Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing
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Product Highlights
- High Precision Filling: Equipped with high-precision ceramic plunger pump for accurate dosage control up to 99% accuracy.
- Sterile Operation Environment: Maintains sterile environment with optional isolator and expandable laminar flow for Class A clean conditions.
- Regulatory Compliance: Meets GMP, FDA 21CFR Part 11, and CE standards with real-time data traceability.
- Flexible Production Capacity: Capacity ranges from 50-200 PCS/Min for syringes or 2000-30000 vials per hour.
- Modular and Customizable Design: Full customization available with modular design for easy upgrades and adaptability.
- Intelligent Control System: Features PLC automatic control, color touch screens, and individual servo motor control.
- Versatile Filling Systems: Supports multiple filling systems including nitrogen filling and vacuum stoppering modes.
- Easy Maintenance: Designed for easy disassembly and cleaning with CIP/SIP functionality.
Product Attributes
- Customization
- Available
- After-sales Service
- Video Online, Field Installation
- Warranty
- 1 Year
- Type
- Volumetric Filling Machine
- Automatic Grade
- Automatic
- Material Type
- Liquid
- Filling Valve Head
- Multi-Head
- Feed Cylinder Structure
- Multi-Room Feeding
- Dosing Device
- Rotor
- Filling Principle
- Pressure
- Packaging Container Lifting Structure
- Customized
- Structure
- Rotary
- Packaging
- Syringe
- Packaging Material
- Glass or Plastic
- Filling Accuracy
- 99%
- Isolator
- Optional
- Rejected System
- Equipped
- Flow Sensor
- Equipped
- CIP/SIP System
- Optional
- Industry Computer
- Realize Part 11
- Electrical Control Program
- Equipped
- Capacity
- 50-200PCS/Min
- Pump
- Ceramic, Stainless Steel
- Buffer Bin
- Optional
- UPS
- Optional
- Syringe Sorting System
- Optional
- Electric Power
- 230V 3 Phase
- Air Velocity
- 0.45m/S
- Filling Volume
- 5ml-10ml
- Transport Package
- Export Wooden Cases
- Specification
- 1200*800*1800mm
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 5000
- Package Size
- 350.00cm * 200.00cm * 200.00cm
- 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 High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing
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Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing -
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing
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Product Description
Marya High-Speed RTU Prefilled Syringe Filling Machine for Sterile Drug Manufacturing
Introduction:
The RTU Pre-Filled Syringe Filling Machine is used for the sterile filling of RTU pre-filled syringe, RTU vial, RTU cartridge, etc., can automatically complete unpacking, filling, stoppering and other process steps, and widely used in pharmaceutical, cosmetic medicine, medical and other industries.
It can accurately fill small doses of drugs, such as vaccines and biological products, antithrombotic drugs, cosmetic medicine products, etc. into containers to ensure precise dosage. In addition, it can effectively isolate the equipment from the external environment, prevent drug pollution, improve efficiency in the drug production links, and make the clinical use of drugs more convenient.
Key Features:
- High Precision: Equipped with a high-precision ceramic plunger pump for accurate dosage control.
- Efficiency: Caters to various production needs with capabilities ranging from medium to high-speed operations.
- Sterile Operation: Maintains a sterile environment throughout the filling and stoppering process to prevent contamination.
- Intelligent Control: Features automatic monitoring and easy operation for seamless production.
- Wide Application: Compatible with a variety of drugs and RTU packaging materials.
- Regulatory Compliance: Meets GMP, FDA 21CFR part 11, and other regulatory requirements.
- Easy Integration: Seamlessly integrates with other production line equipment for a complete system.
- Modular Design: Allows for easy upgrades and adaptability to various packaging materials.
- Easy Maintenance: Designed for easy disassembly and cleaning, reducing maintenance costs.
- Flexible Production Modes: Supports single batch and continuous production to meet diverse needs.
- Intelligent Operation: Adjustable filling volume and stoppering depth with individual servo motor control.
- Safety: Includes stopper missing detection and various overload protection alarms.
- Traceability: Records key production data for quality control and traceability.
- Versatile Filling Systems: Offers multiple filling systems to accommodate different liquid characteristics.
Optional Configurations:
- Nitrogen Filling System: For antioxidant requirements during filling and storage.
- Vacuum Filling and Stoppering Mode: on-damaging and suitable for various types of rubber stoppers.
- Expandable Laminar Flow: Protects product and packaging under class A clean environment.
- PMS Online Monitoring System: Real-time sterile production environment monitoring with data traceability.
- Online Sterilization Plunger Pump: For CIP/SIP functionality of the filling system.
Technical Specifications:
| Feature | Description |
| Compliance | Meets GMP and FDA standards for pharmaceutical production |
| Servo Control System | Automated process control for stability and efficiency |
| Applicable Specification | 1ml-20ml vials (customizable based on user requirements) |
| Filling Range | 0.1ml-20ml |
| Production Capacity | 2000-30000 vials per hour |
| Filling Heads | 2-10 (selectable based on production needs) |
| Filling Pump Options | Metal, peristaltic, ceramic pumps |
Advantages:
- Customizable Solutions: Tailor-made configurations to meet specific production needs and product characteristics.
- High-Quality Material Handling: Frictionless transfer of stoppers and protection under laminar flow to prevent contamination.
- Environmentally Friendly: Major transmission parts are servo-driven, located inside the machine frame, precise and pollution-free.
- Advanced Control Technologies: Utilizing high-precision color touch screens, PLC automatic control, and variable frequency speed adjustment for full automatic control and monitoring.
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 300+ 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 build 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
-
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
- 30 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
FAQ
- What is the warranty period for this machine?
- We provide a 1-year warranty for the machine.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- Can the machine be customized for specific needs?
- Yes, we offer full customization and flexible customization options to meet specific production needs.
- What are the lead times for production?
- The lead time is one month during off-peak season and 1-3 months during peak season.
- What payment terms do you accept?
- We accept LC, T/T, D/P, PayPal, Western Union, Small-amount payment, and Money Gram.
- Is OEM and ODM service available?
- Yes, both OEM and ODM services are available.
- What types of packaging containers can this machine handle?
- It is suitable for RTU pre-filled syringes, RTU vials, and RTU cartridges made of glass or plastic.
- What after-sales services are provided?
- We provide video online support and field installation services.
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