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Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.
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Residual Solvent Testing: Gas chromatography (GC) confirms compliance with ICH Q3C guidelines, ensuring safety and purity.
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Moisture Content Analysis: Using Karl Fischer titration, we achieve residual moisture levels below 1%, critical for long-term stability.
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Automated sterile fill-finish lines minimize human intervention, ensuring precision and sterility in vial filling and packaging.
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High-Potency API Manufacturing with Advanced Containment and Compliance
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Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
All biologics are processed in Grade A cleanrooms with HEPA-filtered air and real-time environmental monitoring to guarantee sterility
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