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 equipment has been validated according to FIA’s quality system and is suitable for GMP work. 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. 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.

Breathing Patterns

  • Forceful inhalation/exhalation profiles (for use with dry powder inhales)
  • Replaying breathing patterns used in the characterization of Nebulizers as stated in e.g. USP <1601> 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 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: 380 x 1036 x 480 mm HxWxD, 80 x 280 x 170 mm HxWxD (Touch Panel)

Download the pdf ABFIA_Patient Realistic Inhaler Testing_LR

Picture 1: Breathing Profile Generator F-SIG 6300 Front

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

Air Flow Control for Inhaler Testing – the FIA Way

Control and monitoring of the air flow is essential for performance testing of inhalation devices in accord with regulatory standards. FIA engineers have designed a user-friendly family of products that enable full compliance with the test requirements of the European Pharmacopoeia and the US Pharmacopeia.

FIA offers three models of flow controllers – basic to advanced – that put you, the USER, in control – repeatably, reliably.
– Need to coordinate MDI dosing and flow sequences? No problem.
– Need to ensure proper flow in real time for DPI testing? Yes.
Flow control, however you want it.

AND with the absolute minimum footprint…as small as 23×13 cm PLUS easy-to-read displays that work even when you wear gloves – “hands-on” equipment made with the analyst in mind.

Download the pdf ABFIA Air Flow control

Trigger Box Model I – Basic

This model gives the analyst the basic functionality in a very compact and easily managed format.

Key features are:

  • Flow actuation: 0-99 min, 0.1s resolution
  • Actuation counter: Resettable, 8 digits
  • Foot switch: Optional
  • Display: 4 and 8 digits
  • P1 Measurement: No
  • P3/P2 Measurement: No
  • Flow Measurement: No
  • dP (e.g. stage dP): No
  • Printable data: No
  • Relay output for actuation of external equipment: No
  • Displayed history of recent actuation data: No
  • USB memory stick export: No
  • Automatic leak test: No
  • Dimensions (cm): 23x13x13
Trigger Box I

Trigger Box Model II – Critical Flow Controller

This model builds on the functions of Model I with the addition of differential pressure transducers for measuring and displaying pressure at P1, P2, and P3.

Key features are:

  • Flow actuation: 0-60 min, 0.1s resolution
  • Actuation counter: Resettable 0-999
  • Foot switch: Yes
  • Display: 4.3” touch
  • P1 Measurement: Yes, 0-16 kPa
  • P3/P2 Measurement: Yes
  • Flow Measurement: No
  • dP (e.g. stage dP): No
  • Printable data: Prints new actuations continuously
    • Flow ”on” time
    • Dose number
    • P1
    • P3/P2 (if < 0.5)
  • Relay output for actuation of external equipment: No
  • Displayed history of recent actuation data: Last 3 actuations
  • USB memory stick export: No
  • Automatic leak test: No
  • Dimensions (cm): 23x13x13
Trigger Box Model II

TrB III Trigger Box – All-in-One Flow Controller

The TrB III Trigger Box ensures compliance with standard pharmacopeial methods, both recording and storing key system parameters, including the actual flow rate and run duration. Many inhaler test methods rely on critical flow conditions across the flow control valve, aiming to ensure the same flow rate on each test. But the TrB III does more – actually measures the flow of each test – so, there are no assumptions.

A calibrated laminar flow element (LFE) internal to each TrB III enables the user to set the flow rate at the beginning of a test sequence; with this LFE, the TrB III then records the flow rate of each test, ensuring against drift, leaks, and other non-ideal behavior that may introduce variability in test results. The TrB III also records the other more traditional run-time parameters, such as the test duration, the pressure drop across the inhaler device (P1), and the flow control pressure ratio (P3/P2, critical flow if ≤ 0.5). To measure pressure drop over, e.g., individual impactor stages to detect blockage, additional internal sensors are used.1

Additional user-friendly functions are leak checking and synchronized device actuation by using the integrated output port. Device actuation enables the flow to start simultaneously with dose actuation of a metered-dose inhaler, allowing a user- defined, fixed flow volume for MDI total dose testing.

Query for details of actuator options.

Key features are:

  • Flow actuation: 0-60 min, 0.1s resolution
  • Actuation counter: Resettable 0-999
  • Foot switch: Yes
  • Display: 7” touch
  • P1 measurement: Yes, 0-16 kPa
  • P3/P2 measurement: Yes
  • Flow measurement: Calibrated 0 – 120 l/min (operating range possibly higher)
  • dP (e.g. stage dP): Yes, high precision 0-6 kPa
  • Automatic leak test: Yes
  • Printable data: Prints new actuations continuously or print all actuations from reset.
    • Date/time of first dose
    •  Instrument ID
    • Instrument ver
    • Flow ”on” time
    • External relay timing
    • Atmospheric pressure
    • Dose number
    • P1 and flow
    • P3/P2 (if < 0.5)
    • dP (stage pressure drop)
  • Relay output for actuation of external equipment: Yes, configurable timing of output relative vacuum opening.
  • Displayed history of recent actuation data: All actuations from reset.
  • Interfaces:
    • Relay output for actuation of external equipment
    • Foot switch actuator
    • USB for CSV export
  • Dimensions (cm): 34x13x13

Download AB Fia folder Trigger Box TrB III

Trigger Box Modell III

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/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 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. 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

  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.