EP3863689A2

EP3863689A2 - Sterilization packaging for sterile products, having a sensor device, and sterilization method with active sterilization process adaptation

Info

Publication number: EP3863689A2
Application number: EP19787200.5A
Authority: EP
Inventors: Matthias Schweizer
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2018-10-11
Filing date: 2019-10-10
Publication date: 2021-08-18
Also published as: WO2020074656A3; CN112703018A; US20220008590A1; WO2020074656A2; CN112703018B; DE102018125180A1

Abstract

The invention relates to a sterilization packaging (1) for medical packaged goods (2), comprising an interior space (4) which is provided and adapted to receive the medical packaged goods (2), and at least one sensor unit (6, 8, 10) which is provided and adapted to measure a first parameter in the interior space (4), characterized in that the sterilization packaging (1) is equipped with at least one data transmission unit (12) which is provided and adapted to receive and transmit parameter values measured by the at least one sensor unit (6, 8, 10), and that the sterilization packaging (1) and the at least one data transmission unit (12) are matched to one another in such a way that a transmission of the parameter values received by the data transmission unit (12) into an outer space (14) around the sterilization packaging (1) is enabled. The invention also relates to a sterilization method for medical packaged goods, comprising the steps of introducing the packaged goods into an interior space of a sterilization packaging and closing the sterilization packaging; introducing the closed sterilization packaging into a receiving chamber of a sterilizer; starting a sterilization process flow in the sterilizer by means of a control unit of the sterilizer, characterized in that the sterilization method further comprises the following steps: detecting parameter values in the interior space of the sterilization packaging and transmitting these detected parameter values to the control unit of the sterilizer; and controlling the sterilization process flow as a function of the parameter values recorded in the interior space.

Description

Sterilization packaging for sterile goods with sensor device and

Sterilization process with active sterilization process adjustment

description

Technical field

The present invention relates to a sterilization packaging for receiving sterile goods, which has a sensor device or sensor unit for sterilization parameters. The invention is particularly directed to a sterilization packaging for sterile medical goods, for example surgical instruments or implants, and relates both to dimensionally stable sterilization packaging, for example lockable sterile containers with or without insertable baskets, and to soft sterilization packaging, for example sterilization bags or sterilization wraps, and individual (individual) Packaging for surgical instruments or implants.

Background of the Invention

Medical items must be sterilized before use. In the case of reusable articles, such as surgical instruments, this is usually ensured in hospital operations by placing the articles to be sterilized in a sterile container after use and cleaning, or packing / wrapping them in a sterilization textile or foil and then together with the sterile container or the Textile / the film can be sterilized in a sterilizer (autoclave). Articles for single use, such as implants, can also be sterilized in this way before use. The bacteria and viruses are usually deactivated in the receiving chamber of the sterilizer (sterilizer chamber) at a high temperature and possibly overpressure and for a certain period of time. The concrete target values for temperature, overpressure and duration depend on the sterility requirements and are determined in a validation for daily operation. After the sterilization, a drying step is carried out.

Condensate that forms during sterilization is dried in this step, as this is considered to be a potential danger point for bacterial growth. The duration and temperature of the drying step are also defined in this validation.

A complete sterilization process sequence therefore includes both

Sterilization step, as well as a drying step, which have to be validated for daily clinical operation. After successful validation, the

Sterilization process sequences then have the character of a standard for the clinical operation, which is provided for certain articles, article groups or certain container or sterilization packaging types to be sterilized. Usually two or three different validated sterilization process sequences can be selected for the operation of the sterilizer. A sterilization process sequence, for example, has a specific one

Temperature and pressure profile on, that is, a specific time course of

Temperature and pressure over the duration of the sterilization process. The profiles of the different sterilization process sequences can differ in the process parameters temperature, pressure and duration and depending on the items to be sterilized or

Sterilization packaging type can be selected. If a sterilization process flow has been validated, the target values of individual parameters and / or the intended profile of this sterilization process flow may no longer be changed in daily clinical operation or if a process parameter changes, the changed one

Sterilization process flow can be validated again.

When validating such a sterilization process, a temperature sensor and a pressure sensor are first introduced into the inside of a sterilization package (container or wrap), which is packed with sterile goods, for example. The temperature sensor and the pressure sensor are usually in one

built-in battery-operated recording module and record the measured temperature and pressure when switched on

Storage medium in the recording module.

Before the execution of the validation process is started, the sterilization packaging for which a validation is to be carried out, then inserted into the sterilizer chamber together with the battery-operated recording module. Standard sensors for temperature and pressure are installed in the sterilizer's receiving chamber, the values of which are continuously measured and recorded during sterilization. The recorded values can then be evaluated after the sterilization process has been carried out.

