Device for providing and handling sterile liquid culture media, method for providing liquid culture media, and use of corresponding device for sampling in clean rooms or isolators

Abstract

The present invention relates to a device for providing and handling a sterile liquid medium, comprising at least one closed ampoule (6) containing a sterile liquid medium, a rod (9) and a swab (10) having a swab head (11) formed at one end of the rod (9), the ampoule (6) and the swab (10) being arranged opposite each other in a housing used for storage and handling, the housing being openable within the area of ​​the swab (10) to release the swab head (11) for its use, and reclosable after use of the swab head (11), the ampoule (6) being openable within the closed housing so that the sterile liquid medium reaches and surrounds the swab head (11) inside the housing. The present invention further relates to a method for providing a liquid culture medium, in particular a liquid nutrient medium, for culturing microorganisms, preferably pathogens, bacteria, fungi, and yeasts, and / or viruses, and preferably for use in a clean room or isolator. Finally, the present invention relates to the use of the corresponding device in a clean room or isolator.

Description

[Technical Field]

[0001] The present invention relates to a device for providing and handling a sterile liquid culture medium or sampling solution, in particular for sampling in a clean room or isolator. The invention further relates to a method for providing a liquid culture medium / sampling solution, in particular a liquid nutrient medium, for use in the production and testing space of a clean room, isolator or the like, hereinafter referred to as the clean room area, for the cultivation or detection of microorganisms, preferably pathogens, bacteria, fungi and yeasts, and / or viruses. The invention finally relates to the use of the corresponding device in a clean room or isolator. [Background technology]

[0002] Clean rooms or aseptically operated insulators are known in practice. For example, the aseptic production of active ingredients in the pharmaceutical industry or biotechnology can be carried out there. Clean rooms or isolators can not only protect the products of concern from environmental influences, but also protect operators from highly active materials. Therefore, clean rooms and isolators are widely used in the final stage of the production of sterile pharmaceutical substances.

[0003] Inspection of cleanroom areas (production and testing spaces of cleanrooms, isolators, or the like) requires constant testing of these areas for the presence of pathogens or bacteria. In the case of smooth, easily accessible surfaces, this testing is typically performed using so-called contact plates. In the case of difficult-to-reach or irregularly shaped surfaces, this testing is typically performed using sterile swab tubes containing a swab comprising a rod and a wad-like swab head. Such an arrangement is usually called a cleanroom swab. After wiping, the swab head must be brought into contact with a nutrient / detection medium to detect pathogen / bacteria growth / detection, and optionally to perform qualitative and quantitative pathogen determination. The handling of most swabs known in practice is complicated and therefore inconvenient. In addition, there is always a risk of contamination due to handling. Typically, products currently on the market are filled in a sterile state and then irradiated, therefore, the possibility of contamination cannot be excluded, which means that false-positive results may occur. Summary of the Invention [Problem to be solved by the invention]

[0004] It is therefore an object of the present invention to identify a device for bio-contamination control that does not have the drawbacks occurring in the prior art, that is simple in design and easy to handle, and that differs from competing products.

[0005] Furthermore, methods of providing liquid culture media using the device according to the invention will be specified, as will corresponding uses in the production and testing spaces (clean room areas) of clean rooms, isolators or the like. [Means for solving the problem]

[0006] These objects are achieved by the features of claim 1 relating to the device according to the invention, which comprises at least one closed (sealed) ampoule containing a liquid culture medium and one swab consisting of a rod and a swab head formed at one end of the rod. The ampoule and the swab are arranged opposite each other in a housing for easy storage and handling, the housing being openable in the area of ​​the swab to release the swab head for its use and reclosable after use of the swab head. The ampoule is openable in the closed housing so that the culture medium reaches and surrounds the swab head inside the housing.

[0007] According to the present invention, a swab product provides a device that both provides and handles the swab and provides the liquid nutrient medium. That is, the swab can be closed (sealed) within the housing after its use, and the swab head is surrounded by the liquid nutrient medium in situ, which means that there is no need for separate handling of the swab and / or nutrient medium / detection solution. That is, the device can also be used for culturing bacteria / pathogens.

[0008] In particular, the housing comprises a first housing part that houses the ampoule and a second housing part that surrounds the swab, the rod of the swab being fixed to or within the first housing part, e.g., inserted therein, the two housing parts being arranged axially or coaxially with each other as an elongated sleeve closed at its ends.

