Nanjing Biocell Environmental Technology Co., Ltd

PHARMACEUTICAL REVERSE OSMOSIS SYSTEM(2024年03月05日)

biocellpharma — 2024-03-05T15:31:03+0900

https://www.biocell-pharma.com/products/pharmaceutical-reverse-osmosis-systems/

PHARMACEUTICAL REVERSE OSMOSIS SYSTEM
With RO membrane separation technology as the core, the reverse osmosis pharmaceuticals system adopts automatic control, integrated design, modular installation, low energy consumption and small floor area. Double pipeline water supply and single pipeline circulation mode are adopted for water production to effectively control the growth of microorganisms. The control system has anti misoperation settings, audit tracking functions, and data is permanently saved and cannot be modified. The electric control system is standardized and reasonable, strong and weak current are separated, safe and stable. The touch screen, instruments, meters and valves are highly humanized and easy to operate and view.

Specification of Pharmaceutical Reverse Osmosis Systems
Item TypeWateroutputMinimum water intakedesalination rateOperating water temperature
（m3/h）（m3/h）（%）（℃）
FSJ41X-0.5XB-20.52.2985-35
FSJ42X-1XB-212.8985-35
FSJ42R-2XB-224.1975-35
FSJ43R-3XB-236.5975-35
FSJ43R-4XB-247.8975-35
FSJ82R-6XB-2612.5975-35
FSJ82R-8XB-2815975-35
FSJ83R-10XB-21015975-35
FSJ83R-15GB-21531975-35
FSJ84R-20GB-22038975-35
FSJ85R-25GB-22541.25975-35
FSJ86R-30G-23047.5975-35
FSJ86R-50G-25079.5975-35

FEATURES OF PHARMACEUTICAL REVERSE OSMOSIS SYSTEMS
01.
The pharmaceutical ro plant has modular design, compact structure, convenient and fast on-site installation.

02.
The ro water system in pharma industry has automatic switching between water making mode and circulating mode to reduce energy consumption.

03.
Double water supply mode is adopted for water production terminal of the reverse osmosis pharmaceuticals system.

04.
The reverse osmosis pharmaceuticals system has concentrated water recovery design (optional), system utilization rate can reach more than 85%.

05.
The reverse osmosis pharmaceuticals system has PLC+HMI full-automatic control mode.

06.
The reverse osmosis pharmaceuticals system is fully comply with GMP, USP and cGMP requirements.

Biocell is committed to providing customers with professional solutions for the production, storage and distribution of pharmaceutical water systems.

Water purification system in pharmaceutical industry is used for production and washing equipments, containers, etc.

MULTI-EFFECT DISTILLER(2024年03月05日)

biocellpharma — 2024-03-05T15:30:05+0900

https://www.biocell-pharma.com/products/multi-effect-distiller/

MULTI-EFFECT DISTILLER
The water for injection preparation system is a key GMP system. Multiple effect distillation water machine is the key equipment of the most widely used WFI system at present. BIOCELL's multi effect distilled water machine and multi column distillation plant adopts high temperature and high pressure operation to ensure stable production of pyrogen free water for injection. The water for injection produced by the multi effect distilled water machine fully meets the requirements for water for injection generation in the current American Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia and Chinese Pharmacopoeia.

Specification of multi effect water distiller
Specification
Output of Distilled Water (L/h)
Steam Consumption (kg/h)
Purifed Water Consumption (L/h)
Cooling Water Consumption(L/h)
Overall Dimension LxWxH (mm)

LD (S) 100-4
>100
30
120
50
900x700x2000

LD (S) 200-4
>200
60
240
100
1000x800x2000

LD (S) 300-4
>300
90
360
150
1100x800x2200

LD (S) 500-4
>500
150
600
250
1400x900x2500

LD (S) 500-5
>500
130
600
100
1600x900x2500

LD (S) 1000-5
>1000
240
1100
200
1700x1100x3100

LD (S) 1000-6
>1000
190
1100
20
2100x1100x3100

LD (S) 1500-5
>1500
350
1670
290
2700x1100x3700

LD (S) 1500-6
>1500
290
1670
90
3200x1100x3700

LD (S) 2000-5
>2000
440
2200
210
3200x1100x4000

LD (S) 2000-6
>2000
390
2200
110
3600xI100x4000

LD (S) 3000-6
>3000
810
3300
150
4000x1200x4100

LD (S) 4000-6
>4000
880
4400
200
4300x1300x4200

LD (S) 5000-6
>5000
980
5500
250
4600x1400x4200

LD (S) 10000-6
> 10000
2250
11000
450
4900x1600x4800

How Does The Multiple Effect Distiller Works?
The working principle of the multi effect distilled water machine is that the fully heated raw water is evaporated and condensed by multi effect to remove non condensable gas and impurities, so as to obtain high-purity distilled water. To ensure the quality of distilled water, the raw water must be pretreated. Because of multiple effect evaporation, the heat of the multi-effect water distiller is fully utilized. Each effect evaporator adopts the principle of vertical tube type falling liquid film evaporation, plus a special structure of feed water distributor, so that the feed water of the multiple effect distillation can form a film and flow evenly in the tube. The multi effect distilled water machine eliminates the dry wall phenomenon caused by uneven distribution of local feed water, greatly improving the evaporation efficiency. The multi effect distilled water machine has the characteristics of small size, light weight, large water yield, and good water quality stability.

ADVANTAGES OF MULTI EFFECT DISTILLER
01.
Unique three-stage separation mode to fully ensure the quality of produced water.

02.
New expansion process, effectively avoiding cross contamination.

03.
PLC+HMI full-automatic control mode.

04.
Fully comply with GMP, USP and cGMP requirements.

Biocell is committed to providing customers with professional solutions for the production, storage and distribution of pharmaceutical water systems.

Purified water system in pharmaceutical industry is used for production and washing equipments, containers, etc.

ELECTRODEIONIZATION (EDI)(2024年03月05日)

biocellpharma — 2024-03-05T15:29:26+0900

https://www.biocell-pharma.com/products/electrodeionization-edi/

ELECTRODEIONIZATION (EDI)
EDI is a pure water manufacturing technology that combines ion exchange technology, ion exchange membrane technology and ion electromigration technology. It skillfully combines electrodialysis and ion exchange technology, uses high voltage of electrodes at both ends to move charged ions in water, and cooperates with ion exchange resin and selective resin membrane to accelerate the removal of ions, so as to achieve the purpose of water purification. During EDI desalination, ions are removed by ion exchange membrane under the action of electric field. At the same time, water molecules generate hydrogen ions and hydroxide ions under the action of electric field, which continuously regenerate the ion exchange resin to keep the ion exchange resin in the best state.

Technical Data of Electrodeionization
Item
Reference value

Nominal Recovery:
90–95%

EDI Water Quality:
15–18 MΩ.CM（25℃）

FEED CONDUCTIVITY (INCLUDING CO2):
< 10 µs/cm（25℃）

Operating Temperature:
50–100° F

Maximum Inlet Pressure:
100 psig

Minimum Inlet Pressure:
60 psig

Expected Pressure Drop:
30–40 psig

Electrical Requirement:
380 VAC, 3-phase, 50 Hz.

