Protecting and Inspecting Your Investment
Lots of planning goes into bringing laboratory automation systems into a lab. But the payout is worth the effort. Automated sample processing brings exciting benefits to your workflow processes, including:
- Increased throughput
- Parallel processing
- Improved consistency
- Reduced cycle times
- Walkaway convenience
Before you fully realize the fruition of your automated system project in production, consider the extra benefits afforded by site acceptance testing (SAT).
SAT is a Valuable Opportunity
During SAT, the newly installed or expanded automation system is tested in its intended final location to ensure that it works according to manufacturer specifications and meets your mandated technical and performance criteria.
SAT confirms that system components were unharmed during transport and no parts are missing. It also helps to ensure that all system components per properly connected and identifies any potential last-minute problems before the automated system is released for production. It can also serve as basic training for your engineers and scientists.
SAT vs. FAT: Key Differences
SAT is often preceded by factory acceptance testing (FAT), which is performed at the manufacturer’s location. In contrast to SAT, FAT testing of the system is often conducted without liquid or using water as the sole reagent. Additionally, third-party devices are not always available to test during FAT, so they must be simulated by the control software.
Unlike FAT, many tests conducted during SAT will involve real-world process conditions. This includes replicating exact production conditions or process parameters and using production-ready reagents. Tests may include visual inspections, confirming environmental conditions, assessing functions and performance, verifying electrical wiring and safety measures, and ensuring proper controls are functional.
For more information on FAT, read our blog, “4 Great Reasons Why FAT is Where It’s At”.
Comparing SAT and Validation Processes
There may be some overlap between SAT and installation qualification/operation qualification/performance qualification (IQ/OQ/PQ) tests performed during validation. The chief difference is that SAT will be performed by engineers to support system quality and ensure that the automated system meets desired criteria. In contrast, validation tests will be performed by your Quality department to support system, product, and results quality and will also be submitted to external regulatory bodies for review and approval.
Another difference is that SAT may test for parameters that fall outside of a Quality requirement. Time is a great example of this. Let’s imagine that you set a threshold for the automated system to process no fewer than twenty microplates each day. This threshold can be verified during SAT, and your Quality department may not be concerned with the number of microplates processed per day so long as the sample and data are not compromised.
Key Benefits of SAT
SAT is highly recommended for critical workflows as it offers several essential benefits such as:
- Strengthening quality and risk management – SAT ensures that the automated system is installed and operating correctly and meets or exceeds all project requirements. It also demonstrates that the system is safe for use in its intended environment. Any last-minute issues can be addressed by the manufacturer prior to handing off responsibility of the automated system to your internal teams.
- Reducing unexpected costs and downtime – The automated system provider is responsible for correcting issues that may arise during SAT. If issues pop up after the system is approved for production and you don’t have a service contract or the warranty period has expired, you could be on the hook for a pricy repair. This also causes delays in workflow production and may also mean having to rework samples.
- Easing validation testing – Simulating regulatory tests during SAT can help to ensure that they will be run smoothly during validation processes. Boosting confidence – SAT is a small price to pay to protect the integrity of your automated hardware and software as well as the samples that it processes and the data it outputs. Peace of mind comes from knowing that the automated system is performing as expected.
Exploring HighRes Biosolutions' SAT Expertise
Implement SAT to confirm that your automation system is the best it could possibly be before heading into production.
Ask About Our SAT Services
HighRes Biosolutions has deep experience when it comes to detailed SAT on simple to complex automated systems. In fact, with our reputations on the line, we believe that SAT is in our best interests just as much as it is in yours. Contact us today to learn more about what goes into SAT and how to build a SAT checklist based on your unique requirements.
Revision: BL-DIG-230710-01_RevC (Increasing SATisfaction)