||Inhalation and Nasal

Inhalation and Nasal

During the decades  we have worked within the area of inhalation and nasal, a number of products have evolved:

Decapper, equipment for separating cap and bottle in a safe and efficient manner.

Breathing Profile Generator F-SIG 6300

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 a generation of  a number of clinical relevant patterns. F-SIG 6300 is not intended for clinical use on humans. Intended use are testing of pharmaceutical inhalers, nebulizers, and respiratory research. The later can be characterization of e-cigarettes.

Breathing Patterns

  • Forceful inhalation/exhalation profiles (for use with dry powder inhales)
  • Replaying breathing patterns used in the characterization of Nebulizers as stated in USP and Ph. Eur. 2.9.44
  • Breathing patterns that comprises small air flows such as smokers profiles or rodent nose breathing

User Friendly and versatile

The handling of the F-SIG 6300 is operator-friendly and comes with a touch panel. The profiles are modified in a spreadsheet in a computer and is then downloaded to the F-SIG 6300. The operator can thereafter easily, 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: 380 x 1036 x 480 mm HxWxD, 80 x 280 x 170 mm HxWxD (Touch Panel)

Picture 1: Breathing Profile Generator F-SIG 6300 Front

Picture 2: Breathing Profile Generator F-SIG 6300 Transparent Box

Critical Flow Controller

TriggerBox I

Critical flow controller with features as
* Flow control valve
* Timer controlled valve
* Resettable counter for actuations
* Actuation by push button or foot switch

TriggerBox II

Critical flow controller with features as
* Flow control valve
* Timer controlled valve
* Resettable counter for actuations
* Actuation by push button or foot switch
* Differential pressure meter for measuring pressure drop at P1, P2 and P3
* 5.7″ LCD touch screen for control and presentation of measured values
* Ability to connect an external printer

TriggerBox III

Critical flow controller with features as
* Flow control valve
* Timer controlled valve
* Resettable counter for actuations
* Actuation by push button or foot switch
* Differential pressure meter for measuring pressure drop at P1, P2 and P3
* Mass flow meter
* 5.7″ LCD touch screen for control and presentation of measured values
* Ability to connect an external printer

Download the pdf Critical and Volumetric Flow Controllers from FIA

Angle of Repose

Powder properties is easily measured with an Angle of Repose instrument. The conical pile’s angle, relative to the horizontal base produced when a granular material is poured on to a horizontal surface, is related to density, surface area and coefficient of friction of the material.

The Angle of Repose characterization system can be used according to pharmacopoeial methods USP1174 and EP 2.9.16.

FIA – Prototypverkstaden has constructed this instrument where the dropping height of the powder can be varied.

Angle of repose measuring instrument

The Φ-angle is related to the material properties.

NGI Cup Tray Hotel

Fully transparent of acrylic glass, fits 6 trays. Economic in space and practical when coating plates. Stable enough to be put onto a shaker table with trays filled with solvent, to aid work-up.

NGI Cup Tray Hotel

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/ms

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 FIA’s F-SIG 6300). The file presents flow, pressure and temperature along with instrument data, e.g. serial number, calibration date and currently used settings.

Download the pdf Metivent Software

Rise-time Measurement Instrument Stig™

This new 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, namely, the rise-time.

It is important that the rise-time is known and under control when testing inhalable devices. Russell-Graham and colleagues1 showed 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, then, 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, 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
  • 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.