SOP for Preventive Maintenance of HPLC

Comprehensive Guide: SOP for Preventive Maintenance of HPLC

HPLC is a very sophisticated instrument in the laboratory. This machine requires high alertness and care while operating. HPLC is a widely used analytical method in the pharmaceutical industry. It is a highly recommended analytical technique by different pharmacopeias. Since HPLC is a highly precise testing technique, the possibility of system errors is also high. To avoid such incidents, we need an SOP for the preventive maintenance of HPLC.

Preventive maintenance is very necessary for every HPLC system. It is essential to determine whether your HPLC is new or old, frequency of use of HPLC less or high. Preventive Maintenance helps to extend the overall performance of the system. 

Some Specific benefits of preventive maintenance for HPLC are:

  • Extends the life of the system and its component
  • Improve system performance and reliability
  • It reduces the downtime of the system
  • Improve the safety of the system

Also read: Pharmaceutical formulation plant for sale in India

Interactive SOP for Calibration of HPLC

Interactive HPLC Calibration SOP

🔬 HPLC Calibration SOP

Interactive Standard Operating Procedure for Quality Control

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📋 SOP Overview

Purpose: To establish a standardized procedure for the calibration of High-Performance Liquid Chromatography (HPLC) systems to ensure accurate and reliable analytical results.

Scope: This SOP applies to all HPLC systems used in quality control testing within the pharmaceutical laboratory.

Frequency: Initial calibration, after maintenance, and as per validation schedule.

Parameter Specification Acceptance Criteria
Flow Rate Accuracy $\pm2\%$ of set value $0.98-1.02$ mL/min for $1.0$ mL/min
Injection Volume Precision RSD $\le 2\%$ For 6 replicate injections
Detector Linearity R$^2 \ge 0.999$ Over working range
Temperature Accuracy $\pm2^\circ C$ of set value Column oven temperature

📚 Reference Documents

USP <1225> Validation of Compendial Procedures ICH Q2(R1) Validation Guidelines FDA Guidance for Industry ISO 17025 Requirements

Pre-Calibration Checklist

Decision Point: System Equilibration

Has the system been equilibrated for at least 30 minutes with the mobile phase?

📝 Equipment Information

Flow Rate Calibration

📊 Flow Rate Results

Injection Volume Precision

Decision Point: Injection Precision

Is the RSD of peak areas $\le 2.0\%$?

System Suitability Verification

📈 System Suitability Results

Documentation Requirements

📋 Calibration Record

🔧 Common Issues and Solutions

Flow Rate Out of Specification

Measured flow rate is not within $\pm2\%$ of set value

High Injection Volume RSD

RSD of peak areas is $> 2.0\%$

Poor Peak Shape

Tailing factor $> 2.0$ or poor resolution

🆘 Emergency Contacts

Instrument Support: +1-234-567-890 QA Department: qa@laafon.com Equipment Manual

SOP for Preventive Maintenance of HPLC

Objective

This SOP describes the procedure for Preventive Maintenance of High-Performance Liquid Chromatography.

Scope

This procedure is applicable to the Quality Control Department of Laafon Galaxy Pharmaceuticals.

Responsibility

QC Chemist.

Accountability

QC Manager

Procedure:

General cleaning:

Before starting the cleaning, you must ensure the power supply to the HPLC system should be switched off.

  • Clean the instrument with a clean,n dry cloth every day.
  • Performance Verification
  • Solvent Delivery Module
  • Check flow accuracy as per SOP  

 Acceptance criteria:  ± 2 % of set flow rate.

DETECTOR

  • Check the Detector Wave length accuracy as per SOP.
  • Clean the detector flow Cell with water so that residues can be removed
  • Replacing the lamp if it has deteriorated, follow the manufacturer’s advice for lamp replacement of lamp.
  • Check the electrical connection for any possible damage or torn wire. Repair the damaged connection, if any.
  • Calibrate the Detector regularly to get accurate results from analysis.

Pump: 

Preventive maintenance of the HPLC pump is essential to get the desired results, some common preventive maintenance tasks are listed below:

  1. Replacing the Seals: It is very necessary to replace the seals in the pump regularly. If seals are worn out they can create fluctuations in pressure and leakage of sample. 
  2. Cleaning the pump head: Clean the pump head regularly to avoid a buildup of dirt and debris. 
  3. Inspecting the check valves: Inspect the check valves regularly. It can create a system breakdown if not repaired on time. 
  4. Calibrate the pump: Calibrate the pump regularly to ensure an accurate flow rate and pressure of the system. Follow the SOP or manufacturer’s guidelines to calibrate the pump.

