Chromatography Forum

Hello

Could someone can share with me his experience regarding the time between instrument calibration for Agilent HPLC`s in the pharmaceuticals industry. We perform this calibration each 6 month but lately we want to expand it to 12 months. Our instruments are working 24 hours a day and used for QC for release products and raw materials.


Daniel

We have ours done once each year. System suitability is performed daily (RSD of retention times, RSD of peak areas, tailing, and resolution if applicable).

My experienence has mainly been 12 months intervals, but it would be useful to ask Agilent as well - especially if you have any unusual detectors or configurations..

When you perform the risk assessment associated with changing the period, the best option is to review the data from the last few 6 monthly tests to see if any issues were detected by the more frequent testing.

The risk assessment will also identify the issues associated with a failure, and the extended retrospective period of suspect data.

It's important to emphasize to beancounters that maintenance and qualifications are different beasts, and need to be considered separately, as some Agilent support systems perform them as part of the same service.

Please keep having fun,

Bruce Hamilton

Hi

Agreeing with previous posts.

Just want to say that we do it annually and yes we also have a few people working nights including weekends.

After visiting a few pharma companies it seems 6month or annually would be the most common.

As stated when doing final products, APIs and raw material you typically have a good set of SST demands to keep track on your instrument.
It is a bit tricker when you have to run in-process controls and you simply not have the time to run 5-6 injections to check the precision (of course easier with more modern column choices etc but when you stuck with some old methods.... .).