Marya Pharmaceutical-Grade Purified Water Machine RO+EDI System USP/Ep Compliant 100L/H for Pharma Factories
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Product Highlights
- USP/EP Compliance: System meets USP and EP standards for pharmaceutical-grade purified water.
- GMP & FDA Certified: Manufactured according to ASME BPE, cGMP, and FDA requirements.
- Full Customization: Offers full and flexible customization options for specific needs.
- OEM/ODM Services: Provides both OEM and ODM services for tailored manufacturing.
- Multi-Effect Distiller: Generates WFI using three-stage separation and falling film evaporation.
- Pure Steam Generator: Produces high-quality pure steam with precise pressure and temperature control.
- Stainless Steel 316L: Critical components made of 316L stainless steel with PTFE sealing.
- Smart Control System: Features automatic electronic reporting, audit tracking, and remote troubleshooting.
Product Attributes
- Customization
- Available
- Application
- Industry
- Capacity
- 400 Gallon
- Model NO.
- MARYA AA
- Function
- Water Distribution
- Material
- Stainless Steel
- Voltage
- 220V-380V
- Standard
- GMP
- Core Components
- RO Systems or EDI Systems
- Qualification Documents
- Dq, Iq, Oq, Pq
- After-Sales Service
- Field Installation, Commissioning and Training
- Transport Package
- Wooden Packing
- Specification
- Standard/ Customized
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 50000pieces/Year
- Package Size
- 2100.00cm * 1200.00cm * 2400.00cm
- Package Gross Weight
- 500.000kg
Shipping
- Shipping Cost:
- Contact the supplier about freight and estimated delivery time.
Online Trading Protection
- Payment Guarantee
-
Platform-protected payments with refund support for eligible order issues.
- Platform Logistics
- Clearer shipment tracking with platform-supported logistics.
- Inspection Service
- Optional pre-shipment inspection for quality and quantity checks.
- After-Sales & Dispute Handling
- Platform-assisted dispute resolution, including refunds or returns when applicable.
Only orders placed and paid through Made-in-China.com Secured Trading are eligible for payment protection and the corresponding platform services.
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Product Description
Marya Pharmaceutical-Grade Purified Water
Machine RO+EDI System USP/EP Compliant 100L/H for Pharma Factories
Phamaceutical water treatment system includes PE water tank, Stainless steel tank, Purified water machine, PW/WFI Storage & Distribution System, multi-effect water distiller, pure steam generator.
1.Pharmaceutical PE Water Tank
Mainly used for the storage of raw water for pharmaceutical water treatment and of medicine liquid for dosing system.
(2)Good drug resistance: excellently resistant to various acids and alkalis corrosion;
(3)Clean and beautiful: beautiful streamline shape, not easy to be dirty,easy to clean;
(4)Economic and durable: tank body is formed in one piece without bonding, not easy to crack;
(5)Good heat and freeze resistance: can be used at 80 to -40ºC;
(6)Difficult to leak: the outlet nozzle is made of the same material as the tank body, and processed by hot melt method, so the risk of liquid leakage is low;
Mainly used for the storage and transport of liquids in the pharmaceutical, food and chemical industries.
(2)Design and manufacture in accordance with ASME BPE standard specifications, and meet cGMP and FDA requirements;
(3) Mechanical and electrolytic polishing of inner surface, and Ra can be 0.28 to 0.4μm;
(4) Internal structure of the jacket is honeycomb or semi-tube, realize heating or cooling;
(5) Chlorine-free thermal insulation materials, shell welding structure, easy to scrub and clean;
(6)Can be used in the formulation system, with optional, various and comprehensive accessories, including light mirror, sight glass, hand hole, manhole, weighing and stirring devices, etc.
3.Purified Water Machine
Based on membrane technology,high efficient and energy-saving pharmaceutical purified water equipment that meets GMP requirements.
(2) Advanced automatic control mode, stable and reliable operation;
(3)Double softeners in series or parallel, alternate resin regeneration, and effective control of microorganisms;
(4)Full pasteurization, and flexible disinfection methods;
(5)Dual water supply and unique circulation mode to prevent breeding bacteria throughout the system;
(6)Constant pressure control prevents system pressure from being too high in the circulation state and prolongs EDI service life;
(7)The recovery rate of reverse osmosis system can be adjusted automatically, or it can be equipped with concentrated water recovery device, which greatly saves energy;
(8)Flexible water supply to reduce shutdown time, save energy and improve equipment life;
Designed with cGMP, ISPE guidelines and FDA specifications for PW/WFI storage and delivery.
(2)Frequency conversion operation of circulating pump, and system flow design and operation in line with GMP and ISPE guidelines;
(3)Fully automatic control of CIP and SIP of storage and distribution system;
(4)Design and manufacture the integrated solutions for purified water, water for injection, pure steam, compressed air, nitrogen, etc. that meet the process requirements of pharmaceutical companies;
(5)The control system can automatically generate electronic reports and records, and has the functions of audit tracking, intelligent maintenance and remote troubleshooting.
5.Multi-effect Water Distiller
Provide a flexible one-stop solution based on distillation (i.e.thermal) to generate the pharmaceutical-grade water for injection (WFI), and mainly used in liquid formulation, biological fermentation, aseptic container cleaning and other applications.
(2)Parts contact with raw water, cooling water, pure steam and distilled water are made of stainless steel 316L, and the sealing is PTFE.
