (3), forms a transfer unit (1) interconnected in a pressure-tight manner. A housing (30) of the lock (3) surrounds a lock chamber (31) having the lock volume (Vs). The lock chamber (31) has an inlet gate (37) which can be closed in a pressure-tight manner and which, in the open state, allows access (33) from the outer setup area (A) for introducing objects (4) into the lock chamber (31). Furthermore, the lock (3) has an outlet (38) which is intended for the transfer of the objects (4) from the lock chamber (31) into the process chamber (21). In addition, the lock (3) has an inlet (34) for introduction of decontamination agent.

Description

[0001] Method for transferring objects from an airlock into the working chamber of a containment under aseptic conditions

[0002] Application area of ​​the invention

[0003] The present invention relates to a method for transferring objects under aseptic conditions from a lock into the process chamber of a containment surrounded by a housing, which forms a pressure-tight transfer unit connected to the lock.

[0004] State of the art

[0005] The prior art known for the above-defined field of application is disclosed in the patent specifications according to EP 3 444 193 A1 , US 10,744,659 B2 and CN 219 638 704 U.

[0006] Object of the invention

[0007] The object of the present invention is to propose a more efficient method for transferring objects under aseptic conditions from an airlock into the process chamber of a containment enclosed by a housing, which forms a pressure-tight transfer unit connected to the airlock. The aim is to transfer the objects in the shortest possible time and to allow the transfer unit to be designed flexibly with minimal technical effort to meet varying requirements.

[0008] Overview of the invention

[0009] The inventive method for transferring objects under aseptic conditions from an airlock into the process chamber of a containment surrounded by a housing, which forms a pressure-tight transfer unit connected to the airlock, is based on the fact that:

[0010] - a housing of the lock surrounds a lock chamber with the lock volume;

[0011] - the lock chamber has: - a pressure-tight lockable entrance gate, which in the open state allows access from the outer installation room for bringing objects into the lock chamber;

[0012] - an exit intended for transferring objects from the lock chamber to the process chamber; and

[0013] - an inlet for introducing decontamination agents;

[0014] - the housing has an access to the process chamber;

[0015] - the exit from the lock chamber leads into the entrance to the process chamber;

[0016] - a lockable transfer door is provided between the exit from the lock chamber and the entrance to the trial chamber; and

[0017] - a single object includes:

[0018] - a container with an aseptic interior and an opening that is closed with a fastener; and

[0019] - Material stored inside, which is to be treated in the process chamber after the closure is opened.

[0020] The following process steps are characteristic:

[0021] - Determining the dimensions and shape of the lock chamber adequate to the external object volume of one or more objects with the aim of minimizing the free lock volume remaining due to the one or more objects lying in the lock volume;

[0022] - Introducing one or more objects into the selected lock chamber through the open entrance gate with the transfer door closed;

[0023] - Introducing decontamination agents via the inlet to the lock chamber with the entrance gate closed;

[0024] - optional rinsing of the lock chamber and drainage of rinsing agent from the lock chamber via an outlet after successful decontamination; and

[0025] - Transferring one or more externally decontaminated objects through the open transfer door from the airlock chamber into the process chamber. Specific embodiments of the invention are defined below:

[0026] Due to the small remaining free airlock volume, the decontamination phase can be kept short, thus minimizing the diffusion of decontamination agent into the interior of the object and allowing the object to be processed quickly within the containment.

[0027] The connection between the lock and the containment is made by means of flange arrangements on both sides, which are preferably designed to be pressure-tight.

[0028] The decontamination agent in the airlock chamber is atomized, e.g. by means of a two-fluid nozzle or by ultrasound, and is preferably liquid H2O2.

[0029] The optional flushing of the lock chamber is carried out by alternating flow in changing flow direction from the gas volumes between the process chamber and the lock chamber.

[0030] The transfer door is located at the exit from the airlock or at the entrance to the containment.

[0031] The flange arrangements present on the lock and the containment are designed as an interface, thus enabling the docking of differently dimensioned locks of different shapes to the containment.

[0032] The transfer of one or more externally decontaminated objects from the lock chamber to the process chamber takes place after partial or complete rinsing of the lock chamber.

[0033] Before loading the lock, the lock chamber and the process chamber as well as the sealing surfaces on the transfer door are decontaminated with the entrance gate closed and the transfer door open.

