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Shanghai Marya China Supplier Pharmaceutical Negative Pressure Sterile Testing Isolator System
US$400,000.00
1 Piece
Product profile
Customization
AvailableAfter-sales Service
Engineers Available to Service Machinery Overseas, Free Spare Parts, Online Support, video Technical SupportAnalysis Speed
High ThroughputModel NO.
MY-01Application
Clinical Diagnosis, Food Safety, Forensic Science, Pharmaceutical IndustryCertification
CE, FDA, GMP, ISO, ULCondition
NewCustomized
CustomizedDetection Range
Hormones, Metabolites, Nucleic Acids, Proteins, Small MoleculesMaterial Compatibility
Capsules, Crystals, Granules, Herbs, Liquid, Powder, TabletsPortability
BenchtopPower Source
Battery OperatedSensitivity
High SensitivityTechnology
Infrared SpectroscopyUser Interface
Software InterfaceVoltage
220V-380VFunction
InspectionDimension
CustomizedUsage
Pharmaceutical InspectionMaterial
304/316 Stainless SteelTransport Package
Wooden PackingSpecification
customizedTrademark
MaryaOrigin
ChinaProduction Capacity
50000pieces/YearKey features
VHPS Sterilization Technology: Controls H2O2 concentration and saturation for reproducible sterilization with shortened cycle time.
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 alarms for pressure, temperature, and humidity.
FDA 21 CFR Part 11 Compliance: System meets FDA electronic records and signatures requirements for pharmaceutical data integrity.
Energy Efficient Operation: Optimized airflow design reduces energy consumption by 20% during eight-hour continuous operation.
Real-time Door Monitoring: Continuously monitors door status and airtight seal to ensure sterile environment integrity.
Customizable Dimensions: Standard outer dimensions 1900*800*2200mm, fully customizable according to specific requirements.
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: ≤4.99h
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 sterilization technology does the isolator use?
A:
It utilizes new VHPS technology to control H2O2 concentration and saturation, ensuring good reproducibility and shorter sterilization times.
Q:Is the system customizable?
A:
Yes, the system features full and flexible customization, including dimensions, with standard outer dimensions of 1900*800*2200mm.
Q:What is the cleanliness level of the isolator?
A:
The isolator meets Class A cleanliness standards and maintains pressure of not less than 10Pa under static conditions.
Q:Does the system comply with FDA regulations?
A:
Yes, the intelligent control system complies with FDA 21 CFR Part 11 requirements for electronic records and signatures.
Q:How is energy consumption managed?
A:
An optimized airflow handling system reduces energy consumption by 20% during eight hours of continuous operation.
Send Inquiry
*To:
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.*Content:
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