| Sop for Column Management |
| 1.0 OBJECTIVE To lay down the procedure for SOP for column management of HPLC columns. 2.0 SCOPE This procedure is applicable for procedure SOP for column management of HPLC columns numbering, handling, washing and storage in quality control department. 3.0 RESPONSIBILITY QC – Officers/Executive 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Whenever a new column is received, check its specification against the purchase order as follows: 5.1.1 Length 5.1.2 Diameter 5.1.3 Particle size 5.1.4 Column packing 5.2 Every new HPLC column received should be entered in column receipt record with details as mentioned in format number XXX. 5.3 On receiving a new column assign a particular number as follows: 5.3.1 Each column shall be numbered as LC/SS/QC/XXX 5.3.2 LC denotes liquid chromatography 5.3.3 “/” is for separation 5.3.4 QC denotes Quality control 5.3.5 “/” is for separation 5.3.6 XXX denotes the serial number of the column starting from 001. 5.3.7 For example, the first column received shall be numbered as LC/XX/QC/001. 5.4 Read and follow the instructions given by the column manufacturer before using any column. 5.5 Every new column is to be qualified for performance with particular product system suitability test for which the column is to be dedicated. Record and file the chromatograms along with certificate in column qualification/ discardations protocol as per format number XXX. 5.6 Separate column card (usage record) for each column shall be maintained. 5.7 Column card number shall be from serial number 001. 5.8 Before using a column, prepare a ‘Column Usage Record’ as per format number XXX. 5.9 Routine handling of column 5.9.1 Connect the column in column compartment of HPLC with the direction mentioned on the column. 5.9.2 Equilibrate the column until the stable baseline is obtained. 5.9.3 Protect HPLC columns from vibration, mechanical shock and rapid changes in pressure. Note: Any thermal, physical or chemical shock (such as changing solvent rapidly or at high flow rates) may result in loss of efficiency of the column. 5.9.4 Ensure that all the solvents for column washing should be of HPLC grade and filtered through 0.45µm or 0.22µm porosity membrane filter. 5.9.5 When the column is taken for use, enter the start date as per format number XXX. 5.10 Column washing: After complete the analysis; wash the column from HPLC or Column washing equipment, first with water at a flow rate of 0.5 or 1.0 ml/minute and after that with the same solvent mixture with water as in mobile phase used for analysis. Prepare the solvent mixture for column washing as per requirement and label it as per annexure no. XXX. 5.10.1 Storage of column: After completion of washing, disconnect the column from the system, tightly cap the end-fittings with end plugs to prevent the packing from drying out and keep it in respective place. 5.10.2 Discarding HPLC column: 5.10.3 Column shall be discarded on confirmation of non- performance. If the column is not producing satisfactory results like failing in system suitability, discard the column by attaching the system suitability chromatogram in the column record file and send to scrap. Fill the column qualification/discardations protocol as per format number XXX and attach with the particular column card. 5.10.4 For discarding the column, bend the column and send to scrap yard after filling the records for the same. |