[0034] The lock has a connection for attaching a media block, which is connected to a process technology that may be part of the containment or the lock, or positioned independently.

[0035] The media block has lines for compressed air and / or decontamination agents, and / or sensors for temperature, humidity, pressure, H2O2 concentration and process and exhaust air.

[0036] The optional rinsing is carried out using compressed air and / or process air, which may be heated above the ambient temperature in the installation room.

[0037] The connection between the port at the lock and the media block is mechanically detachable, non-detachable, or pneumatically coupled.

[0038] After one or more objects have been introduced into the lock chamber, the remaining free lock volume, depending on its selected dimensions, is between 10% and 80%, preferably between 20% and 60%, and in particular between 30% and 50%.

[0039] The adaptation of the dimensioning of the lock volume to the single or multiple objects to be introduced, with the aim of minimizing the remaining free lock volume, is achieved to between 10% and 80%, preferably between 20% and 60%, and in particular between 30% and 50% by narrowing the displacement of walls on the lock chamber and / or by introducing a volume-displacing filler body.

[0040] The object has the form of a container with its outer object volume and includes:

[0041] - a container with an aseptic interior and an opening that is closed with a closure, preferably in the form of a cover; and

[0042] - Material stored inside in the form of vials or medical syringes, which are to be treated in the process chamber after the closure is opened, e.g. to be filled with pharmaceutical substances.

[0043] Alternatively, the object has the shape of a bottle, e.g. a cell culture bottle, or a bag - e.g. containing agar plates - or an ampoule, which forms and encompasses an outer object volume:

[0044] - an aseptic interior space and an existing opening that is closed with a closure or is yet to be created; and

[0045] - material stored inside, which is to be treated in the process chamber after the closure is opened; or

[0046] - the interior space to be filled, e.g. with pharmaceutical substances.

[0047] The flushing of the lock chamber is carried out with the transfer door open by at least one and at least partial entry of the object from the process chamber of the containment into the lock chamber.

[0048] To accelerate the rinsing of the lock chamber, a vacuum pump that can be activated is connected to it.

[0049] During accelerated flushing of the lock chamber:

[0050] - First, an outlet connected to the lock chamber is opened, leading to a gas holder; and then

[0051] - the vacuum pump connected to the gas cylinder is activated; or

[0052] - First, the vacuum pump connected to the gas cylinder is activated; and then

[0053] - an outlet connected to the lock chamber is opened, leading to a gas holder.

[0054] Alternatively, for accelerated flushing of the lock chamber:

[0055] - first, the outlet connected to the lock chamber, which leads to a gas holder, is opened; and then

[0056] - the vacuum pump connected to the gas cylinder is activated; and

[0057] - then, to equalize the pressure between the process chamber and the lock chamber, the seal on the transfer door is released; or - the vacuum pump connected to the gas cylinder is activated first; and then

[0058] - the outlet connected to the lock chamber, which leads to a gas container, is opened; and - then the seal on the transfer door is released to equalize the pressure between the process chamber and the lock chamber.

[0059] The release of the seal on the transfer door for pressure equalization between the process chamber and the lock chamber is achieved by deactivating a pneumatic seal.

[0060] Brief description of the attached drawings

[0061] They show:

[0062] Figure 1 A - a transfer unit with a containment lock in front of it and the object to be processed approaching it, in schematic representation;

[0063] Figure 1B - the object from Figure 1A in the form of a package;

[0064] Figure 1C - the object according to Figure 1B, in exploded view;

[0065] Figure 2A - a transfer unit consisting of the containment and a first-form lock that can be docked to it,'

[0066] Figure 2B - a transfer unit consisting of the containment and a second-form lock that can be docked to it,'

[0067] Figure 2C - a transfer unit consisting of the containment and a third-form lock that can be docked to it,

[0068] Figure 3A - the transfer unit according to Figure 2A with dimensioned lock;

[0069] Figure 3B - a transfer unit consisting of the containment and a fourth-shape lock that can be docked to it;

[0070] Figure 3C - a transfer unit consisting of the containment and a fifth-shape lock that can be docked to it;

[0071] Figure 4 - the process flow carried out using a transfer unit for

[0072] Processing of an object, represented as a flowchart; Figures 5A to 5G: the process flow for processing an object using a transfer unit, in step sequence with schematic diagrams;

