Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection
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Product Highlights
- Class C Cleanliness: Internal environment meets Class C standards and cGMP requirements.
- Full Customization: Flexible customization options including explosion-proof functions available.
- Intelligent Control: Smart control system with expansion ports for printing, storage, and SCADA integration.
- Overseas Service: Engineers available to service machinery overseas for after-sales support.
- High Throughput: High analysis speed suitable for pharmaceutical and food safety applications.
- Multi-Industry Use: Widely used in medical, pharmaceutical, chemical, and food industries.
Product Attributes
- Customization
- Available
- After-sales Service
- Engineers Available to Service Machinery Overseas
- Analysis Speed
- High Throughput
- Model NO.
- IS
- Application
- Food Safety, Pharmaceutical Industry, Chemical, Medical, Food
- Certification
- CE, GMP, ISO
- Condition
- New
- Customized
- Customized
- Detection Range
- Proteins
- Material Compatibility
- Capsules, Granules, Herbs, Liquid, Powder, Tablets
- Portability
- Benchtop
- Power Source
- Electric Operated
- Sensitivity
- High Sensitivity
- Technology
- Ultraviolet-Visible Spectroscopy
- User Interface
- Touchscreen
- Voltage
- 220V
- Driven Type
- Electric
- Certificate
- CE, ISO, SGS
- Capacity
- Cutomized
- Machine Power
- 1 Kw
- Precision
- High Precision
- Computerized
- Computerized
- Type
- Pharmaceutical Workshop
- Finished Dosage Form
- Pharmaceutical Workshop
- Transport Package
- Inner Water Proof Bag, Outer Sea Worth Case
- Specification
- Customized
- Trademark
- Marya
- Origin
- China
- HS Code
- 8409919100
- Production Capacity
- 300 PCS/Year
Product Images of Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection
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Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection -
Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection -
Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection -
Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection -
Pharmaceutical Aseptic Test Negative Pressure Isolator for Inspection
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Product Description
Main Applications
The negative-pressure isolator is often used for the weighing, dispensing, feeding and other operations of highly active, toxic and allergenic drugs. The operation process is isolated through the closed barrier system to protect the health of the operator. Its internal environment cleanliness is Class C and meets process and cGMP requirements. It is widely used in the fields of medical, pharmaceutical, chemical, food industries and so on.
Performance Features
- High protection level: up to the highest OEB 5 (OEL<1ug/m³);
- Professional customization: according to different process requirements (explosion-proof function is optional), we provide the most suitable isolator design and complete MOCK-UP early in the design and three-dimensional display in the middle of a project.
- Intelligent: intelligent control system, a number of expansion ports, such as printing, storage, etc., and can be integrated into SCADA system;
- Perfect WIP system: the bottom of the chamber is designed to be inclined and the internal arc angle R≥20, without hard-to-clean places;
For more information please contact us.
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
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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
- Can the isolator be customized?
- Yes, full and flexible customization is available, including optional explosion-proof functions.
- What is the internal cleanliness class?
- The internal environment is Class C and meets process and cGMP requirements.
- Is overseas service available?
- Yes, engineers are available to service the machinery overseas.
- What industries can use this isolator?
- It is widely used in medical, pharmaceutical, chemical, and food industries.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- What are the payment terms?
- Payment terms include LC, T/T, D/P, PayPal, Western Union, and others.
- What is the lead time for production?
- Peak season lead time is 1-3 months, and off-season is one month.
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