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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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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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. -
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. -
Trigger Box - Configurable for inhaler actuation. Configurable for camera sync. Configurable for load cell. Optional output and inputs configurable according to customer needs. -
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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TrB III Trigger Box Delta āĀ 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 ā actually measures the flow of each test ā 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 ā¤ 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 folderĀ Trigger Box TrB III.
Key features are:
- Flow actuation: 0-60 min, 0.1s resolution
- Actuation counter: Resettable 0-999
- Foot switch: Yes
- Display: 7ā touch
- P1 measurement: Yes, 0-16 kPa
- P3/P2 measurement: Yes
- Flow measurement: Calibrated 0 ā 120 l/min (operating range possibly higher)
- dP (e.g. stage dP): Yes, high precision 0-6 kPa
- Automatic leak test:Ā Yes
- Printable data: Prints new actuations continuously or print all actuations from reset.
- Date/time of first dose
- Ā Instrument ID
- Instrument ver
- Flow āonā 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 ā All in one Flow Controller
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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 Model II āĀ 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: 4.3ā 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 āonā 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 IĀ ā 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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Inhaler mouthpiece adapter to anatomical throat.
Material: Red silicone (softer and more "forgiving"). -
Inhaler mouthpiece adapter to impactor induction port.
Material: Blue silicone (harder and more durable).