[0073] Figure 5A - Start: with step 1

[0074] Figure 5B - Step 2

[0075] Figure 50 - Step 3

[0076] Figure 5D - Step 4

[0077] Figure 5E - Step 5

[0078] Figure 5F - Step 6

[0079] Figure 5G - End: with step 7

[0080] Figures 6A to 6F: the process sequence for processing an object using a transfer unit, including movements of the object and the position of the entrance gate at the lock and the transfer door at the transition from the lock to the containment, in step-by-step sequence with schematic diagrams;

[0081] Figure 6A - Start: with step 1

[0082] Figure 6B - Step 2

[0083] Figure 6C - Step 3

[0084] Figure 6D - Step 4

[0085] Figure 6E - Step 5

[0086] Figure 6F - End: with step 6

[0087] Figures 7A and 7B: the assembly of the lock and containment, in schematic diagrams;

[0088] Figure 7A - the approach of the lock to the containment;

[0089] Figure 7B - the lock is detachably docked to the containment;

[0090] Figures 8A and 8B: the assembly of the lock and containment, equipped with a media block, in schematic diagrams;

[0091] Figure 8A - the approach of the lock to the containment, media block and connection still separate;

[0092] Figure 8B - the airlock is detachably docked to the containment, media block and connection are linked; Figures 9A to 9G: the process sequence for processing an object using a transfer unit, including movements of the object, position of the entrance gate at the airlock and the transfer door at the transition from the airlock to the containment, decontamination and rinsing process, in step-by-step sequence with schematic diagrams;

[0093] Figure 9A - Start: with step 1

[0094] Figure 9B - Step 2

[0095] Figure 9C - Step 3

[0096] Figure 9D - Step 4

[0097] Figure 9E - Step 5

[0098] Figure 9F - Step 6; and

[0099] Figure 9G - End: with step 7

[0100] Figures 10A to 10H: the process sequence for processing an object using a transfer unit, including movements of the object, position of the entrance gate at the airlock and the transfer door at the transition from the airlock to the containment, with decontamination and rinsing process, and additional decontamination of the transfer door, in step sequence with schematic diagrams;

[0101] Figure 10A - Start: with step 1

[0102] Figure 10B - Step 2

[0103] Figure 10C - Step 3

[0104] Figure 10D - Step 4

[0105] Figure 10E - Step 5

[0106] Figure 10F - Step 6; and

[0107] Figure 10G - End: with step 7

[0108] Example of implementation

[0109] With reference to the accompanying drawings, the following is a detailed description of the inventive method for transferring objects under aseptic conditions from a lock into the process chamber of a containment surrounded by a housing, which forms a pressure-tight transfer unit connected to the lock.

[0110] The following rule applies to the entire subsequent description. If a figure contains reference numerals for the purpose of graphical clarity, and it is clearly recognizable from the drawing that these are "recurring" components, but this is not explained in the immediately associated descriptive text, then, in the interest of brevity, reference is made to their explanation in preceding figure descriptions.

[0111] Figure 1A

[0112] The individual transfer unit 1 consists of the containment 2 and the attached airlock 3. At least one object 4 is provided for insertion into the airlock 3 and is initially positioned in front of the closed entrance door of the airlock 3. In production mode, a large number of objects 4 are available for further processing. The individual object 4 is trough-shaped and has an object volume Vo. A unidirectional displacement flow LF is supplied to the object 4 from above. The airlock 3 is surrounded by the housing 30, with the enclosed airlock chamber 31 having an airlock volume Vs. An outlet 35 in the form of an adjustable valve is mounted at the top and bottom of the housing 30. Furthermore, an inlet 34 is installed at the top of the housing 30 to introduce decontamination agents during the relevant process phase.Lock 3 also includes the entrance gate 37 built into housing 30, which faces freely towards the installation room A, in which the entire structure is located.

[0113] At the transition from airlock 3 to containment 2, which is surrounded by housing 20 and encloses process chamber 21, there is outlet 38 on the side of airlock 3. Simultaneously, the access 28 leading into containment 2 is located. The transfer door 5 is situated in outlet 38 and access 28. Two supply air filters 23 are installed above containment 2, through which a uniform displacement flow LF is introduced into process chamber 21. An outlet 25 in the form of an adjustable valve is installed at the bottom of housing 20 of containment 2. Figures 1B and 1C

[0114] A single object 4 comprises:

[0115] - A container 40 with an aseptic interior 41 and an opening 42 at the top, which is closed by a closure 46.