The course of a sterilization process is rigidly programmed.

For example, after a start-up period, within which the target values for temperature and / or pressure are to be realized, a holding period is started, within which the then reached values for temperature and / or pressure are kept and within which the requested sterilization and drying performance in the sterilization packaging is expected.

As soon as the sterilization packaging to be validated is in the

Sterilization chamber, the sterilization process sequence to be validated can be started. During the sterilization process to be validated, the temperature and pressure values are then measured via the sensors for temperature and pressure inside the sterilizer chamber provided as standard and

recorded.

After completion of the sterilization process to be validated, the sterilization packaging to be validated is removed from the sterilizer chamber, opened, the residual moisture in the sterilization packaging is determined and the recording module is removed. The recorded temperature and

Pressure measurement values from inside the sterilization packaging are then read out from the storage medium of the recording module. Now it is checked whether inside the sterilization packaging the required values for temperature and pressure over the intended period of time templates or the recorded chronological course of temperature and pressure corresponds to the intended profile.

If the check is positive, the measured residual moisture was in the

If the target range and the required temperature and pressure were available inside the sterilization packaging for the required period of time, the measured temperature and pressure values from the sterilizer chamber and the Time span in which the temperature and pressure values in the sterilizer chamber templates, or the measured temperature and pressure profile in the sterilizer chamber, are defined as validated reference values and the sterilization process run is considered validated.

If the now validated sterilization process for sterilizing medical articles is carried out, the measurement inside the

Sterilization packaging so that the temperature and pressure during the

Carrying out the sterilization process sequence can only be measured using the sensors in the sterilizer chamber, i.e. outside the sterilization packaging. If the reference pressure and the reference temperature are realized in the sterilizer chamber for the duration of the reference period, it is assumed that the required sterilization conditions have also been reached inside the sterilization packaging.

In other words, in the case of sterilization process sequences after the validation has been completed, only inside the sterilizer chamber and outside the

Sterilization packaging measured and based on the validation result inferred about the sterilization success. It is therefore an indirect indirect sterilization control. The documentation on the performed

The sterilization process for the treated sterilization packaging is also only based on the values measured in the sterilizer chamber and a comparison with the reference values of the validation.

However, this has the disadvantage that the validation results are no longer reliable as soon as the conditions under which the sterilization process is carried out differ from the conditions under which the validation was carried out. In concrete terms, it often happens in everyday clinical practice that the

Sterilization packaging can be loaded with other medical items, in different quantities and / or in a different packing arrangement. As a result, this can lead to the fact that the specified target values of the sterilization parameters (temperature and pressure over the intended period of time) inside the sterilization packaging are either not achieved at all or that the specified target values of the

Sterilization parameters much earlier than in the standard process Can be reached inside the sterilization packaging, even though the temperature and pressure values recorded by the sensors of the sterilizer chamber correspond to the reference values of the validation. It can also happen that the intended

Degree of dryness at the end of the reference period for the drying step has not been reached completely or is achieved well before the end of this reference period.

Consequently, although the validation of the containers is usually already carried out with a maximum load, in the former cases there may be a risk for the patient in exceptional cases if the loaded container (and thus the medical articles contained therein) may not (at every point in the

Sterile container) is sterile, and in the latter two cases, the procedure is inefficient because the sterilization process takes an unnecessarily long time and energy.

Brief description of the invention

It is therefore an object of the present invention to overcome or at least alleviate the disadvantages of the known sterilization process sequences described above. In particular, sterilization packaging and a

Sterilization procedures are provided that are both efficient

Sterilization process sequence are made possible, as can be ensured that the intended sterility and drying conditions are met.

To achieve this object, the invention is based on the general idea that the sterilization process sequence is no longer controlled (only) on the basis of the rigidly programmed sterilization process sequence and consequently only indirectly via the values of the sterilization parameters temperature measured in the sterilizer chamber, i.e. in the outside space around the sterilization packaging and pressure to conclude the sterilization success inside the sterilization packaging, but also to carry out the sterilization process sequence also or exclusively via values of the sterilization parameters temperature and / or pressure and in particular relative (air) humidity measured in the interior of the sterilization packaging and thus to carry out a direct control of the sterilization success. In other words, according to the invention for controlling the

Sterilization process sequence and for sterilization control measurement values are used, which are recorded where the packaged goods are to be sterilized, namely in the interior of the sterilization packaging. A control of the

Sterilization process sequence based on the values measured in the interior of the sterilization packaging necessitates a data transmission of these measured values in real time to the control unit of the sterilizer. For the purposes of the invention, a

Sterilization packaging is provided, with which it is possible to determine measurement values for the sterilization parameters temperature and / or pressure and / or humidity in the interior of the sterilization packaging and the measured values determined in real time to the outside around the sterilization packaging

To transmit data receiving unit of the sterilizer, which can use the received measurement values or measurement data from the interior of the sterilization packaging by means of a control unit to control the sterilization process.

