The Autoinjector Testing System replaces traditional test procedures that often require separate pieces of equipment, enabling users to run a complete sequence of tests on a single system and allowing manufacturers to accelerate time to market by:
REDUCING TIME and number of devices required to complete testing
SAVING MONEY on testing equipment, maintenance, and specimens
SIMPLIFYING data consolidation, analysis, and validation process
STREAMLINING tech transfer to production sites
Run a Complete Sequence of Tests on a Single System
Activation Force
The system activates the device, evaluating the force required to initiate injection.
Click Detection
A microphone confirms there is an audible click at injection activation and needle retraction.
Injection Time
A machine vision camera determines the total time fluid is present in the field of view.
Needle Depth
Images from the machine vision camera are captured at the start and end of the injection.
Delivered Volume
A precision scale weighs the expelled fluid.
Needle Guard Lockout
The system loads the test device to a specified lockout force or until the defeat force is reached.
The Autoinjector Testing System integrates system suitability testing into the testing workflow, automatically prompting users to perform admin-defined daily checks of the load cell, machine vision camera, and scale per internal requirements and Good Manufacturing Practices. Results are stored in the system’s audit trail, making it easier to comply with the requirements of FDA 21 CFR Part 11 and other accrediting bodies.
Control over what gets checked and how often
Ability to prevent system use until all system checks have been successfully completed
Traceability needed to comply with audit requirements
Easy to use hardware kit accelerates the validation process
Optical Measurements
The autoinjector testing system is equipped with a machine vision camera that provides a high-accuracy optical measurement of injection time and identifies the exposed needle depth at both the start and end of injection.
Root Cause Analysis
A high-resolution video camera and machine vision camera provide critical visuals to effectively analyze test results – making it easier to determine if a bad result was truly a device failure or just an issue caused by an error in the testing process.
The autoinjector testing fixtures were designed to minimize side loading during cap removal and support common industry device geometries, while offering flexibility to easily accommodate customized devices.
Simplified alignment
Reduced variability in test results
Increased flexibility and efficiency to test multiple device types
Easily create new inserts to accommodate future devices
Light Shield
The testing system is enclosed with debris shields on three sides and a light shield across the front that prevents operation of the machine when the operator is physically in the test space. Optionally, a physical door may be installed on the front to fully enclose the testing system.
Smart-Close Air Kit & E-Stop
The pneumatic powered upper and side grips utilize the 6800 Series smart-close air kit technology, enabling you to store preferred grip pressure settings in the test method and ensuring consistency between tests. The air kit is fully integrated into the system's emergency stop, triggering the grips to release when the E-Stop is engaged.
Operator Protect
The autoinjector testing system includes Instron’s patent-pending Operator Protect architecture. An intelligent workflow that keeps equipment and operators safer by controlling system status from setup to test completion. The built-in safety coaching provides clear visual feedback regarding system status at all times.
Instron offers a complete turnkey system, including products and services to help testing labs accelerate their in-house validation processes and put their autoinjector testing system into use.
Bluehill Universal’s Traceability module enables users to meet the audit requirements associated with FDA 21 CFR Part 11, ISO 17025, Nadcap, and others. Through seamless integration of electronic approvals and an automated audit trail, this powerful add-on combines with Bluehill’s built-in security to provide unmatched data traceability.
More On TraceabilityManage tech transfer and ensure all sites are using validated test methods by adding Bluehill Central software, a laboratory management tool that enables centralized, remote management of Bluehill Universal software applications associated with multiple Instron test frames. The software allows you to remotely manage all Bluehill Universal users, test templates, results, file revision approvals, and audit trail data from multiple Instron systems.
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Instron Professional Services offers on-site calibration services for the Autoinjector Testing System, including tension and compression force, speed and displacement, and needle depth. These services ensure that testing parameters are being met and that associated results are being calculated accurately.
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Software validation is critical for compliance with FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), and ISO 13485. Instron offers vendor Installation Qualification and Operational Qualification (IQOQ) documentation, which is completed at your site by trained Instron Field Service Engineers. This validation is designed to ensure that your Instron testing instrument has been installed correctly, is suitable for its intended purpose, and is capable of producing valid results. Our experienced Service team will use Instron’s proven documentation pack which contains necessary IQOQ documents, reference files for calculation validation, and manuals.
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