INJECTOR:

  • Flush the injector with mobile phase and water to remove impurities
  • Flush the injector with Isopropyl alcohol also. 
  • Never let the injector unwashed after completion of analysis. 

Check the Injector Linearity Precision as per the SOP.

COLUMN:

Column is an essential part of an HPLC system. Some important steps to prevent columns from hazards and deterioration. 

  • Filter the mobile phases and samples: To filter mobile phases and samples to improve the life of the column, and the accuracy of analysis. 
  • Use an appropriate concentration of samples: The use of highly concentrated samples can damage the filling of the column. 
  • Flush column with water regularly: Flushing the column before and after use increases the lifespan of the column. Flush columns with different types of solvents like water, methanol, and acetone.
  • Equilibrate the column before use: This process will ensure that the column is producing stable results, retention time, and the analytes are reproducible.  
  • Storage of columns: The storage of columns should be proper with caping on ends. The temperature should not be high which can affect the packing of the column. 
  • Troubleshooting the column: If you see any dramatic change in peak, retention time, and HPLC pressure for known samples, then you approach the service engineer for troubleshooting the column. 

Acceptance Limit is:

The % RSD for all peak areas should be NMT 1.0.

The correlation coefficient should be NLT 0.999.

 Prepared ByChecked ByApproved ByDesignationExecutive QCManager QCManager  QASignature   Date   table

5.3 Preventive Maintenance Procedure

Solvent Module 

Switch off the main power switch provided on the rear side.

Sonicate solvent inlet filters; drain valve filter inlet and outlet check valves in methanol or IPA for 5 min. 

Open the pump head check the plunger and plunger seal for scratches on the plunger, and replace if necessary 

  • Re-assemble the pump head, and check for leaks. 
  • Check pump functioning for pressure fluctuations. 
  • Check leak sensor functioning 
  • Detector
  • Remove dirt from the panel and cover.

Reassemble cell and Sonicate flow cells with methanol or IPA for 10 minutes.

Reassemble cells, and check for leaks.

Perform automatic wavelength calibration.

Check sample energy and reference energy, Replace the lamp if necessary

Check for leak sensor functioning.

Stick the under preventive maintenance label before doing preventive maintenance

Frequency:- After each maintenance

List of annexures and formats.

None

Benefits of Implementing a Preventive Maintenance SOP

There are several benefits to implementing a Preventive Maintenance SOP for HPLC:

  • Improved Data Accuracy: If you maintain the HPLC system in a good manner it will produce more accurate data. Roughly used HPLC systems can never provide accurate results of tests. 
  • Reduce Downtime of the system: It helps to prevent system breakdown and failures. Preventive Maintenance HPLC SOP helps to reduce sudden failures of the HPLC system.
  • Enhance Equipments Life: If you follow and implement Preventive Maintenance SOP, it can help to extend the overall life of the HPLC system. 
  • Improve Safety: An SOP can help to improve the safety of the equipment by identifying and addressing possible errors in the HPLC system. It protects the operator and system from any accident. 
  • Improve data compliance: A well-written SOP can help to meet the regulatory compliance and Industry standards for HPLC system maintenance.

References:

    1. SOP on SOPs.
    2. Care, Maintenance, and Troubleshooting of HPLC Columns-Edward Kim, Applications Engineer January 17, 2008 [Agilent Technologies]
    3. Benefits of Preventive Maintenance for your Chromatography  Equipment-[LCServicesLtd(.co.uk)]
    4. Standard Operating Procedure- High-Performance Liquid Chromatography (HPLC)-[University of California, Irvine]
    5. Care, Maintenance, and Troubleshooting of HPLC Columns-

Edward Kim Applications Engineer January 17, 2008 -[Agilent(.com)]

Reason for revision.

  • Due to Validity.
  • Safety Precautions

Abbreviations

10.1  SOP-           Standard Operating Procedure

10.2  QA-           Quality Assurance

10.3   min.-           Minute

10.4   nm –           nanometer

10.5   IPA-           Iso Propyl alcohol

10.6    ml-           Milliliter

Darshan Singh
Darshan Singh

Author is a pharmaceutical professional who is Master in Science (Organic Chemistry) and Diploma in Pharmacy. He has rich experience in pharma manufacturing sector, He Served in many companies as Quality Control Head, and Quality Assurance Head, along with Plant Head supervised all manufacturing processes. He is keen to research of pharma product manufacturing and drugs pharmacology. He is writing on several topics about pharmaceutical products, processes, and SOPs.

Articles: 129

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