OPERATING PRINCIPLES OF ELECTRODEIONIZATION
Operating Principles of Electrodeionization
EDI Process

EDI desalination process is to exchange ions in water with hydroxide ions or hydrogen ions in ion exchange resin, and then migrate these ions into concentrated water；

The above exchange reaction takes place in the freshwater chamber of the module. In the freshwater chamber, the hydroxide ion in the anion exchange resin exchanges with the anion in the water, and the hydrogen ion in the cation exchange resin exchanges with the cation in the water；

The exchanged ions migrate along the surface of the resin ball under the effect of the DC electric field and enter the concentrated water chamber through the ion exchange membrane；

The negatively charged anions are attracted by the anode, and these ions enter the adjacent concentrated water chamber through the anion membrane, while the adjacent cation membrane membrane does not allow them to pass through. These ions are blocked in the concentrated water, while the positively charged cations are attracted by the anion anion, and these ions enter the adjacent concentrated water chamber through the cation membrane, while the adjacent anion membrane does not allow them to pass through. These ions are blocked in the concentrated water.

In concentrated water, ions from both directions maintain electric neutrality. At the same time, the amount of current is proportional to the amount of ion migration. The amount of current consists of two parts, one part from the migration of removed ions, and the other part from the migration of water itself ionized into H+and OH - ions；

When the water flow passes through the fresh water chamber and the concentrated water chamber, the ions gradually enter the adjacent concentrated water chamber from the fresh water chamber and are carried out of the EDI module by the concentrated water；

Under the action of higher voltage gradient, water will generate a large amount of H+and OH- through electrolysis. These generated H+and OH- will continuously regenerate the ion exchange resin. Therefore, the ion exchange resin in EDI module does not need chemical regeneration；

The above is the desalination process of EDI.

OPERATING PRINCIPLES OF ELECTRODEIONIZATION

FEATURES OF ELECTRODEIONIZATION
1.
Regeneration of acid and alkali is not needed.

2.
Zero discharge; no discharge of wastewater.

3.
The running is continuous and the water quality is stable.

4.
Modularization design is adopted so as to facilitate extension.

5.
Less space is occupied.

Now the price of edi water purification system is reasonable, if you have needs to buy electrodeionization system, please contact us.

More details of water system in pharma, please visit our website.

ELECTRIC CLEAN STEAM GENERATOR(2024年03月05日)

biocellpharma — 2024-03-05T15:28:30+0900

https://www.biocell-pharma.com/products/electric-clean-steam-generator/

ELECTRIC CLEAN STEAM GENERATOR
Electric clean steam generator using electric energy as heating source is referred to as electric heating clean steam generator. The steam generated after the purified water is heated and evaporated by the electric heating clean steam generator, through the centrifugal separation structure that can effectively remove the water droplets and pyrogens entrained in the steam, the condensed water of the clean steam produced meets the quality indicators of USP, EP, JP and ChP on "water for injection".

Electric Clean Steam Generator is suitable for production places without industrial steam, and is an ideal sterilization equipment for hospitals, pharmaceutical, catering, electronics, chemical and other industries.

Specification of Electric Clean Steam Generator
SpecificationClean Steam Output(Kg/h)Purified Water Consumption(L/h)Electricity Consumption(KW）Overall Dimension L×W×H(mm)
CSGE50>5065481000x700x2000
CSGE100>100125961200×900×2500
CSGE200>2002501921700×1000×2700
CSGE300>3003752881900×1100×2800

How Does Electric Clean Steam Generator Works?
Industrial steam is the most cost-effective heating source of clean steam generator.

In places without industrial steam, electric heating can be selected if conditions permit. Electric energy is converted into heat energy as an alternative energy for industrial steam.

An electric clean steam generator works by heating purified water with an electric element, producing high-quality, pure steam. The generator separates any liquid water, ensuring only clean, dry steam is produced. The steam can be used in industries like pharmaceuticals and healthcare for sterilization and other critical applications. Safety features are in place to maintain the quality and prevent overpressure or overheating.

FEATURES OF ELECTRIC CLEAN STEAM GENERATOR
01.
The electric clean steam generator has precise control of clean steam output pressure and temperature, fluctuation within+5%.

02.
The electric clean steam generator has clean steam pressure output range: 2-4Bar.

03.
Electric heating of the electric clean steam generatoris adopted to convert electric energy into heat energy.

04.
The electric clean steam generator has PLC+HMI full-automatic control mode.

05.
Rising film/falling film, two working modes are optional of the electric clean steam generator.

06.
The electric clean steam generator is complied with relevant requirements of WS310 supply room management specification

Now the price of purified water system pharmaceutical is reasonable, if you are interested, please contact us.

EDI WATER TREATMENT(2024年03月05日)

biocellpharma — 2024-03-05T15:26:08+0900

https://www.biocell-pharma.com/products/edi-water-treatment/

EDI WATER TREATMENT
EDI module is usually placed behind the reverse osmosis system, which not only overcomes the lack of deep desalination of reverse osmosis effluent, but also further removes trace carbon dioxide, residual salt, silicon dioxide, boron and total organic carbon plasma in RO water, greatly improving the quality of purified water.

Electrodeionization water treatment is widely used in biotechnology, pharmacy and other industries that must generally comply with and comply with USP, EP, JP and ChP regulations.

※ Post EDI Ultrafiltration

※ A post EDI UF System with 6000 Daltons Molecular Weight Cutoff membranes serves to produce highly purified water having a compliance with low endotoxin values.

※ A post EDI UF can have a TOC reduction UV with 194 nm wavelength or 254 nm wavelength for bacterial control as an option.

EDI Plant Water Treatment Specification
Water inflow requirements

TEA（with CO2）
<25mg/L as CaCO3

Hardness
<1mg/L as CaCO3

TOC
<0.5mg/L

Temperature
5-43℃

PH
5-9

Silicon
<0.5mg/L

Free Chlorine
<0.05mg/L

Water inlet pressure
30-100psi

Fe, Mn, H2S
<0.01mg/L

Rate of recovery
90-95%

What Is Edi Water Treatment System
EDI stands for Electrodeionization, which is a water treatment technology that utilizes ion exchange membranes and an electric field to remove ions from water.

The EDI water treatment system is typically used to produce high-quality water for industrial and laboratory applications. The EDI system in water treatment plant works by passing water through a series of ion exchange membranes and electrodes, which remove dissolved salts and other ions from the water.

Unlike other water treatment technologies, EDI water treatment does not require chemicals to regenerate the ion exchange resin, making it a more environmentally friendly option. EDI systems are also relatively compact and easy to maintain compared to other water treatment technologies.

Overall, EDI is an effective and efficient way to remove impurities from water, and it is commonly used in industries such as pharmaceuticals, electronics, and power generation.

EDI Water Treatment PDF
DOCUMENT
DOWNLOAD

EDI Module Water Treatment
DOWNLOAD PDF

How Does EDI Water Treatment Works?
Process Principles

Enhanced transfer regime (high salinity)

– Remove strong ions from water

Electroregeneration regime (low salinity)

– Remove ionizable species (weak acids or weak bases) from water

FEATURES OF EDI WATER TREATMENT
01.
The most cost-effective way to upgrade RO purified water system (PW) to high purified water system (HPW).

