Facility

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      <span class='kt-eyebrow'>Facility</span>

      <h1>Inside the Kangtai plant</h1>

      <div class='kt-p'>A 36,000 m&#178; site in Sishui Town, Xingyang: synthesis workshops, an independent quality control centre, controlled warehousing, a pilot plant and the environmental systems that keep a chemical site running cleanly.</div>

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    <h2>Good Manufacturing Practice</h2>

    <div class='kt-p'>The norfloxacin workshop was comprehensively rebuilt to GMP requirements and certified by the Henan Provincial Food and Drug Administration, with a GMP certificate and EU Written Confirmation for exported active substances. Practice on the floor follows three pillars:</div>

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        <h3>Controlled Environments</h3>

        <div class='kt-p'>Segregated production zones, controlled access and dedicated material flows keep raw materials, intermediates and finished API apart.</div>

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        <h3>Contamination Prevention</h3>

        <div class='kt-p'>Closed transfer where the process allows it, dedicated equipment for high-potency steps, and validated cleaning between campaigns.</div>

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        <h3>Traceability</h3>

        <div class='kt-p'>Every batch carries a production record through from starting material to release, so a certificate of analysis can be traced back to its route.</div>

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    <h2>Research and Pilot Scale</h2>

    <div class='kt-p'>The Xingyang Chemical Synthesis Research Institute sits alongside production: five synthesis laboratories, a standard laboratory, and a pilot workshop of about 2,000 m&#178; where a route is proven before it is scaled. This is where process improvements to the norfloxacin chain &#8212; the work that won provincial technology awards &#8212; were developed.</div>


    <h2>Manufacturing</h2>

    <div class='kt-p'>Two synthesis workshops carry the commercial volume. The trains are multi-purpose rather than dedicated to a single step, which is what makes a focused quinolone portfolio commercially viable: the same equipment can run norfloxacin, fleroxacin or a gatifloxacin intermediate depending on the campaign.</div>

    <div class='kt-p'>Design capacity for norfloxacin is 1,500 tonnes per year. Reaction, crystallisation, centrifugation and drying are followed by milling and packing under controlled conditions.</div>


    <h2>Quality Control</h2>

    <div class='kt-p'>Quality control is independent of production. The centre is equipped with high-performance liquid chromatography and gas chromatography, and runs identification, assay, related-substance and residual-solvent testing against the pharmacopoeia specified by the customer.</div>

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      <li>HPLC for assay and related substances</li>

      <li>GC for residual solvents and volatile impurities</li>

      <li>Wet chemistry for identity, water content and physical properties</li>

      <li>Retained samples and stability monitoring per batch</li>

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    <h2>Warehousing and Logistics</h2>

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        <h3>Controlled Storage</h3>

        <div class='kt-p'>Temperature and humidity monitored in the stores that hold moisture- or heat-sensitive material.</div>

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        <h3>Segregated Areas</h3>

        <div class='kt-p'>Dedicated zones for raw materials, intermediates, finished goods and rejected material.</div>

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        <h3>Inventory Control</h3>

        <div class='kt-p'>Batch-level stock records with first-expiry-first-out issuing.</div>

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        <h3>Export Delivery</h3>

        <div class='kt-p'>40 km from Zhengzhou, beside the Longhai Railway and the Kaifu Expressway, with air freight via Zhengzhou Xinzheng.</div>

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    <h2>Environment</h2>

    <div class='kt-p'>A chemical plant is judged by what leaves it. Wastewater treatment, waste-gas handling and solvent recovery are part of the process design at Kangtai, and the site has been recognised for environmental governance within Henan Province.</div>

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      <li>Wastewater treatment with staged biological and physical-chemical steps</li>

      <li>Waste-gas scrubbing on reactors and driers</li>

      <li>Solvent recovery and reuse where the process allows</li>

      <li>Segregated hazardous waste storage and licensed disposal</li>

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    <h2>Site Gallery</h2>

    <div class='kt-p'>Photographs of the Xingyang site, workshops and laboratory.</div>

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      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-1-1024x576.jpg' alt='Kangtai production workshop' loading='lazy'/><figcaption>Production workshop exterior</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-2.jpg' alt='Landscaped grounds at the Kangtai site' loading='lazy'/><figcaption>Landscaped grounds on the Xingyang site</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-3.jpg' alt='Physical testing bench in the QC laboratory' loading='lazy'/><figcaption>Physical testing bench, quality control</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-4.jpg' alt='Kangtai office building' loading='lazy'/><figcaption>Office building and site grounds</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-5.jpg' alt='Analytical laboratory at Kangtai' loading='lazy'/><figcaption>Analytical laboratory</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-6.jpg' alt='Clean-area corridor at Kangtai' loading='lazy'/><figcaption>Clean-area corridor</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-7.jpg' alt='Utilities and process tower at Kangtai' loading='lazy'/><figcaption>Utilities and process tower</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-8.jpg' alt='Main administration building' loading='lazy'/><figcaption>Main administration building</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-9.jpg' alt='Production building at Kangtai' loading='lazy'/><figcaption>Production building, Xingyang</figcaption></figure>

      <figure><img src='https://ktpharm.ecbasis.com/files/2024/06/Henan-KangTai-Pharmaceutical-views-10.jpg' alt='HPLC instrumentation' loading='lazy'/><figcaption>HPLC instrumentation in the QC laboratory</figcaption></figure>

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      <div class='kt-p'><b>Site visits and customer audits are welcome.</b> We host QA audits and can provide the plant layout, equipment list and GMP certificates in advance.</div>

      <a class='kt-btn kt-btn-outline' href='/p/contact.html'>Arrange a Site Audit</a>

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