INSIGHTS ON QUALITY CONTROL
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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Build A Culture Of Clean To Elevate Your Cleanroom
Keeping your cleanroom spotless is vital for product quality and patient safety. Consider these important factors for how to build a culture of clean and how your cleanroom will benefit.
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Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems
Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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Validating VH2O2 Decontamination Cycles For Product And Personnel Safety
Discover how ultra-sensitive spectroscopy transforms decontamination validation, revealing hidden efficiencies that safely cut facility downtime while ensuring absolute safety.
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Curia's Approach To Regulatory Compliance In Korea9/14/2026
Navigating Asian pharma markets requires alignment with local regulations. Standardized documentation, facility registrations, and strong quality systems support compliance and reliable supply.
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Method Development For Forced Degradation Of GLP-1 Agonist3/18/2026
Gain insight into how a systematic approach reveals impurity behavior, strengthens selectivity, and refines chromatographic conditions to build a reliable degradation method for a GLP‑1 agonist.
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How Can A Stage-Based Program To Determine HME Applicability Benefit Your API?9/1/2026
Poorly soluble APIs can be converted into amorphous solid dispersions to improve bioavailability. A stage-gated approach reduces risk, optimizes polymer selection, and speeds manufacturing.
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Building A Science- And Risk-Based Bio-Decontamination Strategy10/5/2026
Annex 1 has made bio-decontamination central to sterility assurance, with isolator and barrier cycles now expected to be designed, justified, and reviewed across their lifecycle.
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Delivering Innovative Solutions & Relied Upon Turn-Key Systems5/13/2026
Explore advanced aseptic fill-finish automation, modular isolation systems, and the technical drivers behind out-of-nest processing for ready-to-use containers.
QUALITY CONTROL SOLUTIONS
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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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Scaling cell and gene therapies requires transitioning manual workflows to automated, closed environments. Modular platforms optimize cleanroom footprint, accelerate production, and ensure consistent batch quality through real-time monitoring and seamless digital traceability.
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Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.
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The Esco IntelliGlove Tester (EIGT) is Esco’s third-generation wireless glove leak tester, designed for leak detection on gloves, sleeves, and gauntlets used in isolators, RABS, and glove boxes.
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Explore the latest in contaminant detection technology with this pharmaceutical metal detector for tablets and capsules. Ensure the highest quality products with its failsafe rejection system and more.