APPARATUS FOR FILLING CONTAINERS IN A STERILE ENVIRONMENT

Abstract

The present invention relates to an apparatus (10) for filling containers in a sterile environment, comprising a filling unit (40) configured to fill containers with sterilized liquids or powders in a sterile environment comprising interchangeable parts characteristic of each production run; a washer sterilizer (20) configured to wash, sterilize, decontaminate, dry in one single process said interchangeable parts of the filling unit (40) before each run for filling the unit (40). The washer sterilizer (20) is directly coupled to the filling unit (40) and is configured to aseptically transfer the interchangeable parts directly to the filling unit (40).

Claims

1. An apparatus (10) for filling containers in a sterile environment, comprising: a filling unit (40) configured to fill containers with sterilized liquids or powders in a sterile environment, said filling unit (40) comprising interchangeable parts characteristic of each production run; a washer sterilizer (20) configured to wash, sterilize, decontaminate, dry in one single process said interchangeable parts of the filling unit (40) before each run for filling the unit (40); wherein the washer sterilizer (20) is directly coupled to the filling unit (40) and is configured to transfer aseptically said interchangeable parts directly to the filling unit (40).

2. The apparatus (10) according to claim 1, wherein the washer sterilizer (20) is coupled to the filling unit (40) by means of a protection system (30) interposed between said washer sterilizer (20) and said filling unit (40).

3. The apparatus (10) according to claim 1, wherein the washer sterilizer (20) comprises a rotating basket (21) configured to contain said interchangeable parts of the filling unit (40).

4. The apparatus (10) according to claim 1, wherein said rotating basket (21) allows the load rotation around an axis parallel to the direction of loading/unloading of the washer sterilizer (20).

5. The apparatus (10) according to claim 1, wherein the rotating basket (21) of the washer sterilizer (20) is arranged so as to allow an immersion and/or bubbling washing associated to the load rotation of the rotating basket (21).

6. The apparatus (10) according to claim 1, wherein the washer sterilizer (20) comprises an internal chamber (22) configured to be partially or wholly filled with a liquid.

7. The apparatus (10) according to claim 1, wherein the chamber (22) of the washer sterilizer (20) is blown with air or vapour.

8. The apparatus (10) according to claim 1, the protection system (30) being configured to insulate the filling unit (40) from any contact with an operator.

9. The apparatus (10) according to claim 8, wherein the protection system (30) of the filling unit (10) is an insulator, a closed RABS or an open RABS.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Additional features and advantages of the invention will become more apparent from the description which follows of a preferred embodiment and the variants thereof, provided by way of example with reference to the appended drawings, in which:

[0049] FIG. 1 shows a block diagram of a washing, sterilization and/or aseptic transfer treatment process of components of a container filling line according to the prior art;

[0050] FIG. 2 shows a block diagram of a washing, sterilization and/or aseptic transfer treatment process of a known type of alternative to that of FIG. 1;

[0051] FIG. 3 shows a block diagram of a known washing, sterilization and/or aseptic transfer treatment process of a known type of alternative to that illustrated in FIGS. 1 and 2;

[0052] FIG. 4 shows a block diagram of an apparatus for filling containers in a sterile environment according to an embodiment of the invention;

[0053] FIGS. 5 and 6 show a detail of the apparatus of FIG. 4;

[0054] FIGS. 7 and 8 show two examples of aseptic transfer inside the apparatus of FIG. 4.

DETAILED DESCRIPTION OF THE INVENTION

[0055] It should be noted that in the description below, identical or similar blocks, components or modules, even if they appear in different embodiments of the invention, are indicated by the same numerical references in the figures.

[0056] With reference to FIG. 4, an apparatus 10 for filling containers in a sterile environment according to the present invention is shown.

[0057] The apparatus 10 for filling containers in a sterile environment comprises therein a filling unit 40 configured to fill various types of containers with sterilized liquids or powders in a sterile environment. Furthermore, the filling unit 40 comprises interchangeable parts characteristic of each production run.

[0058] In particular, the interchangeable machine parts characteristic of each production run may be, for example, liquid container filling needles, feed systems, rubber stoppers, material storage reservoirs, powder dosing systems, etc.

[0059] The filling unit 40 is contained inside a protection system 30.

[0060] The apparatus 10 further comprises a washer sterilizer 20 configured to wash, sterilize, decontaminate, dry in one single process the interchangeable parts of the filling unit 40 before each run for filling the unit 40.

[0061] It should be noted that the washer sterilizer 20 is also configured to wash and/or sterilize other elements, such as the containers themselves.

[0062] The washer sterilizer 20 according to the present invention is directly coupled to the insulator 30 and is configured to aseptically transfer the interchangeable parts directly inside the filling unit 40.

