Engineering Design for Pharmaceutical Chemicals and GMP Workshops

26-04-16 10:44
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Capability Description

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With extensive project experience in pharmaceutical engineering design, we have completed over 740 pharmaceutical and chemical projects and approximately 230 GMP-related designs. Our design scope covers active pharmaceutical ingredient (API) production facilities, pharmaceutical intermediate workshops, GMP cleanrooms (including aseptic areas and general control zones), and formulation packaging facilities. We can simultaneously deliver specialized documents for safety facilities, occupational health protection, and fire protection design. Our project experience spans various therapeutic areas and manufacturing processes, having provided full-process engineering design for the China-based production sites of multiple international pharmaceutical groups. In recent years, we have also initiated new projects in the fields of biologics and diagnostic reagents. We can flexibly adjust design standards to meet the regulatory requirements of target markets (China GMP/WHO GMP/EU GMP).

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Engineering Design for Pharmaceutical Chemicals and GMP Workshops

在制药工程设计领域有着深厚的项目积累，已完成超过740个医药化工项目及约230个GMP相关设计。设计范围涵盖原料药生产装置、医药中间体车间、GMP洁净厂房（含无菌车间和一般控制区）、制剂包装设施等。配套可同步输出安全设施设计专篇、职业卫生防护专篇和消防设计文件。项目经验覆盖了多种治疗领域的药物品种和生产工艺，并曾为多家国际制药集团的在华生产基地提供全流程工程设计。近年来在生物药和诊断试剂方向也有新建项目布局。可根据目标市场的法规要求（中国GMP/WHO GMP/EU GMP）灵活调整设计标准。

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