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生产工艺常用词汇:
中文
单硫酸卡那霉素
硫酸氢钠
枸橼酸钠
硫酸溶液
中性硼玻璃安瓿瓶
安瓿瓶清洗
安瓿瓶灭菌除热源
配料
过滤
灌封
灭菌和检漏测试
灯检
贴签和包装
关键工艺参数
升温段
传送带
压差
时间间隔
过滤器孔径
过滤压力
灌装量
缓冲罐
灌装前充氮保护
灌装后充氮保护
真空检漏测试
内包材
英文
Kanamycin
sulfate
sodium
bisulfate
sodium
citrate
Sulfuric acid
solution
Neutral
borosilicate glass ampoule
Ampoule washing
Ampoule sterilization and
depyrogenation
Batching
Filtration
Filling and sealing
Sterilization and leakage
test
Visual / Lamp
inspection
Labeling and
packaging
Critical Process
Parameter
heating
section
conveyor
belt
Differential
pressure
Time
interval
Pore size of
filter
Filtration
pressure
Filling
volume
buffer
tank
pre-filling nitrogen
flush
post-filling nitrogen
overlay
Vacuum leak
test
Primary packaging
material
Process
instruction
Livzon
Group
Fuzhou
Fuxing
Pharmaceutical Co. Ltd.
Hunan Erkang Pharmaceutical Co.,
Ltd
Hunan Huari
Pharmaceutical Co., Ltd
Guangzhou Chemical Reagent
Factory
Zhuhai Da Lin Wan
Industrial Gas Co., Ltd
SCHOTT Glass Technologies
(Suzhou) Co.
Ltd
quality
specification
Circulation
water
Rotating speed
QC
常用英文词汇
中文
物理性状
外观
不溶性微粒
溶液颜色
鉴别
保留时间
含量
有关物质
英文
Physical
attributes
Appearance
Particulate matter
Solution color
Identification
retention time
Assay
Related
substance
labeled
amount
Visible
particles
Sterility
Membrane filtration method
Bacterial endotoxins
Initial bioburden
标示量
可见异物
无菌
薄膜过滤法
内毒素
stirring
uniformity
ashy
top
pointed end
bubble
head,
flat
head,
broken
ampoule,
crooked
ampoule, empty ampoule;
中文
英文
GMP: Good
Manufacturing Practice
药品生产质量管理规范
国家食品与药品监督管理局
总则
制剂
原料药
成品
工序
机构与人员
专业知识
生产经验
组织能力
技术人员
实施
药品生产
质量管理
质量检验
专业技术培训
基础理论知识
实际操作技能
高生物活性
高毒性
污染
考核评估
厂房与设施
生产环境
空气洁净级别
昆虫
洁净室(区)
光滑
无裂缝
无颗粒物脱落
耐受
消毒
无菌
交界处
State Food and Drug
Administration
General
Provisions
preparation
API: Active Pharmaceutical
Ingredient
finished
goods
process
organization and
personnel
professional knowledge
production experience
organizational skill
technical staff
implementation
pharmaceutical
manufacturing
quality
management
quality
inspection
professional and technical
training
basic theoretical
knowledge
practical
operation skills
highly
potent
high
toxicity
contamination
assessment
buildings and
facilities
production environment
clean air level
insect
clean
room(area)
smooth
no cracks
no particle shedding
tolerance
disinfection
sterile
junction,
joint
弧形
arc
灰尘积聚
储存区
dust accumulation
store area
production scale
equipment
material
生产规模
设备
物料
中间产品
待验品
intermediate product
quarantined material
cross-contamination
pipeline
交叉污染
管道
公用设施
照明
照度
utilities of
public service
lighting
illumination
emergency
purification,
micro-organism,
monitoring
record
ceiling,
roof
seal
应急
,
紧急情况
净化
clean
microbiology, microbiologic
微生物
,
微生物学
,
微生物的
监测
记录
天棚
密封
静压差
温度
天花板
Static Differential Pressure
temperature
RH:
Relative
floor
drainer
separating
room,
相对湿度
地漏
分装室
Humidity
filling
room
相对负压
废气
relative negative pressure
waste gas, exhausted air
β
-Lactams structure
drug
contraceptives
hormone
β-内酰胺结构类药品
避孕药品
激素类
抗肿瘤类
放射性药品
包装
anti-tumor, oncology
Radiopharmaceuticals
packing, package
recycling
循环使用
微粒
辐射
细菌
病毒
细胞
脱毒前后
particles
radiation
bacteria
virus
cell
Pre-detoxification and post
active vaccine/inactivated
vaccine
blood
products
prevention
products
filling
Chinese
detoxification
活疫苗与灭活疫苗
人血液制品
预防制品
灌装
中药
前处理
提取
浓缩
动物脏器
炮制
通风
除烟
除尘
降温设施
筛选
切片
粉碎
压缩空气
惰性气体
取样
称量室
中药标本
检定
同位素
设备
选型
耐腐蚀
吸附
traditional
medicines
pretreatment
extraction
concentration
viscera of
concocted
ventilation
animal, organ of
animal
smoke
removal
dust
removal
temperature-
reducing
screening
slicing
grinding
establishment,
cooling
compressed air
noble gas
sampling
weighing room
Chinese herbal sample, exemplar of
TCM
鉴定
verification,
Isotope
identification
equipment
model/type
anticorrosion
adsorption, absorption
selection
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