[0116] - A nest 43 stored in the interior 41, in whose trough-shaped receiving contours the materials 44 are placed, which are to be treated in the process chamber 21 of the containment 2 after opening the closure 46.

[0117] - Optionally, an insert 45 is placed between the closure 46 and the nest 43, over the materials 44.

[0118] - In its delivered state, the entire object 4 is mostly surrounded by a closed, bag-shaped covering that keeps the inner volume of the covering sterile.

[0119] The container 40 is, for example, a tub-shaped container. The materials 44 are, in particular, vials, ampoules, or syringes. At least surface areas of the closure 46 and the optional covering preferably consist of a semi-permeable non-woven fabric, such as Tyvek. The closure 46 is typically sealed on the container rim 49 surrounding the opening 42 of the container 40, thus preserving the interior 41 of the container 40 in a sterile state.

[0120] Figures 2A to 2C

[0121] This sequence of figures illustrates a transfer unit 1 consisting of the containment 2 and a dockable airlock 3 in three different configurations, depending on the application requirements and the shape of the containers 40. The containment 2 has the process chamber 21, the access 28, and the flange assembly 29 installed therein. On the respective airlock 3, facing the access 28 and the flange assembly 29, are the outlet 38 and the flange assembly 39. At the other end, the airlocks 3 have the respective inlet gate 37. Figures 3A to 3C

[0122] In the three different configurations of lock 3, lock 3 is dimensioned according to Figure 2A with length I, width b, and height h. Figures 3B and 3C each show a transfer unit 1, consisting of the containment 2 and a lock 3 in its fourth and fifth configurations that can be docked to it. Reference is made to the preceding Figures 2A-2C regarding the existing components.

[0123] Figure 4

[0124] The flowchart shown is intended to illustrate and describe the process flow carried out by means of transfer unit 1 for the processing of an object 4.

[0125] So: This stands for the start phase, i.e., the four objects to be processed are defined.

[0126] Si_: Depending on the shape of the objects 4 to be processed and the batch size - either only one object 4 or several of them - the shape of the lock 3 that can be docked to the containment 2 is selected or, if the lock chamber 31 and lock volume Vs are divisible, adjusted accordingly.

[0127] S2: The object(s) 4 to be processed in a batch are loaded into the airlock 3 through the open entrance gate 37, possibly with the bag-shaped covering around the object 4.

[0128] S3: With the entrance gate 37 closed, the decontamination phase of entrance gate 37 is carried out using a suitable method by spraying, fogging or vaporizing a decontamination agent, e.g. H2O2, or by irradiation.

[0129] S4: Access 28 to Containment 2 is opened.

[0130] S5: The pre-treated object 4, ready for transfer, is moved into containment 2. The rinsing phase may be omitted. S§: Any remaining decontamination agent on object 4 is rinsed off in process chamber 21 of containment 2.

[0131] S7: Further processing of the objects 4 in the process chamber 21 of the containment 2 can take place, usually by opening the closure 46 and removing the materials 44 for their next treatment steps.

[0132] Figures 5A to 5G

[0133] This sequence of figures illustrates the process flow for processing an object 4 using a transfer unit 1, with schematic diagrams showing the sequence of steps.

[0134] Figure 5A - Start, Step 1

[0135] Containment 2, the not yet docked airlock 3, and a still freestanding object 4 are all ready in assembly room A. Transfer door 5 on Containment 2, as well as entrance gate 37 and exit 38 of airlock 3, are closed. The shape and size of airlock 3 were determined according to the upcoming task.

[0136] Figure 5B - Step 2

[0137] Containment 2 and Lock 3 are docked together, the intervening transfer door 5 is closed. Entrance gate 37 is open and object 4 is being moved into lock chamber 31.

[0138] Figure 5C - Step 3

[0139] Entrance gate 37 is closed and the decontamination phase is being carried out. Due to the presence of object 4 in lock chamber 31, only the free lock volume Vf remains of the original lock volume Vs.

[0140] Figure 5D - Step 4

[0141] Transfer door 5 between Containment 2 and Airlock 3 is opened. Figure 5E - Step 5

[0142] Object 4 is transferred through transfer door 5 from the airlock clamp 31 into the process chamber 21 of containment 2.

