Procedure For Receipt performance and handling of columns

1.0 Objective
To describe a procedure for receipt, performance and handling of columns.
2.0 Scope
This SOP is applicable to QC Department at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 RECEIPT AND HANDLING OF NEW COLUMNS
5.1.1 QC Officer shall maintain a record for chromatography columns used for HPLC.
5.1.2 The QC Officer shall have the list of the various types of chromatography

columns available or to be used. The list shall have following details:
5.1.3 S.No. Name and type of column, Manufacturer’s name, Column ID,

Specification (dimensions, particle size, packing material).
5.1.4 The list shall be updated if a new type of column is introduced or deleted from analysis programmed.
5.1.5 The QC Officer shall enter the record for each type of column in the

inventory as per current version of format. And give the unique number to each and every column.
5.1.6 The unique identification number for columns shall be assigned as per the procedure given below:
5.1.7 The manufacturer’s column performance certificate shall be filed by QC Officer and retained for future reference.
5.1.8 QC Officer shall issue column(s) for use only after making proper entries in the record.
5.1.9 The column performance shall be checked by the QC Officer as per the system

suitability requirements of in-house method.
5.1.10 In case of column’s performance is found to be unsatisfactory, the

Manager-QC Manager-QA shall reject and take up the matter with the supplier. The action shall be recorded in the remarks column
5.1.11 During the use, the system suitability parameters obtained on the column

may be recorded along with product analyzed, to track the use and performance of the column.
5.1.12 If during use, the column’s performance is found unsatisfactory, the QC Officer shall report to the QC Officer.
5.1.13 Only after QC Officer has confirmed that the column is not performing satisfactorily,

it shall be withdrawn from use and identified with appropriate sticker “REJECTED”
5.1.14 The date of disposal of the column shall be entered in the record by the QC Officer.
5.1.15 The Manager-QC / Manager-QA shall ensure that the laboratory is equipped with all requisite columns necessary for analysis.
5.2 WASHING OF COLUMNS(For C18, C8, CN, column)
5.2.1 Change the mobile phase to 50:50 % v/v filtered distilled water and appropriate solvent (which is used in the mobile phase).
5.2.2 Allow the water to flow through the column at the rate of 1ml/min. for 60 minutes.

Check that pressure does not exceed 6000 PSI.
5.2.3 Ensure that column contains appropriate solvent.
5.2.4 Disconnect the column from the HPLC unit, put the end fittings and store in designated place.
5.2.5 For protein pack column.
5.2.6 Change the mobile phase to 10% isopropyl alcohol.
5.2.7 Allow 10% Isopropyl Alcohol to flow through the column at the rate of 1ml/min. for 30minutes.

Check that the pressure does not exceed 6000 PSI.
5.2.8 Ensure that the column contains 10% Isopropyl Alcohol.
5.2.9 Disconnect the column from the HPLC unit, put the end fittings and store in designated place.
5.3 REGENERATION OF COLUMNS (For C18, C8, CN.)
5.3.1 First flush the column with 55°C hot distilled water with flow rate 1 ml/min. for 50 minutes.
5.3.2 Then flush the column with solvent in following order with flow rate of 1ml/min. for 50 minutes.
a) Methanol HPLC grade.
b) Chloroform HPLC grade
c) Methanol HPLC grade
5.3.3 Ensure that the column storage solvent is Methanol.
5.3.4 Disconnect the column from the HPLC unit fix the end caps and store it in an appropriate place.
5.4 USAGE OF COLUMNS
5.4.1 HPLC/GC columns shall be used as per the respective standard testing procedure.
5.4.2 Usage of the each and every column shall be recorded.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control