• Patient Realistic Inhaler Testing

    The F-SIG 6300 by AB FIA is a breathing profile generator that is capable of replaying complex breathing patterns. Thanks to a novel multi-cylinder design F-SIG 6300 enables generation of a number of clinical relevant patterns. F-SIG 6300 is not intended for clinical use on humans. The areas of operation are for instance: Testing of pharmaceutical inhalers and nebulizers with human breathing patterns. Characterization of cigarettes (smokers profiles). Rodent profiles and general respiratory research that includes very controlled breathing patterns.

    User Friendly and Versatile

    The F-SIG 6300 is operator-friendly and comes with a touch panel. Profiles, possibly recorded by FIA's Metivent software, are handled and modified in a spreadsheet (e.g. Excel) and the profile library is downloaded to the F-SIG 6300. The operator can thereafter, from the library of profiles, select desired profile on the panel and start the replay of the profile.

    The Equipment:

    F-SIG 6300 consists of a breathing profile generator built into a box with transparent plastic covers and placed on wheels. The control system of the multi-cylinder package is configured and operated by the user through the touch panel.
    Capacity large volume: 0 - 6.3 liters
    Capacity small volume: 0 - 0.1 liters
    Voltage: 95 - 255VAC, 50 - 60Hz, 6.5A
    Dimensions HxWxD: 380x1036x480 mm, Touch Panel: 80x280x170 mm

    Download the pdf Patient Realistic Inhaler Testing

  • Metivent Software - A Companion to TSI Flowmeters

    Metivent is a Windows application for recording air flow measurements from TSI flowmeters (e.g. TSI4040). A standard Windows computer with the installed Metivent software connects to the flowmeter via a USB-serial converter. The acquisition of data from the flowmeter is then controlled by the software. Once started the graph is updated continuously during measurement.

    • The software can be used in several modes and configurations.
    • Start trig (wait to start until the flow has reached the start trigger level)
    • End trig (sample data until stop trigger condition)
    • Gas calibration
    • Number of samples to collect if not using trig
    • Standard or volumetric flow
    • Sampling rate 1-1000/s

    Measurements can be conveniently saved to CSV files and opened in Excel for further data analyses and presentations. The instrument is pivotal when recording inhalations profiles for lung simulation studies (such as F-SIG 6300). The file presents flow and pressure and temperature along with instrument data such as serial number and calibration date and currently used settings.

    Download the pdf ABFIA Metivent Software

  • Adjustable restrictor to put into flow meter with known inlet (e.g. OD 1/2" or 22 mm, we will work out the ID if model no. is given) to regulate dP of flow into e.g. impactor.
    Material: Delrin.
  • This FIA product addresses the dynamics of testing dry-powder inhalers (DPIs). Compendial methods of testing DPIs call for an abrupt start and abrupt end to the air flow. An attribute aimed at representing the way a patient uses a DPI. The starting and stopping of the air flow introduces time-variant conditions in the test equipment (cascade impactor) and in the device itself. Experimental and computational studies of these conditions are continuing to elucidate the important characteristics of the device and test system that should be known and controlled to establish a sound quality control test for products that are or are about to be registered. FIA's latest instrument known as Stig puts in users hands the most important measure of the time-dependent air flow start-up the rise-time. It is important that the rise-time is known and under control when testing inhalable devices. Russell-Graham and colleagues1showed that the fine particle dose increases as the rise time decreases. Previous and subsequent theoretical analyses point out reasons for this effect.2, 3 For established products quality control (QC) testing requires knowing that the rise-time remains in a specified range...now possible with Stig. For GMP QC Stig can be locked to acquire and present the rise-time according to a defined and validated method. Since patients do generate different inhalation air-flow profiles it is also important during the development of a new drug product to adjust the prototype devices to exhibit a sensible rise-time close to what will take place in patient use. This mindset is equally important for DPIs and for breath-actuated MDI devices. Stig also makes possible the recording of air-flow profiles so that they can be reproduced on a breathing simulator (such as F-SIG 6300) for studying nebulizers. Versatile and user-friendly. Best-in-class - that is the new Stig from FIA.

