INSIGHTS ON QUALITY CONTROL
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![GettyImages-1397682833 chromatography]( "Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification")
Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System QualificationExplore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.
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![GettyImages-1363605023-technician-equipment-technology-cleanroom]( "0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?")
0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
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![GettyImages-1415642842 data cloud]( "How LIMS Supports QC Scaling At Forge Biologics")
How LIMS Supports QC Scaling At Forge BiologicsModernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.
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![Risk-GettyImages-1584439434]( "ICH Q9 Revision 1: Enhancing Quality Risk Management")
ICH Q9 Revision 1: Enhancing Quality Risk ManagementICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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The Pain Of Change – Could Suppliers Be Part Of The Cure?10/15/2024
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
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The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO5/14/2025
Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.
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Modernizing Compendial SEC Methods For Biotherapeutics4/16/2024
Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.
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The Scalability Of Depth Filters For CHO Cell Culture Clarification7/19/2024
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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Thermal Analysis In The Pharmaceutical Industry12/30/2024
Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.
QUALITY CONTROL SOLUTIONS
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![mettler-toledo]( "Packaged X-Ray Inspection Systems")
The X2 and X6 Packaged X-ray Inspection Series enhance safety by detecting contaminants and improving product quality with advanced technologies, supporting productivity, compliance, and brand protection.
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![vials]( "Container Closure Integrity Of Parenteral Products")
The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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![TA Instruments dhr-20]( "A Versatile Platform For Pharmaceutical Rheological Measurements")
The most powerful and versatile rheometer for your laboratory.
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![Gear In Hand]( "High-Risk Package Integrity Testing Systems")
The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.
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![Data Analytics Strategy]( "Feasibility Studies For Container Closure Integrity Testing Applications")
PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
