WO2010130784A1

WO2010130784A1 - Identification part for a system part

Info

Publication number: WO2010130784A1
Application number: PCT/EP2010/056552
Authority: WO
Inventors: Peter Grosse; Joachim Huyer
Original assignee: Peter Grosse; Joachim Huyer
Priority date: 2009-05-15
Filing date: 2010-05-12
Publication date: 2010-11-18
Also published as: CH700988A2

Abstract

The invention relates to an identification part (1) for a system part, comprising a main component (10) in which characteristic data and/or an identification number is/are stored. In addition, an activation status, which is set to activated or deactivated, is stored in the main component (10). The identification part (1) further comprises means for changing the activation status, and the main component (10) is designed such that the characteristic data and/or the identification number can be retrieved if, and only if, the activation status is set to the activated state. In this way, a qualification process can be reliably carried out in a simple and fast manner.

Description

Identification part for a plant part

The present invention relates to a marking part for a plant part according to the preamble of the independent device claim and a method for qualification according to the preamble of the independent method claim.

For installations in the life sciences industries, in particular for installations subject to the requirements of national and international approval authorities, e.g. US FDA, especially for GMP facilities (Good Manufacturing Practice) For example, when used in the pharmaceutical industry for the production of pharmaceuticals, high demands are placed on the installed equipment and plant components before the plant is allowed to operate at all and a validation of a manufacturing process can be carried out. These requirements apply to all parts of the plant, such. B. also for systems of the trades HVACS (heating, ventilation, air conditioning, refrigeration and sanitation), but especially for manually or mechanically moving and controlled equipment parts such. As filters, pumps, valves, flaps, motors or fans, which are installed in the system. The plant parts are subjected to a great deal of effort in several steps of a qualification, whereby the plant components are checked for availability during the installation qualification. Even this qualification step is done automatically by the marking part according to the invention.

If a plant or plant component is already tested in the production plant of the plant component and a FAT test (Factory Acceptance Test) is carried out, the characteristics and the Results and the test parameters are already stored on the inventive characterizing part. During the subsequent subsequent acceptance in the system on site, a SAT test (Site Acceptance Test) is carried out so that the stored data can already be accessed. On the occasion of the acceptance at the production site (FAT), it is checked whether the tested part of the plant also meets the specified requirements. On the occasion of the on-site inspection (SAT), it is checked whether every planned part of the system has been installed and installed in the right place according to the RI-Schemes and the installation plans within the system.

Such qualifications, which consist of individual qualification steps, such as DQ, IQ, OQ, PQ and calibration (DQ = Design Qualification, IQ = Installation Qualification, OQ = Operational Qualification or Function Qualification, PQ = Performance Qualification or Performance Qualification) are not only used on the occasion of the Commissioning, even in case of changes to the system and on the occasion of periodic maintenance checks, documents must be updated. These retrofits and requisitions are also complex and cost-intensive, since the individual plant components are often concealed in the plant and are only found after a long search. Also, the administrative effort is enormous to create the corresponding documents and track.

The present invention is therefore based on the object of proposing a device and / or a method with which a qualification and in particular an installation qualification can be made in a simple and fast manner. This object is achieved by the identification part according to the invention, as defined in the independent device claim. The independent method claim defines a method for qualification. Advantageous embodiments will become apparent from the dependent claims.

The essence of the invention consists in the fact that in the marking part according to the invention for a plant part, the marking part comprises a main component in which characteristic data and / or an identification number are stored. The main component also stores an activation status that is either on or off. The identification part comprises means for a change of the activation status and the main component is designed in such a way that the identification data and / or the identification number can be retrieved only if and only if the activation status is set to activated.

The use of the inventive identification part for a plant part is possible both prospectively and retrospectively. In the case of prospective use, the marking part according to the invention for an installation part is already present when the component is mounted on the building component. Preferably, the marking part for a system part according to the invention is attached by the manufacturer of the installation part. In the case of retrospective use, the marking part according to the invention for a plant part is subsequently applied to the plant part. Thus, existing systems can be equipped with the inventive identification part for a system part.