02.
Effective minimum flow interlocking and current overload protection device.

03.
Excellent water quality performance under different working conditions.

04.
Front and rear UV devices (optional), thermal disinfection module (optional).

05.
PLC+HMI full-automatic control mode.

06.
Fully comply with GMP, USP and cGMP requirements.

If you want to know more types of pharmaceutical purified water systems, please visit our website.

CLEAN STEAM GENERATOR(2024年03月05日)

biocellpharma — 2024-03-05T15:24:55+0900

https://www.biocell-pharma.com/products/clean-steam-generators/

CLEAN STEAM GENERATOR
The prototype of the clean steam generator for humidification is a pure steam generator in the pharmaceutical industry. In structural design, clean steam generator simplifies and weakens the complex steam water separation structure. Compact structure, small floor area, no water storage, high quality of clean steam.

Clean steam generator system from clean steam generator supplier Biocell, is widely used in food, beverage, electronics, dairy, medicine and other industries. As one of the leading clean steam generator manufacturers, Biocell provides high quality clean steam generators for humidification.

Clean Steam Generator Specification
Specification
Steam Pressure(Mpa)
Steam Output(Kg/h)
Steam Consumption(Kg/h)
Purified Water Consumption(L/h)
Clean Steam Pressure(Mpa)
Dimension L×W×H(mm)

CSG100
0.4
100
130
125
0.3
700×900×2500

CSG200
0.4
200
260
250
0.3
700×1000×2700

CSG300
0.4
300
390
375
0.3
800×1100×2800

CSG400
0.4
400
520
500
0.3
800×1200×3000

CSG500
0.4
500
650
625
0.3
800×1300×3100

CSG600
0.4
600
780
750
0.3
900×1300×3100

CSG700
0.4
700
910
875
0.3
900×1300×3100

CSG800
0.4
800
1040
1000
0.3
1000×1300×3200

CSG900
0.4
900
1170
1125
0.3
1000×1300×3200

CSG1000
0.4
1000
1300
1250
0.3
1200×1300×3200

CSG1500
0.4
1500
1950
1875
0.3
1400×1300×3200

CSG2000
0.4
2000
2600
2500
0.3
1400×1300×3200

Clean Steam Generator How It Works
A clean steam generator for humidification is a specialized type of pure steam generation system that produces pure, sterile steam for use in pharmaceutical, biotechnology, and other industries where the quality of the steam is critical. Clean steam generation uses a variety of technologies to produce high-quality steam, including reverse osmosis, deionization, and distillation.

The basic operation of a clean steam generator for humidification involves three main stages:

Feedwater Treatment: The feedwater, or the water that is fed into the clean steam generator, undergoes a series of treatments to remove impurities and minerals that could contaminate the steam. This may include reverse osmosis to remove dissolved solids, deionization to remove mineral ions, and other treatments to remove bacteria and other microorganisms.

Steam Generation: Once the feedwater has been treated, it is heated to generate steam. Clean steam generators use a variety of heating methods, including electric heating elements, gas-fired burners, or steam coils.

Steam Purification: The steam generated in the clean steam generator for humidification is then passed through a series of purification steps to ensure that it is free from impurities and microorganisms. This may involve passing the steam through filters, sterilization chambers, or other purification systems.

Overall, the goal of a clean steam generator for humidification is to produce pure, sterile steam that is free from impurities, minerals, and microorganisms. This requires careful attention to the design and operation of the generator, as well as strict adherence to industry standards and regulations. As one of the leading clean steam generator suppliers and clean steam generator manufacturers, Biocell provides high quality clean steam generators.

Clean Steam Generators Supplier Competitive Advantages
Double shell seamless tube sanitary and clean exchanger.

All clean steam generation equipment is made of 316L stainless steel, and the working surfaces of the columns and exchangers are subjected to standard pickling and passivation treatment.

Gaskets made of pharmaceutical-grade polytetrafluoroethylene (Toflon) material are used.

All clean steam generator for humidification components are installed on sturdy carbon steel brackets and can be easily disassembled and assembled.

Mineral wool insulation, covered with AISI304 stainless steel satin polishing protective layer.

Structural design: The sanitary structure and connections have no dead corners, and the pipeline slope is conducive to minimum discharge. The system is equipped with a raw water pump, making operations stable, compact, and cost-saving.

Double tube plate design: Both the external preheater and evaporator are designed with double tube plates, effectively preventing cross-contamination of multiple materials (double tube plates or single tube plates are used according to customer requirements)

Selection of raw materials: SS316L is used for the parts and pipelines in contact with pure steam and pure steam condensate, while SS304 is used for the rest.

Reasonable sealing structure: The majority of the equipment is connected by flanges, and the sealing gasket is made of PTFE. The entire machine is sealed to prevent leakage.

Electrochemical polishing: high surface finish; Improve the corrosion resistance of stainless steel; Polishing treatment can be carried out on positions that cannot be processed by mechanical polishing equipment.

Energy saving: Thanks to the use of thin-walled heat exchange tubes and advanced material water distributors, the heat exchange rate has been improved.

Long service life: Due to the use of large space and low-speed separation, steam friction, and corrosion are avoided. Greatly extending the service life of the machine.

Internal and external argon gas protection fully automatic welding: welding pipelines and equipment barrels to ensure welding quality.

Insulation layer: Composite silicate needle silk blanket, with an outer layer made of SS304 wire drawing board.

Control system: There are multiple control methods for users to choose from manual, PLC+instrument fully automatic, PLC+touch screen, etc. The PLC+instrument can automatically display temperature, conductivity, flow rate, pressure, etc. online. The PLC+touch screen can observe parameter changes (temperature, conductivity, flow rate, pressure, etc.) online through the touch screen, and keep track of the equipment production status at any time. And clean steam generator for humidification can be equipped with paper or paperless recorders according to customer requirements.

For more information, please contact Biocell, one of the professional clean steam generator manufacturers. As one of the leading clean steam generator suppliers and clean steam generator manufacturers, Biocell provides high quality clean steam generators for humidification.

If you want to know more about purified water system in pharmaceutical, please visit our website.

Pharmaceutical Water System(2024年03月05日)

biocellpharma — 2024-03-05T15:23:33+0900

https://www.biocell-pharma.com/products/

Pharmaceutical Water System
Water is the most widely used process raw material in the pharmaceutical industry, which is used as the composition, solvent and diluent of drugs. Pharmaceutical water is mainly divided into two categories:

Purified water: it is pharmaceutical water prepared from raw water by distillation, ion exchange, reverse osmosis or other appropriate methods, and does not contain any additives.

Water for injection: It is the water obtained by taking purified water as raw water, distilling in a specially designed distiller, condensing and cooling. Sterile Water for Injection is the water prepared according to the injection production process.

The pharmaceutical water system is composed of water treatment equipment and transportation system. Through design, installation and confirmation, judge and evaluate whether the equipment meets the predetermined production capacity, water quality standard, capacity, flow rate, pressure, temperature, disinfection method, etc.

The operation and maintenance of water system in pharma company shall be monitored and managed according to the requirements of verification and documents. Ensure that the operating parameters of the system are within the range of operating parameters confirmed by the equipment.

