NCG-400 sensor

NCG sensor system

The NCG system improves and guarantees the quality of your sterilization process

About SolidToo

Read more about the creation of the NCG-400

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Benefits

Why choose NCG sensor?

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Frequently Asked Questions

Questions about the operation and possibilities explained

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About the NCG-400

NCG sensor stands for ‘Non Condensing Gases’ sensor. The sensor measures the amount of gases in the sterilizer chamber that do not condense in the pressure and temperature domain of steam sterilization processes.

Installation

The NCG sensor connects to a steam sterilizer through an existing validation port. The USB output of the sensor controller is connected to a PC or laptop. The programs on this computer convert the measured data into graphs and accessible files.

You can read at least 5 sensors per computer.

Robustness

Only the tubular interior of the NCG sensor comes into contact with steam. This tube is constructed from stainless steel L316, which is highly resistant to steam. Only the fan on the top of the sensor is a moving part. All other components are passive components that are not subject to wear.

Working principle

The NCG sensor is hermetically linked to the chamber of the steam sterilizer. The operating principle is based on the heat transfer of condensing steam to the inside of the sensor. After the sterilization process has started, the space within the sensor is filled with a mixture of steam and air of the sterilization chamber. The steam condenses against the inner wall of the sensor. This releases heat, which is dissipated by the sensor. The amount of heat dissipated per second is measured by the sensor. If there is no air in the steam, the steam condenses to the top of the sensor. If air is present, the steam does not condense all the way to the top of the sensor, so less heat has to be removed. The more air present in the steam, the less heat is dissipated. There is thus a direct relationship between the amount of air in the steam in the sterilizer chamber and the output signal of the NCG sensor. The NCG’s are measured directly in this way.

Detailed information about the operation, measurements and reported data can be found in the files to be downloaded.

View the possible configurations

Instructions and manuals

Figure 1

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NCG sensor and controller

Advantages of the NCG system

Time-saving

  • Because the sterilization process is continuously monitored, it is clear when the sterilization conditions have been met
  • Your steam sterilizer is available sooner and more often
  • Traditional periodic tests such as the Bowie and Dick test and vacuum leak test can be omitted

Certainty

  • Direct and reliable measurements of sterilization conditions during every process
  • Storage of quantitative physical measurement data in accessible files
  • Extensive archiving of the measurement data and process results
  • Optional trend analysis (raw data)

User friendly

  • Can be connected to any steam sterilizer
  • Compact, quick to install and easy to operate

Safety

  • The safety of your patients and your medical staff is increased
  • Fewer human interventions and risk of errors when assessing processes

Sustainability and cost

  • Less waste from traditional tests, such as paper, chemical indicators or hardware components
  • Energy and water savings through fewer periodic tests
  • Fast return on investment

Possible configurations NCG systems

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Figure 1: Validation

Configuration 1: The local computer (PC or laptop) communicates via a USB connection with the controller of the NCG sensor. The data sent by the controller to the computer can be processed on the same computer. The detailed data and the accompanying figures can be copied, archived and printed if desired.

Figure 2: Monitoring

Configuration 2: A computer (PC, laptop or mini-PC) communicates over via USB connection with the controller of the NCG sensor. The data sent by the controller to the computer is immediately processed there. The elaborated data and the associated figures are stored on a server. 2 variants are possible here:

  1. The detailed data is stored in the cloud via an internet connection from the local computer (Dropbox, Onedrive, etc.). This data can then be retrieved and viewed via one or more remote computers. Maintenance of the local computer can be provided by SolidToo. This means, among other things, that software updates and Windows updates are provided via a remote desktop application (for example VNC). These updates are planned and performed in such a way that production with the sterilizers is not disrupted. The elaborated data can be printed locally on a printer with a USB port.
  2. The local computer is linked (for example as a “fat client”) to the local network. The elaborated data is stored on a network drive. This data can then be retrieved and viewed via one or more computers or terminals connected to the network. Maintenance of the local computer, including software updates and Windows updates, is provided by the system administrator. The elaborated data can be printed on a network printer.

Figure 3: OEM

(Original Equipment Manufacturer)

Configuration 3: A configuration that can be used by, for example, manufacturers of steam sterilizers. In doing so, the NCG sensor actually becomes part of the sterilizer. The NCG sensor controller communicates directly with the sterilizer control unit. This can be done via a USB or RS232 connection. The data sent by the NCG sensor to this control unit must be processed by the software running on it. Then the processed data is written to a server, along with the other data from the sterilizer.

Frequently Asked Questions

F.A.Q.

  • Are software updates provided? If so, how often?

    Software updates are made if the functionality of the software gives reason to do so. These can then be downloaded from this website. Only when it concerns critical updates are the users of the NCG sensor actively informed.

  • Are special printers needed to print the figures?

    No. The figures are made in PDF format, and can be printed on any common printer. If a local printer is used, the appropriate printer drivers must be installed on the local computer and a serial or USB connection must be available.

