Los Angeles HPLC Equipment Calibration Company

The team at GL Technologies provides HPLC equipment calibration services to biopharmaceutical and related industries throughout the Los Angeles area. High-performance liquid chromatography (HPLC) is a widely used analytical technique for separating and analyzing complex mixtures of chemicals. For accurate and reliable results, it's important to calibrate the HPLC equipment regularly. GL Technologies has extensive experience in HPLC calibration and certification for biopharma and pharmaceutical organizations throughout the Los Angeles area.

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GL-Tec HPLC Calibration Services

Step 1: Preparation

Before starting the calibration process, we verify that the HPLC equipment is clean and free from any residue. Remove any previous sample residues from the HPLC column by flushing with the mobile phase. Making sure that the HPLC column is properly installed and the mobile phase is prepared as per the manufacturer's instructions.

Step 2: Check System Pressure

An important part of the HPLC equipment calibration is to check the system pressure. This can be done by running the HPLC system at the specified flow rate and measuring the system pressure using a pressure gauge. Compare the measured pressure with the recommended pressure range specified by the manufacturer. If the measured pressure is outside the recommended range, we will evaluate the cause and take corrective action.

Step 3: Verify Flow Rate

Our team of professionals then verifies the flow rate of the mobile phase. This is done by using a flow meter or by weighing the mobile phase before and after a fixed time interval. The measured flow rate should be within the specified range mentioned by the manufacturer.

Step 4: Detector Calibration

The detector calibration is an important step in HPLC equipment calibration. To calibrate the detector, we inject a standard solution of a known concentration and measure the response of the detector. Calculate the detector response factor by dividing the peak area by the concentration of the standard solution. The response factor should be within the acceptable range specified by the manufacturer.

Step 5: Column Calibration

Column calibration is another important step in HPLC equipment calibration. It involves running a standard solution through the HPLC column and measuring the retention time of the analyte peak. We then compare the retention time of the analyte peak with the reference standard retention time, if the retention time is within the acceptable range, the column is calibrated.

Step 6: System Suitability Test

The final step in HPLC equipment calibration is the system suitability test. This test validates that the HPLC system is working within the acceptable limits. The test involves running a known sample through the HPLC system and measuring various parameters such as resolution, peak symmetry, and column efficiency. The measured parameters should be within the acceptable range specified by the manufacturer.

HPLC Calibration Benefits

Accuracy and Precision

The primary objective of HPLC calibration in the biopharma and pharmaceutical industries is to maintain the accuracy and precision of analytical results. Calibration procedures involve verifying the instrument’s measurements against known standards, identifying deviations, and making necessary adjustments. This process validates that the HPLC system consistently provides reliable data, absolutely crucial for drug purity assessments, potency determinations, and impurity profiling.

Compliance with Regulatory Standards

Compliance with strict regulatory standards is non-negotiable in the biopharmaceutical sector. Calibration of HPLC systems matches with regulatory requirements set forth by agencies such as the FDA, EMA, and other global regulatory bodies. Maintaining these standards is important for gaining approval for drug development, manufacturing, and commercialization, with end-patient safety always in mind.

Improved Product Quality

The accuracy of HPLC analysis directly influences the quality of biopharmaceutical products. HPLC calibration helps in detecting and fixing any deviations or irregularities in the HPLC system, minimizing the risk of producing potentially harmful medications. Maintaining consistent quality through proper calibration increases the potency and safety of biopharmaceuticals, creating trust among healthcare professionals and patients.

Cost Efficiency

Regular HPLC calibration can contribute to cost efficiency in Los Angeles biopharma operations. By preventing inaccuracies or failures in analysis, calibration reduces the likelihood of rework, reanalysis, or product recalls due to faulty results. This forward-thinking approach minimizes operational disruptions, minimizes financial losses, and improves resource utilization, benefiting the bottom line.

Longevity of Equipment

Regular calibration not only maintains accuracy but also extends the lifespan of HPLC equipment. Regular maintenance and calibration reduce wear and tear, preventing potential breakdowns and expensive repairs. This proactive approach to equipment care increases reliability, maximizing the life of instruments that are critical to biopharmaceutical research and production processes.

HPLC Articles

Fine-tuning HPLC Calibration for Biopharma Excellence

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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.

Quality and Compliance: HPLC OQ in the Biopharmaceutical Industry

The biopharmaceutical industry plays an important role in developing and producing life-saving drugs and therapies. Maintaining the quality and safety of these products is of utmost importance. HPLC (high-performance liquid chromatography) is a widely used analytical technique in the biopharma industry for assessing the quality and purity of drugs and biologics. To meet regulatory standards for quality, organizations perform HPLC Operational Qualification (OQ). Let’s jump into the significance of HPLC OQ in the biopharma industry, its processes, and the role it plays in meeting compliance and product integrity.

What is HPLC Calibration?

High Performance Liquid Chromatography (HPLC) calibration is the process used to maintain the accuracy and reliability of analytical results obtained from an HPLC system. It involves a series of procedures aimed at fine-tuning and validating the performance of components within the HPLC, including detectors, pumps, columns, and other system parameters. Calibration involves checking and adjusting settings like flow rate, pressure, detector sensitivity, and wavelength accuracy to provide consistent and exact measurements. By calibrating an HPLC system regularly using known reference standards, laboratories can maintain the instrument's accuracy, identify any deviations or issues, and verify the reliability of analytical data obtained during sample analysis.

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.