For the qualification, a marking part according to the invention with the main component is provided for each piece of equipment. - A -

The identification data and / or an identification number of the respective plant part are stored in the main component and delivered to the respective producer of the plant part, which attaches the main component to the plant part. On the occasion of the installation of the plant part in the plant, the activation status is set to activated. Only from this time on, the identification data and / or the identification number of the system component can be called up and can be called up by an external recording device. The external logging device then allows easy creation of necessary documentation of the qualification, e.g. IQ test plans. The activation status then remains set to activated so that the characteristic data and / or the identification number of the installation part can be retrieved during periodic installation checks. Advantageously, a unique identification number is assigned, which allows the proper identification of each identification part and thus also the respective part of the system. The identification numbers are not only unique for a system, but for all inventive identification parts that are produced. Thus, it can also be determined if exchanges or other irregularities should occur in a producer of a piece of equipment.

The means for a change in the activation status of the identification part according to the invention preferably comprise an activating component. The activation status is set to enabled if and only if the activation component is connected to the main component.

For the qualification, an activation component is provided per plant section. The main component is from the attached to the part of the plant at the time of acceptance at the production site (FAT). Preferably, the activation component is designed such that it can be connected to each main component in the system and no special assignment must be maintained. The activation component then remains connected to the respective main component, so that the characteristic data and / or the identification number of the system component can in turn be retrieved during periodic maintenance checks. An activation component enables a simple activation by hardware.

In the case of the identification part according to the invention, the means for a change in the activation status are preferably designed to receive a code. The activation status is set to enabled upon receipt of a suitable code.

The receipt of a code allows to easily set the activation status to activated. The code is preferably transmitted wirelessly, but could also be transmitted with a wired solution.

In the case of the identification part according to the invention, the identification part preferably also comprises at least one additional component which can be connected to the main component or to the activation component and in which additional data of the system part are stored.

For changes and maintenance work on the system, the documents of the qualification must be tracked. This can be done easily by adding additional information with information about the changes or about the maintenance work in stored at least one additional component, the at least one additional component then connected to the inventive identification part and the additional data are retrieved via the external detection device. Thus, the documentation of the installation qualification can be tracked easily. The at least one additional component can be connected, for example via bus lines to the main component or to the activation component. Further additional components are simply connected in series to the already connected at least one additional component. Depending on the bus type used, a large number of additional components can be connected simultaneously. Alternatively, the identification part may also comprise separate connection lines for each connected additional component.

Advantageously, the additional data of the at least one additional component via the main component can be retrieved in the inventive identification part.

Thus, the at least one additional component can be produced simply and inexpensively, because existing components of the main component for retrieving the characteristic data for retrieving the additional data can be shared. If the at least one additional component is connected to the activation component, the additional data of the at least one additional component is looped through to the main component.

In the case of the identification part according to the invention, the identification data, the identification number and / or the additional data of the system part are preferably retrievable in wireless form from the identification part. Thus, the identification data, the identification number and / or the additional data can be easily retrieved by the external detection device from the identification part of the respective part of the plant and prepared for the preparation of the IQ inspection plans and IQ reports.

Advantageously, the identification part according to the invention comprises an RFID transponder (RFID = radio frequency identification).

An RFID transponder is a simple solution for retrieving the identification data and / or the additional data in wireless form from the identification part according to the invention.

The identification part according to the invention preferably comprises a passive RFID transponder and the energy required for retrieving the characteristic data and / or the additional data of the system part in wireless form is wirelessly inducible.

A passive RFID transponder does not require a battery and allows a maintenance-free identification part to be produced in a simple and cost-effective manner. The RFID transponder has, for example, an antenna via which the required energy can be wirelessly inducible. Since passive RFID transponders have a limited range, the external detection device is preferably provided with a paddle or telescopic antenna, with which the system can be driven manually. Alternatively, however, active RFID transponders, ie RFID transponders with their own battery for power supply, can be used in the inventive identification part. Advantageously, the marking part according to the invention comprises means which are designed in such a way that after a removal or manipulation of the marking part attached to the system part, the identification data and / or the identification number of the system part can no longer be retrieved.

