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GMP Compliant Pharmaceutical Water Distribution Module for Global Use
US$18,000.00
1 Set
Product specifications
Distribution
Sample price:US$50000.00/set.Request sample
Product profile
Customization
AvailableApplication
Pharmaceutical IndustryCapacity
500 L/hrModel NO.
Distribution moduleCertification
CE, FDA, GMPControl System
Fully AutomaticTreatment Process
Ozonation, UV DisinfectionWarranty of core components
2 YearsCompoents
Heat ExchangerMain
Sanitary PumpContact Part
SS316LPolish
Electrical Chemical PolishedIncluding
Skid+Looping SystemStandard
GMP, FDA, cGMP, Pharmacopoeia StandardMaterial
SS304 / SS316L Sanitary Stainless SteelSystem Type
Closed Loop Circulation SystemStructure
Integrated Assembled Distribution ModulePipeline Type
Sanitary Seamless PipelineConnection Mode
Clamp Connection, Welded ConnectionTransport Package
Wooden PackageSpecification
PumpTrademark
WEMACOrigin
ChinaHS Code
8413200000Key features
GMP & FDA Compliance: Fully complies with GMP, cGMP, FDA, EP, ChP, and ISO standards for pharmaceutical production.
Zero Dead Leg Design: Seamless welding and clamp connections eliminate stagnant water and prevent microbial growth.
High-Grade Materials: Constructed from SS304/SS316L sanitary stainless steel with electrochemical polishing.
Fully Automatic Control: PLC intelligent touch screen enables automatic circulation, monitoring, and fault alarms.
Modular Design: Compact layout allows flexible customization of flow rate and pipeline configuration.
Multiple Disinfection Methods: Supports pasteurization, hydrogen peroxide disinfection, and pure water circulating sterilization.
2-Year Core Warranty: Provides a 2-year warranty coverage for core components of the distribution system.
Global Validation Support: Provides DQ, IQ, OQ, PQ, FAT, and SAT validation documents for international compliance.
Company profile
Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableAverage Response Time: ≤3.01h
AI-Powered supplier vetting
SummaryThe supplier is identified as a trading company with a broad technical, equipment, software, and engineering-related business scope. It demonstrates professional technical R&D positioning, 3D software design, ODM, OEM, and multiple customization options. Quality and service procedures are partly established, including inspection instructions, complaint handling, supplier assessment, and corrective-action records. However, the supplier has only one quality inspector, has exported for one year, lacks raw-material traceability labels and written quality records, and has no overseas warehouse or showroom. Innovation evidence is mixed because no new products were reported in the past year and no SDK is available. Financial information is present only as year references, without sufficient evidence to assess credibility.
Supplier typeThe supplier is explicitly classified as a Trading Company. Its stated scope covers technical services, technology development, equipment sales, software development, IoT services, industrial engineering design, and equipment repair, indicating a technically oriented trading and service business rather than a clearly documented manufacturer.
After-Sales capabilityThe supplier has documented and followed procedures for complaint handling, supplier service-capability assessment, and corrective/preventive actions, and it reports in-stock service capability. However, it lacks overseas warehouse and showroom capabilities, so the evidence supports structured service handling but not comprehensive overseas support.
R&D capabilityThe supplier reports professional technical R&D capability, 3D software design, ODM services, and OEM services for popular brands. Counterbalancing this, it reported no new products during the past year and has no available SDK, so the evidence supports design and development services but not strong recent product innovation.
Customization capabilityThe supplier explicitly provides customization from samples, full customization, and customization from customer designs. It also offers 3D software design and ODM services, providing clear evidence of broad customization capability.
Product Q&A
Q:What standards does the pharmaceutical water distribution system comply with?
A:
It fully complies with international and domestic industry standards, including GMP, cGMP, FDA, European Pharmacopoeia (EP), Chinese Pharmacopoeia (ChP) and ISO standards, ensuring that the system meets the requirements of pharmaceutical production.
Q:What is a 'dead leg' in the water distribution system, and how do you control it?
A:
A dead leg is a redundant pipeline section with poor fluidity, which is easy to retain stagnant water and breed bacteria. Our design strictly controls the length and ratio of dead legs in accordance with GMP specifications, and adopts a dead-leg-free structure to fundamentally avoid this problem.
Q:Does the distribution system support constant temperature and constant pressure operation?
A:
Yes. The system is equipped with an intelligent constant temperature and constant pressure control system, which can maintain the stability of water temperature and pressure in the pipeline, prevent water quality changes caused by pressure/ temperature fluctuations, and ensure continuous and stable water supply.
Q:What types of water can the distribution system transport?
A:
It is mainly used for transporting pharmaceutical-grade water, including Purified Water (PW), Water for Injection (WFI), high-purity water for biopharmaceuticals, and laboratory pharmaceutical-grade water, which is widely applicable to various pharmaceutical production scenarios.
Q:Is the pharmaceutical water distribution system fully automatic?
A:
Yes. It is equipped with PLC intelligent touch screen control, which can realize fully automatic operation, including automatic circulation, automatic flushing, online water quality monitoring, fault alarm and data recording, reducing manual operation and ensuring operational safety.
Send Inquiry
*To:
Shandong Eagle Pharma Machinery Co., Ltd.
Shandong Eagle Pharma Machinery Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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