  • Can an NCG sensor be supplied with an individual calibration?

    Yes, but this is not necessary and will incur additional charges.

  • Can the client software be made into an APPV package?

    This is not known at this time.

  • Can the client software be made into an MSI package?

    Yes, this type of installer is already being used.

  • Can the NCG sensor overheat?

    The temperature of the cooling fin of the fan is continuously monitored by the controller. If this temperature exceeds the set limit value (75 °C), the heating and cooling element are automatically switched off.

  • Can the product client software be installed on Microsoft Windows?

    The client software only runs under Windows10 or equivalent.

  • Does the local computer need to be connected to a network?

    This is not necessary or not applicable for validation and OEM configurations. This is necessary for the monitoring configuration if others want to have access to the detailed measurement data and the corresponding figures, or if Windows updates have to be installed. If there is (temporarily) no network connection, the data can be saved on the local computer.

  • Does the NCG sensor require preventive maintenance. If so, how often?

    It is recommended to replace the only moving part (the fan) every 5 years.

  • Does the product also use tablets?

    It is possible to view data that are accessed with, for example, an Android or iOS system, but this option is not necessary.

  • Does the product client software have a web browser (IE9 or higher) based client?

    No.

  • Does the product exchange data with other information systems? (e.g. HL7, CSV)

    No, in configuration 2: fat client only data is exchanged between the client and a network server.

  • Does the security of the product's software comply with applicable laws / standards such as NEN7510, the WGBO, WBP?

    The software does not exchange or use any person-related data.

  • Does the sensor have a CE mark within the meaning of the MDR?

    Chemical, biological and physical indicators used in monitoring systems for (steam) sterilization are not covered by the MDR (Medical Devices Regulation). Physical indicators are, for example, thermosensors (Pt100) and pressure gauges. The NCG sensor is a ‘physical indicator’ and therefore does not fall under the MDR. Naturally, the NCG sensor does have the applicable CE declaration of conformity for completed machines (Directive 2006/42/EC, Annex II, sub A).

  • How is the NCG sensor calibrated?

    The output of the NCG sensor is measured during a number of test processes where known amounts of NCGs are present during the sterilization phase. These measurements are performed in the range between 0.1 and 10% (volume NCG relative to volume of condensate).

  • How long does an NCG sensor last?

    At least 10 years.

  • How much disk space does the process data storage use?

    If 10 processes run per day on a sterilizer, roughly 5 MB of data and figures are stored per day. This costs only 2 GB of disk space per paired NCG sensor per year.

  • How should the software be installed on the local computer?

    The NCG sensor programs are delivered as standard MSI packages, which take care of all the necessary steps. Some program modules must be activated using software keys, which are supplied by SolidToo with the NCG sensor. Further information can be found in the installation manuals and instructional videos.

  • Is a license required for the software?

    No, only a software key, but it is included in the price of the NCG sensor.

  • Is special (medical) hardware connected to a workstation for your product?

    Hardware is connected via a USB connection to the stand-alone PC or client, which is usually located in a separate room.

  • What are the system requirements for the local computer running the NCG sensor software?

    The NCG sensor software runs under Microsoft Windows10. Minimum hardware requirements are an Intel i3 CPU or equivalent, 8 GB RAM, 125 GB storage and a USB 2.0 port.

  • What happens if the local computer connected to the controller of the NCG sensor falters?

    No more data is then read and stored, but the NCG sensor continues to run, so the heating element and cooling control circuits continue to operate.

  • What is a generic calibration?

    Different NCG sensors from a production series are calibrated individually. A generic calibration for the other sensors in this series is derived from this data, which exceeds (more than 100 times more accurate) the standard EN285:2015. This procedure can be compared to, for example, the way a Pt100 resistance thermometer is specified (class A, B, etc.).

  • What is the difference between the NCG sensor and the air detectors already in the market?

    The air detector is an instrument based on pressure and/or temperature measurement of gas in a tube. This instrument is therefore not suitable for quantitatively determining the amount of NCGs. Apart from this, the air detector is sensitive to variations in the ambient temperature, while these have no or negligible influence on the signal from the NCG sensor.

  • What standard(s) does the NCG sensor meet?

    To the standard EN285:2015.

  • Why is a Bowie and Dick test no longer necessary when using the NCG sensor?

    The Bowie and Dick test was postulated more than 50 years ago as a way to check whether the steam penetration in a textile package was sufficiently high. This test says nothing about the steam penetration in instruments with narrow channels, as they are sterilized today. At most he says something about the efficiency of the air removal from the sterilizer chamber, ie about the steam quality. Often at the beginning of the day a test is performed with a B&D package or an electronic version of this test. If this test turns out well, it is hoped that the steam quality will remain sufficiently good for all subsequent processes on that day. This does not appear to be the case in practice. The NCG sensor provides quantitative information about the steam quality in each process. This not only gives more certainty, but makes the Bowie and Dick test superfluous.

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