On the occasion of a periodic maintenance inspection intentional or unintentional manipulations, eg. As a reversal of marking parts, are detected, since the identification parts are no longer available. Irregularities of this kind must subsequently be remedied or noted in the documents produced during the periodic installation inspection. For this example, a connection line, z. As a conductor, the main component is formed such that it is interrupted when removing the identification part of the system part.

In the case of the identification part according to the invention, the characteristic data and / or the additional data preferably include coordinates of a planned location of the installation part in a system and / or information about the maintenance status of the system part.

Since the coordinates of the planned location of the respective part of the plant are stored, concealed installation parts can be located more easily. The coordinates are preferably coded as relative coordinates starting from a reference point of the system with respect to the x, y and z axes in the binary system. Such encoding requires little storage space and it can be covered even larger facilities. Alternatively, other codings may be used for the coordinates. After periodic maintenance work Information about the maintenance work can be stored as additional data in the at least one additional component and the at least one additional component can be connected to the identification part. Thus, this information on the maintenance work for periodic maintenance checks can also be retrieved by the external recording device and incorporated into the revised maintenance plans.

In the case of the identification part according to the invention, the main component preferably has at least one electronic line which has an interruption and the activation component at least one electronic bridge which bridges the interruption when the activation component is connected to the main component.

An electronic line with a break in the main component is a simple solution to prevent the retrieval of the characteristics from the main component when the activation component is not connected to the main component. Alternatively, however, a transmission of encoded information between the main component and the activation component take place in order to check their presence. For such a transmission of encoded information, any existing bus lines can also be used for the connection of the at least one additional component.

A further aspect of the invention relates to a method for qualification, which comprises the following steps: storing characteristics of a plant part in a main component of a marking part, attaching the main component of the marking part to the plant part, installing the plant part in a plant, on activated sites of an activation status of the main component of the identification part by connecting an activation component to the main component of the identification part or by sending an appropriate code received from the identification part and retrieving the identification data stored in the main component of the identification part and / or a stored identification number by an external detection device.

In the method according to the invention, an identification part according to the invention with the main component and the activation component is provided per part of the system. The identification data and / or the identification number of the respective part of the installation are stored in the main component and delivered to the respective producer of the part of the installation who attaches the main component to the part of the plant during the acceptance on the production site (FAT). On the occasion of the installation of the plant part in the plant, the acceptance takes place in the plant on site (SAT) and the activation status is set to activated. Subsequently, the characteristics and / or the identification numbers of the plant parts can be retrieved by the external detection device. The respective retrieval of the characteristic data and / or the identification number of an installation part can be visually and / or acoustically displayed by the external detection device.

Preferably, in the method according to the invention, at least one additional component with additional data stored therein is connected to the main component and / or the activation component.

For changes and maintenance work on the system, the documents of the qualification must be tracked. This can done in a simple manner by additional data stored with information about the changes or maintenance in at least one additional component, the at least one additional component then connected to the inventive identification part and retrieved the additional data on the external detection device. Thus, the documents of qualification can be tracked easily.

Advantageously, the characteristics, the identification number and / or the additional data are retrieved wirelessly in the inventive method.

Thus, the identification data, the identification number and / or the additional data can be easily retrieved by the external detection device from the identification part of the respective part of the plant and prepared for the preparation of the IQ inspection plans and IQ reports.

In the case of the method according to the invention, in the external recording device, a setpoint list and an actual list are preferably maintained for all system parts which are printed out after retrieving the respective identification data, the identification number and / or the additional data and / or are transmitted to a data processing system. The target list corresponds to the list of equipment generated by the CAD software from the RI scheme, and e.g. created an Excel spreadsheet.

The external recording device is loaded at the beginning of the qualification with the aforementioned target list, which includes all parts of the system to be qualified. The characteristics and / or the additional data of each part of the system are retrieved on the occasion of the qualification by the external recording device and Parallel to the target list, an actual list is updated automatically in the external recording device. The person responsible for the qualification can preferably see the current status of the requested parts of the system on a display of the external recording device. For example, queried plant parts in green color and unquoted or not found plant parts can be displayed in red. Preferably, the external detection device can also display the stored coordinates of each piece of equipment, so that any remaining parts of the system can be found more easily. At the end of this qualification step or the installation control, the target list and the actual list can be transmitted from the external recording device to a data processing system, which then revises the IQ / OQ test plans and, if necessary, creates a list of pending scenarios.

