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. ...
Mission
A California based Calibration/ Metrology company specializing in servicing the Biopharmaceutical and Medical Device industries with FDA cGMP compliance, product efficacy, lot repeatability, safety of patients, utilities and manufacturing equipment repeatability, and safety of personnel.
ISO/IEC 17025:2017 & ANSI/NCSL Z540-1-1994 SO Certificate
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Equipment Calibration, Asset Management Systems, and Validation
Calibration, Repair, Preventive Maintenance, Qualifications, Validations, IQ, OQ, PQ
Equipment Calibration Services
Whether addressing emergency situations, performing routine maintenance, or installation of new equipment , our customers rely on the expertise and diverse experience that GL Technologies LLC can provide. Our experience performing cGMP compliant calibrations and maintenance has been relied upon by industry leaders in the medical device, biopharmaceutical and life science industries as well as local municipalities and military installations.
We specialize in calibration and troubleshooting of Clean Utilities, Automated Process Equipment, Analytical Laboratory Equipment, HVAC controls, SCADA and Building Management Systems and Passivation.
GL Technologies Calibration Services
GL Technologies is a full service calibration provider specializing in the Biopharmaceutical and Medical Device industries. Our management has worked in, managed, and developed FDA cGMP fully compliant programs. Our services include roving crews for the Biopharmaceuticals for regular scheduled calibrations or shutdown and new system situations. GL Technologies also places qualified individuals on various large and small Biopharmaceutical and Medical Device companies. The services we provide include general Calibration/ Metrology support, asset and CMMS management, compliant program development, SOP development, and maintenance/ facilities support.
GL Technologies can fully setup a compliant program including method development, Identification of items to calibrate in a facility or on a system, tolerance assignment, calibration cycle determination, and SOP design. Our management has personally been audited by and developed programs that have been audited by the FDA, FDB, European, and Asian Regulatory Authorities. We specialize in the placement of personnel on sites and are often used to vet potential new hires for Biopharmaceutical and Medical Device companies. GL Technologies has placed over 180 individuals at sites in California and abroad. There are no fees or penalties for the full time hiring of these individuals. Most of the current CA Biopharmaceutical programs are now managed and staffed by former GL team members.
Equipment Calibration Articles
Biopharmaceutical and medical related research and manufacturing organizations understands the importance of maintaining the highest quality standards and adhering to cGMP (current Good Manufacturing Processes). The cGMP provides verification...
High-Performance Liquid Chromatography (HPLC) is an analytical tool in biopharmaceutical research and development, as well as quality control (QC) applications. This amazing technique allows for the separation, identification...
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 ...
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...
An important aspect of this challenge is the implementation of effective building maintenance systems which have a tremendous impact on product quality, compliance, and operations. ...
Frequently Asked Questions
What are the different calibration standards used in HPLC?
In HPLC (high performance liquid chromatography), various calibrations standards are used to verify accurate and reliable analysis. A common standard is the external standard method where a known concentration of a pure compound is prepared separately and analyzed alongside the sample. This method will work to determine the retention time and peak area of the compound, providing quantification. Another standard is the internal standard method where ea known amount of an internal standard is added to both the calibration standards of the sample. Then a comparison o the response of the analyte to that of the internal standard, variations due to sample preparation and instrument performance can be accounted for. Also, calibration curves can be constructed using a series of standards with different concentrations, allowing for the determination of the relationship between concentration and response. The standards can be prepared by diluting a pure compound or obtaining certified reference standards. The use of calibration standards in HPLC provides an accurate quantitative analysis for reliable results.
What are the acceptance criteria for HPLC calibration?
The acceptance criteria for HPLC calibration is usually defined to provide accuracy and reliability of the instrument’s performance. The criteria varies on the specific laboratory standards and regulatory requirements, but they usually involve parameters such as system suitability, retention time, peak symmetry, resolution, linearity, accuracy, and sensitivity. System suitability tests are performed to verify that the HPLC system is operating within acceptable limits. Retention time and peak symmetry are also evaluated to verify consistent and reproducible elution of analytes. Linearity reviews the instrument’s response across a range of analyte concentrations, while accuracy determines the repeatability of measurements. Sensitivity is tested to make sure the instrument can detect and quantify analytes at the needed levels. By adhering to the accepted criteria, laboratories can validate the calibration of their HPLC systems that they provide accurate analytical results.
