Sterile sampling system - kit for the detection of microorganisms from pipes such as compressed gas networks for single use

Abstract

Sampling system set including - At least one connecting piece; - Connected to a pressure regulator; - Connected with an outlet piece; - characterized in that all components are sterile and prefabricated for single use.

Description

[0001] As part of quality assurance, food and beverage manufacturers must monitor their raw materials, ingredients, intermediate products and finished beverages during production for, among other things, microbiological contamination and viable microorganisms.

[0002] Microorganisms detected in a sample can provide evidence of microorganisms entering the process and thus have a direct impact on the product. Negative changes caused by these germs cannot be ruled out. Examples include coliform bacteria (E. coli), Legionella, bacilli or enterococci, lactic acid bacteria, yeasts, and mold. These germs are undesirable or simply not permitted in the process, which is why testing is essential. Therefore, all raw materials and processes must be tested for the presence of germs.

[0003] For example, in food production, gas is often used in pipes or so-called pressure networks. This can be used as compressed air to control pneumatic valves, but also as a propellant or for cleaning purposes, and as an ingredient. Other gases such as carbon dioxide, nitrogen, oxygen, and argon are also used in the food industry as ingredients, packaging materials, propellants, or in other processes, such as plant preparation or cleaning. Water vapor is also one of these gases, which can often come into contact with products.

[0004] There is currently no standard for testing in food manufacturers' laboratories and contract laboratories. Instead, there are various relatively complex systems that require labor-intensive equipment or machines. Simple and inexpensive systems for rapid on-site testing do not exist.

[0005] Current options include membrane filtration or impaction on Petri dishes.

[0006] Membrane filtration means measuring a specific volume of sample, measured using a gas flow meter. Here, the gas is filtered through a sterile container or device that defines the gas through a special fine filter. This filter, on which any existing bacteria have accumulated, must be removed in a laboratory under sterile conditions. It is then applied to a solid culture medium, typically a Petri dish containing agar medium, and then incubated and analyzed. Before the next use, the entire measuring device must be cleaned and sterilized, and a new sterile filter inserted.

[0007] Impaction means measuring a specific sample volume using the impact principle. The gas is applied to a Petri dish containing solid culture medium via a gas flow meter in a sterile container or device. Germs present in the gas can then accumulate on this Petri dish. This Petri dish must be removed in a laboratory under sterile conditions, then incubated and analyzed. Before the next use, the measuring device must be cleaned and sterilized, and a new sterile Petri dish containing solid culture medium must be inserted.

[0008] Neither method is suitable for rapid detection, nor can it be performed by regular personnel. Ad hoc use, for example, during a disruption or defect in the compressed air network, is also not possible, as these measuring systems require preparation. For cost reasons alone, they are usually not kept on-site or are not used.

[0009] In the real world of industrial laboratories, this regularly leads to only rudimentary or no gas samples being taken from pressure networks. This, in turn, often leads to deviations, product damage, recalls, and even potential consumer harm. There are no rapid test methods available on the market that can be used ad hoc and on-site.

[0010] The goal was to use an available disposable sampling system to obtain information about the microbiological quality of gases from pressure networks at any time, without requiring specialized laboratory personnel and without complex equipment and machinery. Thus, through extensive research, numerous trials, and tests, various systems were developed and refined that could solve this problem while adhering to certain specifications. In addition to sterilizable and heat-resistant materials, the correct flow rate throttling and appropriate containers with nutrient solution had to be tried out, tested, and further developed for this task. Nutrient solutions, for example, must not have an excessive tendency to foam. The pressure or flow rate of the gas must not be too high, which is why pressure control is necessary.

[0011] Two components are therefore required for compressed gas analysis. The first component is a stable liquid nutrient medium or transport solution in a sterile container to capture or release the germs from the gas. This medium should foam as little as possible or have no tendency to foam. The container, such as a 250 ml plastic bottle, is filled with a defined amount, e.g., 100 ml of a liquid medium. Depending on the operating mode, this medium can capture all present germs as a hygiene indicator and can later be tested in the laboratory for product-specific, so-called obligate product-harmful germs.

[0012] The second component is a container or bag containing a set of pneumatic sampling components. All pneumatic components required for sampling are fully pre-assembled and pre-sterilized (e.g., by radiation sterilization) in a closed and sealed bag or container.

[0013] The bottle containing the nutrient solution and the bag containing the pneumatic sampling components are sterile, durable, and packaged in a space-saving manner. This allows them to be easily stored on-site or quickly made available when needed. They are designed for single use and cannot be reused.

