Negative Pressure Isolator Lab Sterilization System for Cleanroom
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Product Highlights
- GMP Compliant Design: Meets new GMP pharmaceutical production specification requirements for sterile processing.
- High Sealing Performance: Chamber leakage rate is not more than 5% within 10 minutes under 500 pa pressure.
- Full Customization: Offers flexible customization for capacity, driven type, and machine structure.
- Operator Safety Protection: Protects operators from toxic substances and ensures safety during handling.
- Versatile Material Handling: Compatible with capsules, granules, herbs, liquids, powders, and tablets.
- Easy Maintenance: Closed structure design with stainless steel options for easy cleaning and maintenance.
- Multiple Configuration Options: Available in single/double side operation, split type, and integrated type designs.
- Certified Quality: Certified by CE, GMP, and ISO standards for reliable pharmaceutical use.
Product Attributes
- Customization
- Available
- After-sales Service
- Engineers Available to Service Machinery Overseas
- Application
- Chemical, Medical, Food
- Model NO.
- IS
- 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
- Package Size
- 1000.00cm * 800.00cm * 1000.00cm
- Package Gross Weight
- 1000.000kg
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 Negative Pressure Isolator Lab Sterilization System for Cleanroom
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Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom -
Negative Pressure Isolator Lab Sterilization System for Cleanroom
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Product Description
Main Applications
Aseptic isolator is fully sealed to control and process pharmaceuticals and biological products into a sterile state. A complete operation may require a system of isolators to separate the entire process from possible sources of contamination, such as surrounding equipment and operators.
Aseptic isolator device is according to the drug production quality management standard (GMP), specially design and manufacture, used in medicine health care products and require a higher level of environment protective barrier system, The device system can maximize the pollution of prevention and control of the product, to protect the safety of the operator, to avoid being hurt by the toxic substances.Provide perfect environmental control technology solutions for aseptic test, aseptic production and production protection of highly allergenic and toxic drugs.
Performance Features
- The Aseptic isolator design, material, manufacture, assembly, debugging and so on met the new GMP pharmaceutical production specification requirements;
- 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;
- 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;
- Chamber sealing: chamber leakage rate is not more than 5% within 10 minutes under pressure of 500 pa;
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 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 certifications does the isolator have?
- The system is certified with CE, GMP, and ISO standards to ensure compliance with pharmaceutical quality management.
- Can the machine be customized?
- Yes, full customization is available including capacity, driven type, and specific structural designs to meet your needs.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- How is the chamber sealing performance?
- The chamber leakage rate is not more than 5% within 10 minutes under a pressure of 500 pa.
- What materials can be processed?
- It is compatible with capsules, granules, herbs, liquids, powders, and tablets.
- What are the payment terms?
- We accept LC, T/T, D/P, PayPal, Western Union, Small-amount payment, and Money Gram.
- What is the lead time for production?
- Peak season lead time is 1-3 months, while off-season lead time is one month.
- Is after-sales service available overseas?
- Yes, engineers are available to service machinery overseas.
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