[0063] Thereby it is avoided to have to bag in a special bagging unit, transfer, sterilize and extract the parts of the filling machine from the bags, thus reducing production costs and the number of machines and avoiding possible contamination.

[0064] Furthermore, having a single filling machine configured to perform all the operations necessary for a given production run reduces the production space required.

[0065] Preferably, the washer sterilizer 20 is coupled to a protection system or insulator 30 of the filling unit 40.

[0066] The protection system 30 is a system configured to maintain a class A environment in a specific area. The protection is ensured by physical and aerodynamic barriers.

[0067] By separating the filling area from the operators, these special insulators allow filling operations to be carried out, ensuring the total protection of the products and the operator without having to resort to sterile rooms.

[0068] Depending on the specific needs of the process, these aseptic systems can be easily integrated with mills, micronizers, dryers or other process instrumentation and find applicability in aseptic filling lines, sterility tests and reactors.

[0069] The protection system 30 of the filling line or unit 40 can be, by way of non-limiting example, an insulator, a RABS (“Restricted Area Barrier System”) or any other system which allows activities under controlled contamination conditions.

[0070] The protection system 30 of the filling line 40 is configured to insulate the filling line 40 from each contact with an operator and from the external environment.

[0071] The washer sterilizer 20 comprises therein a rotating basket 21 configured to contain the interchangeable parts of the filling unit 40 to be washed and/or sterilized. The rotating basket 21 is housed inside a chamber 22 of the washer sterilizer 20.

[0072] The rotating basket 21 allows the load rotation (e.g., the parts of the machine to be washed and sterilized) around an axis parallel to the loading/unloading direction of the washer sterilizer 20.

[0073] Preferably, the rotating basket 21 of the washer sterilizer 20 is arranged so as to allow an immersion and/or bubbling washing associated to the load rotation present in the basket 21. The chamber 22 of the washer sterilizer 20 is partially or wholly filled with a liquid. For example, water.

[0074] Alternatively or in addition to the presence of the liquid in the chamber 22, the washer sterilizer 20 is blown with air and/or vapour.

[0075] The washed and sterilized interchangeable parts characteristic of each production run or assembly 45 can be extracted from the washer sterilizer 20 and installed inside the filling unit 40 (of which they are removably part) by a completely manual transfer or a completely automatic transfer.

[0076] Furthermore, mixed manual/automatic transfer systems are always possible by combining parts of the two main modes. In both transfer systems, the assembly 45 slides on specially made guides 48a, 48b.

[0077] Specific construction details are made from time to time based on the assembly 45 to be treated and the filling unit 40 for which it was designed.

[0078] In manual transfer mode, after activating the door opening command, an operator manually extracts the assembly 45 from the washer sterilizer 20, with or without the aid of a tool, and brings it to the connection position inside the filling unit 40.

[0079] The filling unit 40 will be provided with suitable connections and will make the assembly 45 integral with the line 40 itself.

[0080] The operator acts with gloves insulated from the units 30, 40 by the separation wall of the containment system 30.

[0081] The interchangeable parts 45 are provided with sliding means configured to slide on the guides 48a, 48b and are manually slid by the operator (wearing the gloves), from the outside of the apparatus 10.

[0082] The transfer of the interchangeable parts can occur manually and individually, from the outside of the protection system 30 and the apparatus 10, installing them on the unit 40 to other more complex solutions where the pieces are housed in special frames already configured according to the assembly which the operator always installs manually or with the aid of servo systems installed on the unit 40.

[0083] In automatic transfer mode, after activating the door opening command, the operator activates the automatic extraction commands of the assembly 45. An extraction bar 50 enters the washer sterilizer 20, engages the assembly 45 and places it at the connection point of the line. The line will be provided with suitable connections and will make the assembly 45 integral with the line itself.

[0084] In automatic transfer mode, the operator never acts with gloves on the assembly 45 or other part of the system.

[0085] In the automatic transfer mode, the interchangeable parts 45 are provided with sliding means configured to slide on the guides 48a, 48b and are slid by the extraction bar 50.

[0086] In both transfer modes of the assembly 45 described above, there will never be an operator inside the apparatus 10, thus preserving the complete sterility inside the same.

[0087] It is clear that the specific features are described in relation to different embodiments of the invention with an exemplary and non-limiting intent.

[0088] Obviously a person skilled in the art can make further modifications and variants to the present invention, in order to satisfy contingent and specific needs. For example, the technical features described in relation to an embodiment of the invention can be extrapolated therefrom and applied to other embodiments of the invention. Such modifications and variations are moreover embraced within the scope of the invention as defined by the following claims.