INSIGHTS ON QUALITY CONTROL
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![Syringe vaccine]( "Understanding cGMPs For Phase 1 Investigational Drugs")
Understanding cGMPs For Phase 1 Investigational DrugsLearn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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![GettyImages-1802391110 chromatography lab]( "Method Migration Of A Normal Phase HPLC Method For Tocopherols")
Method Migration Of A Normal Phase HPLC Method For TocopherolsThe ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.
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![stevanato 1]( "Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications")
Solutions In Pre-Filled Syringes For Biologics And Ophthalmic ApplicationsDiscover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
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![Minimizing Particulate Risk]( "Minimizing Particulate Risk")
Minimizing Particulate RiskWhile visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.
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(Cross-) Contamination Control Through Effective Equipment Cleaning5/6/2026
Discover science-driven cleaning strategies that reduce cross-contamination, enable safe multiproduct manufacturing, and support faster, flexible GMP changeovers.
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Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification11/24/2025
Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.
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Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation3/5/2026
Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.
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Compressed Gas Risk Assessment: A Significant Step In Your CCS10/10/2024
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
QUALITY CONTROL SOLUTIONS
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![Milliflex Quantum Rapid Detection System]( "Rapid Bioburden Testing System To Detect Microbial Contamination Earlier")
Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.
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![Business Quality Assurance and Compliance-GettyImages-2225358412]( "Scale GMP Operations Across Sites")
Blue Mountain Regulatory Asset Manager (RAM) helps life sciences manufacturers standardize maintenance, calibration, and asset workflows across sites in one validated platform.
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![GettyImages-1635843645-scientist-smiling-laboratory-equipment]( "Accelerating Product Development With A Non-GMP Small-Scale Laboratory")
Learn how the flexible non-GMP environment of our laboratories supports quick adjustments to formulations, dosage forms, and delivery systems without extensive revalidation.
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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.
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![GettyImages-2173467777-vials-pharmaceutical-gloved-hands]( "Aseptic Fill‑Finish Solutions For Parenteral Drug Products")
Aseptic fill‑finish services support parenteral drug products with advanced formulation development, scalable vial and prefilled syringe manufacturing, and integrated quality and regulatory support.