The object is achieved according to the invention by a sterilization packaging with the features of claim 1 and a sterilization method with the features of claim 9.

In concrete terms, a sterilization packaging for medical packaged goods is proposed with an interior space that is provided and adapted to accommodate the medical packaged goods, for example medical articles such as surgical instruments or implants, and at least one sensor unit that is used for this purpose

is provided and adapted to the current sterilization process

Measure parameter values of at least one first parameter from the sterilization parameters temperature, pressure and relative air humidity in the interior. In other words, the at least one sensor unit measures the values of temperature and / or pressure and / or relative air humidity in the interior. That is further

Sterilization packaging equipped with at least one data transmission unit, which is provided and adapted to receive and send parameter values measured by the at least one sensor unit, and are

Sterilization packaging and the at least one data transmission unit are matched to one another in order to send the data transmission unit received parameter values by means of the data transmission unit in an outside space to enable the sterilization packaging.

The at least one sensor unit is in particular one

Temperature sensor unit and the sterilization packaging preferably has a further, second sensor unit, which is a pressure sensor unit, so that at least the

Temperature and preferably also the pressure in the interior of the sterilization packaging can be measured. This is advantageous because for the common ones

Sterilization requirements must be at least a high temperature, possibly in connection with high pressure (overpressure), and by (a) appropriate

Sensor (s) can be checked whether the conditions inside the

Sterilization packaging meets the sterilization requirements.

The sterilization packaging further preferably has a further, third

Sensor unit on which the relative (air) humidity inside the

Can determine sterilization packaging. In particular, the third sensor unit is a capacitive moisture sensor. It is also advantageous to determine the (relative) humidity in the interior of the sterilization packaging, as the usual ones

Sterilization processes are carried out under the influence of steam (for example during autoclaving) and in the drying step following the sterilization step it can be determined with the aid of a moisture sensor whether the intended drying or the degree of drying to be achieved has been achieved.

In the case of multiple sensor units, data transmission to the outside around the sterilization packaging can be collected via a single one

Data transmission unit take place. In this case it receives one

Data transmission unit the measured parameter values of all provided

Sensor units and sends them into the outside space around the sterilization packaging. Alternatively, a data transmission unit can be provided per sensor unit, which only receives the parameter values determined by the assigned sensor unit and sends them into the outside space around the sterilization packaging. A common data transmission unit can also be provided for a part of the plurality of sensor units, for example a common data transmission unit for the temperature sensor and pressure sensor, which measures the temperature and pressure receives and sends to the outside, and another data transmission unit for the moisture sensor, which receives the moisture measurement values and sends to the outside. In this way, data transmission units

can be used efficiently and according to the situation, while at the same time there is the possibility of retrofitting individual sensor units and / or data transmission units.

The sterilization packaging can be a reusable solid packaging, for example a common sterile container with a flap or lid, or a (one-way) soft packaging. Current examples of

Soft packaging is sterilization bags and sterilization wipes made of textile (special fleece) or foil into which the items to be sterilized are inserted or wrapped (so-called "sterilization wrap").

The data transmission unit preferably sends

received parameter values (by means of the data transmission unit) via

electromagnetic waves, such as WLAN, radio, or Bluetooth. This is an advantage because, especially with sterile requirements and the associated necessary recontamination barriers, a cable solution leads to high costs for the preparation of the lubricant and regular checking of the sterilization packaging, because all cable passages of the sterilization packaging must be demonstrably sealed. In the case of wireless data transmission via electromagnetic waves, however, technical difficulties can arise, particularly in the case of sterile containers which are usually made of a metal or a metal alloy, since metallic material has a shielding effect. In such a case, the coordination of the sterilization packaging, here in particular sterile containers, and the

Data transmission unit to each other a special role. For example, the wall thickness and / or the material of the sterile container to the transmission strength of the

Data transmission unit to be adapted to a passage of the

to allow electromagnetic waves through the container material. Alternatively or additionally, the data transmission unit can be selected or designed so that its transmission power enables the passage of the electromagnetic waves through the existing or intended container material. The coordination of the data transmission unit and the sterile packaging unit

one another can therefore be used both for existing containers in which the sensors and the Data transmission unit to be retrofitted, as well as for new containers created especially for this purpose. The same considerations apply to soft packaging in the form of metallic foils or metallic fabric.