[0014] Example sampling is performed without the need for specialized personnel. The bag containing the pneumatic sampling components (pre-assembled set) contains, for example, the following components, already pre-assembled and assembled: a. Hose with a common diameter of 6 mm, 8 mm or 10 mm, in a length of a few centimeters to one meter b. Connection piece or several different connectors and couplings to connect to the existing pipeline. c. Pressure regulator such as a manual ball valve or other flow regulator such as a throttle, in the closed position. d. Additional hose with a diameter of 4 mm or 6 mm and a length of approximately 10 to 30 cm. e. At the end of the tube there is an outlet piece such as a silencer, a sintered plug or a filter.

[0015] Procedure: The bag is opened and the connector (here, a 6, 8, or 10 mm diameter compressed air hose) is connected to an access point on the compressed gas network pipe to be tested using the coupling or connector. These connections are typically located throughout the compressed gas network and must be selected and documented.

[0016] The remaining pneumatic assembly is removed from the sterile bag and placed directly into a freshly opened bottle of liquid medium so that the outlet piece (silencer / sintered plug) sinks into the medium and is covered by it.

[0017] After opening the compressed gas network, the pressure regulator is manually opened until gas bubbles continuously emerge from the outlet piece (silencer / sintered plug). The gas is then flushed through the medium and then exits the cylinder through the top opening. Any germs present in the gas are absorbed into the medium.

[0018] This process is carried out for a defined time, such as one hour.

[0019] After the time has elapsed, possible germs from the system are contained in the medium.

[0020] The pressure regulator and the gas line are closed. The bottle is removed from the pneumatic assembly and sealed. The bottle containing the medium and any germs from the gas line can now be processed in a laboratory under standard conditions or sent to an external laboratory for analysis.

[0021] The sampling set consisting of the hoses, regulator and outlet that is no longer used is disconnected from the gas network, returned to the bag and can then be disposed of with the residual waste.

[0022] The sketches show the schematic design of the pneumatic components and the bottle containing the nutrient solution. Consisting of (a) connector / coupling; (b) hose; (c) pressure regulator / throttle; (d) hose; (e) outlet / silencer; (f) bag; (g) closure; (h) bottle containing (i) liquid medium.

Claims

[1] Sampling system set including, - At least one connecting piece; - Connected to a pressure regulator; - Connected with an outlet piece; - characterized by that all components are sterile and prefabricated for single use. [2] Sampling system according to claim 1, characterized by that the connection between the connecting piece and the pressure regulator and / or between the pressure regulator and the outlet piece is made via hoses or other gas connections such as pipes, lines or similar systems, preferably commercially available compressed air hoses made of plastic. [3] Sampling system according to one of the preceding claims, characterized by that the sterility of all components has been achieved preferably by radiation sterilization or autoclaving, and particularly preferably not by using disinfectant gases such as ethylene oxide. [4] Sampling system according to one of the preceding claims, characterized by that the connecting piece includes a coupling or other parts suitable for connection to an existing pipe / gas pressure network. [5] Sampling system according to one of the preceding claims, characterized by that the connection piece, the pressure regulator and / or the outlet piece is made of plastic and / or metal. [6] Sampling system according to one of the preceding claims, characterized by that the components are as heat-resistant as possible, up to at least +80°C. [7] Sampling system according to one of the preceding claims, characterized by that the components are designed to be as pressure-stable as possible, preferably up to at least 6 bar. [8] Sampling system according to one of the preceding claims, characterized bythat the connection between the connecting piece and the pressure regulator and / or between the pressure regulator and the outlet piece or the pressure regulator itself includes a currentless flow indicator such as a float. [9] Sampling system according to one of the preceding claims, characterized by that the pressure regulator is selected from a mechanical throttle, control valve, ball valve or other volume flow limiting component. [10] Sampling system according to one of the preceding claims, characterized by that the outlet piece is selected from a silencer, sintered candle, filter or throttle; in order to distribute the escaping gas as finely as possible in the liquid. [11] Sampling system according to one of the preceding claims, characterized bythat it is offered as a unit with a liquid medium. The medium is a cell culture medium, nutrient solution, or transport solution, such as a 0.9% NaCl solution, peptone water, or similar, which is contained in a container or bottle that can be connected to the outlet piece. [12] Sampling system according to one of the preceding claims, which has a particularly effective design, is manufactured as follows: a. A sterile plastic bag containing and installed in series: I. Connector for compressed air lines with a diameter of 6 mm and 8 mm (T-piece) made of plastic. II. Compressed air hose with a diameter of 6 mm made of plastic and a length of approximately 30 cm. III. Manual control valve and mechanical flow indicator. IV. Compressed air hose with a diameter of 6 mm made of plastic and a length of approximately 30 cm. V. Sintered metal throttle silencer as outlet. b. Optionally, a polycarbonate bottle with a gross volume of approximately 300 ml, with a screw cap, containing a sterile liquid transport medium for later detection of general contamination in a volume of approximately 100 ml.

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