INSIGHTS ON QUALITY CONTROL
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Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety
Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.
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Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications
Discover 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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Essential Insights Into Pharmaceutical Product Release: Part 2
Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.
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HPLC Autosampler Performance I: Challenging USP Methods9/16/2024
In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.
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Achieving Licensing For A Healthcare Solution6/16/2025
Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.
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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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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Aseptic Expertise And Delivery Of Services8/20/2024
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
QUALITY CONTROL SOLUTIONS
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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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Pharmaceutical companies face cost, complexity, and speed pressures. Inspection solutions support quality and compliance with fill detection, weighing, foreign body detection, and label verification.
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Flexible, reliable control and bioreactor systems for laboratory applications
Thermo Scientific™ HyPerforma™ bioprocess control systems are designed to optimize your process from the laboratory bench to full cGMP manufacturing. Our innovative control platform combines a flexible operating system with scalable, modular hardware, novel single-use sensors, and state-of-the-art bioreactors for strategic and streamlined bioprocess control.
HyPerforma benchtop solutions offer robust management of both cell culture and fermentation processes. The open architecture provides process flexibility, and dedicated hardware control allows for expansion. Thermo Scientific™ TruBio™ software is designed to support easy process control and scaling.
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Solve your containment challenge by working with a company that understands your process, CPT, expectations, facility allowances and restrictions as well as specific equipment specifications.
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Measure heat flow, weight loss, dimension change, or mechanical properties as a function of temperature.