We are in the process of establishing an HPLC column manufacturing facility, that might turn into a commercialized one in the future. The two most important aspects of this endeavor have been 1. Column Packing, and 2. Quality Control.
For column packing, we have a choice to buy automated column packing machines from Restek (US), Teledyne SSI (US), Galak (CHINA) etc. Initially, we plan to produce reverse phase columns (4.6x150) in limited numbers and evaluate their performance. However, we are being extra cautious on the quality control front and are asking people for any input. We are already familiar with the retention time, plate number, and asymmetry calculations (peak symmetry, USP tailing factor) etc.
So, I'd welcome any suggestions regarding the quality control process. Also, any information regarding packing material and their well-known suppliers will be highly appreciated. I know many packing material suppliers but it's difficult to know who provides the most reliable product.
Thanks.
FMEA - risk analysis method is used to determine key characteristics
Hello Sourav,
"quality control process
Firstly, should you not call it a QUALITY ASSURANCE PROCESS?
Well, the process is simple.
-Identify the parameters/characteristics critical and not so critical to quality.
-Determine whether the parameter can be measured/monitored on line (i.e. during process) or off line.
-Identify the measuring monitoring equipment needed.
-Establish the methods for measuring/monitoring. This would include the frequency and the need for any control chart.
-Train people in the equipment and the method.
-Try out; correct/improve.
-Implement and standardize.
Please let me know if it is OK .
You are welcome to question/discuss further.
Virendra
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