SOP For HPLC Column Maintenance and Washing
1.0 OBJECTIVE
1.1 To describe the procedure for the Maintenance, Column Washing and Usage Record of HPLC Column.
2.0 SCOPE
2.1 This SOP is applicable for the Maintenance, Column Washing and Usage Record of HPLC Column.
3.0 RESPONSIBILITY
3.1 QC Officer or QC Executive
4.0 ACCOUNTABILITY
4.1 QC Manager
5.0 Procedure
5.1 The Column has to be taken serial number has to be seen.
5.2 Check the column there should be no damage.
5.3 Check the Column according to Certificate of Analysis, make, serial number, supplier name, etc.
5.4 Change the mobile phase and column washing with HPLC grade water.
5.5 If everything complies of user requirement, make the entry of the column in as per Annexure also to be write the column ID.
5.6 The Column will be given according to the requirement as mentioned in the standard test procedure at that particular product.
5.7 If the Column Complies the system suitability criteria use the column for HPLC Instrument.
5.8 In case the Column does not complies system suitability Criteria than the column cannot even use an instrument.
HPLC should be tested for column specification.
5.9 Column Fail for system suitability parameter repetitively than it should be returned to the supplier.
5.10 Flush the column using warm water at 55°C at flow rate 0.5 ml/min for 15 minutes. Maintain the
Column temp. at 55°C in the column oven.
5.11 Flush the Methanol : Water (50 : 50) flow rate 0.5 ml/min in 60 minutes.
5.12 Change the Mobile Phase from water to HPLC Grade 80 % Acetonitrile.
5.13 Flush the column using HPLC Water 0.5 ml/min for atleast one hour.
5.14 Disconnect the column from the HPLC instrument and store in an appropriate place.
5.15 Do not use the mobile phase having pH out of the range given in the column.
5.16 Do not over tight the ferrules of the column.
5.17 Wash the column properly minimum for 60 min, the water, methanol & Acetonitrile or specified
solvent given for the column washing.
6.0 ABBREVIATIONS
| Sr. No. | Abbreviation used | Extended Form |
| 1.0 | SOP | Standard Operating Procedure |
| 2.0 | No | Number |
| 3.0 | QC | Quality Control |
7.0 ATTACHMENTS
Annexure-1 : HPLC Column Usage Entry log Book.
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01. | In-House |
Annexure-1 : HPLC Column Usage Entry log Book
sop for cleaning of spillage material
sop for Handling of Reference Standard
sop for hplc column maintenance and washing
procedure for sampling and handling of bulk sample
STP for borewell generation point (raw water storage tank)
sop for preparation and standardization of 0.1M Zinc Sulphate
Operation &calibration of analytical balance (dhona)
Operation and Calibration Procedure for Disintegration Test apparatus
sop for preparation and standardization of 1 M Hydrochloric Acid
Preparation and standardization of 0.1 M ceric ammonium sulphate solution
sop for preparation and standardization of 0.05 m iodine solution
validation of volumetric solution 0.1m ammonium thiocyanate
handling of reference standard and preparation of working standard
sop for water sampling and analysis
sop for operation for validation of excel worksheets
sop for stability of volumetric solutions
sop for preparation of raw material in process finish product packing material data sheets
sop for handling of hazardous chemicals
sop for handling of glassware and allocation of identification number
sop for operation cleaning and calibration of bursting strength tester
sop for rounding off the analytical test results
procedure for Analyst Qualification
sop for operation and calibration of dissolution Apparatus
procedure for maintenance of desiccators
sop for for hplc column receipt checking id no and regeneration
safety data sheet for laboratory chemicals
procedure for handling of poisonous chemicals
sop for cleaning of sampling devices
sop for calibration procedure of instruments
sop for specification and standard testing raw material packing material and finished product
procedure for operation and calibration of potentiometric titrator
procedure for operating and calibration of digital hardness tester
procedure for disposal of expired chemicals, reagents and solvents
sop for behavior in quality control department
sop for preparation and standardization 0.1M sodium thiosulphate
sop for preparation and standardization 0.1M Disodium Edetate
preparation and standardization 0.1M Sodium Hydroxide Solution
Preparation and standardization of 0.1M Perchloric acid solution
sop for preparation 0.05M edetate disodium
sop for preparation 0.1M silver nitrate
sop for Operation and Calibration of High Performance Liquid Chromatography
sop for UV & Visible Spectrophotometer
procedure for Cleaning of laboratory glassware
Cleaning of Instrument, Instrument bench and surrounding area of Quality
Safety Precaution in Quality Control Department
Operation & Calibration of Analytical Balance
Calibration of Glassware in Quality Control Department
handling of samples received in Quality Control
Cleaning and Operation of Refrigerator
Operation, Cleaning and Calibration of water bath
Operation & Calibration of Refractometer
Operation and Cleaning of Centrifuge Apparatus
cleaning, operation & calibration of Vernier caliper
Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)
Cleaning and operation of Moisture Analyzer
Cleaning & Operation of Vacuum pump in Quality Control Department
Operation and Calibration of Polarimeter
Cleaning and operation of Magnetic Stirrer
Cleaning Operation and Calibration of Melting Point
Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department
procedure of operation and Cleaning of Sonicator
Operation Cleaning & Calibration of pH meter in Quality Control Department
Entry and Exit in Quality Control Department