[0009] The housing parts can be easily plugged into one another, screwed into one another or sealably connected to one another by a bayonet connection. What is very important is the sealed connection between the two housing parts, thereby resulting in a housing as a whole.

[0010] The first housing part comprises a space for receiving the ampoule and includes, first, a coupling area for end-side reception of one end of the ampoule and optionally for fastening the ampoule, and, second, a coupling area for opposite fastening of the free end of the rod of the swab and for receiving or attaching the second housing part, the coupling areas substantially forming a spatial separation between the two housing parts and there is a fluid connection for fluid passing through the coupling areas.

[0011] The open end of the second housing part is insertable into the open end of the first housing part, or vice versa, preferably up to a reciprocal stop which limits the insertion distance.

[0012] Formed between the two housing parts, particularly through the joining region of the first housing part, is a flow connection through which fluid can flow or communicate between the housing parts. It is also conceivable that the flow connection extends through at least a portion of the rod of the swab, so that fluid can enter the interior of the second housing part, for example, near the swab head. The flow connection achieved is important.

[0013] The ampoule containing the liquid culture medium is preferably in the form of a glass or plastic ampoule and has at least one predetermined breaking point at one end. The ampoule can also be an ampoule with two ends, each of which has a predetermined breaking point for opening the ampoule. Opening the ampoule at both ends has the advantage that the liquid culture medium can easily flow out of the ampoule without any negative pressure building up inside the ampoule, preventing the liquid from flowing out. It is also conceivable that the ampoule contains two internal spaces for storing two different media.

[0014] More preferably, the first housing part reduces in diameter and / or is elastic in the region of the predetermined breaking point of the ampoule so that the ampoule can be opened and the liquid medium can thereby be released by bending and / or compressing the first housing part, which can smoothly flow unhindered from the ampoule, especially initially, into the first housing part. From there, the fluid passes through the coupling region into the second housing part, where it can contact or surround the swab head.

[0015] The first housing part is closed at its free end, i.e., the side facing away from the connection region, reversibly with a closure or irreversibly by welding, compression, or bonding. What is important here is that the first housing part can be hermetically closed after the ampoule filled with liquid medium has been introduced.

[0016] Particularly advantageously, the first housing part has structures, such as fluting, formed on its outer surface in the region of its end facing the second housing part, which facilitates handling in terms of gripping. The provision of a certain surface roughness is already sufficient for this purpose.

[0017] The two housing parts are preferably manufactured by injection molding, in particular from plastic, and it is particularly advantageous if the second housing part is made from transparent plastic so that the swab head and the culture medium present in the second housing part can be observed.

[0018] As already mentioned above, the housing parts are hermetically connected to one another or they can be sealably connected to one another in order to eliminate the possibility of contaminated medium reaching the outside of the housing or alternatively the possibility of contamination passing from the outside to the inside after sampling.

[0019] In view of the above, the medium is a liquid nutrient medium for the cultivation of microorganisms, in particular pathogens, bacteria, fungi, yeasts, and / or viruses, depending on the particular application. Similarly, the medium can be an analytical or buffer solution for any further processing.

[0020] It is also conceivable that the culture medium may be mixed with a de-inhibitor or neutralizing agent for neutralizing, for example, a disinfectant that may be present on the surface to be wiped. In the absence of such a neutralizing agent, the culture results would be impaired.

[0021] The method according to the invention achieves the object mentioned at the beginning by the features of the additional independent claim 17, which contributes to the provision of a liquid culture medium, in particular a liquid nutrient medium, for the cultivation of microorganisms, in particular pathogens, bacteria, fungi, and yeasts, and / or the detection of viruses or other sample substances. Use in a clean room or isolator can follow a simple provision, either by aseptically filling the culture medium into ampoules and / or by sterilizing the ampoules after they have been filled and closed, under the action of heat, preferably steam, followed by radiation, preferably gamma radiation. The method contributes to the use of the device discussed above.