(3)An incondensable gas emission equipment is installed.
(4)Pure steam can be produced (optional).
6.Pure Steam Generator
Provide a flexible one-stop solution based on distillation (i.e. thermal) to generate pharmaceutical-grade pure steam (PS), and mainly used for high temperature sterilization of clean equipment to meet CIP/SIP requirements of equipment.
(2)Accurate pure steam output pressure and temperature control, fluctuation within ±5%;
(3)Unattended, suitable for the simultaneous use of multiple sterilization points ;
(4)Typical waste discharge rate: 2-8%;
(5)Pure steam production pressure output range: 2-5bar;
(6)Pure steam quality meets the requirements of the content, and degree of dryness and superheat of non-condensable gas defined in HTM2010(EN285) standard.


About the Supplier
This supplier has been audited by TÜV Rheinland. Verify the report on the official TÜV Rheinland website with ID "MIC-ASR2542074". Items marked "" are certified.
Company Profile
With 12 years of industry experience, we have independently developed a comprehensive range of filling lines, including vial, pre-filled syringe (PFS), and cartridge filling lines. In addition, we offer self-developed supporting equipment such as isolators, solution preparation systems, and water treatment systems. Our capabilities also extend to providing turnkey solutions for cleanroom projects and complete filling production lines. Centered around professional filling line technology, we are committed to delivering aseptic production lines and solutions that are stable, compliant, and efficient.
With branch offices located in Shanghai, Hong Kong, Osaka, Changsha, and Guangzhou. With three factories and a team of experts and technicians boasting over 20 years of experience in the pharmaceutical and medical industries, Marya has successfully partnered with pharmaceutical companies and governmental authorities in 60 countries.
Our expertise encompasses factory construction and securing GMP and FDA certifications. We are dedicated to our clients' success, ensuring they enjoy a worry-free and satisfying experience. Our commitment lies in helping clients design and provide high-standard customized aseptic pharmaceutical engineering solutions.
Five Things You Should Know About Marya
1 Engineering design
Our experienced engineering team with more than 20 years experience in pharmaceutical production plants, can ensure that process and equipment for your plant is designed and manufactured in the most cost-effective manner with reliable quality to fulfil GMP/FDA/ISO/SGS requirement.
2 Manufacturing Plants
Marya's 3 manufacturing plants for clean room walls, windows, doors and pharmaceutical machinery are all under strict quality management systems certified to ISO 9001 with a focus on continuous quality improvement.
3 Installation & Commissioning
Experienced, professional, high-efficiency and strictly stick to the schedule, our installation engineers and workers team has successfully installed more than 60+ projects in oversea with high customer satisfaction.
4 Proven Experience
Since 2014, Marya has maintained good cooperation relationship with Novartis, US pharma, MSD, NBA (Zimbabwe National Biotechnology Administration), Novo Nordisk, Techno drugs and other internationally renowned top pharmaceutical companies and national government agencies for a long time. So far, we have assisted famous pharmaceutical factories or government agencies in more than 60+ countries of 6 continents including the United States, Britain, Australia, Malaysia, Argentina and Tanzania to bulid high-grade cleanroom and aseptic preparation filling production lines that meet local requirements and GMP or FDA standards, winning a very good reputation.
5 Continuous Technical Support
Whatever you buy from us, No matter when your project finished, we will provide continuous service on the operation, maintenance, repairing, spare parts supplying improving and upgrading.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- China(Shanghai) Pilot Free Trade Zone, North Fute Road, No. 211, 302 Parts, Room 368, Shanghai, China
-
Plant Area
- 3210 square meters
-
Number of Employees
- 69
- Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment, Money Gram
- International Commercial Terms(Incoterms)
- FOB, EXW, CFR, CIF, DDP, CIP, Others
-
Average Lead Time
- Peak Season Lead Time, 1-3 months, Off Season Lead Time, one month
-
Nearest Port
- Shanghai Port; Ningbo Port
-
Minimum Order Quantity
- 1 Set
-
Supply Chain Partners
- 150
Our Production Capability & Technical Expertise
-
Main Products
- Pharmaceutical Filling Line, Cleanroom Project
-
Production Lines
- 6
-
Production Machines
- Welding Machine, Lathe, Milling Machine, Bench Drill
-
Inspection Type for Finished Products
- 100% inspection Visual inspection Function inspection
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Full Customization,Flexible customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2014-03-10
-
Export Year
- 12 Years
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
-
Repeat Buyers Choice
- 10%~30%
-
Number of Foreign Trading Staff
- 16
-
Overseas Agent/Branch
- No
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE
-
Cooperated with Fortune 500
- Yes
FAQ
- What is the production capacity of this system?
- The system has a capacity of 100L/H and can be configured for up to 400 Gallons.
- Does the system comply with pharmaceutical standards?
- Yes, it is USP/EP compliant and meets GMP, cGMP, and FDA requirements.
- What materials are used for the tanks?
- Tanks are made of polyethylene or stainless steel (316L, 304, 904L, etc.).
- Is customization available for this machine?
- Yes, full customization and flexible customization options are available.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- What are the lead times for production?
- Lead time is one month during off-peak season and 1-3 months during peak season.
- What payment terms are accepted?
- Accepted terms include LC, T/T, D/P, PayPal, Western Union, and Money Gram.
- Do you provide after-sales service?
- Yes, we offer field installation, commissioning, training, and remote troubleshooting.
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