METHOD FOR IDENTITY VERIFICATION OF A GASE

Description

[0001] The present invention relates to a method and an arrangement for checking the identity of a medical or pharmaceutical gas or food gas, in particular nitrogen, according to the respective preambles of the independent patent claims. State of the art

[0002] Various gases are used in pharmacy and medicine. Some of these gases include, for example, the well-known atmospheric gases, which can be obtained, in particular, through low-temperature air separation or other air separation processes. For an overview, see the article "Medicinal Gases - Drugs from Air" by C. and P. Imming, Pharmazeutische Zeitung 09 / 2013, and the relevant pharmacopoeias (DAB, Ph.Eur., USP).

[0003] Whenever reference is made to a "medical or pharmaceutical gas," this term can refer to any gas that is itself used for medical or pharmaceutical purposes, or that serves to provide a gas mixture used for medical or pharmaceutical purposes. Such a gas or gas mixture can be used, for example, as a breathing gas (oxygen, nitrogen, or so-called medical air), as a gas mixture for the treatment of asthma and obstructive pulmonary diseases (e.g., a mixture of oxygen and helium), or as an anesthetic gas (e.g., nitrous oxide or a nitrous oxide mixture).For example, an auxiliary gas used in a synthesis process for the synthesis of a medicinal product or medical device, or used for inerting or to provide a protective atmosphere, for example for the packaging of a medicinal product or medical device, should also fall under the term "medical or pharmaceutical gas" in the sense understood here.

[0004] A "food gas" as understood here shall mean a gas that is used in the production, treatment or packaging of a foodstuff, for example for foaming or inerting.

[0005] The following predominant reference to the pure gas nitrogen is not intended to limit the present invention in any way. Furthermore, the medical or pharmaceutical gas or gas mixture or a corresponding food gas can be present in any desired state of matter (liquid, solid, supercritical) and / or the medical or pharmaceutical gas or a corresponding food gas can be converted from any desired state of matter to any desired other state of matter by suitable methods within the scope of the present invention. For example, liquid nitrogen can be at least partially vaporized within the scope of the present invention before its treatment according to the invention, for example in actively or passively heated vaporization devices.

[0006] In general, if a specific gas such as nitrogen is explicitly mentioned here, this should also include gas mixtures rich in the corresponding gas. For example, if nitrogen is mentioned here, this can also include a nitrogen-rich gas mixture. The term "rich" refers to a content of more than 90 vol.%, more than 95 vol.%, more than 99 vol.%, more than 99.5 vol.%, or more than 99.9 vol.%. In particular, this can refer to a so-called technical gas.

[0007] Substances used in medicine or pharmaceuticals, including corresponding gases, typically must be subjected to at least a so-called identity test before use to prevent confusion. Such identity verification is also particularly desirable in the food industry. The present invention aims to improve the identity testing of medical gases in the sense explained above.

[0008] DE 10 2010 034 654 A1 discloses a method for verifying the identity of a liquid to be filled into a tank, wherein a test quantity of the liquid is transferred to an analysis device. In the analysis device, a density measurement determines a value corresponding to the density of the test quantity of the liquid. Likewise, in the analysis device, the identity check is classified as successful if the value corresponding to the density in the test quantity of the liquid is determined to correspond to a target value, and the identity check is classified as unsuccessful if the value corresponding to the density in the test quantity of the liquid is determined to be inconsistent with the target value. Disclosure of the invention

[0009] Against this background, the present invention proposes a method for verifying the identity of a medical or pharmaceutical gas or a food gas according to claim 1. Further embodiments are the subject of the dependent claims and the following description.

[0010] Overall, the present invention proposes a method according to claim 1 for verifying the identity of a medical or pharmaceutical gas or a food gas, in which a test quantity of the medical or pharmaceutical gas or gas mixture or the food gas is taken from a gas volume and transferred to an analysis device.According to the invention, it is provided that in the analysis device a value corresponding to a gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined by means of a density measurement and the identity test is classified as successful if the value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as corresponding to a target value, and in which the identity test is classified as unsuccessful if the value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as not corresponding to the target value.

[0011] The present invention overcomes in particular the disadvantages of currently used methods for incoming goods testing for the identity of corresponding gases, which the pharmaceutical industry is also obliged to do for excipients such as inerting gases for pharmaceutical packaging, and which could be particularly advantageous in the food industry.