[0022] The method uses a device according to the present invention, which can be completed as follows: Step 1. 1. The ampoule is filled with culture medium; 2. The filled and closed ampoule is inserted into the first housing part, and the insertion side opening of the first housing part is closed with a closure or by welding or compression; Step 2. The swab is inserted into a slot in the first housing part opposite the opening, the first housing part serving as a handle for handling the swab; Step 3. The second housing part is marked or labeled; Step 4. The swab is moistened with a solution, after which the first housing part and the second housing part containing the swab are inserted into each other; Step 5. The devices containing the swabs may be individually packed or in multiples: Step 6. 2 to 10 individual packs, preferably 5 individual packs, are packed in the first outer pack (there can be more or fewer individual packs); Step 7. an illumination indicator is attached to at least one of the outer packs, preferably to the first outer pack, although attachment of an illumination indicator is not absolutely necessary; Step 8. A first outer pack with the individual packs housed therein is placed within a second outer pack or within a plurality of outer packs; Step 9. The entire arrangement in the second outer pack is placed in a carton, the carton having or being printed on it, or it having or being labeled; Step 10. The carton in which the outer pack / individual packs are placed and in which the swabs are present in addition to the device is irradiated and / or autoclaved and / or gassed and / or sterilized in some other way that has at least a reduction in pathogens.

[0023] Furthermore, the object mentioned at the outset is achieved by a further additional independent claim 19 relating to the use according to the invention. Thereby, the packed device with the swab present therein is introduced into a cleanroom zone or insulator classified as A, B, C, or D or ISO8, ISO7, ISO6, or ISO5 or better according to the guidelines for cleanroom classification, the swab is removed from the innermost pack, the critical zone or the zone to be examined is sampled or swabbed with the swab, the swab is then inserted back into the first housing part, the ampoule is broken open at one or both ends so that the solution present therein flows into the second housing part towards the swab head, the liquid flows past the rod of the swab or otherwise through an internal channel in the rod of the swab, the solution is cultured directly, for example in a laboratory, or immediately after use or thereafter the solution is removed completely or partially from the housing and used for other purposes, for example for filtration, for the application of molecular biological methods, for identification, etc.

[0024] There are then various ways in which the teachings of the present invention can be embodied and developed in an advantageous manner. For this purpose, reference can be made to the claims dependent on claim 1 and the following discussion of preferred exemplary embodiments of the device according to the present invention with the aid of the drawings. With regard to the discussion of preferred exemplary embodiments of the device according to the present invention with the aid of the drawings, preferred embodiments of the teachings of the present invention and their developments are also generally discussed below with the aid of the drawings. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a schematic diagram of an exemplary embodiment of a device according to the present invention; [Figure 2] 2 is a schematic diagram of the exemplary embodiment of FIG. 1 rotated 90 degrees about its longitudinal axis. [Figure 3] 3 is a cross-sectional view of the object of FIGS. 1 and 2, showing the interior of the two housing parts. FIG. [Figure 4]FIG. 4 shows the object of FIGS. 1-3 with the second housing part removed and the swab in the exposed use position. [Figure 5] FIG. 4 shows the object of FIGS. 1 to 3 with the second housing part inserted and the swab in the protective / transport position. DETAILED DESCRIPTION OF THE INVENTION

[0026] 1 illustrates a schematic diagram of one exemplary embodiment of a device according to the invention. The device comprises a first housing part 1 and a second housing part 2 sealably inserted into the first housing part 1.

[0027] The first housing part 1 is closed at its free end and an opening 3 through which the ampoule is introduced in front of the closure.

[0028] On the opposite side, the first housing part 1 has a reduced cross section in which the joining area 4 is present.

[0029] At the free end of the first housing part 1 facing the second housing part 2, the first housing part 1 can be provided with flutings 5 ​​which act as a grip on the first housing part 1.

[0030] Figure 2 shows the object rotated 90° about the longitudinal axis from Figure 1, with the free end of the first housing part 1 closed by bonding or welding. An ampoule, not shown, is inside the first housing part 1. As an alternative to bonding / welding, the free end of the first housing part 1 can be provided with a hermetic closure.

[0031] Figure 3 illustrates a cross-section of the object of Figures 1 and 2. It can be clearly seen that in the first housing part 1 there is an ampoule 6, which in each case may have a predetermined breaking point 7 at each end for opening the ampoule 6. The ampoule 6 is made of glass or another suitable material. The ampoule 6 can therefore be opened by breaking the predetermined breaking point 7.

[0032] 3 clearly shows where the ampoule 6 extends into the bonding area 4. The ampoule 6 can be inserted into or secured to the bonding area 4 in some other way using one of two predetermined breaking points 7.