TYPES OF BIOCELL PHARMACEUTICAL WATER SYSTEMS
Pharmaceutical Water purification System
Water For Injection (WFI) Generation System
Pure Steam Generation System(PS/CS)
Purified Water (PW) System
PW/WFI Storage & Distribution Systems
Pharma Water System Control & SCADA
Sanitary Heat Exchanger

Pharmaceutical Water purification System
The purified water system in pharmaceutical industry is composed of water treatment equipment and transportation system. Through design, installation and confirmation, judge and evaluate whether the equipment meets the predetermined production capacity, water quality standard, capacity, flow rate, pressure, temperature, disinfection method, etc.

Ultrapure Water System
Ultrapure water is produced by distillation, deionization, reverse osmosis technology or other appropriate supercritical fine technology. Now ultrapure water has been widely used in biology, medicine, industrial manufacturing and other fields. Ultrapure water system refers to the production system in which raw water and ultrapure water are completely produced. The conductivity of common tap water is less than 10-20 after being treated by the primary reverse osmosis system μ S/cm, permeate conductivity1-5 after secondary reverse osmosis system μ S/cm is even lower. The reverse osmosis system can be supplemented with ion exchange equipment or EDI equipment to prepare ultrapure water, making the resistivity as high as 18.25 megohm. cm.

GOOD DESIGN PRINCIPLES OF BIOCELL PHARMACEUTICAL WATER SYSTEM
01
Customization
Comprehensively understand the customer's actual needs for water preparation process, system configuration, etc., and customize the water system.

02
Cooperation
BIOCELL is a member of China Pharmaceutical Equipment Industry Association, and has long maintained technical exchanges and cooperation with many well-known domestic pharmaceutical enterprises.

03
Experienced
BIOCELL has a group of industry senior experts, professional designers and experienced project installers who have practiced in many application fields for many years, with an average working time of more than 10 years.

Services(2023年06月15日)

biocellpharma — 2023-06-15T16:11:45+0900

https://axispharm.com/

Bioanalytical Service
Bioanalytical Service for Small Molecule Drugs and Metabolites, Large Molecules – Peptides and Proteins, etc. LCMSMS Quantification, GCMS Quantification, HPLC, UPLC and ELISA.

Analytical Services
Analytical Services for Purity Test, Contaminant Test, Pesticide Screening, Essential Oil and Cosmetics Profiling and Quality Control – LCMS, GCMS, HPLC, HPIC, Maldi-TOF, HRMS, FTIR etc.

Proteomics Services
Protein Service
Protein Identification, Quantification – Label Free and iTRAQ, TMT, Post Translational Modification (PTM) analysis – Orbitrap Fusion Lumos, Q-Exactive plus, Maldi-TOF, etc.

Why Choose Our Products And Services
High quality
We guarantee the superior quality of our products by providing real analytical data, such as NMR spectra and HPLC-MS profiles for each lot.

Large selection
We offer a wide range of unique laboratory-made research tools many of which are not available elsewhere.

Competitive pricing
Our pricing is very competitive compared to many other reagent suppliers.

Quick support
We provide the highest level of technical support to our customers. Just call us and we will help you quickly!

Axispharm offers a wide range of unique laboratory-made research tools many of which are not available elsewhere.

SANITARY HEAT EXCHANGER(2023年06月24日)

biocellpharma — 2023-06-15T16:11:07+0900

https://www.biocell-pharma.com/products/sanitary-heat-exchanger/

The sanitary heat exchanger (sterile double tube plate heat exchanger) is designed to work under the working conditions with the highest sanitary requirements, and the double tube plate structure design is adopted. The port of the heat exchanger adopts quick installation or flange structure, which effectively avoids the retention of liquid medicine at the connection between the heat exchanger and the pipeline, realizes the real full emptying design, and also makes the equipment disassembly convenient. The unique design of double tube sheet makes it easy to completely empty and keep the heat exchange tube clean, which can ensure the complete separation of the shell side and tube side media, without internal welding points, and effectively eliminate the cross contamination between products and heat exchange media. It is not polluted and can detect leakage, thus avoiding the risk of cross contamination of conventional heat exchanger.

Technical Data of Sanitary Heat Exchanger
Heat Exchange Area0.5—15m2
Design Temperaturemax 165℃
Design Pressmax 1.6MPa
Surface TreatmentRa=0.25—0.5。
Soldering standardEN-288-3,EN287-1
Mounting TypeHorizontal or vertical installation.

OPERATING PRINCIPLES OF SANITARY HEAT EXCHANGER
Working Principle

The material flows through the inside of the sanitary heat exchange tube,

Pharmaceutical Water Systems

and the refrigerant or heat medium flows through the outside of the heat exchange tube in the opposite direction. The end of the heat exchange tube is fastened with double tube plates, and serves as a leakage monitoring point to prevent the two-way cross contamination of the material and heat exchange medium.

STRUCTURE DESCRIPTION OF SANITARY HEAT EXCHANGER
Structure Description of Sanitary Heat Exchanger
Double tubesheet structure:

This series of heat exchangers adopt double tubesheet structure design, so that the tube side and shell side are connected by their own tubesheet respectively, breaking the traditional of tube heat exchangers, where the tube side and shell side share the same connecting tubesheet, so as to minimize the risk of cross contamination, facilitate the timely discovery of potential leakage, and ensure the safe production of users.

Full emptying design:

the heat exchange tubes are 316L sanitary pipes with smooth surface, straight structure, no dead corners, convenient and thorough cleaning, and the lowest point of the equipment is equipped with an emptying valve, which is conducive to the emptying of materials, cleaning water and condensate after online sterilization. The full emptying design avoids dead corners at the product contact parts, prevents the growth of microorganisms, and is easy to clean and sterilize.

Material and surface treatment:

this series of heat exchanger is made of 316L stainless steel, or the material required by customers. The roughness coefficient of the inner surface of the pipe in contact with the material is from 0.25 - 0.4 μ m.

FEATURES OF SANITARY HEAT EXCHANGER
1.
The heat exchange tube is made of 316L seamless steel pipe.

2.
Double tube sheet design eliminates cross contamination.

3.
The tubesheet is forged and the tubesheet thickness exceeds 10mm.

4.
There is no dead angle at the product contact side and it is completely drained.

5.
There is no dead space in the heat exchange channel.

6.
It can be installed vertically or horizontally.

7.
Product side quick installation interface, shell side flange connection.

8.
It can be designed and manufactured according to the special technical requirements of customers.

9.
Design and manufacture according to GMP requirements.

10.
Provide validation documents for double tube sheet heat exchanger.

APPLICATION OF SANITARY HEAT EXCHANGER
1.
Cooling/heating of water for injection.

2.
Sterilization of water for injection system by superheated water.

3.
Temperature rise and cooling of purified water.

4.
Pasteurization of purified water system.

5.
Pure steam condensation and cooling.

6.
Temperature control of highly clean liquid.

7.
Cooling/heating of liquid medicine.

8.
Cooling and heating of vaccines and blood products.

The water purification system pharmaceutical industry is based on the preparation equipment, storage, and export of purified water system and water for injection system and other functional units, optimized and combined by various functional modules, so as to ensure the high performance and quality of the whole system and make the product water fully meet or exceed the water quality standards of purified water and water for injection plant.

