Agilent Technologies LSCA - Our measure is your success
clear
white
clear
white
clear

Agilent in Pharmaceutical Analysis, Issue 26 

white
clear clear clear clear clear

grey1
Literature Library
Technical Support
Education & Events

grey1
Agilent in Pharmaceutical Analysis

Issue 26 | March 2009

Feedback | Subscribe | Events Calendar | Contact Us | Archives

spacer

EZChrom Elite enables increased throughput, compliance, and custom reporting at contract testing lab

By Jon Welsh
Agilent Product Manager, Laboratory Informatics

Customer Case Study:
LabMark, Sydney, Australia

When an entire analytical laboratory is running smoothly on a single data system platform, switching to a new chromatography data system can be a risky proposition. Worries include a period of lost productivity and a steep learning curve for the entire staff of analysts. But LabMark, a contract pharmaceutical testing laboratory in Sydney, Australia, found that their lab-wide implementation of Agilent EZChrom Elite caused only minimal disruption, and now the lab reaps the benefits of greater productivity, a compliant data system, and custom reports that can be tailored to client needs.

Figure 1. The Agilent EZChrom Elite client/server system is networked to all of LabMark’s LCs and GCs in the pharmaceutical testing facility.

We spoke with Alastair Gibson, Assistant Quality Manager for the lab, about their successful transition from standalone Agilent ChemStation chromatography data systems to an Agilent EZChrom Elite client-server (C/S) system. He explained that 90% of the lab’s work is quality control of pharmaceutical products, including some veterinary products and complementary medicines. The other 10% is spent on method development. His rapidly growing laboratory viewed EZChrom Elite as a vehicle to drive the business forward.

Initial goals: compliance and flexible reporting

Gibson described the two-fold motivation to move to EZChrom Elite. First, the lab needed a data system that supported 21 CFR Part 11. The organization was increasingly being approached by multinational companies, so software that met global regulatory requirements was a necessity for business expansion. While ChemStation has add-on solutions for compliance, the staff also wanted EZChrom Elite’s custom reporting capabilities. Gibson explained, “We are a customer testing laboratory with a wide client base. The clients all have different requests for how we supply data to them. The EZChrom Elite built-in custom reporting solution allows us to be more creative in how we do that reporting, so we can address those needs.”

Another benefit: increased efficiency

Gibson was eager to describe the advantages of having EZChrom Elite C/S control their two Agilent 1200 Series Rapid Resolution LC (RRLC) systems. “The RRLC systems are very, very good for reducing the amount of time it takes to do our analyses. Runs that used to take 30 to 40 minutes – we can now get them down to six or seven minutes. On the Agilent 1100 Series LC systems, one sequence might run for an entire day. As we run shorter sequences on the 1200 Series RRLC systems, we need the ability to monitor more closely when a sequence will be finished. Because EZChrom Elite is networked, with a single glance at the screen, a production manager can straight away see which instruments are running and can quickly determine when an instrument will be finished.”

“We can stack sequences one after another and reduce the amount of time the instrument is idle. That is a big benefit for us.”

Gibson continued, “EZChrom Elite allows stacked sequences, which improves throughput. As a contract lab, we do not run the same method and column every day on a dedicated instrument. Our clients send a variety of samples, so we are constantly reconfiguring our instruments for different methods, columns, and mobile phases. We identify methods that are similar – that use the same column and/or mobile phase – so we can stack sequences one after another and reduce the amount of time the instrument is idle. That is a big benefit for us.”

Compliance features save time, reduce risks

The built-in compliance features have proved quite valuable to the lab. With their networked EZChrom Elite system, analysts can store all of their methods in a common directory, then use copies across multiple instruments. This saves LabMark the time of method entry and review. In addition, the automatic audit trail not only serves their compliance needs, but also provides a convenient record of all the changes that analysts make during method development.

Staged implementation minimized disruption

According to Gibson, switching from Agilent ChemStation to Agilent EZChrom Elite C/S had the potential to be a major interruption. But Agilent took a staged approach and converted and qualified their eight LC systems and four GC systems one at a time. He praised the professionalism of Angela Ong and Peter Harrison, who managed the transition and helped with any problems along the way. “Because it was a staged approach, we kept production going. And analysts could carry out analyses on ChemStation and gradually learn EZChrom Elite.”

Figure 2. Analysts found that like ChemStation, EZChrom Elite has a similar system diagram that you use to establish instrument settings. (Click here to see this image larger.)

Throughput advantage for any lab

“We can get more samples through the lab with the same number of instruments and analysts.”

Gibson commented that while learning a new data system can be challenging, users were very happy with EZChrom Elite and quickly appreciated the custom reporting. He foresees additional benefits in the future. “We have barely scratched the surface on remote login, system suitability testing, and emails for system failures.” He summarized, “EZChrom Elite has increased our flexibility to manage our workflow through the lab. It has offered quite significant savings for us, because we can get more samples through the lab with the same number of instruments and analysts. This would be an advantage to any lab, large or small.”

To learn more about Agilent EZChrom Elite, including multivendor instrument control, flexible/scalable architecture, advanced reporting capabilities, and smart sequencing, see the Agilent product page, or talk with your Agilent representative.

 
 
grey1
related_bottom_left clear clear clear
clear
grey2
Please select your country:
 
   
Registration   |  Login Benefits of Registration