WO2008141936A2

WO2008141936A2 - Plurality of sterilisation objects collected in a transport container, transport container and method for sterilising said objects

Info

Publication number: WO2008141936A2
Application number: PCT/EP2008/055604
Authority: WO
Inventors: Albert Louis Victor Jozef Claessens; Reinhard Louis Jozef Waeben; Ronny Prosper Elisabeth Vrijens
Original assignee: Helvoet Pharma Belgium N.V.
Priority date: 2007-05-23
Filing date: 2008-05-07
Publication date: 2008-11-27
Also published as: DE102007056261A1; WO2008141936A3

Abstract

The invention relates to a plurality of sterilisation objects (3) collected in a transport container (T), such as in particular, stoppers made from rubber or a thermoplastic elastic material for medicine container or medical syringes. According to the invention, sterilisation conditions to which objects are subjected during sterilisation can be improved for sterilisation object in particular a number of sterilisation objects collected in a transport container can be improved in order to provide a favourable possibility with regard to documentation, wherein an RFID transponder (4) displaced in the transport container (T) and the RFID transponder (4) comprises a sensor such as a temperature sensor and /or a time counter, the measured temperature and/or a recorded timespan is recorded in the RFID transponder (4).

Description

Variety of combined in a transport container sterilization objects, transport container, as well as methods for sterilization of such objects

The invention initially relates to a plurality of sterilization objects combined in a transport container, such as, in particular, stoppers made of rubber or a thermoplastic elastomer for medicament containers or medical syringes.

For the sterilization of several, in particular medical objects, it is known to guide them together with a transport container through a sterilization chamber. In particular, steam sterilization, etylene oxide gas sterilization and sterilization with gamma rays are known as sterilization processes. The objects may in particular be stoppers consisting of a rubber material or a thermoplastic elastomeric plastic, further for example mixed with a mineral filler fraction, such as silicate, further magnesium silicate. In general terms, they are pharmaceutical or medical articles, i. Items used for pharmaceutical or medical applications.

There is a need, in particular to document the sterilization process of the summarized in the transport container objects, so as at a later date, the prescribed sterilization, which is dependent u.a. from the temperature level and the residence time in the sterilization chamber.

With regard to the prior art described above, the object of the invention is to provide a sterilization object, in particular a plurality of sterilization objects combined in a transport container. to provide a convenient way to improve the documentation of sterilization conditions to which the objects were subjected during sterilization.

A possible solution to the problem is given by the subject matter of claim 1, wherein it is aimed at that in the transport container further rests an RFID transponder and that the RFID transponder has a sensor, such as a temperature sensor and / or a time counter, wherein the sensory detected value, that is about the measured temperature and / or a detected time period, is stored in the RFID transponder. In principle, the sensor can also exist approximately in a detection unit for radioactivity.

As a result of this embodiment, a documentation can be obtained which is preferably permanently associated with the transport container and thus suitably associated with the summarized sterilization objects. For this purpose, an RFID transponder is attached to the transport container holding the objects to be sterilized. Such an RFID transponder enables non-contact read operations. The RFID transponder usually has an antenna, an analogue circuit for receiving and transmitting, as well as a digital circuit and, as a rule, a permanent memory. The proposed arrangement further provides a writable memory in which the mentioned measurement data can be stored. Thus, an active RFID transponder is preferably provided, which is battery operated. Accordingly, this refers to the power to supply the microchip and to supply the temperature sensor and / or the time counter from a built-in battery. Such transponders are initially in an idle state, send out accordingly no information, so as to increase the life of the power source. For example, the transmitter, but also the measuring devices and the writable memory are activated only when a spe- the initial activation signal is received. Further, it may also be a semi-passive transponder, which is provided with a support battery for the use of the connected sensor or time counter, which support battery is not responsible for the data transmission. This is done as with passive transponders by inductive energy supply. The measured value memory may be an EEPROM, in particular in the case of semi-passive transponders. Furthermore, FRAM or SRAM memory are also possible in this regard, in particular in connection with a battery provided in the transponder.

The RFID transponder is guided in the course of sterilization together with the transport container and the combined sterilization objects through the sterilization chamber, or subjected to the respective sterilization conditions. In this case, it detects via an integrally provided sensor, at least one essential parameter of the sterilization conditions, or its exceeding, that is, in the case of said temperature sensor, for example, the sterilization temperature reached, in particular exceeding a lower sterilization temperature threshold value. This recorded value, that is, for example, the stored temperature value, can later be read out via a corresponding reading unit, with which it is possible to control the proper sterilization of the sterilization objects uniquely assigned to the transponder. In addition, additionally or alternatively to the exemplary temperature measurement, the time span of the stay in the sterilization chamber can also be recorded and stored by means of a time counter. This value is also readable for control. In combination with a temperature and time measurement, the proper temperature exposure can be logged over a predetermined period of time.