RO PLANT WITH RO(2023年06月23日)

biocellpharma — 2023-06-15T16:10:12+0900

https://www.biocell-pharma.com/products/ro-plant-with-edi/

RO RO PLANT
The combination of reverse osmosis and EDI has overcome the deficiency that reverse osmosis effluent cannot be deeply desalted, and further removed trace carbon dioxide, residual salt, silicon dioxide, boron and total organic carbon plasma in RO water, greatly improving the quality of purified water.

It is widely used in biotechnology, pharmacy and other industries that must generally comply with USP, EP, JP and ChP regulations.

Specification of RO Plant With EDI
Water Inflow Requirements
TEA（Containing CO2）<25mg/L as CaCO3
Hardness<1mg/L as CaCO3
TOC<0.5mg/L
Temperature5-43℃
PH5-9
Silicon<0.5mg/L
Free Chlorine<0.05mg/L
Water inlet pressure30-100psi
Fe,Mn,H2S<0.01mg/L
Rate of recovery90-95%

How Does RO Plant With EDI Works?
The reverse osmosis device with EDI (reverse osmosis electrodeionization) is the most preferred purified water preparation technology in the pharmaceutical, food and biotechnology industries. It is basically a combination of reverse osmosis and electrodeionization processes. In reverse osmosis EDI system, single-stage or two-stage reverse osmosis is used to pre desalinate EDI feed water, and then deeply electrodeionize RO production water through EDI to finally produce high-purity water required for application.

FEATURES OF RO PLANT WITH EDI
01.
The most cost-effective way to upgrade RO purified water system (PW) to high purified water system (HPW).

02.
Effective minimum flow interlocking and current overload protection device.

03.
Excellent water quality performance under different working conditions.

04.
Front and rear UV devices (optional), thermal disinfection module (optional).

05.
PLC+HMI full-automatic control mode.

06.
Fully comply with GMP, USP and cGMP requirements.

More applications of water system pharmaceutical industry, please visit our website.

PW/WFI Storage & Distribution Systems(2023年06月22日)

biocellpharma — 2023-06-15T16:09:37+0900

https://www.biocell-pharma.com/products/purified-water-storage-and-distribution-system/

The purified water distribution system is the core unit of the whole pharmaceutical water system, and its main function is to ensure that the pressure, flow and temperature delivered to the process pipeline meet the process production requirements. The system uses online monitoring instruments such as flow, pressure, temperature, conductivity and TOC to conduct safety performance, real-time monitoring and trend analysis of water quality, and effectively control the load of microorganisms in water through periodic disinfection or sterilization. In addition, sampling valves shall be installed on the water supply starting point, water pipeline and end pipeline of the entire distribution system for water quality sampling. The whole system is mainly composed of inverter, exchanger, sampling valve, diaphragm valve, sanitary pipe fittings, online monitoring instrument and other supporting control systems.

TYPES OF PURIFIED WATER STORAGE AND DISTRIBUTION SYSTEM

PW Tank/Skid
The purified water storage tank is manufactured according to the GMP certification requirements, and the tank body is vertical or horizontal.

WFI Tank/Skid
The storage tank is mainly used for the storage of water for injection. Meet the requirements of GMP for water for injection storage tank.

PW/WFI Skid
The liquid medicine storage and distribution system includes a storage part and a distribution part. The design of pharmaceutical water distribution system has various forms, and its basic idea is to minimize the operational risk and microbial risk at a reasonable cost.
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GENERAL PRINCIPLES OF PHARMACEUTICAL WATER STORAGE & DISTRIBUTION SYSTEMS
The storage and distribution system of pharmaceutical water includes storage unit, distribution unit and water point pipe network unit. The design of pharmaceutical water distribution system has various forms, and the basic idea is to minimize the operation risk and microbial risk at a reasonable cost.

The storage unit is used to store pharmaceutical water meeting the requirements of the pharmacopoeia and meet the maximum peak consumption requirements of the system. The storage system must maintain the quality of water supply, so as to ensure that the quality of the end use of the product is qualified.

Circulating design is adopted for the pharmaceutical water supply pipeline.The main function of the distribution system is to deliver pharmaceutical water meeting the requirements of the Pharmacopoeia to the process water point, and ensure that its pressure, flow and temperature meet the requirements of process production or cleaning.

The storage and distribution units need to be disinfected regularly to reduce the possibility of microbial breeding.

HOW IS WATER SYSTEM DISTRIBUTED?
01
PW storage and distribution system
PW storage and distribution system must be disinfected regularly. Automatic control mode is recommended. The common disinfection methods for purified water storage and distribution system are as follows: 1. Pasteurization; 2. Ozone disinfection

02
WFI storage and distribution system
WFI storage and distribution systems must be sterilized regularly. Automatic control mode is recommended. Common sterilization methods of WFI storage and distribution system are as follows: 1. Pure steam sterilization; 2. Sterilization with superheated water

More applications of water system in pharmaceutical industry, please visit our website.

Pure Steam Generation System(PS/CS)(2023年06月21日)

biocellpharma — 2023-06-15T16:09:02+0900

https://www.biocell-pharma.com/products/pure-steam-generation-system/

Pure steam generator is one of the important equipment used in tank equipment, pipeline system and filter sterilization, and can also be used to drive the sterilizer. The quality of pure steam condensate prepared by Biocell pure steam generator meets the requirements for water for injection in the current USP, EP, JP and ChP, and also meets the relevant standards of EN285.

TYPES OF PURE STEAM GENERATION SYSTEM
Pure Steam Generator
Clean Steam Generator
Electric Clean Steam Generator

Pure steam generator is a device that uses water for injection or purified water to produce pure steam. It is widely used for sterilization and disinfection of medical and health care, biopharmaceutical industry and food industry, as well as disinfection of related appliances, to effectively prevent re pollution of impurities such as heavy metals and pyrogens.

Clean Steam Generator
The clean steam generator is used to generate pure and clean steam without any harmful substances and impurities. It is used in the food, cosmetics and pharmaceutical industries, as well as in the sterilization and any direct steam heating processes with high requirements for steam quality.

Electric Clean Steam Generator
The clean electric steam generator generates clean steam by electrically heating pure water. It has the advantages of small size, fast heating, no pollution, convenient operation, and high reliability. It can effectively solve the problems of yellow dressings and equipment rust after sterilization in hospitals.

PURE STEAM GENERATOR WORKING PRINCIPLE
Pure steam generator is composed of evaporator, preheater, buffer tank, condenser, electrical appliances, instruments and pipelines.

Its working principle is: qualified raw water enters the branch condenser after being pressurized by the raw water pump, and then enters the separator and evaporator. The liquid level is controlled by the liquid level switch. The industrial steam enters the evaporator to heat the raw water to the evaporation temperature and form a strong thermal cycle in the evaporation chamber and separation chamber. After the raw water evaporates, the steam with water droplets will enter the separator, and the water droplets in the separator will be separated from the steam under the action of gravity and incorporated into the raw water. In addition, the unique steam water separation device on the upper part of the separator will generate ultra pure steam on the upper part of the separator.

PURE STEAM GENERATION SYSTEM INTERACTIVE FLOW CHART

FEED WATER
Feedwater must be pumped into the generator, typically at 10 psig above the operating pressure. The flow is usually controlled by level.

INDUSTRIAL STEAM
Most pure steam generators use industrial steam heating, but for low capacity systems, electrical heating can be used.

The pressure of industrial steam must be higher than the required pure steam pressure, To provide a temperature difference for heat transfer. For economic reasons, the industrial steam pressure is usually at least 30 psi higher.

