HPLC PM OQ Services

HPLC is a widely used analytical technique in the biopharmaceutical, pharmaceutical, and medical device industries. To maintain accuracy and reliability of HPLC systems, regular preventive maintenance (PM), operational qualification (OQ), and timely repairs are extremely important. The team at GL Technologies has extensive experience working with organization's in these industries throughout California to help implement, maintain, and repair HPLC systems. We make sure our clients analytical data is accurate and meet regulatory standards for compliance.

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

858-202-1408

Preventive Maintenance (PM)

Preventive maintenance has an important role in the upkeep of HPLC systems and involves a series of scheduled tasks aimed at identifying and addressing potential issues before they cause system failures. There are a few key aspects of HPLC PM including:

Column Maintenance

Colum maintenance is an important aspect of HPLC systems. Regular maintenance activities include inspecting the column for physical damage, leaks, or blocks, as well as replacing the needed components such as frits and O-rings. Cleaning the column involves solvent flushing or backflushing to remove contaminants and residual analytes that may compromise separation efficiency. Additional test samples will be performed to verify the column integrity and monitoring key performance parameters like pressure and baseline stability for reliable HPLC analysis.

Pump Maintenance

Pump maintenance includes a series of preventive measures with the goal at preserving the functionality of the pump, a key component that is responsible for delivering the mobile phase in HPLC analysis. Regular pump maintenance activities include cleaning and inspecting the pump equipment including seals, pistons, and check valves. to prevent blockage. It's important to monitor and calibrate the pump's flow rate and pressure regularly to maintain consistent chromatographic results.

Autosampler Maintenance

To start, it's ipmortant to clean the sample injection needle and the sample probe regularly using solvents to prevent cross-contamination between samples. The injection valve should be inspected and replaced if needed to maintain consistent sample introduction. It's important to calibrate the autosampler to verify the correct sample volumes are being injected. Lubrication of moving parts including the syringe drive and carousel should be carried out to reduce friction and provide a smooth operation.

Detector Maintenance

The detector requires regular maintenace to maintain sensitivity and accuracy. It involves a series of tasks including the cleaning of the detector's optical surfaces to remove contaminants or residues that may affect sensitivity and baseline stablility. The detector's flow cell needs to be inspected and replaced periodically to prevent clogging. Routine calibration is important to make sure that the detector meets the required specifications.

Operational Qualification (OQ)

OQ involves testing and verifying that the HPLC system meets predefined operational specs and regulatory requirements. Key components of OQ include:

Performance Verification

The performance verification stage of HPLC OQ involves testing and evaluating of various components including detectors, pumps, columns, and software to validate their functionality and compliance with the predefined specs. Through calibration, accuracy, linearity, and system suitability tests, the performance verification process establishes the system's capability to deliver consistent analytical results.

System Suitability

System suitability is a vital part of HPLC OQ that makes sure the sytem meets predefined acceptance criteria and is capable of consistently delivering accurate results. It involves a series of tests and measurements to evaluate the parameters including resolution, peak symmetry, retention time, and tailor factor. By conducing system suitability as a part of HPLC OQ, analysts can now verify the reliability of the HPLC system which shows that the analytical data generated by routine analysis is valid.

Compliance with Regulations

Compliance with HPLC OQ requirements is important to meet regulatory guidelines, maintain data integrity, and verify the reliability of analytical results. By conducting thorough OQ evaluations, laboratories can demonstrate the reliability and accuracy of their HPLC systems, which in turn, meets compliance standards and assures the quality of analytical data. We work with biopharmaceutical, pharmaceutical, and medical devices companies throughout California including San Diego for their HPLC needs.

HPLC Repair

Even with regular maintenance, occasional breakdowns or malfunctions can occur. Timely repairs are essential to minimize system downtime and maintain continuous operation. GL Technologies has a team of qualified service engineers with experience in a variety of HPLC manfuacturer systems to address repairs quickly.

Troubleshooting

When it comes to troubleshooting HPLC repairs, a systematic approach is needed to identify and fix any issues quickly. The first step is to gather as much information as possible about the problem including error messages, observed symptoms, and any recent changes or maintenance performed on the system. Then a thorough inspection of the hardware such s the pump, injector, and detector just to name a few, should be carried out to check for any visible signs of damage. The GL Tec professionals will verify the proper functioning of HPLC accessories like tubing, fittings, and seals. A review of the software settings, calibration, and method parameters will be conducted to verify they are accurate and properly configured.

Genuine Spare Parts

Genuine spare parts are specifically designed and manufactured by the original equipment manufacturer (OEM), guaranteeing compatibility and quality performance. By utilizing genuine spare parts for HPLC repair, technicians can verify the longevity of the instrument, minimizing downtime and maximizing productivity. The parts will undergo rigours quality control measures so that their reliability and adherence to strict specifications are maintained. Whether it's replacing a column, detector, or any other component, relying on genuine spare parts is important to maintain laboratory efficiency and accuracy of HPLC systems.

Calibration and Testing

GL Technologies offers comprehensive services for HPLC repair, calibration, and testing to make sure the performance of the HPLC system is performing as required. Our team has the knowledge to diagnose and resolve any issues with HPLC systems, from troubleshooting and component replacement, to software udpates and maintenance. We work with our clients closely to deliver a tailored solution to meet their specific needs.

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

858-202-1408

Key HPLC OQ Articles

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.

IQ OQ PQ: Building Blocks of Biopharmaceutical Manufacturing

In the complex and strictly regulated world of biopharmaceutical manufacturing, verifying the safety and quality of products is of utmost importance. To achieve this, the biopharma industry relies on a systematic approach known as IQ, OQ, PQ. These acronyms stand for Installation Qualification (IQ), Operational Qualification (OQ, and Performance Qualification (PQ). Together, they form the cornerstone of building a successful and compliant manufacturing process. Let’s discuss the significance of of IQ OQ PQ and how they contribute to the production of life-saving medications.

Improve HPLC Performance Through Operational Qualification

HPLC (high-performance liquid chromatography) is a widely used analytical technique in the pharmaceutical and biopharmaceutical industries. HPLC provides researchers and analysts with reliable and quantitative data about the composition of complex mixtures. To verify accurate and reproducible results, it’s important to maintain and optimize the performance of the HPLC system. A vital step in this process is OQ (operational qualification). OQ can improve the performance of an HPLC system for organizations in a variety of ways.

GL Technologies Capabilities

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.