Implementation of Dmaic Method to Reduce Damage HPLC Column Type C-18, 250 X 4 mm at Laboratory QC PT. MF


Authors : Nur Islamia, Nofitasari Damayanti, Asep Saiful Anwar

Volume/Issue : Volume 5 - 2020, Issue 1 - January

Google Scholar : https://goo.gl/DF9R4u

Scribd : https://bit.ly/2GC1GLL

PT. MF is a company engaged in the pharmaceutical with the end product of quality drugs. Good drug quality can be guaranteed with the right quality control, while the right quality control is by checking the drug level by using High Performance Chromatography Liquid (HPLC) machine with the most important part is HPLC column. During the period of January - December 2017, the HPLC column of type C-18, 250 x 4 mm often suffered damage by 10.20% with a sigma value of 3.14 this has exceeded the predetermined target of 2.0%. The purpose of this research is to find factors causing damage of column, give suggestion of repair and compare result before and after repair by using DMAIC method so that factor causing damage of HPLC column in factor method is HPLC column leaching process not according to supplier recommendation can be done that is make HPLC column leaching procedure in accordance with supplier recommendation, and do training related HPLC column leaching. By applying the proposed improvements and controls, the proposed improvements can be effective and efficient so as to reduce the damage of C-18, 250 x 4 mm HPLC columns and increase the sigma value during the January - May 2018 period of 1.70% and 3, 89.

Keywords : Quality, HPLC Column Damage, DMAIC, Sigma Value.

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