PURE STEAM
Sterilisation in pharmaceutical manufacturing is usually carried out at 121℃ (equivalent to 15 psig for saturated steam). Equipment and pipelines, where there is often no pressure control and achieving sterilization temperature is entirely dependent on the supply pressure of the pure steam.

DROPLET REMOVAL
The ability of a pure steam generator to remove contaminants depends on preventing droplets from being carried in the steam. Therefore, droplet removal is critical to the generator function.

MATERIALS OF CONSTRUCTION
The overcurrent part of most generators is made of AISI 316L stainless steel to avoid corrosion.

BLOWDOWN
The concentrated water after continuous evaporation is regularly discharged from the bottom of the generator, including the liquid drops (bacterial endotoxin and pyrogen) removed by steam water separation. Usually, timed blowdown is used, which can also be triggered by conductivity measurement. The discharge of concentrated water is about 10% to 15% of the feed water.

VALIDATION OF PURE STEAM SYSTEM
As the pure steam system directly affects the purity of drugs, it is classified as a key system and needs to be verified. The typical activities of a validation process can be described sequentially as follows :

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

PURE STEAM DISTRIBUTION
The key requirement of the pure steam distribution system is to deliver pollution-free, dry and saturated steam to the point of use without overheating.

Materials of Construction
Invariably piping and other contact materials are AISI 316L stainless steel, to resist corrosion. To enhance the corrosion resistance of stainless steel itneeds to be passivated by a procedure such as that described in ASTM380.

Removal of Condensate
In a pure steam system, condensate must be removed because it will cause water hammer and reduce the efficiency of pure steam. In addition, the condensate may cause microbial growth, which may lead to non-compliance with endotoxin specifications.

Removal of condensate relies on :

● Pipes sloped to direct the condensate to low points where steam traps

are used to remove the condensate from the system. Typically horizontal pipes are sloped with a minimum gradient of 1:100.

● Pipes must be properly supported to prevent sagging, steam traps should be placed at the bottom of vertical risers.

● The pure steam header is operated at low liquid level to allow condensate formed in the riser branch to drain back to the main header, which is itself a drain valve.

● Avoid dead corners where condensate may accumulate, for example, place the instrument branch pipe vertically upward.

● Good pipe insulation prevents excessive condensate formation.

Removal of Air
Avoid mixing air into the pure steam system, The mixing of air and pure steam will reduce the effective temperature under the given pressure, leading to sterilization failure. In a pure steam system, air is usually discharged through a steam trap. In order to exhaust a large amount of air when starting sterilization, an exhaust port can be installed at the highest point of the distribution system.

Prevention of Superheat
When the pressure decreases, the steam becomes overheated, and the energy released by the high-temperature steam when the pressure decreases makes the steam higher than the saturation temperature. The presence of condensate reduces the tendency to overheat, and when steam attempts to evaporate condensate, it will return to saturation. In addition, the heat loss of the pipeline causes the steam temperature to drop, making the steam return to the saturated state again.

In actual operation, the pressure should not drop below 50% of the absolute supply pressure to prevent overheating (for example, if the steam supply pressure is 65 psia (50 psig), the pressure reduction should not be less than 33 psia (18 psig).

Sanitary Design
Pure steam systems are usually fabricated from sanitary tubing, using orbitally welded joints.

Special components of sanitary design, such as pressure reducers, instruments and relief valves, are available for use in pure steam systems.

Instrumentation
There are normal operating/maintenance requirments for installing pressure and temperature instruments in pure steam systems, usually at or near the point of generation and at pressure reducing stations. Validation of the system may also demand that these are also placed at the end of long headers, or at other critical points.

Line Sizing
Normal economic pipe sizing criteria apply, and often a maximum velocity criterion of 120 ft/sec is suitable. Pressure drops should be checked on very long distribution headers to ensure that superheat is not generated, and that the rquired delivery pressure at the point of use is maintained.

More applications of water system in pharma industry, please visit our website.

PHARMACEUTICAL REVERSE OSMOSIS SYSTEM(2023年06月20日)

biocellpharma — 2023-06-15T16:08:19+0900

https://www.biocell-pharma.com/products/pharmaceutical-reverse-osmosis-systems/

With RO membrane separation technology as the core, it adopts automatic control, integrated design, modular installation, low energy consumption and small floor area. Double pipeline water supply and single pipeline circulation mode are adopted for water production to effectively control the growth of microorganisms. The control system has anti misoperation settings, audit tracking functions, and data is permanently saved and cannot be modified. The electric control system is standardized and reasonable, strong and weak current are separated, safe and stable. The touch screen, instruments, meters and valves are highly humanized and easy to operate and view.

OPERATING PRINCIPLES OF PHARMACEUTICAL REVERSE OSMOSIS SYSTEMS

FEATURES OF PHARMACEUTICAL REVERSE OSMOSIS SYSTEMS
01.
Modular design, compact structure, convenient and fast on-site installation.

02.
Automatic switching between water making mode and circulating mode to reduce energy consumption.

03.
Double water supply mode is adopted for water production terminal.

04.
Concentrated water recovery design (optional), system utilization rate can reach more than 85%.

05.
PLC+HMI full-automatic control mode.

06.
Fully comply with GMP, USP and cGMP requirements.

More applications of water system in pharma, please visit our website.

ELECTRODEIONIZATION (EDI)(2023年06月19日)

biocellpharma — 2023-06-15T16:07:38+0900

https://www.biocell-pharma.com/products/electrodeionization-edi/

EDI is a pure water manufacturing technology that combines ion exchange technology, ion exchange membrane technology and ion electromigration technology. It skillfully combines electrodialysis and ion exchange technology, uses high voltage of electrodes at both ends to move charged ions in water, and cooperates with ion exchange resin and selective resin membrane to accelerate the removal of ions, so as to achieve the purpose of water purification. During EDI desalination, ions are removed by ion exchange membrane under the action of electric field. At the same time, water molecules generate hydrogen ions and hydroxide ions under the action of electric field, which continuously regenerate the ion exchange resin to keep the ion exchange resin in the best state.

Technical Data of Electrodeionization
ItemReference value
Nominal Recovery:90–95%
EDI Water Quality:15–18 MΩ.CM（25℃）
FEED CONDUCTIVITY (INCLUDING CO2):< 10 µs/cm（25℃）
Operating Temperature:50–100° F
Maximum Inlet Pressure:100 psig
Minimum Inlet Pressure:60 psig
Expected Pressure Drop:30–40 psig
Electrical Requirement:380 VAC, 3-phase, 50 Hz.

OPERATING PRINCIPLES OF ELECTRODEIONIZATION
Operating Principles of Electrodeionization
EDI Process
EDI water purification system desalination process is to exchange ions in water with hydroxide ions or hydrogen ions in ion exchange resin, and then migrate these ions into concentrated water；

The exchanged ions migrate along the surface of the resin ball under the effect of the DC electric field and enter the concentrated water chamber through the ion exchange membrane；

The above is the desalination process of EDI.

OPERATING PRINCIPLES OF ELECTRODEIONIZATION

FEATURES OF ELECTRODEIONIZATION
1.
Regeneration of acid and alkali is not needed.

