AUTOINJECTOR TESTING SYSTEM

Streamline Your Testing of Pen and Autoinjector Devices to ISO 11608


Developed in close partnership with pharmaceutical device manufacturers and CDMOs, Instron’s latest generation Autoinjector Testing System can perform full functionality testing on a wide range of drug delivery devices – such as needle shield and button-activated devices, as well as safety syringes. This system measures a variety of essential performance requirements, including cap removal, dose accuracy, activation force, injection time, needle depth, click detection, and needle guard lockout – allowing labs to meet internal quality requirements and international standards such as ISO 11608.


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ALL-IN-ONE SOLUTION

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



Autoinjector Testing System



FULL FUNCTIONALITY TESTING
Run a Complete Sequence of Tests on a Single System

Autoinjector Test Sequence

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.











DEDICATED TEST METHODS

Bluehill® Universal uses simplified test types that empower users to develop and change method parameters with ease, while offering the flexibility to readily accommodate future devices without requiring Instron’s support. Users simply select the required functional tests – cap removal, injection, and safety check of the needle shield – and enter the parameters. The system automatically runs the tests in the appropriate sequence, optimizing test time and ensuring consistency. Pre-loaded templates are included with the software, making it fast and easy for a user to create a new device method and begin testing.

  Quick and easy to create a new device method and begin testing

   Improved consistency in testing between operators

  Flexibility to modify method parameters as needed

  Preloaded templates for 2-step, 3-step, and safety syringe devices









SYSTEM SUITABILITY TESTING

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



System Suitability Testing on Autoinjector Testing System



ADVANCED CAMERA CAPABILITIES



Optical Measurements

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

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.
 







Device Flexibility




DEVICE FLEXIBILITY

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







SAFER



Light Shield

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.
 
 


E-Stop Integration

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

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.
 







SYSTEM VALIDATION

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.



Traceability

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.

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Centralized Lab Management

Manage 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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Bluehill Central

On-Site Calibrations

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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Bluehill Central

IQOQ Validation

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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