by | OBJECTIVE |
| To lay down the procedure for cleaning or flushing of HPLC and UPLC system in Quality |
| Control Department. |
| 2.0 SCOPE |
| This SOP is applicable for cleaning and flushing of HPLC and UPLC system used in Quality Control department . |
| 3.0 RESPONSIBILITIES |
| Officer / Executive / Team leader – Quality Control shall be responsible to perform and maintaining relevant documentation. |
| Head QC/Designee shall be responsible for ensuring overall compliance of the SOP. |
| 4.0 DISTRIBUTION |
| Master copy : Quality Assurance Department |
| Controlled Copy 1 : Quality Control Department |
| 5.0 PROCEDURE |
| Clean the exterior of the instrument with a dry lint free cloth or soft hair brush and ensure that system shall be switch off during exterior cleaning. |
| Before start the cleaning or flushing, restart HPLC / UPLC system. |
| Sonicate all suction filters and inline filters with boiled 10% nitric acid for about 15 minutes after that further sonicate with water than methanol. |
| For HPLC / UPLC fill all the reservoirs with properly labeled respective solvents. All lines shall dry and wet prime or purge all the solvent lines before start the analysis. Wet prime or purge each pump to ensure that no air is inadvertently introduced. |
| For Shimadzu HPLC system clean rinsing bottle with water on daily basis. |
| Perform the cleaning or flushing of HPLC / UPLC once in a month, preferably in the first week of month with hot water for about 02 hours followed by methanol for 30 minutes. During hot water flushing the column shall be replaced by union. |
| ANNEXURES |
| NA |
| ABBREVIATIONS |
| SOP : Standard Operating Procedure |
| HPLC : High Pressure Liquid Chromatography |
| UPLC : Ultra Performance Liquid Chromatography |