A transmission of those received from the data transmission unit

Parameter values via a cable nevertheless represent an alternative preferred solution, which is to be preferred in particular in the case of thick-walled or otherwise strongly shielding sterilization packaging, in particular containers, or radiation-sensitive sterilization goods or other radiation-sensitive components in the environment in order to favor the sterilization packaging. In these cases, the sealed in the sterilization packaging

Cable passages sufficient for sterilization requirements must be introduced. Under specially sealed and the sterilization requirements will be sufficient

in particular understood a seal that is adapted both to the high temperature, excess pressure and / or air humidity present during sterilization and is suitable or adapted as a recontamination barrier. For example, in the case of containers, the sensor cable (s) can be placed between the seal and the tub. A cable solution is also conceivable, in which e.g. the sensors are installed in the lid and the cables from the lid are connected to the sterilizer.

In addition, the at least one data transmission unit is preferably provided and adapted to send the received parameter values from the sterilization parameters of temperature, pressure or humidity only when a predefined limit value for a first parameter has been reached.

In a case in which the sterilization packaging is equipped with at least one further, second sensor device, which is provided and adapted for this purpose, it is further preferred that parameter values (relating to the current sterilization process) of a second parameter from the aforementioned

Capture sterilization parameters in the interior, and the at least one

Data transmission unit is provided and adapted to receive and send the parameter values measured by the second sensor unit

Data transmission unit to be provided and adapted to receive the received parameter values of the first and second parameters only when the to send a predefined limit for the first parameter and a predefined limit for the second parameter.

Accordingly, may also be preferred in a case where the

Sterilization packaging is equipped with at least one further, third sensor device, which is provided and adapted for this (the current

Parameter values relating to the sterilization process of a third parameter from the aforementioned sterilization parameters in the interior, and the at least one data transmission unit is provided and adapted to receive and transmit the parameter values measured by the third sensor unit, the data transmission unit is provided and adapted to the to send received parameter values of the first, second and third parameters only when the predefined limit value for the first parameter, the predefined limit value for the second parameter, of a predefined limit value for the third parameter.

In this way, the period in which the data transmission unit

Sends measured values to the outside, can be limited to the period of time required for the control of the sterilization process and the control of the

Success of sterilization is essential to be limited. Hence a

Sterilization-resistant battery or other sterilization-resistant energy source to which the data transmission unit is connected are protected and energy consumption is reduced.

The at least one sensor unit and / or the at least one data transmission unit is preferably permanently installed with the sterilization packaging. This is particularly relevant for reusable sterile containers. The fixed installation can ensure that the intended

Data transmission unit is also matched to the intended sterilization packaging and vice versa. An unfavorable combination of data transmission unit and sterilization packaging made by the user, which are not coordinated and a transmission of the

Data transmission unit received parameter values in the outside around the Not enable sterilization packaging, can already be prevented by the manufacturer.

The sterilization packaging is particularly preferably a sterile container which has a container trough and an associated container lid, and is the at least one sensor unit and / or the at least one

Data transmission unit that is permanently installed with the sterilization packaging, permanently installed with the container trough or the container lid, preferably the container lid. The associated container lid is understood to be a lid for the container trough which is provided and adapted to tightly close the container trough according to the sterilization requirements. Container lids often fit on different container trays of different sizes / volumes. The selection of the container trough depends, for example, on the size / volume of the packaged goods and the container trough is then closed with a lid that fits each of the different container troughs. Will the at least one

Sensor unit and / or the at least one data transmission unit arranged firmly in the cover has the advantage that the costs in the manufacture or

Retrofitting can be kept to a minimum, since the same number of lids as container trays do not necessarily have to be provided in the clinic. Alternatively, the at least one sensor unit and / or the at least one data transmission unit can also be arranged on the container trough or on a basket into which the packaged goods are placed and which is placed in the container trough. From the cost point of view, it is advantageous to arrange the at least one sensor unit and / or the at least one data transmission unit on the component (cover, tray or basket) that has the lowest wear-related replacement frequency.

Alternatively, the at least one sensor unit and / or the is preferred

at least one data transmission unit is installed to form a sterilized, separate, encapsulated module and the module is provided and adapted to be placed anywhere in the interior. The module can also be a sieve basket

Sterilization packaging can be attached. A separate module is understood to mean a module that is not (permanently) connected to the sterilization packaging and is available or freely movable independently of the sterilization packaging. Such a module can protect the packaged goods in the interior of the sterilization packaging Sterilization process flow are added and then remains in the sterilization packaging until use of the items to be sterilized. This has the advantage that the

(Wear-related) replacement of parts of the sterilization packaging (lid, when, basket) can be replaced independently of the at least one sensor unit and / or the at least one data transmission unit. Disposable sterilization packaging such as sterilization wipes or films (sterilization wraps) can be easily added to a separate module. The module also has a sterilization-resistant battery or a sterilization-resistant energy source

is particularly designed so that the stored energy is sufficient for at least one sterilization process.

