Inhaler testing Archives - AB FIA Online Store

Waste Station Ellipta

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.

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Waste collection station

Waste Collection Station
Our basic yet efficient and flexible waste collection station. The user loads the dose and inserts the device into a dedicated mouthpiece adapter. 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.

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TSI flowmeter adapter

Adapter between flowmeter ISO 22 and NGI/ACI induction port.

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Trigger Box model III Delta
TrB III Trigger Box Delta – 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). The Delta version can measure pressure drop over, e.g., individual impactor stages to detect blockage, using additional internal sensors.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.

Download AB Fia folder Trigger Box TrB III.

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 the pdf TrB III – All in one Flow Controller
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Trigger Box model III Classic
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).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.

Download AB Fia folder Trigger Box TrB III.

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)
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)
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 the pdf TrB III – All in one Flow Controller
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Trigger Box Model II
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
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Trigger Box model I
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
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Trigger Box – Training and IQ Model III

Training and IQ Model III. 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.

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Trigger Box – Training and IQ Model II

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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Trigger Box – Training and IQ for Model I

This is our well-proven and appreciated flow controller with a timed shut-off of valve and high-quality regulating valve. See our other range of flow controllers here

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Trigger Box – Configurable for Inhaler Actuation

Trigger Box - Configurable for inhaler actuation. Configurable for camera sync. Configurable for load cell. Optional output and inputs configurable according to customer needs.

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Training and IQ Rise Time Equipment Stig

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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Training and IQ Metivent Software

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.

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Training and IQ Breating Profile Generator F-sig 6300

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.

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Threaded Adapter NGI-SF

Threaded adapter (female) connecting NGI outlet to 25 mm (male) side of a ISO 22 mm standard filter. Recommended to be combined with this product with barbed fitting to connect to vacuum hose.

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Rise-time Measurement Instrument Stig Restricted Version
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
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.
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.
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.
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Rise-time Measurement Instrument Stig Full Version
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
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.
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.
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.
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Restrictors

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.

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Respimat Actuator

Respimat Actuator

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pMDI Actuator Standard

pMDI Actuator Standard

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NGI Stage Pressure Drop Lid

This precisely machined lid temporarily replaces that on the NGI and is used together with the highly versatile flow controller TrBIII Delta

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NGI Lid, refurbished or new

To reduce evaporation and and avoid contamination. We have both new and refurbished.

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NGI Internal Filter Holder, refurbished

Fully inspected and comes with a certificate.

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NGI Induction Port, refurbished

Fully inspected and comes with a certificate.

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NGI Impactor, refurbished

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NGI Cup Tray, Grade 316 Stainless Steel-New!

New, plenty in stock.

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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.
Material: Poly carbonate.

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NGI Collection Cups, small, refurbished

Fully inspected and comes with a certificate.

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NGI Collection Cups, Large, refurbished

Fully inspected and comes with a certificate.

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Nasal Spray Actuator
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.
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Nasal Expansion Chambers 1, 2 and 5 L; O-2330-001

For nasal administration, expansion chamber as recommended by the FDA for the estimation of the deposition in the respiratory tract. The configuration consists of an expansion chamber (in which the nasal aerosol is generated) assembled to an impactor (e.g. an ACI, NGI, etc.). Three different sizes: 1 L for powder aerosols, 2 L and 5 L for liquid sprays. Comes with a clamp and adapter between glass and NGI. Optionally with a stand for the 5 L chamber. Adapters available for the insertion of the device.

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Multi Stage Liquid Impinger, refurbished

Fully inspected and comes with a certificate.

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Modifications NGI UIP

Mechanical modifications to the outside of the port w/o compromising pharmacopoeial requirements. To, e.g., facilitate assembly of MP adapters and introduce P1 tap.

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Mixing Inlet – Air-Flow Moderating Inlet (AMI)

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.

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Metivent Software
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
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Inhaler Mouthpiece Adapter TSI

Durable adapter connecting flow meter with known outlet (e.g. 1/2" or 22 mm) to impactor induction port.
Material: Nylon and Viton.

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