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模块化解决方案

Modern pharmaceutical industry and laboratory require the flexible and rapid solutions and minimize the risk of product and person.

现代的制药和生物实验室需要灵活快速的解决方案,同时,也需要将产品和人员的风险降低到最小。


Not only Top Leader can provide the equipment, but only the turn-key modular facilities to ours customer. Some features as follows:

拓领不仅提供设备,也为客户提供完整的交钥匙模块化厂房。有如下特点:

 

Standard sizes of containers and module design, very easy for trains, trucks and ships.

全集装箱尺寸、模块式设计,可以方便的进行铁路、汽运和海运。

Single-story and multi-story buildings, all materials are recyclable and reducing pollution.

可单层或多层结构,所有材料可回收减少环境污染;

Outdoor or indoor installation, for example install inside of the simple frame structure.

可安装在室外或室内,例如安置在简易的框架式厂房;

Dismantling, assembly and installation are very simple and easy. All connect for utilities are quick connector or tri-clamp type. Normally the only tool is wrench.

分解、装配及安装简单方便,公用工程接口采用快插快接式设计。安装工具通常仅为扳手;

Complete sanitary design with sanitary material. Conformance to the cleaning room rules of pharmaceutical industry and bio-containment facilities.

全卫生级设计,使用卫生级材料,符合制药行业和生物实验室的洁净室要求;

The tightness of the module facilities is excellent, durability and easy for cleaning and sterilization.

厂房密封性好,耐用、易清洁清洗和消毒灭菌;

Complex construction and equipment installation are not required. The delivery is very short and less than 6 months. The training, pre-qualification and mimic production can be done in the Top Leader’s factory.

避免复杂的施工和设备安装,交货时间最短可为6个月。拓领工厂可完成培训、预验证及模拟生产;

Fully isolation design. All equipment will be isolation type. This design will reduce the cost of cleaning room, Operation energy consumption and risk of production. The cleaning room can be Class C/D.

全隔离化设计,内部设备全部为隔离式,降低洁净室造价成本、运行能耗及生产风险,洁净级别可为CD级;

Fully automatic, integrated MES (Manufacturing Execution System), environmental monitoring system and CCTV.

全自动化,集成MES ( Manufacturing Execution System)系统、环境监控、视频监控系统等;

Can Integrate the sterilization and protection units for example VHP space sterilization system, air-tight door, VHP transfer hatch etc.

集成VHP空间灭菌系统、气密门、VHP传递窗等灭菌防护装置;

Can integrate the power supply, HAVC, sanitary piping system and Wastewater collection and treatment system.

集成供电系统、HAVC系统、洁净管道系统以及排水收集、废水处理系统;

Fully validation documents and performance, Conformance to the CGMP/GLP rules and requirement of US FDA,EU and WHO.

提供完整验证文件和验证服务,符合US FDA, EU ,WHOCGMP/GLP规范和要求

 

Module cleaning room-for pharmaceutical plant and laboratory.

模块化洁净室-适用于制药工厂及实验室

      

Modular Bio-Containment Facilities for Biosafe laboratory.

模块化生物安全实验室

     


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