Reverse Omosis EDI Pharmaceutical Water Treatment Plant GMP 2T/H
GMP 2T/H Reverse Omosis EDI Pharmaceutical Purified Water Distilled Water Machine
Purified water is widely used for preparation, solution and cleaning process in pharmaceutical industry. It has strict requirement for bacterial and pyrogen. Our PW/WFI system is totally designed according to GMP standard and customer's requirement,all joints using automatic orbital argon-arc welding, whole system can realize fully automatic PLC control and sterilization. Over past decade, we have supply and design GMP or UPS standard pure water system for above 100 pharmaceutical factories.
| Parameter |
USP requirements
|
Molecular pure water
|
Result
|
|
Conductivity (25℃)
|
< 1.3 μs/cm
|
< 1.3 μs/cm
|
Qualified
|
|
TOC
|
< 500 ppb
|
< 50 ppb
|
Qualified
|
|
Microorganism
|
< 100 cfu
|
< 10 cfu
|
Qualified
|
Typical flow process for distilled water for pharmaceutical:
1. Pre-treatment + Double stages RO
2. Pre-treatment+Double stages RO+EDI
3. Pre-treatment+Double stages RO + EDI+ Multi-effect distillator
1) All major Pretreatment, RO,EDI can be located in Skid
2) Unit is complete wired, piped, assembled,tested and commissioned in factory
3) All running parameter are qualified and recorded before Exwork
4) Automatic backwash, rinse, recirculation and sanitization functions
5) Pasteurization hot water sanitization for activated carbon filter and for purified water
6) Orbital welding for pipeline, and 3D rules for sterilized water systems for pharmaceutical use.
7) CIP system to clean ro membrane
8) Comprehensive documentation package
9) Pump with Various Frequency Drive(VFD)
10) Optional for TOC monitoring, 21 CFR Part 11 , SCADA
Specification of Pharmaceutical SS304 Reverse Omosis Distilled Water & WFI Plant
| Source Water | Tap water quality |
| Water capacity | 250LPH to 10,000LPH |
| Pretreatment | Multimedia ,active carbon ,softener filter |
| Sterilization | Chemical, heat disinfection ,UV lamp ,Ozone sterilizer |
| RO membrane | DOW /GE USA |
| EDI brand | Ionpure or Micronix |
| Water pump | Groudfos or CNP |
| Online monitoring | Conductivity,temperature,pressure,TOC,flow rate etc. |
| Meter brands | Chinese & burket ,Jumo &others |
| Control | Automatic PLC with HMI |
| Welding | Automatic |
| Standards | GMP or USP, European standard |
| Other attached products | Distribution system with Loop |
| Other service | Oversea installation |
| Application | capsules, tablets, syrups, suspensions, injectables, soft gelatin capsules, suppositories, creams, and ointments ,healthcare medicine,animal medicine production and so on. |
Sterilization ways:
1. UV sterilizer
2. Pasteurization for activated carbon filter and purified water and return water
3. Ozone disinfection
Documentation for RO EDI Purified Water Distilled Water Machine:
1) FAT, DQ, IQ, OQ documents
2) English user manual
3) Calibration / test report for materials and instruments
4) P&ID drawing
5) Electrical wire diagram
6) Layout drawing
7) Welding Point diagram
8) Videos and photos of purified water machine before shipping
9) Endoscopy test report
10) Components certificate
Details:
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