Furthermore, the RFID transponder can contain stored data on the associated sterilization objects readable, so on, for example with regard to the type of object, the choice of materials and, for example, with regard to production characteristics, such as date, batch, etc

The data and measured values stored in the RFID transponder relate to all sterilization objects combined in the transport container. Accordingly, this creates a solution that does not require documentation of each individual sterilization object.

The invention further relates to a transport container for sterilization objects, for example in the form of a bag-like transport envelope or formed by means of a molded part.

With respect to such transport containers arises in a similar way the task of creating an advantageous condition for the traceability of sterilization conditions to which the objects were subjected in the container.

A possible independent solution to this problem is initially given by the fact that in the transport container rests an RFID transponder. With regard to the properties of the RFID transponder and the possibilities that are then associated with the transponder, reference is made to the above statements.

In particular, it is preferable for the RFID transponder to lie in one of the subregions of the container that is separate from the sterilization objects. The sub-area may be formed as a separate compartment or separate pocket space. In particular, it may be advantageous here that the transponder is trapped therein, in the partial area, without requiring any special fastening. In particular with respect to a transport container formed by means of a molded part, in particular a plastic deep-drawn part, optionally closed on the opening side by a vapor-permeable, in any case vapor-permeable film, as already mentioned above, it may also be advantageous to form-fit the RFID transponder. for example, by clipping, or even materially by gluing to the wall, preferably the bottom of this container to connect.

Furthermore, features are described which are preferred in combination with the features of the claims discussed above, but also with regard to the method aspect of the invention explained further below, but in principle only in combination with some features of these claims or alone have meaning can.

Thus, in a development of the subject invention, it is provided that the RFID transponder has a moisture sensor and that the measured moisture value is stored in the RFID transponder. Accordingly, the proposed RFID transponder is further suitable for detecting a proper steam sterilization in an autoclave, in which the sterilization objects are heated together with the transport envelope and the transponder for 15 minutes at 121 ° C at 2 bar pressure in steam or, for example, for 3 minutes at 134 ° C at 3 bar, the air inside the autoclave is completely replaced by water vapor. The moisture level can be recorded accordingly via the moisture sensor of the transponder and stored afterwards.

Particularly advantageous is a development in which the RFID transponder has a date counter. It can be constantly active and up-to-date via the battery required for the other sensors. Alternatively, however, before the objects and the transponder ders be impressed by the sterilization chamber the current date via a transmitting unit on the transponder. In any case, the measured temperature value and / or the detected time period and / or the measured moisture value are stored associated with the date, whereby not only the correct sterilization process can be checked by a readout of the transponder data, but also the sterilization time. In a development, in addition to the date in addition, the time can be recorded or stored in addition, also further information on the design of the sterilization chamber and the location dersel- ben.

The RFID transponder can be provided in the simplest way loosely together with the sterilization objects in the transport container. In this regard, however, an embodiment in which the RFID transponder is arranged captively on the transport container is preferred, so more preferably in a pocket of the transport container. This bag can not be designed to clearly assign the transponder, at least not non-destructive. In this regard, it is further preferred that the pocket is an inner pocket, so on in an inner region of the transport container, which is accessible only after opening a closure closure.

In one embodiment, the transport container can be a transport bag, in particular, at least in one section, consisting of a vapor-diffusion-open film-like material. It is often a non-woven material, for example, a material marketed under the trade name "Tyvek." Basically, the entire container may be made of this vapor-permeable material, but it is preferred that only a portion be made of this material In the case of a transport bag, for example, this may consist of two interconnected, preferably sweat-bonded, film layers, one of the film layers consists of said vapor diffusion-open material and the other film layer of a conventional plastic film. The latter can be transparent, which is associated with the advantage that the objects located therein, but also the said RFID transponder, can be detected immediately.

It is particularly preferred that in the case of the transport bag this is immediately welded on three sides to form a shell, wherein an upstream seam is provided parallel to a lower seam, and further in the formed by this bottom seam, the two edge welds and the upstream seam pocket, which can not be opened without destruction, the RFID transponder rests.

