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Bulk Drug/Pharmaceutical preparation equipment Solutions

GMP compliance assurance

Material and design compliance

The core equipment (such as sterile reaction vessels and storage tanks) is made of 316L stainless steel material, with a mirror polished surface (roughness Ra ≤ 0.8 μ m), which meets the hygiene requirements of the pharmaceutical industry;

The equipment structure design has no dead corners, is easy to clean, avoids material residue and cross contamination, and meets GMP standards for equipment cleanliness and sterilization.

Certification and testing support

The entire production process of the equipment follows the GB/T19001 quality management system, and a complete set of compliance documents such as material testing reports and pressure testing reports are provided before leaving the factory to assist pharmaceutical companies in preparing GMP certification materials;

Can cooperate with pharmaceutical companies for equipment validation (such as FAT factory acceptance testing, SAT on-site acceptance testing) to ensure that equipment performance matches process requirements.

Customized production of active pharmaceutical ingredients

Provide a complete set of equipment solutions for "reaction separation drying" for chemical synthesis raw materials, such as the entire process equipment from acylation reaction kettle to vacuum rake dryer, optimizing reaction time and yield;

Customized fermentation tanks and sterilization filtration equipment for biological fermentation raw materials, suitable for strain cultivation and product separation processes.

Customized formulation production

Customize mixing equipment, granulation equipment, filling equipment, etc. according to different types of formulations such as tablets/capsules/injections, to meet the requirements of uniformity and stability in formulation production;

For example, customizing sterile filling lines for injection companies to achieve aseptic operations from drug filtration to filling.

Full process equipment matrix

GMP compliance assurance
  • Aseptic reaction kettle

    Magnetic stirring and sterile sealing design are suitable for processes such as raw material synthesis and formulation pre mixing to ensure the sterility of materials.

  • Efficient distillation tower

    Corrugated packing design, high separation accuracy, suitable for raw material purification; Centrifugal scraper film evaporator: Low temperature concentration to reduce the loss of active ingredients.

  • Aseptic storage tank

    316L material, sanitary grade polished, equipped with a breathing valve and liquid level gauge, to achieve sterile storage of raw materials/finished products.

  • Pipelines and valves

    Sanitary grade quick installation interface, reducing dead corners; CIP cleaning system: automatic cleaning to ensure equipment cleanliness.

  • Technical services and certification support

    GMP compliance assurance
  • Compliance consulting services

    Equip pharmaceutical industry technical consultants to provide GMP equipment selection and layout planning suggestions for pharmaceutical companies, avoiding equipment compliance risks.

  • Verification and Training Services

    Assist pharmaceutical companies in completing equipment IQ (installation confirmation), OQ (operation confirmation), and PQ (performance confirmation);

    Provide equipment operation and maintenance training to ensure that pharmaceutical personnel master GMP equipment management standards.

  • After-sales service guarantee

    Equipment warranty for 1 year, lifetime maintenance and repair provided;

    Establish a fast response channel for GMP equipment to ensure that equipment failures do not affect the production compliance of pharmaceutical companies.

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  • +86-17712362975
  • hongtuyaohua@126.com