The at least one data transmission unit is preferably further provided and adapted to receive signals from the outside, and the sterilization packaging and the at least one data transmission unit are matched to one another in order to enable reception of the signals from the outside. In this way, the data transmission unit can be switched off by a signal received from the outside, for example when a target state has been reached in the interior of the sterilization packaging, and energy can be saved.

Furthermore, a sterilization system is provided according to the invention. The

The sterilization system according to the invention is equipped with a sterilizer and at least one sterilization package, the sterilizer having a receiving chamber for receiving the at least one sterilization package, at least one

Data receiving unit that is at least one in the outdoor area

Sterilization packaging is arranged, and has a control unit and the

Control unit is provided and adapted to be in contact with the data receiving unit and to control a sterilization process in the receiving chamber. The at least one

Sterilization packaging around one of those described above

Sterilization packaging, the at least one data receiving unit is provided and adapted to receive the parameter values sent by the at least one data transmission unit of the sterilization packaging and to forward them to the control unit, and the control unit is provided and adapted for this purpose, to control the sterilization process sequence depending on the parameter values received by the data receiving unit.

In this way, it is possible for the sterilizer to carry out and adapt the sterilization process sequence taking place in the receiving room depending on the real conditions on the sterile goods, namely in the interior of the sterilization packaging. The sterilization process sequence can thus be adapted in real time to the real conditions or aligned to them in such a way that a defined one

The sterilization and / or drying target is reliably achieved and the time required to achieve the sterilization process is kept as short as possible.

Within the scope of the invention, a sterilization method for medical packaged goods is further proposed, comprising the following steps: i) introducing the packaged goods into an interior of a sterilization pack and then closing the

Sterilization packaging; afterwards ii) introduction of the closed

Sterilization packaging in a receiving chamber of a sterilizer; thereafter iii) starting a (pre-programmed) sterilization process sequence in the sterilizer, the start and execution of the sterilization process sequence being carried out by a control unit in the sterilizer. This points

Sterilization procedures continue the following steps: vi) Capture

Parameter values in the interior of the sterilization packaging and transmission of these detected parameter values (in real time) to the control unit of the sterilizer; and vii) controlling the sterilization process sequence depending on the parameter values detected in the interior.

In other words, the method according to the invention provides one

manually entered by the user or from the program library of the

Sterilizer selected sterilization process sequence to start after a sealed sterilization packaging, in the interior of which there is packaged goods to be sterilized, has been introduced into the receiving chamber of the sterilizer, and at least one parameter, preferably two parameters and further preferably three parameters from the sterilization parameters temperature, pressure and / or

Measure moisture in the interior of the sterilization pack and control the sterilization process as a function of the measured parameter values. The Control of the sterilization process can optionally be supported by parameter values that are determined in the receiving chamber of the sterilizer.

The transfer of the parameter measurement values from the interior of the

Sterilization packaging to the control unit of the sterilizer has the advantage that the sterilization performance is recorded directly on the items to be sterilized and the like

The items to be sterilized can be actively adapted accordingly. Of the

The sterilization process sequence can thus be optimized, since the active control detects in real time when the target state inside the sterilization chamber has been reached. An early termination of the sterilization process flow or a sterilization process flow that goes beyond reaching the target state

prevented. This ensures that the sterilization goal is always achieved and the sterilization process remains efficient. In addition, in the case of multiple sterilization packages in the receiving chamber of the

A separate, individual proof of the sterilization has been provided for each of these sterilization packaging.

The sterilization method according to the invention is preferably carried out with the sterilization packaging described above.

Brief description of the figures

The invention is described below on the basis of preferred exemplary embodiments with reference to the attached drawing. Show it:

Figure 1 is a schematic representation of a sterilization package according to a first embodiment of the invention.

2 shows a schematic illustration of a sterilization packaging according to a second exemplary embodiment of the invention;

3 shows a schematic illustration of a sterilization packaging according to a third exemplary embodiment of the invention; 4 shows a schematic illustration of a sterilization packaging according to a fourth exemplary embodiment of the invention;

5 shows a schematic illustration of a sterilization system according to the invention;

Fig. 6 is a schematic representation of a sterilization process according to the invention.

