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:
Before you fully realize the fruition of your automated system project in production, consider the extra benefits afforded by site acceptance testing (SAT).
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 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”.
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.
SAT is highly recommended for critical workflows as it offers several essential benefits such as:
Implement SAT to confirm that your automation system is the best it could possibly be before heading into production.
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)