Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers
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Product Highlights
- VHP Sterilization Technology: Controls H2O2 concentration and saturation for high reproducibility and shorter sterilization time.
- Intelligent PLC Control: Siemens PLC+IPC system with multi-level authority, meeting FDA 21 CFR Part 11 requirements.
- Advanced Safety Interlock: Double-door interlocking, automatic sealing, and anti-opening protection prevent H2O2 leakage.
- Customizable Dimensions: Dimension is customized to fit specific workshop requirements and spatial constraints.
- Efficient Decomposition Filter: Optional exhaust filter shortens H2O2 degradation time and reduces residual concentration.
- CE Certification: Product holds CE certification ensuring compliance with European safety and quality standards.
- Low Noise Operation: Operates with noise level of 0-20db, ensuring a quiet environment in pharmaceutical workshops.
Product Attributes
- Customization
- Available
- Optional Accessory
- Timer Switch, Intercom, Sterilization Lamp, Floodlight
- Noise
- 0-20db
- Surface Treatment
- Baking Finish
- Inside Diameter
- 800*800*800mm
- Installation
- Embedded Type
- Operating Principle
- Laminar
- Type
- Self-Cleaning
- Whole Power
- 0.35kw
- Power Supply
- 220V/50Hz
- Efficiency
- H14, 99.995%
- Cleanliness Level
- ISO 8
- Dimension
- Customized
- Laminar Flow
- 70%
- Exhaust
- 30%
- HEPA
- H14
- Main Body Material
- Galvanized Steel with Powder Coated
- Work Surface
- 304 Ss
- UV Light
- Equipped
- UV Control Programes
- Equipped
- Light Intensity
- 800lux
- Front Window Glass
- Tempered
- Automatic Alarm
- Equipped
- Transport Package
- Export Wooden Package
- Specification
- Standard/customized
- Trademark
- Marya
- Origin
- China
- Package Size
- 200.00cm * 150.00cm * 100.00cm
- Package Gross Weight
- 300.000kg
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 CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers
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Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers -
Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers
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Product Description
Marya CE Certification VHP Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers
Introduction
VHP Pass box is used for automatic sterilization during transfer, with energy saving and high efficiency as its core pursuit. Integrate microbial control and cross-contamination prevention throughout the entire production process, ensuring that each step of the operation is completed accurately in an ultra-high purity environment, effectively guaranteeing the safety and effectiveness of material transfer, and helping customers achieve sterile transfer and protect the room environment.
Characteristics
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New VHPS technology: it can control the concentration and saturation of hydrogen peroxide, have good reproducibility of sterilization and shorten the time of chamber sterilization. It can be equipped with a 35-42mJ/cm² UVC sterilization system.
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Circulation system: It is divided into internal circulation and external circulation, including various air ducts, fans, control dampers and other components inside the isolator. Its function is to control the gas circulation and replacement inside the isolator, and to perform self-purification and VHP filtration and decomposition on the air environment inside the isolator.
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Intelligent control system: adopts Siemens PLC+IPC control system, pressure, hydrogen peroxide solution concentration, ambient temperature and humidity, wind speed and other monitoring parameters, to realize intelligent alarm, the system has multi-level authority control, in line with the FDA 21 CFR part 11 requirements.
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Real-time monitoring of door status: The double-door structure features double-door interlocking, automatic air-filled sealing, rubber strip pressure alarm, automatic locking, and anti-opening protection during operation to prevent hydrogen peroxide leakage. It can monitor the door opening status online and continuously monitor the door gas sealing status.
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Preferred manufacturing materials: the materials in the cavity are made of 316L or PTFE, and the cavity polishing grade is 0.4μm~0.6μm;
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Decomposition filter: The exhaust can be equipped with a decomposition filter to effectively shorten the degradation time of hydrogen peroxide after sterilization and effectively reduce the residual concentration level of sterilization;
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Easy maintenance: The maintenance surface is the back, and the space requirement for the laboratory is not high.
Product Parameters
| Control system | PLC+IPC control system |
| Material | 316L or PTFE |
| Cavity polishing grade | 0.4μm~0.6μm |
| Optional | Decomposition filter |
| Optional | UVC sterilization system |
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.
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Company Profile
Marya is a professional aseptic filling line manufacturer with turnkey solutions. With 12 years of industry experience, we have independently developed a comprehensive range of filling lines, including cartridge, vial, and pre-filled syringe (PFS) filling lines. In addition, we offer self-developed supporting equipment such as isolators/RABS, solution preparation systems, and water treatment systems, and VHP sterilizers. Our capabilities also extend to providing turnkey solutions for cleanroom projects and complete filling production lines. We have expanded business to over 70 countries worldwide, serving clients covering European, American and other mainstream markets, including renowned pharmaceutical enterprises and official governmental institutions. Centered around professional filling line technology, we are committed to delivering aseptic production lines and solutions that are stable, compliant, and efficient.
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 70+ 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 70+ 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
- No211, North Fute Road, Pudong Area, 200131, Shanghai, China
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Plant Area
- 3210 square meters
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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
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Average Lead Time
-
Peak Season Lead Time: 1-3 months
Off Season Lead Time: one month -
Nearest Port
- Shanghai Port; Ningbo Port
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Minimum Order Quantity
- 1 Set
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Supply Chain Partners
- 150
Our Production Capability & Technical Expertise
-
Main Products
- Pharmaceutical Filling Line, Cleanroom Project
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Production Lines
- 6
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Production Machines
- Welding Machine, Lathe, Milling Machine, Bench Drill
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QA/QC inspectors
- 3 people
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Inspection Type for Finished Products
- 100% inspection(Visual inspection & Function inspection)
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Inspection Method for Finished Products
- Have instructions and uniformly followed
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Customization Options
- Full Customization, Flexible customization
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ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 30 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2014-03-10
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Export Year
- 12 Years
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
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Repeat Buyers Choice
- 10%~30%
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Number of Foreign Trading Staff
- 16
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Overseas Agent/Branch
- No
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New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE
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Cooperated with Fortune 500
- Yes
FAQ
- What is the sterilization principle of this pass box?
- It uses VHP (Vaporized Hydrogen Peroxide) technology to control concentration and saturation, ensuring high reproducibility and short sterilization time.
- Does the system comply with FDA regulations?
- Yes, the intelligent control system meets FDA 21 CFR Part 11 requirements with multi-level authority control.
- Is the dimension customizable?
- Yes, the dimension is customized to fit specific workshop requirements.
- What is the minimum order quantity?
- The minimum order quantity is 1 Set.
- What is the lead time for production?
- Peak season lead time is 1-3 months, while off-season lead time is one month.
- What certifications does the product have?
- The product has CE certification.
- Can OEM and ODM services be provided?
- Yes, both OEM and ODM services are available with full customization options.
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