Are there any regulatory requirements for HPLC calibration?
Yes, there are regulatory requirements for HPLC calibration. The FDA (Food and Drug Administration) and the ICH (International Conference on Harmonization) have established guidelines and standards that mandate regular calibration of HPLC systems used in pharmaceutical and other regulated industries. The requirements make sure the accuracy and traceability of analytical results of the instrument are properly calibrated, qualified, and maintained. Documentation of calibration activities including instrument logs, calibration certificates, and SOPs (standard operating procedures), is required to demonstrate compliance with these requirements. The documentation will also be used for inspections and audits.
What documentation is required for HPLC calibration?
Documentation includes a calibration plan which outlines the specific calibration procedures and parameters to be followed. A detailed instrument qualification report is necessary to document the qualification process and confirm that the HPLC system meets predefined acceptance criteria. The calibration log needs to be filled out during the calibration process including that has the date, time, and results of each calibrated standard or reference materials used is important to validate their authenticity. Finally, any deviation or incidents encountered during the calibration process need to be recorded in an incident report which provides an account of the issue and any corrective actions taken. Together, these documents verify the accuracy and reliability of HPLC calibration and provide a full record for future reference and quality assurance.
What is Operational Qualification (OQ), and what does it involve?
Operational Qualification (OQ) is an important phase in the validation process of equipment, systems, instruments, or processes in the bio-pharmaceutical and manufacturing industries. It involves a series of documented tests designed to verify that the equipment or system operates according to its intended functions with predetermined operational parameters. OQ includes activities including performance testing, calibration verification, functionality testing, and a documentation review to make sure that the equipment or system meets the predefined specs and regulatory requirements. By conducting OQ, companies can establish confidence in the reliability and consistency of their operational processes which maintains product quality and safety.
Are there any specific regulations or guidelines that outline the requirements for IQ, OQ, and PQ?
Yes. There are regulations and guidelines that outline the requirements for IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). These qualifications are used in the pharmaceutical industry and manufacturing where equipment systems and processes need to be validated so they meet predefined standards and perform consistently. Regulatory entities like the FDA and ISO provide comprehensive guidance on IQ, OQ, and PQ requirements where the guidelines define the scop and objectives of each qualification, provide instructions for test protocols, acceptance criteria, and documentation.
Why are IQ, OQ, and PQ important in regulated industries such as pharmaceuticals?
IQ, OQ, PQ play an important role in the pharmaceutical industry because they verify the quality, reliability, and compliance of critical equipment and processes. IQ validates that the equipment is installed correctly and meets required specifications including appropriate utilities and documentation. OQ verifies that the equipment is operating as intended and performs within predefined parameters to maintain functionality and accuracy. PQ is the final phase, it includes demonstrating that the equipment consistently produces desired results and meets the acceptance criteria. By implementing these qualification phases, pharmaceutical companies can maintain the integrity of their operations and minimize risks which verifies the safety of pharmaceutical products.
What are the key components of OQ HPLC?
The key components of OQ HPLC (Operational Qualification High-Performance Liquid Chromatography) includes various elements that are required for its operation and performance. To start, there is a solvent delivery system which consists of pumps and solvent reservoirs responsible for delivering the mobile phase of a consistent flow rate. This is followed by the sample injection system which allows for the exact and reproducible introduction of samples in to the chromatography column. The column is an important component where the separation of analytes takes place utilizing its stationary phase and optimized dimensions. The data acquisition and analysis system captures and processes the detector’s output, generating chromatograms and providing relevant quantitative information. Temperature control systems are often used to maintain stable operating conditions for sensitive analysis. Finally, the system should have appropriate software and interfaces that allow for instrument control, method development, and data management. The successful validation of each of these components is critical to maintaining the reliability of OQ HPLC analysis.
How does OQ affect the overall reliability and accuracy of HPLC results?
