Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality
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Product Highlights
- GMP and ISO Compliance: Complies with GMP/GLP requirements for pharmaceutical aseptic handling.
- PLC Auto Control System: Features programmable logic controller for precise pressure adjustment and pollution prevention.
- Dual Sterilization Options: Available with Ozone or VHP sterilization to ensure aseptic conditions.
- Class 100 Cleanliness: Double door transfer technology maintains Class 100 grade to prevent contamination.
- Comprehensive Monitoring: Online monitoring of pressure, temperature, humidity, and clean grade levels.
- Full Customization Support: Offers flexible and full customization options for specific production needs.
- Global Certification: Certified by CE, GMP, ISO, and SGS standards for international safety.
- Professional After-Sales: Includes field installation, commissioning, and training services.
Product Attributes
- Customization
- Available
- Warranty
- 1 Year
- Control System
- PLC Auto Control
- Pressure
- Adjustable
- Monitoring System
- Complying with GMP/GLP
- Sterilizer Type
- Ozone Sterilization or Vhp Sterilization
- Type
- Preparation Machinery
- Finished Dosage Form
- Granules
- Precision
- High Precision
- Certification
- CE, GMP, ISO, SGS
- Voltage
- 380V
- Computerized
- Computerized
- Customized
- Customized
- Condition
- New
- After-Sales Service
- Field Installation, Commissioning and Training
- Transport Package
- Wooden Box
- Trademark
- Marya
- Origin
- China
Product Images of Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality
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Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality -
Marya GMP ISO Compliant Pharmaceutical Aseptic Isolator High-Grade Quality
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Product Description
Main application of Pharmaceutical Isolator:
Pharmaceutical inspection dispensing isolator is mainly used for injection production and inspection for active pharmaceutical ingredient, 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
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
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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?
- The product comes with a 1-year warranty.
- Is the isolator customizable?
- Yes, full customization and flexible customization options are available.
- What sterilization methods are supported?
- The isolator can be equipped with either Ozone sterilization or VHP sterilization.
- 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.
- Does the system comply with GMP standards?
- Yes, the monitoring system complies with GMP and GLP requirements.
- What payment terms are accepted?
- Accepted terms include LC, T/T, D/P, PayPal, Western Union, and Money Gram.
- Is OEM and ODM service available?
- Yes, both OEM and ODM services are available for this product.
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