[0143] Fiqur 5F - Step 6

[0144] Transfer door 5 is closed. Degassing of the lock clamp 31 takes place via inlet 34 at airlock 3.

[0145] Figure 5G - End, Step 7

[0146] In process chamber 21 of containment 2, the further processing of object 4 or the batch of objects 4 from a process cycle takes place.

[0147] Figures 6A to 6F

[0148] Based on this sequence of figures, the process flow for processing an object 4, carried out by means of a transfer unit 1, with movements of the object 4 and position of entrance gate 37 at the lock 3 and transfer door 5 at the transition from the lock 3 to the containment 2, is described in the step sequence.

[0149] Figure 6A - Start. Step 1

[0150] Entrance gate 37 at lock 3 and transfer door 5 are open. Object 4 is ready, everything is in staging room A.

[0151] Figure 6B - Step..?

[0152] Entrance gate 37 at airlock 3 is closed. Transfer door 5 remains open. To decontaminate the seals on transfer door 5, a combined decontamination phase is carried out, in which the entire interior of process chamber 21 and airlock chamber 31 is decontaminated. The same applies to the subsequent rinsing phase.

[0153] Figure 6C - Step 3

[0154] With entrance gate 37 and transfer door 5 in their unchanged positions, a flushing phase takes place. Fisur öD - Step 4

[0155] Transfer door 5 is closed and then entrance gate 37 is opened to load object 4 into lock chamber 31.

[0156] Figure 6E - Step 5

[0157] Object 4 is located in lock chamber 31. Now, entrance gate 37 is closed, and a decontamination phase is carried out for lock chamber 31 and object 4 within it, e.g., by introducing the decontamination agent via inlet 34. Thus, due to the presence of object 4 in lock chamber 31, only the free lock volume Vf remains of the original lock volume Vs.

[0158] Figure 6F - End of Step 6

[0159] Transfer door 5 is opened to transfer the externally decontaminated object 4 from lock chamber 31 to process chamber 21 of containment 2 for further processing.

[0160] Figures 7A and 7B

[0161] This pair of figures shows the assembly of lock 3 and containment 2 in schematic diagrams: Lock 3 approaching containment 2 (Figure 7A) and lock 3 detachably docked to containment 2 (Figure 7B). Here, the inlet 29 on containment 2 and the outlet 38 of lock 3 align, and the flange assemblies 29 and 39 on both sides are connected.

[0162] Figures 8A and 8B

[0163] This pair of figures shows the assembly of Lock 3 and Containment 2, equipped with a media block 6, in schematic diagrams: Lock 3 approaching Containment 2, media block 6 and connection 36 on Lock Chamber 31 still separate (Figure 8A), and Lock 3 detachably docked to Containment 2, media block 6 and connection 36 connected to each other (Figure 8B). - 15 -

[0164] For example, a process technology 22 is provided above the process chamber 21. The following lead to this process chamber 21: an exhaust air line 60, a compressed air line 61, a compressed air line 62, an FhC^ line 63, a

[0165] 5. Temperature sensor 64, a humidity sensor 65, a pressure sensor 66, an H2O2 sensor 67 with percentage display, and a pressure relief line 68. All are connected to a media block 6. Filter 600 and valve 601 are installed along the exhaust air line 60. Filter 610 and valve 611 are installed along the compressed air line 61. The pressure relief line 68 contains the

[0166] 10 Valve 681. The ends of compressed air line 62 and H2O2 line 63 lead to a two-fluid nozzle 69. In the operational state, containment 2 and lock 3 with their flange arrangements 29, 39 are detachably docked to each other and the media block 6 is connected to the port 36.

[0167] 15 figures 9A to 9G

[0168] This sequence of figures illustrates the process flow for processing an object 4, carried out by means of a transfer unit 1, including movements of the object 4, the position of entrance gate 37 at the airlock 3 and transfer door 5 at the transition from the airlock 3 to the containment 2, now with decontamination and

[0169] 20. Rinsing process, described in the step sequence.

[0170] Fiflur.9A - Start, Step 1

[0171] Equivalent as described in Figure 6A.

[0172] 25 Fiflur 9B - Step 2

[0173] Equivalent as described in Figure 6B.

[0174] Figure 9C..- Step 3

[0175] Equivalent as described in Figure 6C.