The first remaining filling opening of the transport bag can be closed after filling the sterilization objects such as. Plug. It can also be closed by welding, for example. For both the mentioned vapor diffusion open sheet material, as well as the example transparent plastic film material are each - by heat - welded together.

The separate bag receiving the RFID transponder can accordingly be designed as an inner pocket in the transport bag. However, in a further embodiment, this separate pocket can also be formed on the side of the closure facing away from the receiving bag, so on, for example, in the region of a broadened closure collar.

Also, the transport container may be a molded part with a cover, so on, for example, a molded part in the manner of a transport box, further example. For receiving injection vials or the like. Such a molded part is preferably a plastic deep-drawn part. However, it can also be a molded part. Again, the RFID transponder can be added to the interior of the molded part. be arranged, so on, for example, in a arranged in the interior of the molding bag or another separate receiving space. In this regard, an embodiment is preferred in which the transport container is divided into at least two compartments by means of the cover, namely a compartment for receiving the sterilization objects and a compartment for receiving the RFID transponder. The cover, for example a film-like, vapor-permeable or in any case vapor-permeable cover, is adapted in this case in accordance with the preferred juxtaposition of the two compartments. Although not strictly required, it is generally desirable, not only with respect to this embodiment, for the RFID transponder to be in the same

Manned, i. the - is exposed - environmental conditions, such as the sterilization objects. In this respect, it is advantageous if the, possibly separate, recording of the RFID transponder in the same way (partially) is covered by the vapor-permeable film.

The invention further relates to a method for the sterilization of sterilization objects, such as in particular stoppers made of rubber or a thermoplastic elastomer material for medicine containers or medical syringes, wherein the sterilization objects are combined in a transport container.

In order to improve a method of the type in question such that with respect to the sterilization objects a clearly assignable logging of the sterilization process is achieved, it is provided that in addition an RFID transponder is added to the transport container that a RFID transponder assigned, preferably structurally associated with this, sensor, such as a temperature sensor is provided and that by means of the RFID transponder or the sensor, a value such as a temperature is measured and / or a period of time is detected, such as the measured temperature and / or the detected Time span is stored in the RFID transponder. As a result of this refinement, a documentation can be obtained which is preferably associated with the transport container in a captive manner and thus suitably associated with the combined sterilization objects. For this purpose, an RFID transponder is attached to the transport container holding the sterilization objects. Such an RFID transponder enables non-contact read operations. The RFID transponder usually has an antenna, an analogue circuit for receiving and transmitting, as well as a digital circuit and, as a rule, a permanent memory. The proposed arrangement further provides a writable memory in which the mentioned measurement data can be stored.

The RFID transponder is guided in the course of sterilization together with the transport container and the combined sterilization objects through the sterilization chamber, recorded here via the sensor such as the temperature sensor, the achieved values such as the sterilization temperature, in particular further exceeding a lower sterilization temperature threshold value , This recorded and stored temperature value can later be read out via a corresponding reading unit, with which it is possible to control the proper sterilization of the sterilization objects uniquely assigned to the transponder. In addition, in addition to or alternatively to the temperature measurement, the time span of the stay in the sterilization chamber can also be detected and stored by means of a time counter. This value is also readable for control. In combination, for example, a temperature and time measurement, the proper temperature exposure over a predetermined period of time is logged.

In addition, features are described which preferably have meaning in combination with the features of claim 9, but in principle also with only some features of claim 9 or alone may have meaning.

Thus, in a development of the subject invention, it is provided that a moisture value is measured by means of the RFID transponder or a sensor assigned to it and stored in the RFID transponder. Accordingly, the proposed RFID transponder is further suitable for detecting a proper steam sterilization in an autoclave, in which the sterilization objects are heated together with the transport container and the transponder under pressure in water vapor.

A further development proves to be particularly advantageous in which the measured temperature value and / or the recorded time span and / or the measured moisture value are stored assigned to the date, whereby not only the correct sterilization process can be checked in a check by reading the transponder data, but also beyond also the sterilization time. In a development, in addition to the date in addition, the time can be recorded or stored in addition, also further information on the design of the sterilization chamber and the location of the same.

Particularly advantageous is a further development of the method in which the storage of temperature value and / or time and / or humidity value in response to exceeding a certain temperature and / or Zeitspannen- and / or moisture threshold value is made. For example, the storage of the individual or several measured values only starts when a temperature threshold of 100 ° C. is exceeded. After this, storage can continue for a period of, for example, 5 minutes upon further detection of the temperature value above the temperature threshold value. Accordingly, according to This solution stores only the measurement data relevant for proper sterilization.

