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Marya GMP-Compliant Sterility Testing Isolator Sterile Isolation System for Pharmaceutical Aseptic Testing
US$14,000.00
1 Piece
Product profile
Customization
AvailableCertification
GS, RoHS, CE, ISO9001Noise
>100dbApplication
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 & FDA Compliance: Conforms to Class A environment, FDA 21 CFR Part 11, and GMP standards for aseptic testing.
Advanced VHPS Technology: Controls H2O2 concentration and saturation for reproducible sterilization and shorter cycle times.
Modular Design: Includes transfer chamber, operation chamber, and bacteria collector for easy installation and transport.
Intelligent Control System: Siemens PLC+IPC with multi-level access control and intelligent alarms for pressure, temperature, and humidity.
Energy Saving: Optimized airflow design reduces energy consumption by 20% during eight-hour continuous operation.
Real-Time Monitoring: Monitors door status online and continuously checks the airtight seal of the door for safety.
OEM/ODM Customization: Offers full customization and flexible options for material, power supply, and design.
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: ≤4.63h
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 certifications does the isolator have?
A:
The system is certified with GS, RoHS, CE, and ISO9001, and complies with FDA 21 CFR Part 11 requirements.
Q:What is the power supply requirement?
A:
Standard power supply is 380V 50Hz. Other voltages require a transformer.
Q:Is customization available?
A:
Yes, full customization and flexible customization are available, including material, power supply, and design.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 1 Set.
Q:What is the lead time for production?
A:
Peak season lead time is 1-3 months, while off-season lead time is one month.
Send Inquiry
*To:
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.*Content:
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