[0176] 30

[0177] Figure 9D - Step 4

[0178] Equivalent as described in Figure 6D. - 16 -

[0179] Figure 9E - Step 5

[0180] Equivalent as described in Figure 6E.

[0181] Figure 9.F. - Step 6

[0182] 5. Transfer door 5 is opened to transfer the externally decontaminated object 4 from airlock chamber 31 to process chamber 21 of containment 2 for further processing. During this phase, a rinsing process can take place, e.g., by moving object 4 back and forth, similar to an alternating pump piston, or by externally supplied and subsequently

[0183] 10 externally routed purge air.

[0184] Figure 9G - End, Step 8

[0185] In this alternative, the externally decontaminated object 4 is located in process chamber 21 and transfer door 5 is closed. Access 33 into the

[0186] 15 Lock chamber 31 is made permeable to fresh air Lf by opening the seal 32 at the entrance gate 37. By connecting a vacuum Lv to the lock chamber 31, a purging phase is initiated; the airflow occurs through the flow passage aamm at the entrance gate 37. A subsequent process cycle according to Figure 9D can begin.

[0187] 20

[0188] Figures 10A to 10G

[0189] Based on this sequence of figures, the process flow for processing an object 4, carried out by means of a transfer unit 1, is shown, including movements of the object 4, the position of the entrance gate 37 at the sluice 3, and the transfer door 5.

[0190] 25 at the transition from the airlock 3 to the containment 2, with decontamination and rinsing process, and additional decontamination of the transfer door 5, as described in the sequence of steps.

[0191] Figure I.OA - Start Step 1

[0192] 30. Containment 2 and the attached airlock 3, as well as a freestanding object 4, are all available in installation room A. The shape and size of the airlock 3 were again determined according to the task at hand. In modification to the previous setup of transfer unit 1, the adjustable transfer door 5 is located between the process chamber 21 of containment 2 and the airlock chamber 31. This door is sealed by means of a preferably pneumatically actuated seal 32, so that when the transfer door 5 is open, the inlet 28 and the outlet 38 are open. The inlet 33 to the airlock chamber 31 can be closed by the entrance gate 37, preferably by means of a pneumatically actuated seal 32. A pneumatic line 70 extends from the lock chamber 31 to a gas container 7, wherein an outlet valve 35 is installed in the line 70 and a vacuum pump 8 is connected to the gas container 7.

[0193] Fiflur .QB. -.Step 2

[0194] The entrance gate 37 at the airlock 3 remains closed, and the pneumatic seal 32, for example, is activated. The transfer door 5 is opened, and the pneumatic seal 32, for example, is deactivated. To also decontaminate the seals 32 at the transfer door 5, a combined decontamination phase is carried out, which simultaneously acts into the process chamber 21, for example, by introducing the decontamination agent H₂O₂ into the airlock chamber 31 via the inlet 34. Advantageously, decontamination devices, such as several two-fluid nozzles 69 (equivalent to Figure 8A), can be installed on the containment 2 to introduce H₂O₂. Due to the closed outlet 35, acting as a valve, no gas volume can be drawn into the gas holder 7 by the vacuum pump 8 via the line 70, which would otherwise flow into the airlock chamber 31 via the inlet 34 as decontamination agent. Overpressure is created in process chamber 21 and lock chamber 31.

[0195] Fiflur C - Step 3

[0196] When outlet 35 opens, gas volume is drawn from process chamber 21 and airlock chamber 31 into gas holder 7 by vacuum pump 8 via line 70, acting as a purging phase. The purging air is preferably supplied via inlet 34. The ventilation system on containment 2 also advantageously contributes to the purging phase. Figure 1OD - Step 4

[0197] First, transfer door 5 is closed, then entrance gate 37 is opened to load object 4 into lock chamber 31. Outlet 35 remains open and the extraction via gas holder 7 using vacuum pump 8 continues.

[0198] Figure 10E - Step 5

[0199] Transfer door 5 remains closed, outlet 35 and entrance gate 37 are closed. A decontamination phase now takes place in lock chamber 31 with object 4 located therein, for example by introducing the decontamination agent H2O2 via inlet 34. Thus, due to the presence of object 4 in lock chamber 31, only the free lock volume Vf remains of the original lock volume Vs.

