厂房设施

苏州智享位于苏州相城区生物医药产业园,建筑面积12000㎡,研发实验室、分析检测中心、200 L中试车间、2000L GMP原液生产车间、无菌制剂灌装及冻干车间。

IntellectiveBio locates in Biomedical Industrial Park, Xiangcheng District, Suzhou in China, with 12000㎡building area of, including R&D labs, analysis and test center, 200L pilot plant, 2000L GMP drug substance manufacturing factory, sterile drug product filling/ finish and lyophilization factory.

公司厂房及其配套的相关设施设备齐全,包括配电系统、供热通风与空气调节系统(即HVAC系统)、工业介质系统(压缩空气、真空、氮气、蒸汽、冷热媒等系统)、给排水系统、制药用水系统(纯化水、注射用水、纯蒸汽系统)、消防设施(火灾自动报警系统、自动灭火系统、消防栓系统、防烟排烟系统、应急广播、应急照明、安全疏散设施等)、安防系统(摄像监控系统、门禁系统、可燃气体监测系统等)、防雷系统、通信系统(电话、网络)等。

The IntellectiveBio pilot plant has complete facility and equipment, including power system, heating, ventilation and air-conditioning system (HVAC), Industrial medium system (compressed air, vacuum, nitrogen, steam, hot and cold media and other systems), water supply and drainage system, pharmaceutical water system (purified water, water for injection, clean steam system) and fire protection facilities (automatic fire alarm system, automatic fire extinguishing systems, fire hydrant system, smoke exhaust system, emergency broadcast, emergency lighting, safety evacuation facilities, etc.), security system (monitoring system and access control system, gas monitoring system, etc.), lightning protection system, communications system (such as telephone, Internet).

厂房设施采用的设计及确认验证标准为:

中国《药品生产质量管理规范》

美国cGMP, 21CFR

欧盟GMP

《洁净厂房设计规范》GB50457-2008

《医药工业洁净厂房设计规范》

《工业企业采暖通风和空气调节设计规范》

《室外排水设计规范》

《室外给水设计规范》

《工业企业照明设计规范》

《建筑结构荷载规范》

《建筑设计防火规范》

《工业企业爆炸和火灾危险环境电力设计规范》

《厂矿道路设计规范》

《通风与空调工程施工质量验收规范》

《洁净室施工及验收规范》

《现场设备、工业管道焊接工程施工及验收规范》

《工业金属管道工程施工验收规范》

《给水排水管道工程施工及验收规范》

经审核批准的设计图纸或方案

用户需求说明

EHS相关的法律、法规、规范

The design and validation standard of plant facility are referred to:

China Drug Manufacturing Quality Management

USA cGMP, 21CFR210 & 211

EU GMP

Code for design of clean room

Code for design of pharmaceutical industry clean room (GB50457-2008)

Code for design of heating ventilation and air conditioning for Industry enterprise

Code for design of outdoor wastewater engineering

Code for design of outdoor water supply engineering

Code for Industrial enterprise lighting design

Code for building structures load

Code for fire protection design of buildings

Code for electrical design of explosion and fire hazard environments in industrial enterprises

Code for road design of factories and mines

Code for construction quality acceptance of Ventilation and air-condition engineering

Code for construction and acceptance of clean room

Code for construction and acceptance of welding works for field equipment and industrial pipelines

Code for acceptance of construction of industrial metal pipelines

Code for construction and acceptance of water supply and drainage pipeline works

Approved design drawing or proposal

User Requirement Specification

EHS related laws, regulations, standards

工艺设备选型及确认验证标准:

中国《药品生产质量管理规范》

美国cGMP, 21CFR210&211

欧盟GMP

GAMP5

ISPE制药工程指南、GEP、GDP

中国药典(2015版)

洁净厂房设计规范 GB50457-2008

美国药典-39(2016年版)

欧洲药典-8.0(2014年版)

再设计、建造过程中所有与医药工程相关的法律、法规、规范

EHS相关的法律、法规、规范

The selection and qualification standard of process equipment are referred to:

China Drug Manufacturing Quality Management

USA cGMP, 21CFR210 & 211

EU GMP

GAMP5

ISPE Guideline and Annex, GEP, GDP

Pharmacopoeia of China (2015)

Code for design of pharmaceutical industry clean room (GB50457-2008)

Pharmacopoeia -39 (2016)

European Pharmacopoeia-8.0 (2014)

All the laws, regulations, standards related to pharmaceutical engineering during the design and construction period

EHS related laws, regulations, standards