San Diego HPLC Equipment Calibration

High-performance liquid chromatography (HPLC) is a widely used technique in biopharmaceutical and life science industries for separating, identifying, and quantifying complex mixtures of compounds. The accuracy and reliability of HPLC analysis depend on the proper PM, OQ, or Repair of the equipment. HPLC services are important for these organizations so the results obtained from HPLC are accurate and meet the regulatory requirements. As the experts in HPLC calibration and repair, GL Technologies works with a variety of biopharmaceutical and medical equipment companies throughout San Diego for their HPLC needs.

To speak with the experts about your HPLC equipment calibration needs, please fill out our online form or give us a call!

858-202-1408

HPLC Calibration Experts When You Need Us

HPLC and mass spec, Dissolution, and Sartorious PMs, OQ, or Repair services involve a series of procedures to validate and verify the performance of the equipment. GL will verifies that the instrument is functioning properly and providing accurate results by providing more data than OEM Service. We have worked hard to earn the trust of Biopharmaceutical, Pharmaceutical,, Life Science, and Medical Device companies throughout California. As GL Management comes from these companies our goal is to maintain the equipment being used in their laboratories so they are producing reliable results. Our services include Roving Crews, Personnel Placement, annd Annual Service Contracts for new, used, or relocated equipment.

Significance in Biopharma

In biopharmaceutical analysis, where small variations can have large implications, the reliability of HPLC systems becomes vital. Calibration guarantees that the equipment operates within predefined tolerances, minimizing errors and deviations. This is important when analyzing biomolecules, proteins, peptides, or complex drug formulations, where exact measurements are indispensable for efficacy, safety, and regulatory compliance.

HPLC Calibration Benefits

Accuracy of Results

When HPLC systems are properly calibrated, accurate results will be obtained from subsequent sample analysis and can be improved. Calibration will verify that your instrument/s are operating with the needed parameters and the response gathered is directly proportional to the concentration of the target analyte. For environmental monitoring and pharmaceutical analysis, a properly calibrated HPLC system will provide further confidence in the obtained results, giving scientists and analysts the ability to make informed decisions.

Precision

The precision a properly calibrated HPLC system provides is consistent and reproducible measurements, allowing researchers and lab workers to compare and interpret data over time. Exact calibration will minimize variability and error, increasing overall quality of the HPLC analysis.

Efficiency

With the proper calibration of HPLC systems, various parameters like retention time, peak width, and peak area can be exactly determined and adjusted. This increases the overall efficiency of the HPLC system by increasing its performance and reducing method development time.Scientists and researchers will be able to achieve faster separations and higher resolutinos, leading to increased productivity. This translates into faster analysis, allowing researchers to get reliable data quicker.

Maintain Analytical Data

Calibration is also essential for maintaining the integrity of the analytical data, which is important for research, development, and quality control. Any deviation from the standard operating procedures or incorrect calibration can lead to inaccurate and unreliable results, which can have serious consequences in the pharmaceutical and chemical industries. We have also become the experts helping San Diego companies with IQ OQ PQ validation processes for their company.

Importance of HPLC Calibration

Accurate calibration is essential for obtaining reliable analytical data and maintaining the integrity of analytical results. Proper calibration ensures that the instrument operates within specified parameters, minimizing errors and inaccuracies in sample analysis. It also helps in meeting regulatory compliance requirements and quality assurance standards.

Steps Involved in HPLC Calibration

Initial System Check

Inspect the entire HPLC system for any visible damage or defects.
Ensure that all components are clean and properly connected.
Verify power supply and instrument status indicators.

Performance Verification

Run system suitability tests using standard reference materials.
Check baseline stability, resolution, and peak symmetry.
Verify detector linearity and sensitivity.
Calibration of Pump:

Prime the pump and check for consistent flow rates.
Calibrate pump pressure and flow rate using a calibrated flowmeter.

