Enaps 走向未来，向世界飞跃！！
事业领域
Water for Biopharmaceutical
我们提供满足美国药典（USP）和韩国药典（KP）要求水品质的BIO、制药用水处理解决方案及Package System.
SOLUTION
- Purified Water Generation
- Storage & Distribution
- Water For Injection Distillation
- Pure Steam Generation
SCOPE OF WORK
- Project Design & Execution
- Quality & Execution Plan
- Technical Service
- Installation & Commissioning
- Validation
-
PW SYSTEM
Conceptual Design / Basic Design / Detail Design
-
KEY DESIGN PHILOSOPHIES
-
Suitable Process
- Water Conductivity
- Total Organic Carbon
-
Suitable Process
-
COMPONENTS
- Softner & Filter
- Degassing Membrane
- Ion Exchanger Columns
- Reverse Osmosis
- EDI
Parameter Unit USP Ph.Eur TOC
ppb C
≤500
≤500
Conductivity
㎲/㎝@20℃
-
≤1.1
Conductivity
㎲/㎝@25℃
≤1.3
-
Nitrate(NO3)
ppm
-
≤0.2
Aerobic Bacteria
CFU/100ml
≤10
≤10
Bacterial Endotoxins
EU/ml
≤0.25
-
Bacterial Endotoxins
I.U./ml
-
≤0.25
-
-
WFI & PS
-
KEY DESIGN PHILOSOPHIES
-
Suitable Process with Distillation
- Bacterial Endotoxin
- Microbial Growth
-
Suitable Process with Distillation
-
COMPONENTS
- WFI Generator
- PS Generator
Parameter Unit USP Ph.Eur TOC
ppb C
≤500
≤500
Conductivity
㎲/㎝@20℃
-
≤1.1
Conductivity
㎲/㎝@25℃
≤1.3
-
Nitrate(NO3)
ppm
-
≤0.2
Aerobic Bacteria
CFU/100ml
≤10
≤10
Bacterial Endotoxins
EU/ml
≤0.25
-
Bacterial Endotoxins
I.U./ml
-
≤0.25
-
-
PROCESS OF WATER FOR BIOPHARMACEUTICAL
-
REFERENCE
-
-
US Pharmacopia
- Purified water by distillation or a purification process that is equivalent or superior
to distillation in the removal of chemicals and microorganisms - European Pharmacopoeia - Purified water by distillation
- Japanese Pharmacopia - Distillation or Reverse Osmosis-Ultrafiltration
- Canadian GMPs - Produced by Distillation or RO
- ISPE Guide Line Volume 4 - Water and Steam System
-
US Pharmacopia
- Purified water by distillation or a purification process that is equivalent or superior
-