San Diego biopharmaceutical companies rely heavily on high-performance liquid chromatography (HPLC) to analyze and purify their products. For organizations that utilize Shimadzu equipment, GL Technologies provides calibration and certification for those laboratory's that are utilizing the Shimadzu brand for their research and development With a team of qualified HPLC experts, GL Technologies, we have deep experience in calibration and as an ISO 17025 certification company, can keep your company compliant with federal regulations.
To speak with the experts about your Shimadzu HPLC needs, please fill out our online form or give us a call!
Shimadzu Equipment Calibration
GL Technologies offers a range of Shimadzu equipment calibration services, including system qualification, instrument calibration, and performance verification. Our consultants use state-of-the-art calibration procedures and equipment for measurement accuracy and reliability.
The team of experts at GL Technologies are highly trained and experienced technicians that follow strict quality control procedures for all calibrations that are performed. GL Technologies is committed to providing our clients with the highest level of service and support, and we work closely with researchers and laboratory workers to develop customized calibration programs that will meet an organization's specific laboratory needs. With our expertise and commitment to quality, GL Technologies is a trusted partner for Shimadzu HPLC calibration services.
Our Services are Designed For
Compliance with Regulatory Standards
Biopharmaceutical manufacturers are subject to strict regulations from agencies like the FDA, EMA, and others. These regulations mandate the use of calibrated and validated analytical instruments for product quality and patient safety. Shimadzu equipment calibration helps biopharma companies maintain compliance with these standards, reducing the risk of costly regulatory issues.
Accurate Data for Research and Development
The biopharma industry relies heavily on data-driven decision-making. Inaccurate data from uncalibrated instruments can lead to flawed research outcomes, impeding the development of new drugs and therapies. Calibrated Shimadzu equipment makes sure that the data generated is reliable, promoting effective research and development processes.
Quality Control and Assurance
Product quality is of the utmost importance in the biopharma industry. Equipment calibration plays an important role in maintaining quality control and assurance throughout the manufacturing process. Precise measurements are necessary for confirming product consistency and safety, reducing the likelihood of batch rejection and product recalls.
Cost Efficiency
Calibration is an investment that pays off in the long run. Regularly calibrated Shimadzu equipment reduces the risk of equipment malfunction, so that instruments last longer and require fewer repairs. This turns into to cost savings for biopharmaceutical companies over time.
2 Benefits of HPLC Calibration
Accuracy and Precision
Calibration makes sure that the HPLC system is accurately measuring and separating compounds in a sample. By calibrating the system with known standard compounds of interest, you can establish a reliable correlation between the detected signal and the concentration of the analyte. This improves the accuracy and precision of quantitative analyses, allowing for more reliable and reproducible results. Researchers and analysts can confidently determine the concentration of target compounds in their samples, which is crucial in various fields such as pharmaceuticals, environmental monitoring, and food safety.
Quality Control and Compliance
Calibration is a critical component of quality control in HPLC systems. Regular calibration and performance verification aims to make sure that the instrument is functioning correctly and within defined specifications. This is particularly important in regulated industries such as pharmaceuticals, where compliance with Good Manufacturing Practices (GMP) and other quality standards is mandatory. Proper calibration also helps in meeting the requirements of regulatory agencies like the FDA, which demand traceable and validated methods to maintain data integrity and product quality. It provides confidence that the results are valid, which is vital for making informed decisions based on analytical data.
To speak with the experts about your Shimadzu HPLC needs, please fill out our online form or give us a call!
HPLC Education Corner
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.
Perfecting the Process: HPLC Calibration for Biopharmaceutical Analysis
High-performance liquid chromatography (HPLC) has become a critical tool in the biopharmaceutical industry for the analysis of various biological molecules, including proteins, peptides, nucleic acids, and other biopolymers. The accuracy and reliability of HPLC analysis are paramount to ensuring the quality, safety, and efficacy of biopharmaceutical products. This article provides a comprehensive overview of the importance of HPLC calibration for biopharmaceutical analysis and offers practical advice on optimizing the calibration process to achieve accurate results.
Raising the Bar: Advancements in HPLC Calibration for Biopharmaceuticals
The biopharmaceutical industry is continuously evolving with new developments in technology, research, and methodologies. One critical aspect of biopharmaceutical production is High-Performance Liquid Chromatography (HPLC), a powerful analytical tool used for the separation, identification, and quantification of various components in complex mixtures. Over the recent years, HPLC calibration has made significant advancements that have increased the accuracy and reliability of this analytical method.
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.
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. We also serve Los Angeles and San Francisco.
Shimadzu Medical Equipment Manufacturer
Shimadzu Medical Equipment is a well known name in the field of healthcare technology, recognized for their cutting-edge innovations and commitment to excellence. With a legacy spanning over a century, Shimadzu has continuously evolved its medical equipment offerings to meet the changing demands of the healthcare industry. From diagnostic imaging systems to advanced medical diagnostic tools, Shimadzu's products are designed with precision engineering and backed by extensive research and development. The company's dedication to quality and reliability has earned it the trust of healthcare professionals worldwide, making Shimadzu a preferred choice in hospitals, clinics, and medical facilities across the globe.
At the core of Shimadzu Medical Equipment's philosophy is a pursuit of advancements that improve patient outcomes and streamline healthcare workflows. Leveraging state-of-the-art technology such as artificial intelligence and digital imaging, Shimadzu's products provide healthcare providers with diagnostic tools that improve accuracy, efficiency, and patient comfort. Whether it's X-ray systems delivering crystal-clear images with minimal radiation exposure or solutions for cardiovascular imaging and ultrasound diagnostics, Shimadzu remains at the forefront of medical innovation. By consistently pushing the boundaries of what's possible in medical technology, Shimadzu Medical Equipment continues to redefine standards of care and contribute to the advancement of healthcare worldwide.
To speak with the experts about your Shimadzu calibration needs, please fill out our online form or give us a call!