• Mixing Inlet - Air-Flow Moderating Inlet (AMI)

    The purpose of this product is inhaler testing aimed at achieving greater clinical relevance when testing dry-powder inhalers. Much like traditional mixing inlets, this product allows the user to maintain a constant flow rate into the cascade impactor with any chosen, time-varying flow rate through the DPI itself. We call it the Air-Flow Moderating Inlet (AMI)…a new friend of the inhaler testing community.

  • Electrically Operated Dispenser ED Range

    Dispensers with selected volume of 5 ml, 10 ml, 25 ml, 50 ml, 100 ml or customized volumes. To be integrated and controlled on other equipment. Enquire for more information.
    Please specify specific volume in the additional message bar on checkout

  • Waste Station Ellipta

    This is our dedicated waste station for Ellipta. The user puts the Ellipta in a nest and closes a safety cover. The station then automatically mates the inhaler with the mouthpiece adapter, withdraws dose and then reverts. The process is repeated according to a user defined number, with selectable delay-time in between. The doses are collected on a high-capacity filter, with a holding capacity of about 10 g. The disposable filter is then safely and easily replaced. The integration with FIA’s TriggerBox III gives the user full control of the flow process and relevant data recorded on file or printer. Can be equipped with anti-static-device. See here for more information.

  • Dose Station Ellipta ®

    This is our dedicated delivered dose uniformity test station for Ellipta ®, using the brilliant impinger filter dose collector. The latter is washable in-situ and can be ready for the next dose as part of the wet chemistry work-up procedure. The user works with the equipment in a fixed process which starts by the user placing the device in a nest which mates with the dose collector inlet. Thereafter aided by the station with functions such as dose actuation, solvent delivery, sample agitation and after which the user collects the sample manually. The process is ended with an automated drying procedure. The integration with FIA’s TriggerBox III gives the user full control of the flow process and relevant data recorded on file or printer. Ellipta ® is one of the devices on this product category, see also Turbuhaler ® implementation , but can be made for essentially all devices upon customer request. See also attached flyer for more information for in-depth information.

  • Induvidually Controlled Dissolution Baths

    Dissolution bath with four separate vessels with stirrer motors. The stirrers are controlled individually, in terms of start (CW/CCW), stop and speed adjustment. Speed is adjustable between 20-300rpm and actual speed for each stirrer is presented digitally. The motors rest on hinges for better access when preparing the samples in the vessels. Stirrer shaft diameter is 10mm. Immersion heater is centrally positioned in the common water bath. The bath has ample lightning and it is possible to inspect the vessels underneath.

  • Inhaler mouthpiece adapter insert which is put into the standard mouthpiece for induction port. Connecting to 22 mm standard filter or ISO 22 mm flow meters.
    Material:  Delrin.
  • Durable adapter connecting flow meter with known outlet (e.g. 1/2" or 22 mm) to impactor induction port.
    Material:  Nylon and Viton.

  • Inhaler mouthpiece adapter to anatomical throat.
    Material: Red silicone (softer and more "forgiving").
  • Nasal Spray Actuator

    Take the worries out of Nasal Spray testing with FIA’s configurable NASAL SPRAY ACTUATOR. This actuation system enables the user to define multiple actuation methods. The nasal actuator measures the stroke travel distance and the force constantly, most notably end force at actuation. The velocity can be calculated from the distance and the time, recorded by the software.

    The nasal actuator control box can be used to set number of actuations for dosing, rest time between each actuation, number of waste dose etc. The equipment can be easily adapted to most device geometries. The compact and open design makes it perfect to integrate with dose collection on filter, and with optical techniques for determination of, e.g., spray pattern, plume geometry (laser pulsed camera) and droplet size (laser diffraction). We can guide you to the best possible solution based on our historic implementations.

    Main benefits:

    • Control pivotal parameters affecting the dose and the spray
    • Release technical staff from routine functions and potential ergonomic strain
    • Elucidate and record actuations in documented fashion

    The regulatory guidelines which are applicable:

    • US (FDA) – Guidance for Industry: Bioavailability and Bioequivalence for Nasal Aerosols and Nasal Sprays for Local Action, Draft 2003.
    • US (FDA) – Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products CMC Guidance, Draft 2002.
    • EU (EMEA) – Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, EMEA 2006.
  • Female adapter to the 22 mm (male) side of a ISO 22 standard filter. Comes with a barbed fitting for vacuum hose. The adapter will also fit a, e.g., TSI 22 mm flow meter.

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