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Water treatment Equipment > Medical apparatus and instruments factory GMP certification zl - ylqj001 purified water equipment

Medical apparatus and instruments factory GMP certification zl - ylqj001 purified water equipment
Source:Water treatment technology center   Author:Zhonglan  Release time:2015-08-31

  Equipment basic configuration:
Product name: medical instrument factory GMP certification purified water equipment
Model: zl - ylqj001
Operating pressure: 0.1-0.6 Mpa
The water yield: 250 l/H
Water resistivity: 0.5
Voltage: 380 v
Power: 3 kw
Electrical conductivity: 2 us/cm2
The desalination rate: 97%
Stand-alone power: 250 l/h
Whether the custom:

Pharmaceutical water purification equipment is mainly for biological pharmaceutical, medical equipment production, injection drug production, health care products production, hospitals and other related medical drugs industry with pure water equipment, the water quality standard must conform to the Chinese pharmacopoeia, the minimum rules, its electrical conductivity, microorganism and toxin inside all have certain index requirements.In blue group for medical treatment, biological pharmaceutical and food industries design of purified water equipment, all adopt the stainless steel material, the technological process for different customer needs can adopt two-stage reverse osmosis craft or EDI process.

  Water quality:
In the AAMI/ASAIO (USA) blood dialysis water standard, conform to the national blood dialysis water YY0572-2005 standard
Bacteria endotoxin, ≧ removal rate 99%
Dissolve salt ≧ removal rate of 97%
Water recovery rate of 70%
≧ system emptying rate 99%, no dead space
A typical preparation of purified water system reverse osmosis method:
Reverse osmosis pure water preparation technology is a new technology developed in the '60 s.Due to its simple operation process, salt and heat removal efficiency is high, and more economic.The journal of the American pharmacopoeia since 19 edition contains this method, one is the legal method of the preparation of water for injection.

  Purified water quality standard:
Resistivity: 0.5 M or more omega. CM conductivity: 2 mu S/CM @ 25 ℃ or less
Ammonia acuities were 0.3 mu g/ml
Nitrate 0.06 mu g/ml or less
Heavy metal 0.5 mu g/ml or less
Microbial 10 cfu / 100 ml
Endotoxin 0.25 EU/ml

  Technological process:

1, the original water tank, ultrapure water tank is used to store water equipment, set up a float switch, prevent damage of water pump, and the pretreatment tank.The original water tank general tank with PE, or stainless steel material.
2, the original water pump: the original water pump from raw water, the water in the oven for pretreatment, through reverse osmosis pretreatment filtering in supply.Our company adopts the original water pump is mainly domestic pump and southern Denmark grundfos pumps, can guarantee the quality performance.
3, flocculants, flocculant is mainly with positive (negative) electrical group and some of the water with a negative (positive) electrical is difficult to separate some particles or particles, reduce its potential, to make it in a stable state, and by using the aggregation property makes the particles concentration, and separated by physical or chemical method.
4, quartz sand filter, quartz sand filter is made of glass fiber reinforced plastic tank, or stainless steel, carbon steel tank filling fine quartz sand, and then use the pressure tap water or surface water into the tank, so as to remove the suspended solids in the water, organic matter, colloid particles, microorganism, chlorine, smelling and some heavy metal ions
5, activated carbon filter, activated carbon filter function is mainly to remove macromolecular organic matter, iron oxide, residual chlorine.This is because the organic matter, residual chlorine, iron oxide easily poisoned ion exchange resin, and residual chlorine, cationic surface active agent and so on will not only make the resin poisoning, will also destroy the membrane structure, disable reverse osmosis membrane.
6, scale inhibitors: reverse osmosis scale inhibitor is mainly used for ultrapure water reverse osmosis membrane equipment, mainly to prevent reverse osmosis membrane fouling surface, so as to protect the reverse osmosis membrane, keep ultrapure water quality.Works: reverse osmosis scale inhibitor ionization occurred after soluble in water, generate negatively charged sexual molecular chains, and Ca2 + form soluble in water or chelate complex, thus make inorganic salt solubility increases, anti-scaling effect.
7, security filters: security filter device in the back of the pretreatment, front of reverse osmosis membrane, with stainless steel or plastic material, the built-in precision filter, have 5 um filtration precision and filtration precision of 1 um, selected according to the design requirement.
8, reverse osmosis membrane, reverse osmosis membrane made of a simulated biological membrane has certain characteristics of artificial semi-permeable membrane.Commonly used polymer materials.Such as cellulose acetate membrane, aromatic hydrazide film, aromatic polyamide film.Surface pores between 0.5 ~ 10 nm in diameter, and the size of the permeability and the chemical structure of the membrane itself.Some polymer materials good repellency of salt, and water through the speed is not good.Some polymer chemical structure with more hydrophilic group, and water through the speed is relatively fast.So a satisfactory reverse osmosis membrane should have appropriate osmotic quantity or desalination rate.
9, PH adjustment system: the PH control system is used to adjust the PH value of level 1 reverse osmosis water production, sodium hydroxide is used to adjust.
10, health level aseptic water tank: container heat preservation material with high temperature resistance, anti-aging, pearl cotton insulation as a whole.Interface is the international standard fast loading chuck type, bladder use imported SUS316L or 304 material is qualitative, the surface of the mirror polishing Ra 0.28 m or less, outer surface primary inferior smooth inferior smooth, mirror sanding or the cold rolling mill.Tanks level gauge, air breathing mouth, thermometer, in and out of the liquid interface, manhole, CIP cleaning mouth, circulating pump, sight glasses, ball lamp.
11, EDI system: continuous electrical equipment to ions.Don't need to acid and alkali regeneration, the effluent water quality can reach 17 M omega. CM above.
12, purified water pump: USES SUS316 material, bringing the outlet of well-known brands at home and abroad (according to the design requirements).
13, UV ultraviolet sterilizer: ultraviolet light is a kind of invisible to the naked eye, exists in the spectral violet rays on the lateral, therefore calls the ultraviolet ray.Uv sterilizer is a special form of matter run, bits are not connect particles.Every grain of 253.7 nm wavelength ultraviolet photons with the energy of 4.9 eV.When ultraviolet rays to microorganisms, energy transfer and accumulation, the accumulation of the results caused by microorganisms inactivated, so as to achieve the purpose of disinfection.
14, microporous filter: use SUS316 material tanks, built-in 0.22 um folded filter.

  Scope of application:
* pharmaceutical, biological medicine, hospital, medical equipment cleaning in the use of water
* large infusion, injection, oral liquid preparations production, etc
The extraction of * API washing, injection, capsule production


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