Marya High Quality GMP Standard Pharmaceutical Filling Machine Aseptic Isolator Isolationequipment System Manufacturer
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Product Highlights
- GMP Standard Compliance: Meets new GMP pharmaceutical production specification requirements for safety and quality.
- Class 100 Cleanliness: Double door transfer technology ensures sustainable Class 100 grade isolation from human and material contamination.
- Full Customization Options: Offers flexible customization including single/double side operation, split/integrated types, and module design.
- Advanced Sterilization: Equipped with VHP or Ozone sterilizer with residue levels below 1 PPM for effective disinfection.
- Automated Control System: PLC auto-control adjusts pressure to prevent pollution and monitors temperature, humidity, and clean grade online.
- Easy Maintenance Design: Smooth edges, polished welding, and internal arc angles ensure easy cleaning and maintenance without burrs.
- Stainless Steel Construction: Constructed with stainless steel for a closed structure design that is durable and hygienic.
- 1 Year Warranty: Includes a 1-year warranty covering mechanical defects and after-sales service support.
Product Attributes
- Customization
- Available
- Warranty
- 1 Year
- Type
- Preparation Machinery
- Model NO.
- MY-Isolator
- Finished Dosage Form
- Liquid
- Precision
- High Precision
- Certification
- CE, ISO
- Voltage
- 220V
- Computerized
- Computerized
- Customized
- Customized
- Condition
- New
- After-Sales Service
- 1 Year Warranty
- Transport Package
- Export Wooden Case
- Specification
- Standard/Customized
- Trademark
- Marya
- Origin
- China
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Product Description
Main Application of Pharmaceutical Isolator:
Pharmaceutical inspection dispensing isolator is mainly used for injection production and inspection for API, dispensing, weighing, packing. It includes aseptic handling area, material transfer zone, bag in and bag out area, pneumatic sealing system, control system and monitoring system. Can be equipped with VHP sterilizer.
Features of Pharmaceutical Isolator:
- Double door transfer technology, make sure sustainable Class 100 grade to keep the cleanliness from affecting by human and material.
- Monitoring System: Online checking the pressure, temperature and humidity and clean grade. Complying with GMP/GLP requirement.
- Control System: PLC Auto control
- Pressure can be adjusted, can prevent pollution.
- Cabinet can be easily moved and save cost.
- Sterilizer type: Can adopt Ozone sterilization or VHP Sterilization.
1.The machine design, material, manufacture, assembly, debugging and so on met the new GMP pharmaceutical production specification requirements;
2. Can choose stainless steel material, the machine structure and operation platform at the top of the whole closed structure design, the sterilization system, integrated control unit, in and out of the air system and air filtration unit, more beautiful and easy to clean and maintain;
3.The machine body adopts smooth edges and corners, and the welding place is polished without burr. Internal arc Angle design, easy to clean;
4. Each chamber according to the functional requirements for design, gloves with a standard size, no blind spot operation, special hull bust garment design may be adopted;
5. Isolator equipment module design, uses the rat holes connection between each module, each part has obvious differential pressure gradient important areas to ensure that the amount of pressure difference relative to other areas for positive pressure;
6. Isolator equipment can design according to the need for two kinds of single side or double side operation; The equipment has two design methods: split type and integrated type;
7. Isolator can according to the function, increase the buffer tank shell, outgoing module or other chanbers were combined with the main hull, manufacture customized isolation system;
8. Equipment exhaust device, remove excess hydrogen peroxide decomposition, avoid residues;
9. VHP residue levels: < 1 PPM (residue level determined by the technological requirements);
10. Chamber sealing: chamber leakage rate is not more than 5% within 10 minutes under pressure of 500 pa;






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
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 all mechanical defects and after-sales service.
- Can the machine be customized?
- Yes, we offer full customization including flexible options for operation sides, design types, and module combinations.
- What sterilization methods are available?
- The system can be equipped with either VHP (Vaporized Hydrogen Peroxide) or Ozone sterilizers.
- Does the machine meet GMP standards?
- Yes, the design, material, and manufacturing process meet the new GMP pharmaceutical production specification requirements.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- What are the lead times for production?
- Lead time is one month during off-peak season and 1-3 months during peak season.
- Is OEM and ODM service available?
- Yes, both OEM and ODM services are available for this product.
- What is the cleanliness grade of the isolator?
- The isolator maintains a sustainable Class 100 grade to ensure cleanliness is not affected by human or material.
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