The transmission between the external detection device and the data processing system can be wired, z. B. via USB or LAN, or wireless, z. B. via WLAN or Bluetooth.

In the following, the identification part according to the invention and the method for installation qualification according to the invention will be described in more detail with reference to the attached drawings with reference to several exemplary embodiments. Show it:

Fig. 1 - a first embodiment of a erfindungsge- mässen marking part;

2 shows a second embodiment of a marking part according to the invention; 3 shows a third embodiment of a marking part according to the invention;

4 shows a fourth exemplary embodiment of a marking part according to the invention; and

5 shows an exemplary embodiment of a flowchart of the method according to the invention for installation qualification.

1 shows a first embodiment of a marking part 1 according to the invention for a plant part. The identification part 1 comprises a main component 10 and an activation component 11. The main component 10 comprises a memory 100 for the part of the plant data and an interface 106 for programming the memory 100 with the characteristic data. The main component 10 further comprises a passive RFID transponder 101 with an antenna 102, via which both the energy required for retrieving in the wireless form of the characteristic data is wirelessly induced, and the characteristic data can also be called up. The main component further comprises an electronic line 104, which has an interruption 105.

The activation component 11 can be connected to the main component 10 and comprises an electronic bridge 114, which bridges the interruption 105 in the electronic line 104 of the main component 10 when the activation component 11 is connected to the main component 10. The characteristics of the plant part are thus and only then retrievable when the activation component 11 is connected to the main component 10. The identification part 1 may further comprise at least one additional component 12, which has its own memory 120 for additional data. The at least one additional component 12 can be connected via bus lines 103, 113, 123 via the activation component 11 to the passive RFID transponder 101 of the main component 10. The additional data of the at least one additional component 12 can be called up via the main component 10 in wireless form. The at least one additional component 12 further comprises an interface 126 in order to be able to program the memory 120 with the additional data. The active RFID transponder variant, with a larger range, differs in its self-sufficient power supply (battery).

FIG. 2 shows a second exemplary embodiment of a marking part 2 according to the invention for a system part. The identification part 2 comprises a main component 20 and an activation component 21. The main component 20 comprises a memory 200 for characteristics of the plant part and an interface 206 in order to be able to program the memory 200 with the characteristic data. The main component 20 further comprises a passive RFID transponder 201 with an antenna 202, via which both the energy required for retrieving in wireless form the characteristic data is wirelessly induced, and the characteristic data can be called up. The main component further includes an electronic line 204 having an interrupt 205.

The activation component 21 can be connected to the main component 20 and comprises an electronic bridge 214 which, when the activation component 21 is connected to the main component 20, has the interruption 205 in the electronic circuit. device 204 of the main component 20 bridged. The characteristics of the plant part are thus and only then retrievable when the activation component 21 is connected to the main component 20.

The identification part 2 may further comprise at least one additional component 22, which has its own memory 220 for additional data. The at least one additional component 22 can be connected via bus lines 203, 223 to the passive RFID transponder 201 of the main component 20. The additional data of the at least one additional component 22 can be called up via the main component 20 in wireless form. The at least one additional component 22 further comprises an interface 226 in order to be able to program the memory 220 with the additional data. The active RFID transponder variant, with a longer range, differs in its self-sufficient power supply (battery).

3 shows a third exemplary embodiment of a marking part 4 according to the invention for a system part. The identification part 4 comprises a main component 40 and an activation component 41. The main component 40 comprises a memory 400 for the part of the plant and an interface 406 for programming the memory 400 with the characteristics. The main component 40 further includes a passive RFID transponder 401 having an antenna 402 and an electronic lead 404 having an interrupt 405.

The activation component 41 is connectable to the main component 40 and includes an electronic bridge 414, which the interruption 405 in the electronic line 404 of Main component 40 bridged. The characteristics of the plant part are thus and only then retrievable when the activation component 41 is connected to the main component 40.

