The company’s manufacturing facility in Runcorn, Cheshire started to use RADIOMETER ANALYTICAL equipment in 2003, when a CDM230 Conductivity Meter package was installed in the QC laboratory for pure water measurements according to the current General Chapters within the USP-NF. Shortly after, the Development Laboratory decided to upgrade its titration capabilities.

Steve England (C Chem M.R.S.C), Principal Scientist in New Product Development, describes the reasons: “Our development team routinely performed potentiometric titrations. However, the system in place was relatively old and did not meet the FDA 21CFR requirements for data storage and traceability of results. It was essential that we were able to comply with the FDA regulations when performing our laboratory analysis.”

The company set out to look at various suppliers for PC-controlled automatic titration. Steve explains, “We routinely perform a range of potentiometric tests including pH, complexometric and redox titrations.Our new system needed the flexibility and ease-of-use to switch between methods with minimum effort. Also, being a Development Laboratory, we need to be able to implement new methods easily.”

So, the process of evaluation began, and there were many features that it soon became apparent were needed for the equipment to be acceptable to a high-profile pharmaceutical laboratory like those at IVAX. “It goes without saying that first and foremost the equipment has to be of a high analytical standard. Accuracy and precision are of critical value to our laboratory. However, we also need a system that is easy to use, owing to our multiple methods. In addition, we need software that is compliant with both 21CFR and our own quality regulations - it is absolutely essential that we can qualify and install our equipment with full traceability and calibration.”

Steve evaluated each instrument (a TitraLab 865 from RADIOMETER ANALYTICAL was one of the units put through its paces) and used his check-list of features to decide which system met their requirements. RADIOMETER ANALYTICAL came out on top.

So just why did Steve come to that decision?
“Well, the equipment from RADIOMETER ANALYTICAL ticked all of the boxes. The TitraLab 865 (with its 18,000-step burette) was the most accurate unit we looked at. RADIOMETER ANALYTICAL also manufacture a vast array of electrodes. This gave me the confidence that they could meet all of our application demands, not just now but in the future. Bi-directional TitraMaster 85 Software met all of our21CFR requirements. I looked at the software in detail and the multiple user levels, signing off of results, and audit trail meant it satisfied all of our needs. Finally, I needed equipment qualification. The DQ/IQ/OQ/PQ is very important. It was essential that the supplier could perform this on-site and cover not only the titrator but also the software installation in their report. Thankfully, RADIOMETER ANALYTICAL offered such a document.”

So, IVAX have now been using the TitraLab 865 for some time. How have they adapted to the unit?
“It is very easy to use. We have added new methods with ion-selective electrodes since the original purchase. This was one of the reasons I liked what RADIOMETER ANALYTICAL had to offer. I suggested a new method to a HACH LANGE Specialist, who recommended the necessary ISE. It was purchased by IVAX and installed by the specialist with minimum fuss.”

So the support from HACH LANGE has been good?
“Yes, we order certified buffers and standards regularly from the company without delay. Their product portfolio meets the needs of the pharmaceutical industry perfectly.” Does that mean IVAX are interested in other products? “Our HACH LANGE representatives keep us up to date on any new developments. We certainly know where to go when new equipment is needed.”

To find out more about the TitraLab 865 Potentiometric Titration Workstation please click here.