[0012] Traditionally, for example, to verify the identity of medical or pharmaceutical nitrogen, laboratory personnel would use a canister filling device to withdraw liquid nitrogen from the tanker's refueling line upon delivery by tanker truck and perform at least one smoldering chip test. A smoldering chip test is based on the extinguishing of a smoldering wood chip in a nitrogen atmosphere. The smoldering chip test is neither specific (equivalent results would be obtained with carbon dioxide or argon, for example) nor automatable (because it requires a visual inspection). Furthermore, sampling and internal transport of liquid nitrogen pose various safety concerns.Similar safety problems also arise with other analytical methods such as gas chromatography with thermal conductivity detection, which is also currently used in some cases, but which requires a long waiting time until the result is obtained.

[0013] The present invention, in particular, eliminates the manual sampling described above, and shortens the waiting time, for example, for a tanker truck driver. The automated process proposed by the invention allows analysis to be performed directly via a tanker truck's measuring line in under five minutes. This relieves the burden on the customer's laboratory staff because the identity verification can be performed without the need for highly qualified personnel.

[0014] Within the scope of the present invention, safety problems when handling cryogenic gases can be eliminated and documentation is improved, for example, by a printed or an audit-proof stored protocol.

[0015] The gas density determination for identification is also more specific than the thermal conductivity measurement prescribed in various pharmacopoeias, which is routinely used as an alternative to the methods explained.

[0016] The measuring device used for the medical, pharmaceutical, or food gas can be installed near a customer's tank. According to the invention, the contents of a delivering tanker truck are checked via its existing sample gas connection. A calibration gas can be provided or used for regular self-checks before or after the measurement. According to the invention, the sample gas is then analyzed after the measuring device has been appropriately purged.

[0017] In particular, within the scope of the present invention, the mentioned value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas can be determined as corresponding to the target value if it deviates from the target value by less than a predetermined threshold value, and the value corresponding to the gas density in the test quantity can be determined as not corresponding to the target value if it deviates from the target value by more than a predetermined threshold value.

[0018] As mentioned, the present invention can be used for all medical or pharmaceutical gases and food gases, so that a gas containing at least one of the components nitrogen, oxygen, argon, helium, nitrous oxide and carbon dioxide can be subjected to the identity test as the medical or pharmaceutical gas or food gas.

[0019] Particularly advantageously, within the scope of the present invention, the gas volume is provided in a tank of a tanker truck. In this context, the present invention enables particularly rapid on-site testing of the medical, pharmaceutical, or food gas and, if necessary, the immediate rejection of faulty or non-specified deliveries.

[0020] The test quantity of the medical, pharmaceutical, or food gas within the scope of the present invention is taken from the tanker's supply tank using a sample gas connection. In this way, a corresponding, possibly already existing device on a tanker can also be advantageously used for the present invention.

[0021] According to a preferred embodiment of the present invention, a release signal is provided if the identity check of the medical or pharmaceutical gas or food gas is classified as successful. In contrast, an alarm signal, for example a visual alarm to a tanker driver, can be provided if the identity check of the medical or pharmaceutical gas or food gas is classified as unsuccessful, i.e., if no identity has been determined.

[0022] Particularly advantageously, a previously locked discharge device on the tanker truck, such as a cryogenic pump or an electrically controlled valve for forwarding the medical, pharmaceutical, or food-grade gas, can be released based on the corresponding signal, allowing the tested gas to be transferred to a customer storage tank, for example. If the identity check of the medical, pharmaceutical, or food-grade gas is unsuccessful, i.e., no identity was established, the release of the discharge device can be prevented. Particularly advantageously, the release of the discharge device can be designed to be tamper-proof, and any attempt at unauthorized release can be logged accordingly.

[0023] Within the scope of the present invention, the target value can advantageously be determined using a calibration gas, which is subjected to a density measurement before and / or after the density measurement of the test quantity. The calibration gas corresponds in its composition to the medical or pharmaceutical gas or food gas to be sampled. The calibration gas can, in particular, be provided in a corresponding storage container provided by the gas supplier and factory-tested for identity and purity. It can also be provided to provide different calibration gases for different medical or pharmaceutical gases or food gases to be tested in respective separate containers designed as described and to supply them to the measuring device as required.

[0024] The method according to the invention can include storing the results of the identity check of the medical or pharmaceutical gas or food gas in an audit-proof manner. This makes the method according to the invention audit-proof, for example, and the results of previous identity checks of corresponding medical or pharmaceutical gases or food gases can be traced at any time.

[0025] Within the scope of the present invention, in principle all known methods are suitable for the density measurement provided according to the invention.