The identification part 4 may further include at least one additional component 42, which has its own memory 420 for additional data. The memory 420 of the at least one additional component 42 is connected via individual lines 413 via the activation component 41 to the passive RFID transponder 401 of the main component 40. The at least one additional component 42 further comprises an interface

426 to program the memory 420 with the additional data. The active RFID transponder variant, with a larger range, differs in its self-sufficient power supply (battery).

4 shows a fourth exemplary embodiment of a marking part 5 according to the invention for a system part. The identification part 5 comprises a main component 50 and an activation component 51. The main component 50 comprises a memory 500 for the part of the plant data and an interface 506 for programming the memory 500 with the characteristic data. The main component 50 further includes a passive RFID transponder 501 having an antenna 502 and an electronic lead 504 having an interrupt 505.

The activation component 51 can be connected to the main component 50 and comprises an electronic bridge 514, which bridges the interruption 505 in the electronic line 504 of the main component 50. The characteristics of the plant part are therefore and only then retrievable when the activation component 51 is connected to the main component 50.

The identification part 5 may further comprise at least one additional component 52 having its own additional data memory 520. The memory 520 of the at least one additional component 52 is connected via individual lines 513 to the passive RFID transponder 501 of the main component 50. The at least one additional component 52 further comprises an interface 526 in order to be able to program the memory 520 with the additional data. The active RFID transponder variant, with a larger range, differs in its self-sufficient power supply (battery).

Finally, FIG. 5 shows a prospective embodiment of a flowchart of the method according to the invention for installation qualification. In a first step, a company 30 tasked with the qualification prepares 301 main components 10 of a marking part 10 according to the invention by programming characteristic data of a system part 310 into the main component 10. This takes place with customer-specific data and the data according to RI schematics and / or the installation plans for a system 32 of a customer. Subsequently, in a second step 302, the corresponding main components 10 are sent to a respective producer 31 of plant components 310, or made available to the plant instal lator. The main component 10 of the marking part according to the invention is attached by the producer of the plant part to the respective plant part 310. In a third step 303, the respective plant part 310 is supplied to the plant 32 and installed in this. At the same time, in a fourth step 304, the company 30 charged with the qualification prepares 304 activation components 11 for the identification part according to the invention, which are also delivered to the system 32 in a fifth step 305. The activation components 11 are connected on the occasion of installation by the system installer, or in parallel to the assembly of the contracted with the qualification company 30 to the respective main component 10 of the inventive identification parts. From this point in time, the key data stored in the main component can be queried.

Parallel to this or even later, the company 30 charged with the qualification prepares in an sixth step 306 an external detection device 33 which is loaded with a nominal list of the system parts 310 to be qualified. Subsequently, in a seventh step 307 with the external detection device 33, which comprises a paddle or telescopic antenna 330, the entire system is passed and all characteristics of the identification parts according to the invention are queried. In this case, an actual list is tracked on the basis of the set list and the found identification parts, which list is then transmitted to a data processing system 34 and stored there on the server 35 via LAN. With the aid of the data processing system 34, OQ / PQ test plans are subsequently created and, if necessary, a list of pendencies is created.

All automatically generated lists (eg apparatus, measuring point index, calibration list) and test plans (eg IQ / OQ / PQ) are stored in a project-related pool of data processing 34 and on the server. In the additional components 12th Fig. 1, the individual parts of the system, all desired data can be stored such as dimensions, status, test parameters and test results.

After completion of a qualification, all data (characteristic data, status, test parameters, etc.) remain stored in the additional components of the characterization according to the invention, parallel to the server. To comply with the rules of the US Food and Drug Administration (FDA), the regulations 21 CFR (Code For Regulations) Part 11 are established for the handling of the stored data and their access and modification.

For the above-described marking parts further constructive variations can be realized. In particular, wireless programming of the characteristic data, identification number and / or the additional data, for example via the RFID transponder, is also conceivable.

