1.Regulations and standards of appliance
The following normative will be considered during detail design execution:
EU Pharmacopoeia 6.0 :( issue for purified water)
USP-35: (Regulations for Water for Pharmaceutical Purposes).
ISPE: Volume 4, (water and Steam Systems), First Edition/January 2001 GAMP5
2. System description:
2.1. Purified Water System
2.1.1. Pretreatment Section
The raw water disinfection is by means of free chlorine and will be collected in Raw water tank.
The raw water will be transferred to Multi-Media Filter.
NaClO dosing was controlled by meter which is installed in Raw Water Tank. Which aim is to protect bacteria through whole pretreatment
2.1.2. Multi-Media Filter
For the reduction of the Total Suspended Solids (TSS) the micro-flocculation can be adjusted during commissioning.
The special multimedia filters remove traces of suspended matter and reduce the fouling index of the raw water tothe lowest possible level. Each filter capable of softening is 100% of the feed flow.
The filters are filled with three layers, gravel, sand and anthracite, resulting in:
an increased capacity of the filter for accumulated dirt,
longer operating times,
less waste water.
The multi-layer filters are back-washed automatically on a timer or as soon as the pressure drop becomes too high.
2.1.3. Duplex Softener(IF available)
The water softeners are two ion exchange filters and each filter capable of softening is 100% of the feed flow.In the softeners, the calcium and magnesium salts are replaced with sodium. The total salt content of the water remains unchanged.
The each softener is controlled on the basis of the outlet hardness or volume of soft water it generates,measured by the water meter
The regeneration of two softeners will be interlocked so that both water softeners cannot be
Regeneration of the softener resins will be achieved with sodium chloride, (common salt), which will be provided in the form of a salt solution.
2.1.4. Active Carbon Filter
Activated carbon filter to reduce the content of total organic carbon (TOC) in the raw water is quite effective. In addition, also remove residual chlorine (raw water). Activated carbon can be regularly with hot water (> 80°C) disinfection, the purpose is to remove organic debris and destruction of biological bacteria grow in the filter.
The filters are filled with three layers, gravel, sand and carbon, resulting in:
remove the free chlorine, chroma, microbe, organics, heavy metal and hazard matters
longer operating times
outlet water chlorine ＜0.1ppm,COD＜1.5ppm
Keep the organic material and microbe blocking.
The active carbon filters are back-washed automatically on a timer or as soon as the pressure drop becomes too high.
Adoption of pasteurization and reduction of application and procurement of chemicals .it is to convenient for quality person validation work to avoid the chemical remains problems when chemical sanitization and to reduce pollution risk.
Full automatically running to reduce the operator labor intensity and the labor cost.
The manual operation can be realized through touch screen for convenience to maintain the equipment for the maintenance person.
Active carbon can be sanitized up to > 80°C hot water.
2.1.5. Make-Up Section (PWG)
PWG is combined with Heat exchanger, Cartridge Filter, Reverse Osmosis, Electrodeionisation, UF and control system with touch panel.