[0026] The invention also extends to an arrangement for verifying the identity of a medical or pharmaceutical gas or food gas, which arrangement comprises an analysis device configured to supply a test quantity of the medical or pharmaceutical gas or food gas taken from a gas volume for verifying the identity of the medical or pharmaceutical gas or food gas. However, such an arrangement is not claimed.

[0027] The analysis device is designed to determine a value corresponding to a gas density in the test quantity of the medical or pharmaceutical gas or food gas by means of a density measurement and to classify the identity test as successful if the value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined to be in accordance with a target value, and to classify the identity test as unsuccessful otherwise.

[0028] For further features of a corresponding arrangement for checking the identity of a medical or pharmaceutical gas or food gas, which is advantageously designed to carry out a method as described above in a large number of different embodiments, express reference is made to the explanations concerning the method according to the invention and its embodiments.

[0029] It is understood that the features mentioned above and those to be explained below can be used not only in the combination specified in each case, but also in other combinations or on their own, without departing from the scope of the present invention.

[0030] The invention is explained in more detail below with reference to the accompanying drawings, which illustrate an embodiment of the present invention. Character description

[0031] In Figure 1An arrangement for carrying out the identity verification of a medical or pharmaceutical gas or food gas according to the invention is shown. The arrangement is designated overall by reference numeral 100.

[0032] From a gas volume of the medical or pharmaceutical gas or food gas 12, which is provided here in a tank 11 of a tanker truck 10, a test quantity of the medical or pharmaceutical gas or food gas is withdrawn via a measuring gas connection 13 and transferred to an analysis device 20. The analysis device 20 is configured to determine a value corresponding to a gas density in the test quantity of the medical or pharmaceutical gas or food gas by means of a density measurement.

[0033] The analysis device 20 is further configured to classify the identity test as successful if the value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined to correspond to a target value, or to classify the identity test as unsuccessful if the value corresponding to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined to not correspond to the target value.

[0034] On this basis, for example, a release signal can be provided and displayed to a driver of the tanker truck 10 or other operating personnel by means of a visual display 15, in particular in the form of a yes / no signal, if the identity verification is classified as successful. Accordingly, an alarm signal can also be provided by means of the visual display if the identity verification is classified as unsuccessful. Based on a corresponding release signal, a discharge device 14 of the tanker truck can also be released, for example.

[0035] The analysis device 20 can, for example, have a printer and an audit-proof storage device in which a result of the identity verification can be stored in an audit-proof manner.

Claims

1. Method for verifying the identity of a medical or pharmaceutical gas or food gas, in which a test quantity of the medical or pharmaceutical gas or food gas is taken from a gas volume (12) of the medical or pharmaceutical gas or food gas from a supply tank (11) and transferred to an analysis device (20), a value that corresponds to a gas density in the test quantity of the medical or pharmaceutical gas or food gas being determined in the analysis device (20) by means of a density measurement, the identity verification being classified as successful if the value that corresponds to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as corresponding to a target value, and the identity verification being classified as unsuccessful if the value that corresponds to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as not corresponding to the target value, characterized in that the test quantity of the medical or pharmaceutical gas or food gas is taken from the supply tank (11) using a sample gas connection (13) and in that the analysis device is purged prior to the analysis.

2. Method according to claim 1, in which the value that corresponds to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as corresponding to the target value if it deviates from the target value by less than a predetermined threshold value, and in which the value that corresponds to the gas density in the test quantity of the medical or pharmaceutical gas or food gas is determined as not corresponding to the target value if it deviates from the target value by more than a predetermined threshold value.

3. Method according to either claim 1 or claim 2, in which a gas comprising at least one of the components nitrogen, oxygen, argon, helium, nitrous oxide and carbon dioxide is subjected to the identity verification as the medical or pharmaceutical gas or food gas.

4. Method according to any of the preceding claims, in which the gas volume of the medical or pharmaceutical gas or food gas is provided in a tank (11) of a tank truck (10).

5. Method according to any of the preceding claims, in which a release signal is provided if the identity verification is classified as successful.

6. Method according to any of claims 4 to 5, in which an alarm or blocking signal is provided if the identity verification is classified as unsuccessful.

7. Method according to claim 5, in which a discharging device (14) of the tank truck (10) is released on the basis of the release signal, or according to claim 7, in which the discharging device (14) of the tank truck (10) is or remains blocked on the basis of the alarm or blocking signal.

8. Method according to any of the preceding claims, in which the target value is determined using a calibration gas which is subjected to a density measurement before and / or after the density measurement of the test quantity.

9. Method according to any of the preceding claims, in which the results of the identity verification are stored or printed out in an audit-proof manner.