Description of the embodiments

The figures are only schematic in nature and serve only to understand the invention. The same elements are provided with the same reference symbols. The features of the individual exemplary embodiments can be interchanged.

1 shows a schematic illustration of a sterilization packaging 1 for a medical packaged product 2 according to a first exemplary embodiment of the invention. The sterilization packaging 1 has an interior 4 in which the medical packaged goods 2 are inserted. A temperature sensor unit 6, which measures the temperature in the interior 4, a pressure sensor unit 8, which measures the pressure in the interior 4, and a moisture sensor unit 10, which measures the relative humidity in the interior 4, are arranged on the sterilization packaging 1. A data transmission unit 12 is also arranged on the sterilization packaging 1. The sensor units 6, 8, 10 are connected to the data transmission unit 12 via cables and give the measured values

Parameter values to the data transmission unit 12. The

Data transmission unit 12 sends the received parameter values in the

Outside space 14 around the sterilization packaging 1. Sending takes place through

electromagnetic waves, for example via WLAN, radio or Bluetooth. Alternatively, any other data transmission standard is conceivable. In this exemplary embodiment, the sterilization packaging 1 is a sterile container that has a trough 16 and a lid 18. The sensor units 6, 8, 10 are permanently installed with the sterile container 1. FIG. 2 shows a schematic illustration of a sterilization packaging 1 for a medical packaged product 2 according to a second exemplary embodiment of the invention. The sterilization packaging 1 according to the second exemplary embodiment essentially corresponds to the first exemplary embodiment shown in FIG. 1, with the difference that the data transmission unit 12 does not transmit the received parameter values to the outside 14 via electromagnetic waves, but instead has a cable 20 that starts from of the data transmission unit 12 extends through an opening 22 in the container wall into the outer space 14. The cable 20 can be passed through the wall of the container trough or through the container lid. A passage of the cable 20 between the cover and the tub is also conceivable. The opening 22 is sealed in accordance with the requirements of a sterile-compatible recontamination barrier. About the cable 20 can

Data transmission unit 12 can be connected to an external data reception unit (not shown).

3 shows a schematic illustration of a sterilization packaging 1 for a medical packaged product 2 according to a third exemplary embodiment of the invention. The sterilization packaging 1 according to the third embodiment corresponds to

Essentially the first exemplary embodiment shown in FIG. 1 with the difference that the sensor units 6, 8, 10 and the data transmission unit 12 are not firmly connected to the sterilization packaging 1, but in a separate,

encapsulated module 24 are installed. The separate module 24 is spatially independent of the sterilization packaging 1 and can be placed anywhere. As in the first

In the exemplary embodiment, the data transmission unit 12 sends the received data

Parameter values via electromagnetic waves in the outside space 14. In this third exemplary embodiment, the sterilization packaging 1 can also be a

Be a sterile container or a soft packaging, for example in the form of a

Sterilization wraps.

FIG. 4 shows a schematic illustration of a sterilization packaging 1 for a medical packaged product 2 according to a fourth exemplary embodiment of the invention. The sterilization packaging 1 according to the fourth exemplary embodiment essentially corresponds to the third exemplary embodiment shown in FIG. 3 with the difference that the separate module 24 does not exceed the received parameter values sends electromagnetic waves into the exterior 14, but instead has a cable 20, which is based on the built in the module 24

Data transmission unit 12 through an opening 22 in the

Sterilization packaging wall extends into the outer space 14. In this

In one embodiment, the sterilization packaging 1 is a sterile container and the opening 22 is sterile-compatible in accordance with the requirements

Sealed recontamination barrier. About the cable 20 can

Data transmission unit 12 can be connected to an external data reception unit (not shown)

5 shows a schematic representation of a sterilization system according to the invention. The sterilization system has a sterilizer 26 with a

Receiving chamber 28 into which one or more sterilization packages 1

can be introduced, a data receiving unit 30 and a control unit 32. During sterilization, measured values are taken from the inside of the

Sterilization packaging 1 arranged data transmission unit 12 to that arranged in the outer space 14 around the sterilization packaging 1

Data receiving unit 30 transmitted. The data receiving unit 30 transmits the measured values to the control unit 32, which are dependent on the measured values from the

Interior of the sterilization packaging 1 controls the sterilization process.

The sterilization packaging 1 can be one or more

Act (different) of the sterilization packaging 1 described above, i.e. containers and / or soft packaging with data transmission via

electromagnetic waves and / or cables and permanently installed and / or modular sensor units.

