Editor’s note: This is the second in a three-part series. Lizzie Gallager contributed to this post.
It’s true that upgrading to the Thermo Scientific™ Vanquish™ HPLC or UHPLC platform offers many performance benefits, as well as peace of mind for system robustness, but can a Vanquish system integrate into a lab’s older fleet of HPLC systems and software?
In our last blog post we described how Thermo Scientific SII for Empower works to integrate the Vanquish platform into third-party chromatography data systems (CDS), such as Waters™ Empower™ or Agilent™ Open Labs™, with no hang-ups or compliance issues. But how about integrating a new HPLC? The following questions provide some helpful insight and guidance.
System integration: Where do I begin?
Step 1 is to determine the Vanquish platform that’s right for you. All of our platforms start with robustness in mind, but your lab may need specific configurations based on expected back-pressure, biocompatibility or flow-rate flexibility.
Step 2 is to check compatibility with your current CDS. To run Vanquish under a third-party CDS, we use the Standard Instrument Integration (SII) plugin, which is based on the Chromeleon CDS and offers smart, unique features to deliver maximum ease-of-use, reliability and performance. Your local Thermo Fisher support team can help you confirm compatibility.
Step 3 is to evaluate the connections, such as running through an LAC/E box to ensure everything is communicating with each other. Again, we can help you confirm proper connectivity.
Step 4 is to start enjoying your evenings with peace of mind that your samples are running as expected and that your results will be waiting for you.
My old system was already qualified. How can I be sure my new system is working?
To ensure the data you generate is of the highest standard, you need to be sure your equipment can be trusted from the day of installation. That confidence comes from a comprehensive qualification process, which includes the following stages:
Installation Qualification (IQ):
- The IQ process verifies that the Thermo Scientific Vanquish HPLC system has been delivered, installed, and configured correctly.
- It involves checking equipment specifications, verifying electrical and mechanical connections, confirming instrument calibration, and ensuring proper environmental conditions are met.
- IQ documentation typically includes equipment manuals, installation records, calibration certificates, and environmental monitoring data.
Operational Qualification (OQ):
- The OQ stage ensures that the Thermo Scientific Vanquish HPLC system functions properly and operates within predetermined specifications.
- It involves testing system components, functionality and performance to verify that they meet the defined requirements.
- OQ activities may include system initialization, calibration check, performance of system suitability tests, testing of control functions, and evaluation of system alarms and alerts.
- OQ documentation includes test protocols, test results, and any necessary corrective actions taken.
Performance Qualification (PQ):
- The PQ stage evaluates the overall performance and suitability of the Thermo Scientific Vanquish HPLC system for its intended use.
- It involves conducting method validation or verification experiments using well-characterized samples or reference standards.
- PQ activities include evaluating system performance, such as accuracy, precision, linearity, specificity, and robustness, as required for the specific analytical methods and applications.
- PQ documentation includes protocols, test results, data analysis, and acceptance criteria.
- Typically, the PQ stage is a customer responsibility as it’s often driven by application-specific criteria.
Fortunately, you are not alone in any of these processes. Thermo Scientific has a multitude of cGMP trained engineers who will perform all the necessary tests to ensure your systems are fully qualified for the right environment.
|Parameter||cGMP trained Thermo Scientific FSE||cGMP trained end user|
|Installation Qualification (IQ):||X|
|Operational Qualification (OQ):||X|
|Performance Qualification (PQ):||X|
What resources are available to meet the unique needs of regulated analytical labs?
With overburdened technicians and compressed production timelines, today’s regulated laboratories operate in an increasingly challenging environment. System uptime is paramount, so the Unity™ Lab Services Perform service plan was developed based on feedback from laboratories that can’t afford unnecessary downtime. The Perform service plan helps regulated labs achieve their business goals through a personalized service partnership. Here’s what the plan entails:
How can we keep operators at their peak with training?
There’s nothing more frustrating than when something doesn’t go right and you need to get your batch on today. Recently I (Jon) used the HPLC modules on the Thermo Scientific Learning Portal to walk me through some basic troubleshooting and maintenance procedures. This resource was a lifesaver, as it enabled me to quickly identify and fix the issue with no waiting around.
Vanquish customers also have around-the-clock access to Thermo Fisher’s eLearning portal, which covers a wide range of simple maintenance procedures on a variety of analytical equipment. This resource empowers users to perform simple operations and fixes to keep the data flowing. It can also serve as a great onboarding tool with its modules focused on instrument and software operation, user-level maintenance and troubleshooting.
What are other labs saying about the Vanquish HPLC and the SII interface?
“I love my Vanquish HPLC so much because its performance is so reliable. During the pandemic, we didn’t get a chance to work on it, and it was turned off for over a year. But after we returned to the lab, we did quick routine maintenance and injected some QC samples. The retention times of the standards aligned SO WELL with previous QCs. I was absolutely in awe of the reproducibility. I would definitely recommend Vanquish to my colleagues.”
— Harong L. | Academia
“The SII interface is easy to control and requires no significant training on use beyond a short demonstration. The instrument works within the fully enabled audit trail in Waters™ Empower™ 3 software and changes are tracked in the instrument audit log which is displayed at the bottom of the SII interface.”
– Nolan Dean, Staff Scientist, Patheon
How can I learn more about integrating Vanquish Flex with SII software?
Connect with your Thermo Scientific account manager to discuss your specific liquid chromatography needs.
For more information on Vanquish integrations, read these resources:
- Case study: Seamlessly integrating state-of-the-art (U)HPLC into an existing CDS framework
- Case study: Avoiding headaches by a straightforward analytical strategy for successful method transfer / Migrating USA Atorvastatin Calcium impurity analysis from an Agilent 1260 Infinity system to a Vanquish Flex UHPLC system
- Technical Note: Integrating Thermo Scientific LC systems into Waters Empower 3 Chromatography Data Systems in regulated environments
- Empowering success by adopting new LC instruments within an existing network
Watch AnalyteGuru for the next blog post on using the Vanquish Flex with SII software.