Hello everyone:

I want to start a column log system for my HPLC Lab. Can anyone explain what sections I should have in the column log book and basically how to create and operate this system?

Thanks

Sean,
A few to consider:
Instrument
Date
Operator
Column
Mobile phase
Sample Type
Sample ID
Run Time
Column pressure at the start of a run
Column Temperature
Injection volume
Run time
Gradient profile
Integration parameters
Detector parameters affecting detection
Detector parameters that change upon ageing.
Repairs and maintenance
Instrument configuration
Internal standard retention time
Resolution for a peak pair for each assay


Look at the configurations for all your equipment and consider each item that can change. If it can and the change affects the results of your assays' accuracy or precision, include the field in your log. Benefits in troubleshooting and proving quality will out weigh the work of recording the values. Newer equipment may record many of the values for you. Include in your written procedure: their location, purpose, use, and a verifiable method to show their use by your operators.

Jim

but whatis the regularatory requirements for this
how many parameters you have to control.

You may want to add the number of injections in a particular run sequence

Should I make a single log book for all instruments or is it better to have a log book each for every instrument.

Depends if all you are going to do is chart the changing of columns and conditions of the column. If you are also going to want to document every in-line filter/gaurd column/lamp/frit change...and so on you may want to look into a Maintainence log per instrument. In this log you can enter all of the above changes and why the changes were made. You will also have the ability to look back in the future if you are troubleshooting a problem that has been faced before on that particular instrument.

It is not entirely clear what you want or need but, in the long run, you will probably be best served by several "log books". One for each instrument and several just for the columns. Particularly if you have a lot of columns (we have about 900 at the present time), you may wish to consider some type of electronic format for your column log/database. You could easily do it yourself using Access or Oracle or there are some commercial options. Your choice may be determined by your need to be 21 CFR 11 compliant or not.

Bill,

Please tell us this is a bad May Fools joke. A Part 11 compliant Oracle database to keep track of our columns - give us a break!!!

Bill,

How about using a paper loogbook for the columns and for the instrument. It will be any problems with FDA ?

Thanks

logbook paper will be a probelm by FDA simply becuase loose paper can be lost loosing many information specially if it is GLP. in our lab we have binded logbook for each column with ID# and we keep track of the column usage on a daily basis. how many samples we run or batches so that provide us information about column life...etc.

DEAR SIR
PLEASE GIVE US THE INFORMATION REGARDING THE MINIMUM REQUIRED VALUES OF RESOLUTION, CAPACITY FACTOR, COLUMN PLATES NO. IF THERE IS ANY SPECIFIC CONDITIONAL METHOD FOR THE TARTRAZINE (FOOD ADDITIVE)& QUINOLINE YELLOW (FOOD ADDITIVE).