[0200] Figure 10F - Step 6

[0201] Transfer door 5 is opened; outlet 35 and entrance gate 37 remain closed. The externally decontaminated object 4 is then transferred from airlock chamber 31 to process chamber 21 of containment 2.

[0202] Figure WG - Step 7

[0203] This figure illustrates the accelerated purging of the lock chamber 31 using a vacuum. For this purpose, the outlet 35 is opened and the pneumatic seal 32 at the entrance gate 37 is deactivated, allowing air from the installation room A to flow into the lock chamber 31. The gas volume generated during the purging phase is drawn off through the open outlet 35 via the gas reservoir 7 by the vacuum pump 8. A subsequent process cycle according to Figure 10D can then begin.

Claims

P a t e n t a n s p r ü c h e 1. Method for transferring objects (4) under aseptic conditions from an airlock (3) into the process chamber (21) of a containment (2) surrounded by a housing (20), which forms a pressure-tight transfer unit (1) with the airlock (3), wherein: a) a housing (30) of the airlock (3) surrounds an airlock chamber (31) with the airlock volume (Vs); b) the airlock chamber (31) has: ba) a pressure-tight closable entrance gate (37), which, when open, allows access (33) from the outer installation room (A) for introducing objects (4) into the airlock chamber (31); bb) an outlet (38) intended for transferring the objects (4) from the airlock chamber (31) into the process chamber (21); bc) an inlet (34) for introducing decontamination agents; c) the housing (20) has an access (28) to the process chamber (21); d) the outlet (38) from the lock chamber (31) opens into the access (28) to the process chamber (21);e) a lockable transfer door (5) is provided between the exit (38) from the airlock chamber (31) and the access (28) to the process chamber (21); f) a single object (4) comprises: fa) a container (40) with an aseptic interior (41) and an opening (42) which is closed by a closure (46); and fb) material (44) stored in the interior (41), which is to be treated in the process chamber (21) after opening the closure (46), characterized by the following process steps: g) determination of the dimensions and shape of the airlock chamber (31) adequate to the external object volume (Vo) of one or more objects (4) with the aim of minimizing the free airlock volume (Vf) remaining due to the one or more objects (4) lying in the airlock volume (Vs); h) Introducing one or more objects (4) into the selected lock chamber (31) through the open entrance gate (37) with the transfer door (5) closed; i) Introducing decontamination agent into the lock chamber (31) through the inlet (34) with the entrance gate (37) closed; j) Optionally rinsing the lock chamber (31) and draining rinsing agent from the lock chamber (31) through an outlet (35) after successful decontamination; and k) Transferring the one or more externally decontaminated objects (4) from the lock chamber (31) into the process chamber (21) through the open transfer door (5).

2. Method according to claim 1, characterized in that, due to the small remaining free lock volume (Vf), the decontamination phase can be kept short, thus minimizing the diffusion of decontamination agent into the interior (41) of the object (4) and allowing the processing of the object (4) in the containment (2) to take place quickly.

3. Method according to at least one of claims 1 or 2, characterized in that the connection between the lock (3) and the containment (2) is made by means of flange arrangements (29, 39) on both sides, which are preferably designed to be pressure-tight.

4. Method according to at least one of claims 1 to 3, characterized in that the decontamination agent is atomized in the lock chamber (31), e.g. by means of a two-component nozzle (69) or by ultrasound, and is preferably liquid H2O2.

5. Method according to at least one of claims 1 to 4, characterized in that optional flushing of the lock chamber (31) is carried out by alternating flow in changing flow direction from the gas volumes between the process chamber (21) and the lock chamber (31).

6. Method according to at least one of claims 1 to 5, characterized in that the transfer door (5) is provided at the exit (38) from the lock chamber (31) or at the access (28) to the containment (2).

7. Method according to at least one of claims 1 to 6, characterized in that the flange arrangements (29, 39) present on the lock (3) and on the containment (2) are designed as an interface, thereby enabling the docking of differently dimensioned locks (3) of different shapes to the containment (2).

8. Method according to at least one of claims 1 to 7, characterized in that the transfer of the single or several externally decontaminated objects (4) from the lock chamber (31) into the process chamber (21) takes place after partial or complete rinsing of the lock chamber (31).

9. Method according to at least one of claims 1 to 8, characterized in that, prior to loading the lock (3) with the entrance gate (37) closed and the transfer door (5) open, the lock chamber (31) and the process chamber (21) as well as the sealing surfaces on the transfer door (5) are decontaminated.