2.
Zero discharge; no discharge of wastewater.

3.
The running is continuous and the water quality is stable.

4.
Modularization design is adopted so as to facilitate extension.

5.
Less space is occupied.

More different pharmaceutical purified water systems, please visit our website.

ELECTRIC CLEAN STEAM GENERATOR(2023年06月18日)

biocellpharma — 2023-06-15T16:07:03+0900

https://www.biocell-pharma.com/products/electric-clean-steam-generator/

Clean steam generator using electric energy as heating source is referred to as electric heating clean steam generator. The steam generated after the purified water is heated and evaporated by the electric heating clean steam generator, through the centrifugal separation structure that can effectively remove the water droplets and pyrogens entrained in the steam, the condensed water of the clean steam produced meets the quality indicators of USP, EP, JP and ChP on "water for injection".

This machine is suitable for production places without industrial steam, and is an ideal sterilization equipment for hospitals, pharmaceutical, catering, electronics, chemical and other industries.

HOW DOES ELECTRIC CLEAN STEAM GENERATOR WORKS?
How Does Electric Clean Steam Generator Works?
Industrial steam is the most cost-effective heating source of clean steam generator.

In places without industrial steam, electric heating can be selected if conditions permit. Electric energy is converted into heat energy as an alternative energy for industrial steam.

FEATURES OF ELECTRIC CLEAN STEAM GENERATOR
01.
Precise control of clean steam output pressure and temperature, fluctuation within+5%.

02.
Clean steam pressure output range: 2-4Bar.

03.
Electric heating is adopted to convert electric energy into heat energy.

04.
PLC+HMI full-automatic control mode.

05.
Rising film/falling film, two working modes are optional.

06.
Comply with relevant requirements of WS310 supply room management specification

If you want to know more details of purified water system pharmaceutical, please visit our website.

Water For Injection System (WFI)(2023年06月17日)

biocellpharma — 2023-06-15T16:06:32+0900

https://www.biocell-pharma.com/products/wfi-water-for-injection-system/

BIOCELL water for injection system & system adopts an advanced three-stage separation process of steam and water, and the quality of produced water meets the standards of Chinese, American, and European Pharmacopoeia, GMP, FDA, and other certification requirements; Humanized design, modular installation, small floor area, stable operation, one button start, simple operation and maintenance, high efficiency, and energy saving.

DIFFERENT TYPES OF WFI SYSTEM
Multi-Effect Distiller
Single Effect Distiller
Electrically Heated Distiller
Combis TWO in ONE
WFI Cold Generation System

Multi-Effect Distiller
The multi effect industrial distilled water machine is designed and manufactured according to the industry standard YY0229 Multi effect Distilled Water Machine. All parts are made of 304 and 316L stainless steel. The distilled water produced is of high purity and pyrogen free, and fully complies with the quality indicators of water for injection in the Pharmacopoeia of the People's Republic of China (2020). It is the ideal equipment for manufacturers of various blood products, injections, infusion, biological antibacterial and other drugs and manufacturers of drinking distilled water.

Single Effect Distiller
The single effect distilled water machine is a small distillation unit designed to meet the needs and budgets of growing organizations interested in developing new products. Up to 300L of water for injection can be produced per hour.

Electrically Heated Distiller
The electric heating distilled water machine uses purified water as raw water and electric energy (converted into heat energy) as heating source, and the distilled water produced completely meets the quality indicators of "water for injection" in the Chinese Pharmacopoeia 2020.

Combis TWO in ONE
This model is applicable to the production conditions of producing pure steam disinfection on one side and water for injection on the other side. Disinfection and water preparation can operate simultaneously and independently without mutual interference. It is a production equipment that can operate in dual synchronization, and water production and steam production do not affect each other.

WFI Cold Generation System
The production capacity of cold water for injection (full membrane method) is 200-30000L/H, which is used in medical, daily chemical and other industries. It uses terminal ultrafiltration technology to remove heat source impurities on the basis of traditional purified water, so that the endotoxin index is lower than the standard requirements of "water for injection" in the pharmacopoeia, providing a new, stable and reliable choice for related enterprises to prepare water for injection.

WHAT IS THE WORKING PRINCIPLE OF WFI SYSTEM?
The wfi system design has low investment cost, low operation, and energy consumption, and can operate continuously and dynamically. Under the condition of low-temperature storage and turbulence, it can effectively control the microbial breeding risk of the whole system and can realize large-scale water supply.

WHAT IS WATER FOR INJECTION?
Water for injection (WFI) is a high-purity water used in the pharmaceutical industry for the preparation of injectable medications and medical devices. WFI system must meet strict quality standards to ensure that it is free from microbial and chemical contaminants that could harm patients.

What Is Water for Injection Used For
The water for injection (WFI) system is used as a diluent or solvent for drugs that are administered by injection, including intravenous, intramuscular, and subcutaneous injections. It is also used as a component in the preparation of medical devices, such as wound dressings and contact lenses.

The high purity of WFI is critical to ensure the safety and efficacy of the medications and devices prepared with it. Even trace amounts of contaminants can cause adverse reactions in patients, such as infections or allergic reactions. Therefore, water for injection systems is subject to strict quality standards and is regularly tested to ensure that it meets the required specifications.

Wfi Generation Process
The generation of water for injection (WFI) system in the pharmaceutical industry typically involves a multi-step process to remove impurities and contaminants from the feed water. The WFI generation process may include the following steps:

Pretreatment: The first step is to remove large particles and suspended solids from the feed water. This may be accomplished by using filters, such as sand or cartridge filters.

Reverse osmosis (RO): The pretreated water is then passed through a reverse osmosis membrane, which removes dissolved salts and other impurities. RO uses high pressure to force water through a semi-permeable membrane that separates the water from dissolved salts and other contaminants.

Electrodeionization (EDI): The RO permeate is then passed through an electrodeionization (EDI) module, which uses a combination of ion exchange and electrochemical processes to remove the remaining ions from the water.

Distillation: In some cases, WFI is generated by distilled water. This involves heating the feed water to generate steam, which is then condensed to produce high-purity water.

Ultrafiltration: Ultrafiltration is a process that can be used in combination with the other steps to remove endotoxins and other small particles from the water.

If you want to know more details of purified water system in pharmaceutical, please visit our website.

TYPES OF PHARMACEUTICAL WATER PURIFICATION SYSTEMS(2023年06月16日)

biocellpharma — 2023-06-15T16:05:58+0900

https://www.biocell-pharma.com/products/pharmaceutical-water-purification-systems/

01
Water For Injection System (WFI)
Water for injection is distilled from purified water, and its indicators such as bacterial endotoxin meet the requirements of Water for Injection in the Chinese Pharmacopoeia. The water for injection equipment system mainly includes main modules such as water for injection preparation, circulating storage, dynamic distribution and process control.

02
Pure Steam Generation System(PS/CS)
The pure steam system consists of a preparation unit and a distribution unit. Pure steam can be prepared by rising film evaporation and falling film evaporation. Pure steam generator usually uses industrial steam as the heat source, uses heat exchanger and evaporation column to exchange heat and generate steam, so as to conduct effective vapor liquid separation to obtain pure steam.