6 shows a schematic representation of a sterilization method according to the invention. In step S1, sterilization packaging is first used

Filled and closed items to be sterilized. The sterilization packaging either has a separate module with a pressure sensor unit, a temperature sensor unit, a moisture sensor unit and a data transmission unit or the

Sensor units and the data transmission unit are fixed to the

Sterilization packaging installed. The sealed sterilization packaging is then placed in the receiving chamber of a sterilizer in step S2. In step S3, the user either manually turns on

Enter the sterilization process sequence (sterilization program) into the sterilizer control via a user interface or the user selects a pre-programmed sterilization program and adjusts it optionally. The selection and

Adjustment can, for example, depend on the present

Sterilization packaging type or loading with items to be sterilized.

Target temperatures, target pressures, values for the relative humidity to be achieved and the duration over which one or more target values are to be maintained can be adjusted.

A full sterilization program has a sterilization step and a drying step. An exemplary sterilization step has one

Target temperature value of 134 ° C at a target pressure value of 3.1 bar and lasts (in total) 25min to 35min. The drying step can take between a few minutes and more than half an hour. During the sterilization step, the target temperature and the target pressure are maintained for a predetermined period of time. Specifically, in order to inactivate bacteria and viruses, it is necessary to reach a temperature of at least 134 ° C in the entire interior of the container, i.e. also in crevices and between the loads, and to maintain it for at least 3 minutes purely normatively. Due to the compensation time until all container areas have reached the required temperature, the holding time is usually extended to 5 minutes in practice. Low-temperature sterilization processes are not very widespread, in which the normative minimum holding time is 15 minutes at 121 ° C. The DIN standard DIN EN 285: 2015 is also relevant here.

It is also possible for the sterilization step to have a plurality of process sections started in succession with different target parameter values, each of which must be present for a specific period of time. For example, before the actual sterilization at 3.1 bar and 134 ° C, various vacuum cycles are carried out in order to evacuate contaminated air from the container. After each vacuum cycle, the vacuum is equalized by (sterile) water vapor. The sterilization step is followed by the drying step in which the water which is formed in the sterilization packaging during the exposure to steam is evaporated and the items to be sterilized are thus dried. Drying parameters can be the temperature and the relative humidity, optionally the pressure, or just the temperature and a required period of time in which the target temperature must be present. The moisture sensor can be used to determine whether the desired one

Degree of dryness is reached. After configuration of the sterilization program, the sterilization program is started in step S4.

After the start of the sterilization program in step S5

the temperature, pressure and relative humidity in the interior of the sterilization packaging are measured continuously or at specific intervals and transmitted to the control unit of the sterilizer. For this purpose, the data transmission unit located in the interior of the sterilization packaging sends the data from the

Sensor values receiving parameter values to the control unit of the sterilizer in the outer space around the sterilization packaging. While step S5 continues, step S6 is started. The two steps S5 and S6 then run in parallel until the end of step S6.

In step S6, the control unit of the sterilizer compares the measured values received in step S5 with the target parameters (target values) defined in step S3 from the configured sterilization program. Once the target parameters have been reached, the defined (column) period begins to run. During this period the runs

Measure the parameters as in step S5 and the control unit compares the measured values with the target values. This serves as a check since the defined target parameter values must be available over the entire defined period (holding time). If one of the measured values falls below a tolerance range of the target value, the defined time period is reset to 0 and step S6 starts again. If the defined target parameter values remain in the target range until the end of the defined period, the sterilization target is considered to have been reached. In the case of a sterilization step, which has several process sections, each with different target parameter values and associated (periods), step S6 is for each one

Process section driven in sequence and after reaching the

Process stage target of the last process stage, the sterilization target is considered reached. The sterilization step S6 is then ended and the sterilization program then continues to step S7.

The defined drying step is started in step S7. As in step S6, step S5 also continues in parallel with step S7. In step S7, the compares the

Control unit the measured parameter values with the defined target parameter values of the drying step. The drying step is considered complete when the measured relative humidity reaches the defined target value. Alternatively, the drying step is considered complete if, instead of a target value for the relative humidity, only a required period of time has been defined and the defined one

Period of time was run through. If the drying step is completed, steps S7 and step S5, which are carried out in parallel, are ended, and that

The sterilization program has ended.

The control and adaptation or control of the sterilization process sequence thus takes place in real time and as a function of the sterilization parameters measured on the items to be sterilized, that is to say in the interior of the sterilization packaging. Validation processes upstream of the sterilization process flows and indirect ones

Process controls are thus obsolete and replaced by the method according to the invention, which enables more efficient and safer process management. As an option, parameters measured in the receiving chamber can be used to support

Process control can be used and documented.

By recording the real-time data, a control can be carried out for each individual

Sterilization packaging is made possible and the sterilization result or the ID of the sterilization packaging are electronically linked to the patient record. The method according to the invention thus also offers the possibility of simplified and consistent electronic clinic documentation.