10. Method according to at least one of claims 1 to 9, characterized in that the lock (3) has a connection (36) to which a media block (6) is connected which is connected to a process technology (22) which may be part of the containment (2) or the lock (3) or may be positioned independently thereof.

11. Method according to claim 10, characterized in that the media block (6) has lines for compressed air (62) and / or decontamination agent (63), and / or sensors for temperature (64), humidity (65), pressure (66), H2O2 concentration (67) and process and exhaust air (61, 60).

12. Method according to at least one of claims 1 to 11, characterized in that the optional rinsing is carried out using compressed air (62) and / or process air (61), which may be heated above the ambient temperature in the installation room (A).

13. Method according to at least one of claim 11 or 12, characterized in that the connection between the connection (36) on the lock (3) and the media block (6) is mechanically detachable or non-detachable or pneumatically coupled.

14. Method according to at least one of claims 1 to 13, characterized in that after introducing one or more objects (4) into the lock chamber (31), according to its selected dimensioning, the free lock volume (Vf) remaining from the lock volume (Vs) is between 10% and 80%, preferably between 20% and 60%, in particular between 30% and 50%.

15. Method according to at least one of claims 1 to 14, characterized in that the adaptation of the dimensioning of the lock volume (Vs) to the single or multiple objects (4) to be introduced, with the aim of minimizing the remaining free lock volume (Vf) to between 10% and 80%, preferably to between 20% and 60%, in particular to between 30% and 50%, is achieved by constricting displacement of walls on the lock chamber (31) and / or by introducing a volume-displacing packing material.

16. Method according to at least one of claims 1 to 15, characterized in that the object (4) has the shape of a container with its outer object volume (Vo) and comprises: a) a container (40) with an aseptic interior (41) and an opening (42) which is closed with a closure (46), preferably in the form of a cover; and b) material (44) stored in the interior (41) in the form of vials or medical syringes which, after opening the closure (46), are to be treated in the process chamber (21), e.g. to be filled with pharmaceutical substances.

17. Method according to at least one of claims 1 to 15, characterized in that the object (4) has the shape of a bottle, e.g. a cell culture bottle, or a bag - e.g. containing agar plates - or an ampoule, which forms an outer object volume (Vo) and comprises: a) an aseptic interior space (41) and an existing opening (42) which is closed with a closure (46) or is to be created; and b) material (44) stored in the interior space (41), which is to be treated in the process chamber (21) after opening the closure (46); or c) the interior space (41) to be filled, e.g. with pharmaceutical substances.

18. Method according to at least one of claims 1 to 17, characterized in that the optional rinsing of the lock chamber (31) with the transfer door (5) open is carried out by at least one and at least partial insertion of the object (4) from the process chamber (21) of the containment (2) into the lock chamber (31).

19. Method according to at least one of claims 1 to 18, characterized in that a vacuum pump (8) which can be activated to the lock chamber (31) is connected to accelerate the rinsing of the lock chamber (31).

20. Method according to claim 19, characterized in that, during accelerated purging of the lock chamber (31): a) first an outlet (35) connected to the lock chamber (31) is opened, leading to a gas container (7); and then b) the vacuum pump (8) connected to the gas container (7) is activated; or c) first the vacuum pump (8) connected to the gas container (7) is activated; and then; d) an outlet (35) connected to the lock chamber (31) is opened, which leads to a gas holder (7).

21. Method according to at least one of claims 19 and 20, characterized in that, during accelerated purging of the lock chamber (31): a) first, the outlet (35) connected to the lock chamber (31), which leads to a gas container (7), is opened; and then b) the vacuum pump (8) connected to the gas container (7) is activated; and c) then, to equalize the pressure between the process chamber (21) and the lock chamber (31), the seal (32) on the transfer door (5) is released; or d) first, the vacuum pump (8) connected to the gas container (7) is activated; and then e) the outlet (35) connected to the lock chamber (31), which leads to a gas container (7), is opened; and f) then, to equalize the pressure between the process chamber (21) and the lock chamber (31), the seal (32) on the transfer door (5) is released.

22. Method according to claim 21, characterized in that the release of the seal (32) on the transfer door (5) for the purpose of pressure equalization between process chamber (21) and lock chamber (31) is carried out by deactivating a pneumatic seal (32).

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