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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
英文
Kanamycin
sulfate
sodium bisulfate
sodium citrate
Sulfuric acid
solution
Neutral borosilicate glass
ampoule
Ampoule washing
Ampoule
sterilization
and
depyrogenation
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
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
_
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
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
标示量
可见异物
无菌
薄膜过滤法
内毒素
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
stirring uniformity
ashy top
pointed
end
bubble head, flat head,
broken ampoule,
crooked ampoule, empty
ampoule;
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中文
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
英文
GMP:
Good
Manufacturing
Practice
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
_
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
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
_
无菌
交界处
弧形
灰尘积聚
储存区
生产规模
设备
物料
中间产品
待验品
交叉污染
管道
公用设施
照明
照度
应急
,
紧急情况
净化
微生物
,
微生物学
,
微生物的
监测
记录
天棚
天花板
sterile
junction,
joint
arc
dust
accumulation
store
area
production
scale
equipment
material
intermediate
product
quarantined
material
cross-
contamination
pipeline
utilities
of
public
service
lighting
illumination
emergency
purification, clean
micro-organism, microbiology,
microbiologic
monitoring
record
ceiling,
roof
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密封
静压差
温度
相对湿度
地漏
分装室
相对负压
废气
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
循环使用
微粒
辐射
细菌
病毒
细胞
脱毒前后
seal
Static
Differential
Pressure
temperature
RH:
Relative Humidity
floor
drainer
separating
room, filling
room
relative
negative
pressure
waste
gas,
exhausted
air
β
-Lactams structure
drug
contraceptives
hormone
anti-
tumor,
oncology
Radiopharmaceuticals
packing,
package
recycling
particles
radiation
bacteria
virus
cell
Pre-
detoxification
and
post
detoxification
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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
active
vaccine/inactivated
vaccine
blood
products
prevention
products
filling
Chinese
traditional medicines
pretreatment
extraction
concentration
viscera
of animal,
organ
of
animal
concocted
ventilation
smoke
removal
dust
removal
temperature-reducing establishment,
cooling
screening
slicing
grinding
compressed
air
noble
gas
sampling
weighing
room
_
中药标本
检定
鉴定
同位素
设备
选型
耐腐蚀
吸附
润滑剂
,
润滑
冷却剂
流向
纯化水
注射用水
滋生
储罐
死角
盲管
纤维
疏水性
仪表
量具
衡器
Chinese
herbal
sample,
exemplar
of
TCM
verification,
identification
Isotope
equipment
model/type selection
anticorrosion
adsorption,
absorption
lubricant,
lubricate
coolant
flow
direction
PW:
Purified
Water
WFI:
Water
for
Injection
breeding
tank
neglected
portion
blind
pipe
fiber
hydrophobicity
instrumentation
measuring
tool
weighing instrument
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