Claims

Expectations

1. Sterilization packaging (1) for medical packaged goods (2) with

an interior (4) which is provided and adapted to the medical

Packaged goods (2) to record, and

at least one sensor unit (6, 8, 10) which is provided and adapted to measure parameter values relating to the current sterilization process of at least one first parameter from the sterilization parameters temperature, pressure and relative air humidity in the interior (4),

characterized in that

the sterilization packaging (1) is equipped with at least one data transmission unit (12) which is provided and adapted to receive and transmit the parameter values measured by the at least one sensor unit (6, 8, 10), and

the sterilization packaging (1) and the at least one data transmission unit (12) are matched to one another in order to send the data from the

Data transmission unit (12) received parameter values in a

Outside space (14) to enable the sterilization packaging (1).

2. Sterilization packaging (1) according to claim 1, characterized in that the parameter values received from the data transmission unit (12) are transmitted via electromagnetic waves.

3. Sterilization packaging (1) according to claim 1 or 2, characterized in that the at least one data transmission unit (12) is provided and adapted to send the received parameter values only when a predefined limit value for the first parameter is reached.

4. Sterilization packaging (1) according to claim 3, characterized in that the sterilization packaging (1) with at least one further sensor device (6,

8, 10), which is provided and adapted to, parameter values relating to the current sterilization process from a second parameter to measure the sterilization parameters temperature, pressure and relative air humidity in the interior (4), and the at least one data transmission unit (12) is provided and adapted to receive and send the parameter values measured by the further sensor unit (6, 8, 10), and the

at least one data transmission unit (12) is provided and adapted to receive the parameter values received only when the predefined value is reached

Limit for the first parameter and a predefined limit for the second parameter.

5. sterilization packaging (1) according to any one of claims 1 to 4, characterized

characterized in that the at least one sensor unit (6, 8, 10) and / or the at least one data transmission unit (12) is fixed to the

Sterilization packaging (1) is installed.

6. Sterilization packaging (1) according to claim 5, characterized in that the sterilization packaging (1) is a sterile container, which has a container trough and an associated container lid, and the at least one

Sensor unit (6, 8, 10) and / or the at least one data transmission unit (12), which is firmly installed with the sterilization packaging (1), firmly with the

Container lid or the container trough is installed.

7. sterilization packaging (1) according to any one of claims 1 to 4, characterized

characterized in that the at least one sensor unit (6, 8, 10) and / or the at least one data transmission unit (12) is built into a separate, encapsulated module (24) and the module (24) is provided and adapted for this purpose, freely in the interior (4) to be placeable.

8. sterilization packaging (1) according to any one of claims 1 to 7, characterized

characterized in that the at least one data transmission unit (12) is further provided and adapted to receive signals from the outside (14), and the sterilization packaging (1) and the at least one

Data transmission unit (12) are matched to one another

To enable reception of the signals from the outside (14).

9. Sterilization system with a sterilizer (26) and at least one sterilization package, the sterilizer (26) having a receiving chamber (28) for receiving the at least one sterilization package (1), at least one data receiving unit (30) in the outside space (14) the at least one sterilization packaging (1) is arranged, and has a control unit (32) and the control unit (32) is provided and adapted for this purpose with which

Data receiving unit (30) to be in information exchange contact and to control a sterilization process in the receiving chamber (28), characterized in that

the at least one sterilization package (1) is a sterilization package (1) according to one of claims 1 to 8,

the at least one data reception unit (30) is provided and adapted to that by the at least one data transmission unit (12)

Receive sterilization packaging (1) sent parameter values and forward them to the control unit (32) and

the control unit (32) is provided and adapted to the sterilization process as a function of that received by the data receiving unit (30)

Control parameter values.

10. Sterilization procedure for medical packaged goods with the steps

i) bringing the packaged goods into an interior of a sterilization packaging and

Closing the sterilization packaging;

ii) placing the sealed sterilization packaging in a

Receiving chamber of a sterilizer;

iii) Start a sterilization process flow in the sterilizer by a

Control unit of the sterilizer, characterized in that

the sterilization process further comprises the following steps:

iv) detection of parameter values of at least one first parameter from the

Sterilization parameters temperature, pressure and relative humidity in the interior of the sterilization packaging and transmission of these recorded

Parameter values to the control unit of the sterilizer; and

v) Controlling the sterilization process as a function of the parameter values recorded in the interior.

11. Sterilization process according to claim 10, characterized in that the sterilization process is carried out with a sterilization packaging (1) according to one of claims 1 to 8.