We have Shimadzu 10As and HP 1100Series HPLCs in our lab and work under GLP and cGMP regulations. Trying to be compliant, we perform preventative maintenance on each instrument every 3 months followed by re-calibration. Preventative maintenance "includes but is not limited to"
- washing of the entire system with isopropanol,
- replacement of the UV lamp after 2000 h of operation,
- replacement of the pump seals,
- cleaning/replacement of the plungers,
- cleaning/replacement of all the inlet & outlet valves,
- replacement of the purge valve frit,
- cleaning/replacemtn of the line filters,
- cleaning/replacement of the sampling needle,
- replacement of the needle seal, etc.
(Maintenance differs for Shimadzu and HP).
Now, do we overkill ourself? What are the other companies doing? Are there any regulations on this subject?

If it ain't broke, don't fix it. You're probably introducing more variation into the system by doing all this PM than if you just left it alone. Routine system suitability (every run) and annual OQ/PV should be sufficient. If something breaks in between times, then repair it and perform the relevant OQ/PV tests on the affected modules. HP 1100 HPLC is extremely reliable and may not require maintenance for years (depending on usage). You should consider an HPLC troubleshooting class if you are unaware of the symptoms of common HPLC problems. PM is great if it's applied based upon experience with the instrument or the manufacturer's recommendations. However, unnecessary replacement of good parts is expensive, time consuming, and can cause more problems than it solves.

You might consider finding a good consultant familiar with laboratory operations and FDA regulations to help set up your laboratory procedures.

Best Regards,

Michael Hinsberg
http://www.hinsbarlabs.com

Michael:
Thank you for your responce.
I just wanted to add that all this preventative maintenance is not my idea and I am not sure it is right. So, your comment is exactly what I was looking for. You mentioned FDA regulations. Could you reference any document on this issue? Such a reference would help a lot.
Also, if someone thinks otherwise I would be interested to hear about that as well.

As far as I know, there are no definitive regulations regarding HPLC IQ/OQ/PV testing, however a couple of references I have are:

1) "Validation of Computerized Liquid Chromatographic Systems," William B. Furman, Thomas P. Layloff, Ronald F. Tetzlaff, U.S. Food and Drug Administration, presented at the 106th AOAC International Meeting and Exposition, August, 1992

2) "Guideline on General Principles of Process Validation," U.S. Food and Drug Administration, May, 1987

I believe (2) is available on the FDA's web site. I don't recall how I got a hold of (1). There may even be newer material available on the FDA's web site.

Both of these documents provide a general idea of the FDA's thinking regarding instrument/process validation, however, they do not provide specific instructions. Each company needs to develop its own standards based upon their own testing and experience.

Best Regards,

Michael Hinsberg

http://www.hinsbarlabs.com