Marya Single-Use Negative Pressure Isolator in Sterile Vaccine Production Cleanrooms
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Product Attributes
- Customization
- Available
- After-sales Service
- Video Online, Field Installation
- Warranty
- 1 Year
- Model NO.
- Marya AG
- Machine Power
- 1kw
- Material
- Stainless Steel
- Control System
- Automated Control
- Sterilization
- Vhp Generator
- Compliance
- GMP
- Manufacturing Materials
- 316L or PTFE
- High Protection Level
- Oeb 5 (Oel<1ug/M³)
- Vhp Residue Levels
- 1 Ppm
- Rtp Valve
- Optional
- Transport Package
- Export Wooden Cases
- Specification
- Standard/customized
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 5000pieces/Year
- Package Size
- 350.00cm * 250.00cm * 250.00cm
- Package Gross Weight
- 400.000kg
Shipping
- Shipping Cost:
- Contact the supplier about freight and estimated delivery time.
Online Trading Protection
- Payment Guarantee
-
Platform-protected payments with refund support for eligible order issues.
- Platform Logistics
- Clearer shipment tracking with platform-supported logistics.
- Inspection Service
- Optional pre-shipment inspection for quality and quantity checks.
- After-Sales & Dispute Handling
- Platform-assisted dispute resolution, including refunds or returns when applicable.
Only orders placed and paid through Made-in-China.com Secured Trading are eligible for payment protection and the corresponding platform services.
Product Images of Marya Single-Use Negative Pressure Isolator in Sterile Vaccine Production Cleanrooms
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Product Description
in Sterile Vaccine Production Cleanrooms
Marya's single-use negative pressure isolator provides an aseptic containment solution for sterile vaccine production, eliminating cross-contamination risks between batches. Designed for Grade A/B cleanrooms, this disposable isolator features integrated HEPA filtration (ISO 5), pre-validated gamma-irradiated polymer walls, and ergonomic glove ports for closed processing. The maintenance-free system ensures consistent negative pressure (-15 to -40 Pa) during live virus handling or mRNA vaccine filling, with seamless disposal after use. Compatible with automated filling lines and RABS interfaces, it reduces validation burden while meeting FDA/EMA guidelines for single-use systems. Ideal for pandemic-response manufacturing, the isolator includes built-in particle monitoring ports and sterile transfer adapters for rapid changeover.
| Feature | Description |
| Protection Level | OEB 5 (OEL < 1ug/m³) |
| Customization | Professional design, early MOCK-UP, and 3D project display |
| Intelligent Control | Smart system with expansion ports |
| WIP System | Inclined chamber bottom, R≥20 internal arc angles |
| Emergency System | Automatic leak detection and fan frequency adjustment |
| Door Status Monitoring | Real-time door opening and sealing monitoring |
| Material Transfer | RTP and online waste discharge port options |
Key Features:
Customization and Integration:
- Modular Design: Allows for the integration of various modules to create a customized isolation system.
- Accessories: Configurable with different shelves, cleaning water guns, and dehumidification systems to suit specific needs.
- Control System: Features automatic control of gas pressure, water and oxygen content, and self-adaptive cleaning air circulation.



About the Supplier
This supplier has been audited by TÜV Rheinland. Verify the report on the official TÜV Rheinland website with ID "MIC-ASR2542074". Items marked "" are certified.
Company Profile
With 12 years of industry experience, we have independently developed a comprehensive range of filling lines, including vial, pre-filled syringe (PFS), and cartridge filling lines. In addition, we offer self-developed supporting equipment such as isolators, solution preparation systems, and water treatment systems. Our capabilities also extend to providing turnkey solutions for cleanroom projects and complete filling production lines. Centered around professional filling line technology, we are committed to delivering aseptic production lines and solutions that are stable, compliant, and efficient.
With branch offices located in Shanghai, Hong Kong, Osaka, Changsha, and Guangzhou. With three factories and a team of experts and technicians boasting over 20 years of experience in the pharmaceutical and medical industries, Marya has successfully partnered with pharmaceutical companies and governmental authorities in 60 countries.
Our expertise encompasses factory construction and securing GMP and FDA certifications. We are dedicated to our clients' success, ensuring they enjoy a worry-free and satisfying experience. Our commitment lies in helping clients design and provide high-standard customized aseptic pharmaceutical engineering solutions.
Five Things You Should Know About Marya
1 Engineering design
Our experienced engineering team with more than 20 years experience in pharmaceutical production plants, can ensure that process and equipment for your plant is designed and manufactured in the most cost-effective manner with reliable quality to fulfil GMP/FDA/ISO/SGS requirement.
2 Manufacturing Plants
Marya's 3 manufacturing plants for clean room walls, windows, doors and pharmaceutical machinery are all under strict quality management systems certified to ISO 9001 with a focus on continuous quality improvement.
3 Installation & Commissioning
Experienced, professional, high-efficiency and strictly stick to the schedule, our installation engineers and workers team has successfully installed more than 60+ projects in oversea with high customer satisfaction.
4 Proven Experience
Since 2014, Marya has maintained good cooperation relationship with Novartis, US pharma, MSD, NBA (Zimbabwe National Biotechnology Administration), Novo Nordisk, Techno drugs and other internationally renowned top pharmaceutical companies and national government agencies for a long time. So far, we have assisted famous pharmaceutical factories or government agencies in more than 60+ countries of 6 continents including the United States, Britain, Australia, Malaysia, Argentina and Tanzania to bulid high-grade cleanroom and aseptic preparation filling production lines that meet local requirements and GMP or FDA standards, winning a very good reputation.
5 Continuous Technical Support
Whatever you buy from us, No matter when your project finished, we will provide continuous service on the operation, maintenance, repairing, spare parts supplying improving and upgrading.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- China(Shanghai) Pilot Free Trade Zone, North Fute Road, No. 211, 302 Parts, Room 368, Shanghai, China
-
Plant Area
- 3210 square meters
-
Number of Employees
- 69
- Terms of Payment
- LC, 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 Time
-
Peak Season Lead Time: 1-3 months
Off Season Lead Time: one month -
Nearest Port
- Shanghai Port; Ningbo Port
-
Minimum Order Quantity
- 1 Set
-
Supply Chain Partners
- 150
Our Production Capability & Technical Expertise
-
Main Products
- Pharmaceutical Filling Line, Cleanroom Project
-
Production Lines
- 6
-
Production Machines
- Welding Machine, Lathe, Milling Machine, Bench Drill
-
QA/QC inspectors
- 3 people
-
Inspection Type for Finished Products
- 100% inspection(Visual inspection & Function inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Full Customization, Flexible customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2014-03-10
-
Export Year
- 12 Years
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
-
Repeat Buyers Choice
- 10%~30%
-
Number of Foreign Trading Staff
- 16
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE
-
Cooperated with Fortune 500
- Yes
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