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Shanghai Marya Laboratoty Isolation System GMP Cell Preparation Station with Data Recording
US$14,000.00
1 Piece

Product profile

Customization

Available

Application

Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Pharmaceutical Industry

Certification

CE, GMP

Model NO.

Marya-AD

Control System

Fully Automatic

Customized

Customized

Material

Stainless Steel

Machine Power

1kw

Sterilization

Vhp Generator

Compliance

GMP

Rtp Valve

Optional

Vhp Residue Levels

1 Ppm

High Protection Level

Oeb 5 (Oel<1ug/M³)

Professional Customization

Provided

Cdcv Service

Provided

Manufacturing Materials

316L or PTFE

Transport Package

Export Wooden Cases

Specification

Standard/customized

Trademark

Marya

Origin

China

HS Code

8409919100

Production Capacity

5000pieces/Year

Key features

GMP Compliant Sterile Environment: Provides Class A clean environment meeting GMP sterile production requirements for cell therapy.
Advanced VHPS Decontamination: Integrated vaporized H2O2 system ensures effective bio-decontamination of operating areas.
Modular Customizable Design: Freely combine multiple functional modules and configurations based on specific customer needs.
Full Data Recording & Traceability: Records key parameter data to ensure traceability and comply with FDA 21 CFR Part 11.
Intelligent Control System: Siemens PLC+IPC system with multi-level access control and intelligent alarms for monitoring.
Optional Wireless Glove Leak Detector: Enhanced safety with optional integrated or wireless glove leak detection capabilities.
CDCV Service Support: Includes sterilization cycle development, validation studies, and comprehensive services.

Company profile

Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
Flexible CustomizationProduct CertificationYears of Export ExperienceR&D Capabilities
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 certification status of this system?
A:
The system holds CE and GMP certifications, ensuring compliance with international standards.
Q:Can the machine be customized for specific needs?
A:
Yes, full customization and flexible customization options are available, including material and configuration choices.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 1 set.
Q:What are the lead times for production?
A:
Peak season lead time is 1-3 months, while off-season lead time is one month.
Q:Is OEM and ODM service available?
A:
Yes, both OEM and ODM services are available for this product.

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