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Critical aspects for sustainable implementation and testing of injection systems

Based on our many years of experience in introducing testing processes and testing solutions, we have determined four critical aspects that facilitate the implementation of injection systems and create sustainable, effective processes for testing injection systems.

4 Critical Aspects for the Sustainable Implementation and Testing of Injection Systems

Choose clever solutions
This allows you to minimize risk and reach your goals faster.

Decrease efforts
Speed up the planning phase with our off-the-shelf URS templates and qualification packages for DQ, IQ, OQ.

Minimize errors, maximize output
Our fail safe design ensures smooth processes and prevents unnecessary errors.

Optimize system uptime
To keep your tests running.

What proven and intelligent testing systems can do

The responsibility towards your customers is immense. Minimize risks and rely on our tried and tested solutions that are founded on many years of experience and are designed to avoid potential errors and help you reach your goals quickly. Here are a few examples:

Examples: intelligent testing solutions and their benefits

Wearable injectors / OBDS: reproducible test results
Autoinjectors: testing in practice
PFS: cover a wide range of test methods with efficiency
Batch testing: enable high specimen throughput
Customized injection systems
Testing injection systems: wearable injectors / OBDS

Wearable injectors / OBDS: reproducible test results

Wearable injectors, also knows as on-body delivery systems (OBDS), are used to measure a large number of test values: actuation force of the injection start button, injection depth, injection profile, click times, and much more. If each test value is recorded in a separate test or on a new test specimen, the results are not easily reproducible. Unpleasant discussions are the result. It is therefore important to determine as many test values as possible in a single run with one single injector, which guarantees reproducible and repeatable test results when testing these injection systems.

More information:

  • OBDS: Product Manager, Peter Schmidt interview explaining proper measures that generate reliable test results.
  • Ondrug Delivery Magazine: product showcase describing the complete system for standard-compliant testing of wearable injectors.
  • In this case study, our customer Ypsomed reports on the introduction of the testing solution.

Testing injection systems: autoinjectors and other combination products

Autoinjectors: testing in practice

According to the required IFUs (instructions for use), patients rotate autoinjectors during application: First, the cap is pulled upwards, then the injector is rotated and applied. This sequence influences the test forces. Meaningful results are obtained if the test is carried out exactly as the patient would use it: in this case, upward cap removal, downward injection test—all in a single test run. This allows injection systems to be tested with a high level of reproducibility.

More information:

Testing injection systems: different test methods for syringes

PFS: cover a wide range of test methods with efficiency

For PFS (prefilled syringes) with NSD (needle safety device), there is a wide range of available test methods, including determination of the break-loose, glide and actuation force in accordance with ISO 11040. The ability to quickly change different test fixtures on the same testing machine increases cost-efficiency. A testing machine with two test areas provides additional flexibility: a simple mouse click switches the test from the lower work area to the upper work area, and test conditions and parameters are automatically set by the testing software, allowing you to start testing immediately. This is how injection systems are tested with efficiency.

More information:

Testing injection systems: economical, serial syringe testing

Batch testing: enable high specimen throughput

Batch testing often requires high specimen throughput. Different levels of automation provide the right solution, from serial automation and portable handling systems to 24/7 testing via industrial robot.

More information:

Customized injection systems

Are you currently working with new, customized injection systems and requirements?

Then, look no further. Customized solutions and good advice are our specialty!

Please contact us!

Decrease efforts: use URS templates and qualification packages for DQ, IQ, OQ and save valuable time

To support you during your planning phase, we have put our experiences down on paper. For your user requirement specifications (URS), you will receive a complete specification sheet from us, where you can go through the individual points step by step to ensure that nothing is overlooked. This is a service for which our existing customers continuously sing their praises. It guarantees that you are always on the safe side and saves valuable time.

This also simplifies the qualification process, because the URS specifications contain the invaluable experience of our qualification team. With the special packages for design qualification (DQ), installation qualification (IQ) and operational qualification (OQ), you are in excellent hands.

We’re with you all the way, from the URS through qualification.

When it comes to traceability, we’ve got it covered: our white paper provides assistance and answers all the important questions regarding FDA 21 CFR Part 11.

Fail safe design: minimize errors, maximize output

Fail safe design ensures smooth processes and helps you avoid unnecessary errors. A defective sensor, an improper or incorrectly placed injector, or wrong change parts – all these are errors that can be avoided.

The following components prevent unnecessary costs and ensure that batches are reliably released:

Daily Check

To recheck the proper run of the test relevant sensors on a daily basis, we have a full range of Daily Check tools and software.

  • Daily Check for load cell
  • Daily Check laser sensor
  • Daily Check for camera based measuring systems
  • Daily Check for scale
  • Daily Check for microphone
  • Daily Check for color sensors
  • Customized Daily Check solutions

Poka Yoke

This mechanical coding feature ensures that every part is in the right place when the test on the injection system starts. In addition, a scanning function guarantees that the correct interchangeable parts are used.

Vision sensor

The vision sensor ensures that the correct test specimen is used and that it is inserted in the correct orientation. To do this, the sensor detects colors, shapes, and edges to also ensure that the correct injector has been inserted. The vision sensor detects user errors and alerts you if something is wrong.

Repeatable test conditions

If you use your testing machine for different injection system tests, our testXpert testing software guarantees automatically repeatable test conditions after the application and testing fixtures have been changed. The settings and parameters are loaded automatically, and you can start testing right away. The software also protects the sensors against overload and damage.

Semi-automatic testing of injection systems: autoinjector example

The video shows different components to maximize output when testing autoinjectors. The use of automated functions also prevents errors and increases the efficiency of injection system testing.

Fast, standard compliant and cost efficient testing of PFS (prefilled syringes)

For the latest OndrugDelivery magazine edition, ZwickRoell contributed valuable information for systematic increase in productivity in the testing lab using different testing solutions for prefilled syringes. Take a look!

>> ONdrugDelivery Magazine article

Optimize system uptime

Ensuring high machine availability avoids unwanted costs. The outstanding product quality of our testing machines and components is already a very good foundation for this, and the documentation for machine downtimes provides assistance in an emergency.

We also offer options that allow you to increase machine availability even further:

  • customized spare parts packages for immediate repairs on site
  • Service response packages
  • Customized training for your employees

We will advise you on the right options so that you are prepared in an emergency and put together the right package for your needs. We look forward to working with you and supporting you with your testing requirements. Let's talk!

“Use our web demo and discover your options for creating sustainable, effective processes. We will be happy to assist you in your planning phase.”

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