[0033] The coupling region 4 comprises a flow connection between the first housing part 1 and the second housing part 2 , which may be coaxial within the second housing part 2 .

[0034] 3, a slot 8 is provided in the coupling region 4 into which the rod 9 of the swab 10 fits and / or is frictionally connected, e.g., plugged, bonded, or welded. In either case, the swab 10 is rigidly held in the slot 8.

[0035] The rod 9 of the swab 10 extends until it reaches a free end at which the swab head 11 is formed as a wad or the like.

[0036] Furthermore, it can be seen in Figure 3 that the second housing part 2 can be provided with a stop 12 extending annularly therearound. The stop 12 acts as a sliding limiter for the first housing part 1 and thus defines the insertion of the second housing part 2 into the first housing part 1 (or vice versa).

[0037] Figure 4 shows the device according to the invention in its position or condition for use, with the second housing part 2 removed, i.e. the swab head 11 exposed and ready for use while retained on the first housing part 1. After use or wiping of the critical surface, the device can be closed by inserting the second housing part 2 and consequently closing the device, as illustrated in Figure 5.

[0038] As a result of the opening of the ampoule, not shown in Figure 5, the liquid medium is released and, depending on the positioning of the entire device, reaches the area of ​​the second housing part 2, in particular the swab head 11, so that the wiped bacteria can grow in the medium, generally a nutrient medium / culture medium.

[0039] With regard to further advantageous embodiments of the device according to the invention, reference is made to the entire specification and the appended claims in order to avoid repetition.

[0040] Finally, it must be expressly pointed out that the above-described exemplary embodiments of the device according to the invention merely serve for the discussion of the claimed teachings and do not limit it to the exemplary embodiments. [Explanation of symbols]

[0041] List of Reference Numbers 1 First housing part 2 Second housing part 3 Openings and Closures 4 Combined area 5 Fluting 6 ampoules 7 Predetermined Breaking Points 8 slots 9 Rod 10 swabs 11 Swab Head 12 stops

Claims

1. 1. A device for providing and handling sterile liquid media, comprising: At least one closed ampoule (6) containing said sterile liquid medium; A swab (10) consisting of a rod (9) and a swab head (11) formed at one end of the rod (9); Including, The ampoule (6) and the swab (10) are arranged opposite each other in a housing that facilitates storage and handling; the housing is openable within the area of ​​the swab (10) to release the swab head (11) for its use and reclosable after use of the swab head (11); The ampoule (6) is openable within the closed housing so that the sterile liquid medium reaches and surrounds the swab head (11) inside the housing.

2. 2. The device according to claim 1, characterized in that the housing comprises a first housing part (1) that houses the ampoule (6) and a second housing part (2) that surrounds the swab (10), the first housing part (1) and the second housing part (2) being arranged axially or coaxially with each other as an elongated sleeve closed at its ends.

3. 3. The device according to claim 1 or 2, characterized in that the first housing part (1) and the second housing part (2) are plugged into each other, screwed together or hermetically connected by a bayonet connection.

4. 4. The device according to claim 1, wherein the first housing part (1) comprises a space for receiving the ampoule (6) and further comprises a coupling area (4) firstly for end-side receiving of one end of the ampoule (6) and optionally for fixing the ampoule (6), and secondly for fixing the opposite side of the free end of the rod (9) of the swab (10) and for receiving or attaching the second housing part (2).

5. 5. A device according to claim 2 and optionally claim 3 or claim 4, characterized in that the open end of the second housing part (2) is insertable into the open end of the first housing part (1), preferably up to a stop (12), or vice versa.

6. 6. A device according to claim 2 and optionally any one of claims 3 to 5, characterized in that a flow connection is formed between the two first and second housing parts, in particular through the joining area (4) of the first housing part (1), and a fluid can flow through the flow connection between the first and second housing parts (1) and (2).

7. 7. A device according to any one of claims 1 to 6, characterized in that the ampoule (6) is in the form of a glass or plastic ampoule having at least one predetermined breaking point (7) at one end, preferably at both ends, for opening of the ampoule (6).

8. 8. The device according to claim 2 and claim 7, characterized in that the first housing part (1) reduces in diameter and / or is elastic in the area of ​​the predetermined breaking point (7) of the ampoule (6) so that the ampoule (6) can be opened and the sterile liquid medium thereby can be released by bending and / or compressing the first housing part (1).

