Conclusion

Conclusion

One major step of the design qualification process is to make a clear list of items covering all critical matters and understand how dependent on each other those items are. HPLC/TOFMS is a highly sophisticated and complex system, especially modern FAST-LC which uses high pressure which can easily cause leaks at the injector valve, pump plunger seal, etc. Design personnel should pay attention to the size of the column and the total volume of tubing space which will be small compared with conventional LC tubing. Unlike GC, dead space will cause major errors on a narrow HPLC (2mmID) column. Things that have been written in HPLC text books based on a 4.6mmID column may not hold true for a 2mmID column with sub 2um packing material. In the case that a 1mmID or narrower column is to be used (called a “micro-bore column”) even more may not hold true.

All calculations should be done by the designer according to liquid chromatography theory.