Device Robustness / Inhaler Misuse
Inhaler misuse and poor technique are widely recognised issues associated with the use of inhalers, resulting in inadequately controlled respiratory disease and an over-reliance on emergency remedies. Copley offers solutions to aid those developing inhaled drug devices and products in understanding the impact of poor patient technique on the critical quality attributes (CQAs) of inhalers to help optimise inhaler designs for more robust drug delivery.
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Drop Test Apparatus (DTA)
The Drop Test Apparatus DTA provides a repeatable and reproducible solution for drop-testing in accordance with the guidance provided in ISO 20072.
The DTA enables analysts to evaluate device robustness over a range of drop heights and against a standardised test surface to understand the impact on product performance.
Drop testing is vital for assessing device performance under realistic handling conditions, ensuring the inhaler or nasal device remains intact and functional after a free-fall drop. The DTA helps developers assess device robustness and the performance of a product following a simulated drop.
The DTA provides an off-the-shelf method for standardised testing between laboratories and analysts, and across product types.
Key Features and Benefits
- Compliance: conforms to ISO 20072:2009 for free-fall testing of drug devices.
- Adjustable Gripper: secures a wide range of devices in differing orientations.
- Simple and robust height gauge: allows easy and accurate adjustments to test height, ensuring repeatability across tests.
- Transparent Shield: surrounds the base of the DTA to retain the device and any parts after impact while providing an unobstructed view.
Dry Powder Inhaler held horizontally in DTA gripper.
Nasal Sprayheld with spray nozzle vertical in DTA gripper
Metered Dose Inhaler being released from DTA gripper.
Drop Test Apparatus DTA: Technical Specifications | |
Device Drop Height: | Up to 1 meter (with mm graduations) |
Device Gripper Width: | Adjustable to maximum 95 mm width |
Materials of Construction – Test Surface: | 12 mm thick wooden base with 3 mm thick 316 Stainless Steel top plate |
Dimensions (w x d x h): | 375 mm x 425 mm x 1130mXX mm Shield height: 300 mm |
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