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AutoInjector Test System SA-41
Auto Injector and Syringe Test System SA-41

The SA-41 automated autoinjector and syringe test system from AutomationsPartner ensures a precise product quality control and is easy to operate. The SA-41 fulfills requirements by relevant authorities which state that pre-filled syringes and autoinjectors must be tested by the legal manufacturer prior to batch release. The test system for autoinjectors is designed for GMP production environments. AP also offers the same functionality in automated in-line process control (IPC) systems, integrated into autoinjector assembly machines. Testing of prefilled syringes can be combined in the same platform or can be offered as a stand alone solution.

Autoinjector and Syringe Test System Technology

Function

Autoinjectors are loaded into the machine. The machine collects one product at a time for testing. The protective cap is removed and the force is measured and verified against pre-set values. The vision system triggers a timer when the injection starts and measures the time to completed injection. The activation force of the device is measured and verified. The length of the needle is measured by the vision system. The dispensed fluid is measured by a precision scale and the volume is calculated automatically from the pre-set liquid density value.

Standard Injector Tests

Optical System Technology
Optical System Technology
  • Activation force — Needle cover activation or push button
  • Injection time — Liquid dispensing time measurement)
  • Dose accuracy — Precise weighing of dispensed liquid
  • Injection depth — Measurement of needle extension during liquid dispensing
  • Protective cap removal force

Standard Syringe Tests

  • Needle shield removal force
  • Break loose force
  • Glide force
  • Dose accuracy — Precise weighing of dispensed liquid
Standard Tests
Batch report of results

Optional Tests and Functions

  • Graphs of test values – High speed sampling accuracy
  • Secure encrypted communication to other systems (OPC-UA)
  • Verification of correct product thru barcode or QR-code
  • Customer defined number of devices to be loaded
  • Product in-feed from trays

Benefits

  • Easy to use and designed for use in clean-room production
  • Standard automation components ensure a flexible solution
  • Easy to adapt to specific customer requirements
  • PLC platform ensures software stability

Platform

  • CE machinery directive compliant
  • Designed for cleanroom (ISO class 8)
  • Aluminium frame
  • Cabinet with frameless laminated toughened glass
  • Electrical cabinets fitted inside the frame

Automation & Software

  • Siemens PLC & HMI
  • CFR 21 part 11 with audit trail
  • Siemens servo motors
  • Omron FHV7 vision system
  • Mettler Toledo scales and loadcells
  • Digital test reports (digitally signed by operator)

Autoinjector and Syringe Test System Footprint

The SA-41 automated autoinjector and syringe test system is compact with a small footprint.

Autoinjector Test System with Small Footprint
Auto Injector and Syringe Test System with Small Footprint