Calibration of Detector

Optimize detector settings such as wavelength, sensitivity, and range.
Perform wavelength accuracy and linearity tests using standard solutions.
Verify detector response with known analytes at different concentrations.

Column Equilibration

Condition the column with mobile phase to ensure reproducible separations.
Verify column temperature and stability.

Software Calibration:

Verify software settings and parameters.
Perform software validation and ensure proper integration with the HPLC system.

Documentation

Maintain comprehensive records of calibration procedures, results, and any deviations observed.
Ensure that calibration records comply with regulatory requirements.

HPLC Education

The Intersection of HPLC and Biopharmaceutical Innovation

In the wordl of biopharmaceuticals, the advancement of analytical techniques plays a pivotal role in making sure the safety, efficacy, and quality of therapeutic drugs. High-Performance Liquid Chromatography (HPLC) stands at the forefront of these technological advancements, driving innovation and precision in the development and manufacturing processes of biopharmaceuticals.

Biopharma HPLC for Small and Large Molecule Analysis

High-Performance Liquid Chromatography (HPLC) has long been a cornerstone technique in the field of biopharmaceutical analysis. It plays a crucial role in the separation, quantification, and characterization of various compounds, including both small and large molecules. In the world of biopharmaceuticals, the significance of HPLC cannot be overstated. We'll explore the role of HPLC in biopharma, focusing on its application in the analysis of both small and large molecules.

HPLC Questions

Can you explain the concept of traceability in HPLC OQ?

Traceability in HPLC OQ refers to the ability to link and document the entire analytical process, making sure that each step, from the initial system setup to the results can be accurately retraced and verified. It involves recording and maintaining records of critical information including instrument calibration, system suitability tests, reference standards, sample prep details, and data analysis methods.

What are the differences between HPLC OQ and HPLC PQ (Performance Qualification)?

HPLC OQ makes sure that the equipment is properly installed and functional, while HPLC PQ demonstrates the system’s suitability for accurate and reliable analytical applications. HPLC OQ focuses on verifying and documenting that the equipment functions according to its operational specification and manufacturer’s guidelines. OQ involves testing system components and calibration, so the instrument operates within predefined parameters. HPLC PQ aims to evaluate the system’s performance capabilities under “real-world” conditions by analyzing standard samples and evaluating critical method attributes like accuracy, linearity, and precision.

What are the documentation requirements for HPLC OQ?

The documentation requirements for HPLC OQ involve comprehensive records and reports to verify the system’s performance and suitability. The documentation needs to include a detailed description of the instrument’s specifications including model and serial number, and the acceptance criteria for each parameter tested during OQ. Documentation should also include calibration certificates, SOPs (standard operating procedures related to the instrument’s operation and maintenance along with data on system suitability tests and performance verifications. Deviations and corrective actions need to be recorded as well. The documentation will serve as evidence of the HPLC system’s compliance and validates its reliability in pharmaceutical analytical applications.

What are the acceptance criteria for HPLC OQ tests?

The acceptance criteria for HPLC OQ tests are specific parameters that must be met to verify the proper functioning and performance of the HPLC system. The criteria include aspects such as system suitability, calibration, precision, accuracy, limit of detection, limit of quantification, and linearity.

How does HPLC OQ differ from HPLC method validation?

HPLC OQ and HPLC method validation serve distinct purposes. HPLC OQ involves comprehensive testing and verification of the HPLC system’s operational parameters and performance. HPLC method validation focuses on evaluating the suitability and reliability of a specific analytical method to accurately quantify analytes of interest.

Are there specific calibration requirements for the instruments used in HPLC OQ?

Yes, there are specific calibration requirements for the instruments used in HPLC OQ. OQ is an important part of the validation process to verify that the HPLC system performs accurately and consistently within its specified parameters. The calibration process should include the use of certified reference standards to confirm the accuracy of the system’s measurements.

About GL Technologies

As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. We also provide HPLC calibration services to organizations throughout Orange County HPLC.