Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications
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Product Highlights
- GMP & FDA Compliance: Meets stringent FDA and EMA regulatory requirements for pediatric oral suspensions.
- Precise Dosing Control: Integrates automated dosing, homogenization, and viscosity control for low-dose accuracy.
- Cross-Contamination Prevention: Closed-loop design with CIP/SIP functionality simplifies cleaning validation.
- Real-Time PAT Monitoring: Supports real-time Process Analytical Technology monitoring for critical quality attributes.
- Flexible Customization: Full customization options for operation modes, filling pumps, and intelligent interfaces.
- Wide Volume Capacity: Available in volumes ranging from 2L to 15000L for various production scales.
- Multi-Material Options: Constructed from 304, 316L, 904L, or TA2 stainless steel for durability and safety.
- Comprehensive Warranty: Includes a 1-year warranty covering mechanical defects and technical support.
Product Attributes
- Customization
- Available
- Application
- Chemical Industry, Clinical Diagnosis, Cosmetics Industry, Food Industry, Food Safety, Pharmaceutical Industry
- Main Material
- Stainless Steel
- Model NO.
- Marya AF
- Power Source
- Electric
- Safety Features
- Emergency Stop Button, Overload Protection, Safety Interlock
- Warranty
- 1year
- Compliance
- GMP, FDA
- Operation
- Manual, Semi-Automatic, Fully Automatic
- Filling Pumps
- Peristaltic Pump, Plunger Pump, Piston Pump
- Intelligent Interface
- Equipped
- Orabs
- Optional
- Anti-Drip Device
- Equipped
- Integrated System
- CIP/SIP
- Transport Package
- Exported Cases
- Specification
- customized
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 5000pieces/Year
- Package Size
- 380.00cm * 250.00cm * 200.00cm
- Package Gross Weight
- 300.000kg
- Lead Time
-
200 days (1 - 1 Pieces)
To be negotiated ( > 1 Pieces)
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 GMP-Compliant Formulation System for Oral Suspension Pediatric Medications
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Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications -
Marya GMP-Compliant Formulation System for Oral Suspension Pediatric Medications
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Product Description
Marya GMP-compliant formulation system ensures precise and consistent production of pediatric oral suspensions, meeting stringent FDA and EMA regulatory requirements. Designed for accuracy in low-dose formulations, this system integrates automated dosing, homogenization, and viscosity control to handle sensitive APIs and flavor-masking excipients. The closed-loop design prevents cross-contamination, while CIP/SIP functionality simplifies cleaning validation. Compatible with sucrose-free and dye-free formulations, it supports real-time PAT (Process Analytical Technology) monitoring for critical quality attributes. Ideal for antibiotics, antimalarials, and vitamin suspensions, our system reduces batch variability and accelerates scale-up.
2)Complex formulation system: It is used in the production of preparations with complex processes, such as suspensions, emulsions, liposomes, microspheres and other special preparations.
3)Biological formulation system: It is used for the preparation of various products of biological engineering technology, such as the semi-finished preparation of antibodies, vaccines, blood products, recombinant proteins and so on, and it can also be used for the preparation of culture medium production, purified buffer solution and other auxiliary liquid.
| Volume | 2~15000L |
| Material | 304,316L,904L,TA2 |
| Stirring type | Upper mechanical stirring, lower magnetic stirring |
| Stirring speed control accuracy | Speed range 0~450rpm |
| Temperature control accuracy | Temperature range-10~150ºC |
| Pressure control accuracy | Pressure range-0.01Mpa~0.06Mpa ±0.01MPa |
| Weighing control accuracy | 3‰ |
| Power supply | 380V 50Hz |
Why Choose Our Formulation System?
- Quality and Compliance: Ensures that your products meet the highest quality standards and regulatory requirements.
- Flexibility and Customization: Adapts to various production needs and scales with ease.
- Efficiency and Cost-Effectiveness: Streamlines operations, reduces resource waste, and lowers overall production costs.
- Safety and Reliability: Minimizes human error and maximizes the safety of your production environment.
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
- Is the formulation system GMP and FDA compliant?
- Yes, the system ensures precise production of pediatric oral suspensions and meets stringent FDA and EMA regulatory requirements.
- What customization options are available?
- We offer full customization including manual, semi-automatic, or fully automatic operation, various filling pumps, and optional anti-drip devices.
- What is the minimum order quantity?
- The minimum order quantity is 1 Set.
- What materials are used for construction?
- The system is made from high-quality stainless steel, including grades 304, 316L, 904L, and TA2.
- What is the lead time for production?
- The average lead time is one month during the off-season and 1-3 months during the peak season.
- Does the system support real-time monitoring?
- Yes, it supports real-time PAT (Process Analytical Technology) monitoring for critical quality attributes.
- What payment terms are accepted?
- 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 with flexible customization options.
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