Skip to main content

SOP for Washing of HPLC Column After Use

SOP for Washing of HPLC Column After Use

Standard operating procedure to wash the HPLC column after analysis.

1.0 OBJECTIVE

To clean the column thoroughly after its each use to avoid any interference on repeated usage.


2.0 SCOPE

This procedure is applicable for different groups of H.P.L.C columns used in Quality Control laboratory.

3.0 RESPONSIBILITY

2.1 Doing: Technical Assistant

2.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 For C18, C8, C6, Phenyl, (CN, Amine, Silica column.:)

5.1.1 Wash the column with the solvent which is use in individual product mobile phase preparation. eg. suppose water is use in mobile phase preparation then wash the column with water.

5.1.2 Allow the minimum 30 ml washing medium to flow through the column.

5.1.3 Disconnect the column from the HPLC unit and store in an allocated place.

5.2 For Protein pack column:

5.2.1 Wash the column with minimum 30 ml of 2.5 M acetic acid.

5.2.4 Disconnect the column from the H.P.L.C unit and store in an allocated place.

5.3 For L17 column :

5.3.1 Change the mobile phase to a mixture of 0.01 N H2SO4 : ACN : 85:15 v/v and flush at flow rate of 0.6 ml/min. minimum for 2 hrs.

5.3.2 Take care that flow rate should not exceed 0.6 ml/minute.

5.3.3 Flush the column with water at flow rate of 0.6 ml/min, for 2 hours.

5.3.4 Disconnect the column from the H.P.L.C unit and store in an allocated place.

6.0 ABBREVIATIONS

6.1 H.P.L.C. = High Performance Liquid Chromatography

6.2 PSI = Pound per square inch

6.3 ACN = Acetonitrile

6.4 H2SO4 = Sulphuric acid

6.5 nm = Nanometer

6.6 ml = Millilitre

6.7 v/v = Volume by Volume

Related: Relative Response Factor in HPLC

Comments

Popular posts from this blog

Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records:  Air pressure differential  Particulate monitoring  Temperature  Humidity  Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4:  Air-lock to the critical ar...

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture  sterile pharmaceutical products   as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the  FFS   and BFS is to reduce the  contamination   by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of  sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...