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Marya Pharmaceutical Vhp Sterility Testing Isolator for Injectable Drug Quality Control
US$200,000.00
1 Piece
US$190,000.00
2+ Pieces

Product profile

Customization

Available

Application

Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry

Certification

CE, GMP, ISO

Model NO.

MARYA AA

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

Chamber Polishing Grade

0.4um~0.6um

Transport Package

Inner Water Proof Bag, Outer Sea Worth Case

Specification

Standard/customized

Trademark

Marya

Origin

China

Production Capacity

5000pieces/Year

Key features

Advanced VHPS Technology: Precise H2O2 control, excellent reproducibility, and reduced sterilization time.
Modular Design: Includes transfer chambers, operation chambers, and bacterial collectors for flexibility.
Smart Control System: Siemens PLC + IPC with smart alarms and FDA 21 CFR Part 11 compliant access control.
CDCV Service: Comprehensive sterilization cycle development and validation services provided.
Energy Saving: Optimized airflow reduces energy consumption by 20% during 8-hour operation.
Real-time Monitoring: Online monitoring of door status and continuous airtight seal checks.
Global Compliance: Meets China GMP, EU GMP/FDA, and cGMP/USP-NF standards.

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: ≤4.83h

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 is used?
A:
The isolator uses advanced VHPS technology for precise H2O2 control and rapid sterilization.
Q:Can the machine be customized?
A:
Yes, full customization and flexible customization options are available.
Q:Does it support batch and continuous operations?
A:
Yes, the system supports both continuous and batch operations.
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, and off-season lead time is one month.

Send Inquiry

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