OQ (Operational Qualification), has an important role in determining the overall reliability and accuracy of HPLC results. OQ involves the verification and documentation that the HPLC system meets predetermined specifications and performs consistently within acceptable limits. Conducting a thorough OQ, sources of error or deviations in the HPLC system can be identified and fixed quickly to maintain accurate results. OQ involves evaluating parameters including column performance system suitability, detector response, injection precision, and calibration accuracy. It also establishes the systems baseline performance and identifies any deviations so correct measures can be taken.
Are IQ, OQ, and PQ required for all equipment and instruments?
IQ, OQ, PQ qualifications are validation processes commonly used in the pharmaceutical industry. While these procedures are not universally mandatory for all equipment and instruments, they are required for critical or high-risk equipment. The purpose of IQ is to make sure that the equipment is installed correctly, OQ tests that it functions properly, and PQ validates its performance under normal operations conditions. The qualifications need depend on a few factors including the nature of the equipment, its impact on product quality, and regulatory requirements. It’s important for organizations to evaluate the criticality of their equipment to determine the level of qualification needed for compliance and quality assurance.
Calibration Software
GL-Tec Capabilities Include:
Hood Certification (Fume & Bio Safety Cabinets
Analytical Services
(HPLC PM OQ Repair, Sartorious)
sPRT Calibration (Standard Resistance Thermometer)
Building Maintenance Systems
CMMS Software
Fume Hood Certification
Join the GL Technologies Team!
For some of us, GL Technologies is the best first job they can have. For others, this is their career-long home. And there are many more in between. Whatever your career goals, if you work with integrity and committment there’s a place for you!
IQ OQ PQ Services
The team at GL Technologies provides IQ OQ PQ services for biopharmaceutical and pharmaceutical clients throughout California to implement theses processes in to their organization. A company’s commitment to IQ OQ PQ qualifications is of the utmost importance. IQ focuses on verifying proper equipment installation and documentation, making sure there is a solid foundation for subsequent operations. OQ dives into the equipment’s functionality, confirming that it operates within defined specifications under various conditions. Finally, PQ assesses the system’s performance by subjecting it to real-world scenarios, verifying it consistently meets the desired outcomes and regulatory requirements.
Mass Spec Calibrations
Biopharmaceutical and pharmaceutical companies throughout California rely on the team at GL Technologies for their mass spectrometry calibration needs. Mass spectrometry is a critical process in analytical chemistry that verifies the accuracy and precision of mass spectrometers, which are vital tools for identifying and quantifying chemical compounds in various samples. Calibration involves adjusting the instrument’s settings and parameters to align the measured “mass-to-charge (m/z)” of ions with their known values. We achieve this alignment by introducing a known standard compound into the mass spectrometer and adjusting its parameters until the measured mass spectra match the expected values. For biopharma and pharmaceutical organizations, proper calibration not only increases the reliability of analytical results but also allows for the detection of subtle differences in molecular masses, making it indispensable in these industries.
HPLC Calibration
As a well-established HPLC Calibration Company, GL Technologies has emerged as a premier provider of high-quality calibration services for High Performance Liquid Chromatography (HPLC) systems throughout California. With a commitment to precision and accuracy, our expert technicians use state-of-the-art equipment and methodologies to verify that HPLC instruments deliver reliable results for our clients in pharmaceutical, biotechnology, medical, and research industries. We offer comprehensive calibration solutions tailored to meet the unique needs of each customer, adhering to strict regulatory standards while maximizing instrument performance and longevity. As a trusted partner in analytical instrumentation, GL Technologies continues to set the industry standard for proficiency, reliability, and customer satisfaction.
HPLC REPAIR
As a leading HPLC repair company, we pride ourselves on delivering exceptional service and expertise to provide the seamless functioning of your high-performance liquid chromatography systems. With a team of skilled technicians with in-depth knowledge and experience, we offer comprehensive HPLC repair solutions tailored to meet the specific needs of each client. From diagnosing issues to sourcing and replacing components, we prioritize precision to minimize downtime and maximize productivity in your laboratory. Whether it's troubleshooting minor glitches or undertaking major overhauls, trust the GL-Tec HPLC repair specialists to deliver quick, reliable, and cost-effective solutions, allowing you to focus on your research with confidence.