Claims

claims

An identification part (1; 2; 4; 5) for a plant part (310), wherein the identification part (1; 2; 4; 5) comprises a main component (10; 20; 40; 50) in the characteristic data and / or an identification number is stored, characterized in that in the main component (10; 20; 40; 50) an activation status is also stored which is either activated or deactivated, that the identification part (1; 2; 4; 5) means for a change of the activation status and that the main component (10; 20; 40; 50) is designed such that the identification data and / or the identification number can be called up only if the activation status is set to activated.

The tagging portion (1; 2; 4; 5) of claim 1, wherein the means for changing the activation status comprises an activation component (11; 21; 41; 51) and wherein the activation status is activated if and only if the activation component (11; 21; 41; 51) is connected to the main component (10; 20; 40; 50).

3. The tag part (1; 2; 4; 5) according to claim 1 or 2, wherein the means for changing the activation status are adapted to receive a code, and wherein the activation status is set to activated upon receipt of an appropriate code.

4. The identification part (1; 2; 4; 5) according to claim 2 or 3, wherein the identification part (1; 2; 4; 5) further comprises at least one additional component (12; 22; 42; 52) attached to the Main component (20; 50) or to the activation component (11; 41) is connectable, and stored in the additional data of the plant part (310).

5. identification part (1; 2; 4; 5) according to claim 4, wherein the additional data of the at least one Zusatzkomponen- te (12; 22; 42; 52) via the main component (10; 20; 40; 50) are retrievable.

6. identification part (1; 2; 4; 5) according to claim 4 or 5, wherein the identification data, the identification number and / or the additional data of the system part (310) in wireless form from the identification part (1; 2; 4; 5) retrievable are.

7. identification part (1; 2; 4; 5) according to claim 6, wherein the identification part (1; 2; 4; 5) comprises an RFID transponder (101; 201; 401; 501).

8. identification part (1; 2; 4; 5) according to claim 7, wherein the identification part (1; 2; 4; 5) comprises a passive RFID transponder (101; 201; 401; 501) and for retrieving the characteristic data and / or the additional data of the system part (310) in wireless form required energy is wireless inducible.

9. identification part (1; 2; 4; 5) according to one of claims 1 to 8, wherein the identification part (1; 2; 4; 5) Means, which are designed such that after removal or manipulation of the attached part of the system (310) identification part (1; 2; 4; 5), the characteristics and / or the identification number of the plant part (310) are no longer available.

10. identification part (1; 2; 4; 5) according to one of claims 1 to 9, wherein the characteristic data and / or the additional data coordinates of a planned location of the plant part (310) in a system (32) and / or information for Maintenance condition of the plant part (310) include.

An identification part (1; 2; 4; 5) according to any one of claims 2 to 10, wherein the main component (10; 20; 40;

50) has at least one electronic line (104; 204) having an interruption (105; 205; 405; 505), and the activation component (11; 21; 41;

51) has at least one electronic bridge (114; 214; 414; 514) which when connecting the activation component (11; 21; 41; 51) to the main component (10; 20; 40; 50) has the interruption (105; 205, 405, 505).

12. Installation qualification procedure comprising the following steps:

- storing characteristic data of an installation part (310) in a main component (10; 20; 40; 50) of a marking part (1; 2; 4; 5);

Attaching the main component (10; 20; 40; 50) of the identification part (1; 2; 4; 5) to the system part (310);

- Installing the system part (310) in a system (32); On activating an activation status of the main component (10; 20; 40; 50) of the identification part (1; 2; 4; 5) by connecting an activation component (11; 21; 41; 51) to the main component (10; 40; 50) of the tag (1; 2; 4; 5) or by sending an appropriate code received from the tag (1; 2; 4; 5);

Retrieving the identification data stored in the main component (10; 20; 40; 50) of the identification part (1; 2; 4; 5) and / or a stored identification number by means of an external detection device (33).

13. The method according to claim 12, wherein at least one additional component (12; 22; 42; 52) with additional data stored therein is connected to the main component (20; 50) and / or the activation component (11; 41).

14. The method of claim 13, wherein the identification data, the identification number and / or the additional data are retrieved wirelessly.

15. The method according to claim 13 or 14, wherein in the external detection device (33) a nominal and an actual list of all plant parts (310) are performed, printed after retrieving the respective characteristics, the identification number and / or additional data and / or to a data processing system (34).