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Marya Quality-Assured Pharma Isolator with Barrier Function for Drug Manufacturing
US$14,000.00
1 Piece
Product profile
Customization
AvailableApplication
Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Pharmaceutical IndustryCertification
CE, GMP, ISOModel NO.
MY-IsolatorControl System
Fully AutomaticCustomized
CustomizedMaterial
Stainless SteelMachine Power
1kwSterilization
Vhp GeneratorCompliance
GMPRtp Valve
OptionalVhp Residue Levels
1 PpmProfessional Customization
ProvidedCdcv Service
ProvidedManufacturing Materials
316L or PTFEChamber Polishing Grade
0.4um~0.6umTransport Package
Export Wooden CasesSpecification
Standard/customizedTrademark
MaryaOrigin
ChinaHS Code
8409919100Production Capacity
5000pieces/YearKey features
Class A Barrier Function: Segregates operators and machines, meeting Class A standards for sterile processes.
New VHPS Technology: Precise H2O2 concentration control with rapid sterilization and high reproducibility.
Modular Design: Includes transfer chamber, operation chamber, and bacteria collector for flexible integration.
Siemens PLC Control: Intelligent control system with multi-level access and alarms for pressure, temperature, and humidity.
FDA 21 CFR Part 11: System complies with FDA 21 CFR part 11 requirements for electronic records.
Energy Saving Design: Optimized airflow reduces energy consumption by 20% during eight-hour continuous operation.
Optional Glove Leak Detector: Available as integrated or wireless detector for enhanced safety monitoring.
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: ≤4.67h
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 barrier function standard?
A:
The isolator meets Class A standards, segregating operators and machines for sterile processes.
Q:What sterilization technology is used?
A:
It uses New VHPS technology to control H2O2 concentration and saturation for rapid, reproducible sterilization.
Q:Is the system customizable?
A:
Yes, it features a modular design allowing integration of various modules and configurable accessories.
Q:Does it comply with FDA regulations?
A:
Yes, the control system complies with FDA 21 CFR part 11 requirements.
Q:What is the energy consumption reduction?
A:
The optimized airflow design reduces energy consumption by 20% during eight-hour continuous operation.
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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