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Marya GMP Cell Drug Preparation Station Isolator for Cell Therapy Product Testing
US$14,000.00
1 Piece
Product profile
Customization
AvailableCertification
GS, RoHS, CE, ISO9001Noise
>100dbModel NO.
MY-IsolatorApplication
IndustrialControl Mode
TouchUsage
Fragrance, Dust Removal, Smoke Removal, Adding Negative Ion, Humidification, Formaldehyde Formaldehyde, Adding Oxygen, SterilizationMaterial
Stainless Steel 316LPower Supply
380V 50HzDesign
Modular DesignControl System
Siemens PLC+Ipc Control System;Transport Package
Wooden PackageSpecification
CustomizedTrademark
MaryaOrigin
Shanghai, ChinaKey features
GMP Class A Sterility: Provides Class A clean environment ensuring sterility for the entire cell production process.
Advanced VHPS Decontamination: Integrated vaporized H2O2 system for effective bio-decontamination of operating areas and channels.
Modular Custom Design: Freely combine multiple functional modules and configurations to meet specific customer needs.
Intelligent Siemens Control: Siemens PLC+IPC system with multi-level access control and intelligent alarms for monitoring.
FDA 21 CFR Part 11 Compliance: System complies with FDA 21 CFR part 11 requirements for electronic records and signatures.
Full Data Traceability: Control system records key parameter data to ensure complete process traceability.
Company profile
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization, Flexible customization CertifiedExport Year: 12 Years CertifiedNearest Port: Shanghai Port; Ningbo PortAverage Response Time: ≤4.57h
About Our Factory & Business Background
AddressNo211, North Fute Road, Pudong Area, 200131, Shanghai, China
Plant Area3210 square meters
Number of Employees69
Terms of PaymentLC, 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 TimePeak Season Lead Time: 1-3 months Off Season Lead Time: one month
Minimum Order Quantity1 Set
Supply Chain Partners150
Our Production Capability & Technical Expertise
Main ProductsPharmaceutical Filling Line, Cleanroom Project
Production Lines6
Production MachinesWelding Machine, Lathe, Milling Machine, Bench Drill
QA/QC inspectors3 people
Inspection Type for Finished Products100% inspection(Visual inspection & Function inspection)
Inspection Method for Finished ProductsHave instructions and uniformly followed
R&D Engineers30 people
Traceability of Raw MaterialsYes
Our Industry Experience & Global Business Record
Year of Establishment2014-03-10
Main MarketsNorth America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
Repeat Buyers Choice10%~30%
Number of Foreign Trading Staff16
Overseas Agent/BranchNo
New Products Launched in Last yearYes
Our Certifications, Standards & Industry Recognition
Product CertificationCE
Cooperated with Fortune 500Yes
Product Q&A
Q:What is the cleanliness level of the isolator?
A:
The isolator provides a Class A clean environment suitable for the entire cell production process.
Q:Does the system support custom configurations?
A:
Yes, it features a modular design allowing free combination of functional modules and flexible customization.
Q:What is the power supply requirement?
A:
The standard power supply is 380V 50Hz; other voltages require a transformer.
Q:Is the system compliant with FDA regulations?
A:
Yes, the intelligent control system complies with FDA 21 CFR part 11 requirements.
Q:Can the system monitor environmental parameters?
A:
Yes, it features online environmental monitoring and intelligent alarms for pressure, temperature, humidity, and more.
Send Inquiry
*To:
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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