The invention with reference to the accompanying drawings, which illustrates several embodiments, explained in more detail. It shows:

1 shows a perspective view of a transport container in the form of a transport cover with an RFID transponder arranged in an inner pocket, as well as assignable sterilization objects,

FIG. 2 shows a further embodiment of the transport container according to FIG. 1; FIG.

Fig. 3 is a corresponding to FIG. 1 perspective view, but after

Summarizing the sterilization objects in the transport envelope and closure thereof;

Fig. 4 is a representation corresponding to Fig. 3 in a container according to Fig. 2;

5 shows the greatly enlarged section according to the line V-V in Figure 3 through the inner pocket of the transport case receiving the transponder ..;

FIG. 6 shows an illustration according to FIG. 5 with respect to the object according to FIG. 4, cut along the line VI-VI; FIG.

7 shows a transport container in a further embodiment as a molded part;

8 shows a cross section through the article according to FIG. 7, cut along the line VIII-VIII. Shown and described is first with reference to FIG. 1, a transport container T in the form of a transport cover 1, consisting for example of a plastic film material. This transport cover 1 is sealed along three sides, for example by welding. The opening 2 can be closed to protect the objects to be stored in the transport envelope 1 and to be transported. The closure means provided along the line 6 are not shown here. In principle, it can also be a simple welding, so that the bag is to open a total of destructive. But it may also be repeatedly disclosed opening means.

In the illustrated embodiment, the transport cover 1 sterilization objects 3 in the form of existing from a thermoplastic elastomer material plug for medicine containers can be assigned.

The sterilization objects 3 and the transport cover 1 are supplied for sterilization of a sterilization chamber or an autoclave. The proper sterilization process is logged by an RFID transponder 4 which can be unambiguously assigned to the objects 3 for sterilization. The latter is permanently connected to the transport casing 1, so further accommodated in a pocket 5 of the transport casing 1. In the exemplary embodiment of FIG. 1, the pocket 5 is positioned close to the edge of the opening 2, this further in a collar section 7 facing away from the bag with reference to the closure line 6.

In the embodiment of FIG. 2, a separate pocket 16 is provided in the bottom of the transport container T by a closure 21 crossing the transport container T, in the embodiment in the form of a simple welding, in which the RFID transponder 4 is received. He is recorded in it freely movable. It can be seen from the cross-sectional representations of FIGS. 5 and 6 that the object of FIG. 5 is provided with a separate pocket 5 by means of an envelope of the film 18 in the edge region in the film 18. Alternatively, it may be provided by welding an additional film layer 19 under the film layer 18.

In the case of the object of FIG. 2, the pocket 5 for the RFID transponder 4 is made simpler. Because here are along the line 21, cf. 4, simply the two film layers 18 and 17, which in any case form the transport container T, are welded together.

The RFID transponder 4 is used to detect the temperature, further possibly also the degree of moisture, further in particular as a function of a period of time during the sterilization process. The detected values are stored, if appropriate, also assigned a date value, and can subsequently be read out via a conventional transponder reading unit. Thus, for example, immediately after passing through the sterilization chamber to check the proper sterilization and beyond that also the proper storage in the transponder.

In Fig. 7, another embodiment of a transport container T is shown. This is formed here as a molded part 8, in particular plastic deep-drawn part. This molded part 8 serves to receive sterilization objects 3 in the form of injection ampoules, for which purpose an intermediate layer 9 with a multiplicity of tube-section-shaped several receptacles 10 for vertical holding of the ampoules is provided in the molded part 8.

The receiving space of the molded part 8 forms a first compartment 11. This is adjacent in a first variant, ie further assigned to a side wall of the molded part 8, a second compartment 12 with a reduced footprint. assigns. This compartment 12 extends from an upper edge of the opening edge of the molded part 8 or of the compartment 11 under a central arrangement on the associated side wall over a partial region of the height of the molded part 8.

The compartment 12 is used in this variant for receiving the RFID controller. 4

The opening edge edges of the compartments 11 and 12 extend in a common plane. The associated side wall of the molded part 8, which at the same time forms the dividing wall between the compartments 11 and 12 in a partial section, can be designed so that it is permeable to vapor in the separation area so as to be able to make a corresponding moisture measurement via the RFID controller 4. On the other hand, a desired vapor diffusion openness can then also - only - be achieved by the corresponding foil cover (cover 13) of the compartment 12.