03
Purified Water System(PW)
According to the quality of raw water in different regions, we can provide customers with water preparation process design tailored to local conditions, effectively control microorganisms, and minimize cross contamination from other products or production processes. At the same time, the equipment is highly automated and the water quality is stable for a long time, which can provide the greatest guarantee for the clean production of customers. The purified water produced can fully meet the requirements for purified water in the current Chinese Pharmacopoeia, American Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia.

04
PW/WFI Storage & Distribution Systems
The storage and distribution system of pharmaceutical water includes storage unit, distribution unit and water point pipe network unit. The design of pharmaceutical water distribution system has various forms, and the basic idea is to minimize the operation risk and microbial risk at a reasonable cost.

How Do Pharmaceutical Water Purification Systems Work?
The water purification system pharmaceutical industry is based on the preparation equipment, storage, and export of purified water system in pharmaceutical industry and water for injection system and other functional units, optimized and combined by various functional modules, so as to ensure the high performance and quality of the whole system and make the product water fully meet or exceed the water quality standards of purified water and water for injection plant.

WHAT IS WATER PURIFICATION SYSTEM IN PHARMACEUTICAL INDUSTRY?
In the pharmaceutical industry, a water purification system is a system designed to remove impurities and contaminants from water to ensure that it is of high quality and meets stringent regulatory standards. Water is a crucial component in the manufacturing process of pharmaceutical products, and its purity is critical to the safety and efficacy of the final product.

The water purification systems in pharmaceutical industry employ various techniques to remove impurities and contaminants from the water. These techniques may include reverse osmosis, deionization, ultrafiltration, electro-deionization, distillation, ozonation, and ultraviolet radiation.

The specific type of water purification system used depends on the quality of the raw water source and the intended use of the water in the manufacturing process. For example, water used for injection (WFI) must meet even higher purity standards than water used for other manufacturing processes.

Water purification systems in the pharmaceutical industry are subject to strict regulations, and the water must be regularly monitored and tested to ensure that it meets the required quality standards. By employing these pharmaceutical water purification systems, pharmaceutical companies can ensure that the water used in their manufacturing processes is of the highest quality and meets all regulatory requirements, thereby ensuring the safety and efficacy of their products.

ADVANTAGES OF PHARMACEUTICAL WATER PURIFICATION SYSTEMS
01
Fully automatic welding mode is adopted, meeting the special requirements of the Pharmacopoeia.

02
Intelligent automatic control helps to save labor costs. Modular design mode saves more floor space for you.

03
24-hour online monitoring to ensure that every drop of treated water is qualified.

DIFFERENT WATER PURIFICATION SYSTEMS IN THE PHARMACEUTICAL INDUSTRY
01
Reverse Osmosis (RO) Systems: This technology uses a semi-permeable membrane to remove dissolved solids and impurities from water. RO systems are often used to purify raw water sources, such as well water or surface water, before further treatment.

02
Deionization (DI) Systems: This technology removes ions from water by passing it through an ion exchange resin. DI systems are typically used to remove dissolved minerals and other impurities from water.

03
Ultrafiltration (UF) Systems: UF technology uses a semi-permeable membrane to remove suspended solids, bacteria, and viruses from water. It is commonly used in the pharmaceutical industry to remove endotoxins from water.

04
Electrodeionization (EDI) Systems: EDI technology combines deionization and electrochemistry to remove impurities from water. It is commonly used to produce high-purity water for manufacturing processes.

05
Distillation Systems: Distillation involves boiling water and condensing the resulting steam to produce pure water. It is commonly used to produce high-purity water for injection systems.

06
Ozone Systems: Ozone is a powerful oxidizing agent that can destroy bacteria, viruses, and other microorganisms in water. It is commonly used to disinfect water.

07
UV Systems: Ultraviolet (UV) radiation can destroy microorganisms in water. UV systems are commonly used to disinfect water in the pharmaceutical industry.

Pharmaceutical Water Systems In Medical Technology(2023年06月15日)

biocellpharma — 2023-06-15T16:05:23+0900

https://www.biocell-pharma.com/medical-water-purification-systems/

Biocell provides professional solutions for purified water system, water for injection system, pure steam system, storage and distribution system in the medical device industry: in vitro diagnosis, implanted artificial organs, cardiac intervention, orthopedic intervention, syringe, dialysis consumables, dressings and other industries.

PHARMACEUTICAL PURIFIED WATER SYSTEMS IN MEDICAL TECHNOLOGY
The process water involved in the production process of medical devices mainly includes purified water and water for injection, which are widely used in the production process, such as cleaning (environment, tools or clothing), solution preparation, and as components in products.

As required in the medical device management regulations, the process water shall comply with the relevant regulations and technical standards, and the specific water quality standards shall comply with the relevant provisions of the Chinese Pharmacopoeia on purified water and water for injection.

MEDICAL WATER PURIFICATION SYSTEMS BENEFITS
Medical water purification systems offer several benefits in healthcare settings. Some of these benefits include:

Improved patient safety: Medical pharmaceutical water purification systems ensure that the water used for medical procedures is free from harmful contaminants and bacteria, reducing the risk of infections and other complications.

Enhanced efficiency: Medical water purification systems provide a reliable and continuous source of purified water, reducing the need for staff to manually monitor and handle water storage and distribution.

Compliance with regulations: Medical water purification systems are designed to meet strict regulations and standards for water quality in healthcare facilities, ensuring compliance and reducing the risk of fines or penalties.

Cost savings: Medical water purification systems can reduce the cost of purchasing bottled water and eliminate the need for costly maintenance and replacement of outdated equipment.

Environmental sustainability: Medical water purification systems reduce the use of single-use plastic bottles, which can help reduce waste and promote environmental sustainability.

Overall, medical water purification systems are a valuable investment for healthcare facilities, offering benefits that can improve patient safety, efficiency, compliance, cost savings, and sustainability.

CASE STUDY OF PHARMACEUTICAL WATER SYSTEMS IN MEDICAL TECHNOLOGY
purified water generation and distribution system
In Vitro Diagnostic Reagents
In vitro diagnosis, namely IVD (In Vitro Diagnosis), refers to the products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body to judge diseases or body functions.

In vitro diagnostic (IVD) products are tools for virus detection and provide important scientific basis for virus epidemic prevention and control.

water system in pharma company
Disposable Sterile Medical Instruments
The disposable sterile medical instruments refer to the products that can be sold and used only after being sterilized and sterilized in accordance with the requirements of the production process flow of disposable sterile instruments in a clean workshop that meets the requirements. Once unsealed, this product should be used immediately, and must be destroyed after use to prevent continued use.

water treatment system in pharmaceutical industry
Implantable Medical Device
Any instrument that enters the human body or natural cavity in whole or in part with the aid of surgery; These instruments are considered as implant instruments if they are left in the body for a long time after the end of the surgical procedure, or if some of these instruments are left in the body for at least 30 days.

water treatment system in pharmaceutical manufacturers
Medical Filler Materials
Fillers mainly refer to medical materials that are filled under the skin of the human body by surgery or injection to supplement the volume and make the appearance more beautiful.

IMPORTANCE OF PHARMACEUTICAL WATER SYSTEMS IN MEDICAL TECHNOLOGY
Water is an indispensable material in the medical device industry.

The process water involved in the production process of medical devices mainly includes purified water and water for injection, which are widely used in the production process, such as cleaning (environment, tools or clothing), solution preparation, and as components in products.