    Key features of Stig:

    • Rise-time measurement 0.1-1 s using a thermal flow meter
    • Average rise-time from a series of measurements
    • Touch-screen which displays a graph of flow vs. time, rise-time and the final flow
    • Printed records of the measurement with optional printer. Has been validated together with Mettler-Toledo printers, customer can use own printers (e.g. from lab balances)
    • Rise-time profile saved to USB-memory
    • Date and time
    • Battery powered
    • Optional IQ/OQ and quality certificate for the regulated industry

    Download the pdf Rise-time Measurement Instrument Stig

    1. Russell-Graham, D., A. Cooper, B. Stobbs, E. McAulay, H. Bogard, V. Heith, E. Monsallier, "Further Evaluation of the Fast-Screening Impactor for Determining Fine-Particle Fraction of Dry Powder Inhalers, "Drug Delivery to the Lung, December 8 to 10, 2010, Edinburgh, Scotland.
    2. Roberts, D. L., M. Chiruta, "Transient Impactor Behavior during the Testing of Dry-Powder Inhalers via Compendial Methods, "Drug Delivery to the Lung 18, The Aerosol Society, Edinburgh, Scotland, December 13-14, 2007.
    3. Versteeg, H., P. Zhao, C. Blatchford, M. Copley, D. L. Roberts, J. P. Mitchell, "A Computational Fluid Dynamics (CFD) Model of the Start-Up Kinetics of the Andersen Cascade Impactor (ACI), "Drug Delivery to the Lung, Aerosol Society, Edinburgh, Scotland, December 9-11 2015; pages 18-21.
  • This FIA product addresses the dynamics of testing dry-powder inhalers (DPIs). Compendial methods of testing DPIs call for an abrupt start and abrupt end to the air flow. An attribute aimed at representing the way a patient uses a DPI. The starting and stopping of the air flow introduces time-variant conditions in the test equipment (cascade impactor) and in the device itself. Experimental and computational studies of these conditions are continuing to elucidate the important characteristics of the device and test system that should be known and controlled to establish a sound quality control test for products that are or are about to be registered. FIA's latest instrument known as Stig puts in users hands the most important measure of the time-dependent air flow start-up the rise-time. It is important that the rise-time is known and under control when testing inhalable devices. Russell-Graham and colleagues1showed that the fine particle dose increases as the rise time decreases. Previous and subsequent theoretical analyses point out reasons for this effect.2, 3 For established products quality control (QC) testing requires knowing that the rise-time remains in a specified range...now possible with Stig. For GMP QC Stig can be locked to acquire and present the rise-time according to a defined and validated method. Since patients do generate different inhalation air-flow profiles it is also important during the development of a new drug product to adjust the prototype devices to exhibit a sensible rise-time close to what will take place in patient use. This mindset is equally important for DPIs and for breath-actuated MDI devices. Stig also makes possible the recording of air-flow profiles so that they can be reproduced on a breathing simulator (such as F-SIG 6300) for studying nebulizers. Versatile and user-friendly. Best-in-class - that is the new Stig from FIA.

    Key features of Stig Restricted Version:

    • Rise-time measurement 0.1-1 s using a thermal flow meter
    • Average rise-time from a series of measurements
    • Touch-screen which displays a graph of flow vs. time, rise-time and the final flow
    • Battery powered
    • Optional IQ/OQ and quality certificate for the regulated industry

    Download the pdf Rise-time Measurement Instrument Stig

    1. Russell-Graham, D., A. Cooper, B. Stobbs, E. McAulay, H. Bogard, V. Heith, E. Monsallier, "Further Evaluation of the Fast-Screening Impactor for Determining Fine-Particle Fraction of Dry Powder Inhalers, "Drug Delivery to the Lung, December 8 to 10, 2010, Edinburgh, Scotland.
    2. Roberts, D. L., M. Chiruta, "Transient Impactor Behavior during the Testing of Dry-Powder Inhalers via Compendial Methods, "Drug Delivery to the Lung 18, The Aerosol Society, Edinburgh, Scotland, December 13-14, 2007.
    3. Versteeg, H., P. Zhao, C. Blatchford, M. Copley, D. L. Roberts, J. P. Mitchell, "A Computational Fluid Dynamics (CFD) Model of the Start-Up Kinetics of the Andersen Cascade Impactor (ACI), "Drug Delivery to the Lung, Aerosol Society, Edinburgh, Scotland, December 9-11 2015; pages 18-21.
  • Training and IQ F-SIG 6300. Can be done remote via Skype or on-site. Request preference. The IQ results in a wet-ink protocol. The user gets a license to copyrighted text for e.g. internal maintenance work.

  • Training and IQ Metivent Software. Can be done remote via Skype or on-site. Request preference. The IQ results in a wet-ink protocol. The user gets a license to copyrighted text for e.g. internal maintenance work. Configurable for inhaler actuation. Configurable for camera sync. Configurable for load cell.

  • Training and IQ Rise Time Equipment Stig. Can be done remote via Skype or on-site. Request preference. The IQ results in a wet-ink protocol. The user gets a license to copyrighted text for e.g. internal maintenance work.

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