The two compartments 11 and 12 are covered after assembly of the molding 8 with the sterilization objects 3 by said cover 13, which is preferably in one piece. This floor plan is adapted to the total ground plan area resulting from the two compartments 11 and 12, correspondingly has a cover extension 14 extending from a marginal edge.

The cover 13 consists, for example, of a vapor-permeable sheet material. Accordingly, the cover extension 14, which covers the second compartment 12 accommodating the RFID controller 4 and thus allows the moisture measurement to be carried out.

Fig. 8 shows a cross section through the article according to Fig. 7, taken along the line VIII-VIII. As can be seen in the bottom 22 of the container T shown in FIG. 7, the RFID transponder 4 may be arranged. He can glued, clipped or welded. But it can also be provided freely movable lying only in the bottom area.

All disclosed features are essential to the invention. The disclosure content of the associated / attached priority documents (copy of the prior application) is hereby also incorporated in full in the disclosure of the application, also for the purpose of including features of these documents in claims of the present application.

Claims

1. Variety of in a transport container (T) summarized sterilization objects (3), in particular stoppers made of rubber or a thermoplastic elastomer material for medicine containers or medical syringes, characterized in that in the transport container (T) further rests an RFID transponder (4) and in that the RFID transponder (4) has a sensor such as a temperature sensor and / or a time counter, wherein the measured temperature and / or a detected time span is stored in the RFID transponder (4).

2. Sterilization objects summarized in a transport container according to claim 1 or in particular according thereto, characterized in that the RFID transponder (4) has a humidity sensor and that the measured moisture value is stored in the RFID transponder (4).

3. Sterilization objects combined in a transport container according to one or more of the preceding claims or in particular according thereto, characterized in that the RFID transponder (4) has a

Having the date counter and that the measured temperature value and / or the detected time period and / or the measured humidity value associated with a date are stored.

4. Sterilization objects combined in a transport container according to one or more of the preceding claims or in particular according thereto, characterized in that the RFID transponder (4) is arranged in a pocket of the transport container (T).

5. Sterilization objects combined in a transport container according to one or more of the preceding claims or in particular according thereto, characterized in that the pocket is an inner pocket (5).

6. Sterilization objects combined in a transport container according to one or more of the preceding claims or in particular according thereto, characterized in that the transport container (T) is a transport bag (1).

7. Sterilization objects combined in a transport container according to one or more of the preceding claims or in particular according thereto, characterized in that the transport container (T) is a molded part (8) with a cover (13).

8. In a transport container summarized sterilization objects according to one or more of the preceding claims or in particular according thereto, characterized in that the transport container (T) by means of the cover in at least two compartments (11, 12) is divided.

9. A method for sterilizing sterilization objects (3), such as in particular stoppers made of rubber or a thermoplastic elastomer material for medicine containers or medical syringes, wherein the sterilization objects (3) are combined in a transport container (T), characterized in that in addition an RFID transponder (4) is added to the transport container (T) and that by means of the RFID

Transponders (4) or a sensor associated therewith a value such as a temperature measured and / or as well as the measured value, so for example the measured temperature and / or the detected time period in the RFID transponder (4) is stored.

10. The method according to claim 9 or in particular according thereto, characterized in that by means of the RFID transponder (4) a moisture value is measured and stored in the RFID transponder (4).

11. The method according to one or more of claims 9 to 10 or in particular according thereto, characterized in that the measured temperature value and / or the detected time period and / or the measured moisture value associated with a date are stored.

12. The method according to one or more of claims 9 to 11 or in particular according thereto, characterized in that the storage of temperature value and / or time period and / or humidity value made in response to exceeding a certain temperature and / or Zeitspannen- and / or Feuchtigkeitsschwellwertes becomes.

13. Transport container for sterilization objects, for example in the form of a bag-like transport cover or formed by means of a molded part, characterized in that in the transport container rests an RFID transponder.

14. Transport container according to claim 13 or in particular according thereto, characterized in that the RFID transponder rests in one of the separate for the sterilization objects portion of the container.

15. Transport container according to one or more of the preceding claims 13 to 14 or in particular according thereto, characterized in that the portion is formed as a separate compartment or separate pocket space.

16. Transport container according to one or more of the preceding claims 13 to 15 or in particular according thereto, characterized in that the transport container consists at least partially of a vapor-permeable ons open material.

17. Transport container according to one or more of the preceding claims 13 to 16 or in particular according thereto, characterized in that the RFID transponder has a sensor.

18. Transport container according to one or more of the preceding claims 13 to 17 or in particular according thereto, characterized in that the RFID transponder has a time recording device.