9. 9. A device according to claim 2 and optionally any one of claims 3 to 8, characterized in that the first housing part (1) is closed at its free end, i.e. on the side facing away from the joining area (4), by means of a closure (3) either reversibly or irreversibly by welding, compression or bonding.

10. 10. A device according to claim 2 and optionally any one of claims 3 to 9, characterized in that the first housing part (1) can have structures formed on its surface, such as fluting (5), which facilitate handling in the region of its end facing the second housing part (2).

11. 11. A device according to claim 2 and optionally any one of claims 3 to 10, characterized in that the first housing part (1) and the second housing part (2) are preferably manufactured from plastic by injection moulding.

12. 12. A device according to claim 2 and optionally any one of claims 3 to 11, wherein the second housing part (2) is made of transparent plastic.

13. 13. A device according to claim 2 and optionally any one of claims 3 to 12, characterized in that the first housing part (1) and the second housing part (2) are hermetically connected or connectable to each other.

14. 14. The device according to any one of claims 1 to 13, characterized in that the sterile liquid medium is a liquid nutrient medium for the cultivation of microorganisms, in particular pathogens, bacteria, fungi and yeasts, and / or a medium for the sampling and detection of viruses.

15. 14. The device of any one of claims 1 to 13, wherein the sterile liquid medium is an analytical or buffer solution for any further processing.

16. 16. The device according to claim 14 or claim 15, wherein the sterile liquid medium is mixed with a de-inhibitor or neutralizing agent for neutralization, such as a bactericide.

17. 1. A method for providing a liquid culture or sampling medium, in particular a liquid nutrient medium, for the cultivation of microorganisms, in particular pathogens, bacteria, fungi and yeasts, and / or viruses, and preferably for use in clean rooms or isolators, comprising the steps of:

17. A method for use in a device according to any one of claims 1 to 16, wherein the liquid culture medium is filled aseptically into an ampoule (6) and / or the ampoule (6) is sterilized after it has been filled and closed under the action of heat, preferably steam, and then under the action of radiation, preferably gamma radiation.

18. The device used is completed, for example, according to the following steps: The order of steps 1 to 3 is freely selectable: Step 1.

1. The ampoule (6) is filled with culture medium / sampling medium / transport medium; 2. The filled and closed ampoule (6) is inserted into the first housing part (1) and the insertion opening (3) of the first housing part (1) is closed with a closure or by welding or by compression; Step 2. A swab (10) is inserted into a slot in the first housing part (1) opposite the opening (3), and the first housing part (1) serves as a handle for handling the swab (10); Step 3. The second housing part is marked or labeled; Step 4. The swab (10) is wetted with a solution, after which the first housing part and the second housing part containing the swab (10) are inserted into each other; Step 5. The devices containing the swabs (10) are individually packed or packed in multiples; Step 6. 2 to 10 individual packs, preferably 5 individual packs, are packed in a first outer pack; Step 7. An illumination indicator is attached to said first outer pack, although this is not essential; Step 8. The first outer pack with the individual packs contained therein is placed inside a second outer pack or inside a plurality of outer packs, the outer packs being suitable for cleanrooms / insulators; Step 9. the entire arrangement in said second outer pack is placed in a carton, said carton having or being printed thereon; Step 10.

18. The method according to claim 17, wherein the carton in which the outer pack / individual packs are placed and in which the swabs (10) are present in addition to the device is irradiated and / or autoclaved and / or gassed and / or sterilized in any other way that has at least a reduction in pathogens.

19. Use of a device according to any one of claims 1 to 16, in particular by use of a method according to claim 17 or claim 18, The packed device with the swab (10) present therein is introduced into a cleanroom zone or into an insulator classified as A, B, C, or D or ISO 8, ISO 7, ISO 6, or ISO 5 or better according to the guidelines for cleanroom classification, The swab (10) is removed from the innermost pack and the critical zone or zone to be tested is sampled or wiped using the swab (10); The swab (10) is then inserted back into the first housing part (1), the ampoule (6) is torn open at one or both ends so that the solution present therein flows into the second housing part towards the swab head (11); The liquid flows past the rod (9) of the swab (10) or otherwise through an internal channel within the rod (9) of the swab (10), The solution can be directly cultured, for example in a laboratory, or immediately after use or thereafter the solution can be completely or partially removed from the housing and used for other purposes, for example for filtration, for the application of molecular biological methods, for identification, etc. use.

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