Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations
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Product Highlights
- Absolute Containment: Robust sealed rigid-wall construction with inward airflow ensures safe handling of potent antibiotic powders.
- GMP Compliance: Fully compliant with GMP standards and stringent containment regulations for hazardous pharmaceuticals.
- Automated Control: Intelligent control system with built-in automatic operation, management procedures, and expansion ports.
- Multi-Parameter Monitoring: Real-time monitoring of temperature, humidity, and pressure with support for printing and data storage.
- Flexible Customization: Customizable inner compartment size, built-in weighing device, and optional explosion-proof functionality.
- High Cleanliness: Maintains Class A cleanliness degree with leakage rate less than 5% within 10 minutes at 500Pa.
- Versatile Installation: Can be installed in Class D cleanrooms or unclassified rooms, featuring compact space-efficient design.
- Premium Materials: Constructed from 316L stainless steel and PTFE for durability and resistance to corrosion and contamination.
Product Attributes
- Customization
- Available
- Application
- High-voltage
- Material
- Stainless Steel
- Model NO.
- MY-CL
- Structure
- Strain Insulator
- Type
- B Type Insulator
- Usage
- Human and Product Protection
- Connection Method
- Spherical Type
- Size of Bearing Capacity
- 300KN
- Certification
- ISO9001
- Color
- Customized
- Brand
- Marya
- Control System
- Automated Control
- Cleanliness Degree
- Class a
- Compliance
- GMP
- Manufacturing Materials
- 316L or PTFE
- Machine Power
- 1kw
- Transport Package
- Wooden Package
- Specification
- customized
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 1000 Sets/Year
Product Images of Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations
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Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations -
Marya Advanced Mobile Negative Pressure Isolator for Potent Powder Weighing Stations
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Product Description
for Potent Powder Weighing Stations
Introduction
The Marya Negative Pressure Isolator provides a critical barrier for safe sterile antibiotic processing. Its robust, sealed rigid-wall construction maintains a stable, inward airflow to ensure absolute containment of potent and sensitizing antibiotic powders and aerosols. Designed for operations like weighing, mixing, and sterile filling, this isolator protects operators from occupational exposure while safeguarding the product from cross-contamination. It integrates seamlessly into sterile suites, featuring automated decontamination cycles and compliance with stringent containment regulations for handling hazardous pharmaceuticals.
Applications
Features
1. To achieve maximum operating space and need for rapid delivery of materials to fully meet regulatory requirements;
2. Employs a compact, space-efficient design with reduced height and width, facilitating effortless installation.;
3. With intelligent control system, built-in equipment automatic operation and management procedures, with a number of expansion ports and applications;
4. With monitoring system of temperature, relative humidity, pressure, and other multi-parameters, supporting real-time printing, storage, and other functions;
5. Customizable with a built-in weighing device and optional explosion-proof functionality, it ensures comfortable operation, low noise levels, and minimal energy consumption.
6. With all functions of negative pressure isolators, can be installed in Class D cleanrooms or in unclassified rooms.
Technical data
| MOC | 316 stainless steel wire drawing board |
| Sealing | The leakage rate of the cabin is less than 5% within 10min under the pressure of 500Pa |
| Wind speed | 0.35~0.65m/s, adjustable wind speed, keep 20~60Pa during aseptic operation, maintain the pressure under static conditions to a set value of not less than 10Pa |
| Automatic removal efficiency | <1PPM, 10~20min |
|
Cleanliness Degree |
Class A |
| Power source | AC220V±22V, 50Hz±1Hz |
| Size |
Standard inner compartment 1800*710*850 Standard outer dimensions: 1900*800*2200, can be customized according to requirements |
| Verification content | Sterilization efficiency: biological indicator, chemical test paper |
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
Maya 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 vial, pre-filled syringe (PFS), and cartridge filling lines. In addition, we offer self-developed supporting equipment such as isolators, solution preparation systems, and water treatment systems. Our capabilities also extend to providing turnkey solutions for cleanroom projects and complete filling production lines. Centered around professional filling line technology, we are committed to delivering aseptic production lines and solutions that are stable, compliant, and efficient.
With branch offices located in Shanghai, Hong Kong, Osaka, Changsha, and Guangzhou. With three factories and a team of experts and technicians boasting over 20 years of experience in the pharmaceutical and medical industries, Marya has successfully partnered with pharmaceutical companies and governmental authorities in 60 countries.
Our expertise encompasses factory construction and securing GMP and FDA certifications. We are dedicated to our clients' success, ensuring they enjoy a worry-free and satisfying experience. Our commitment lies in helping clients design and provide high-standard customized aseptic pharmaceutical engineering solutions.
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 60+ 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 60+ 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
-
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 primary application of this isolator?
- It is designed for safe sterile antibiotic processing, including weighing, mixing, and sterile filling, protecting operators from exposure and products from cross-contamination.
- What is the cleanliness degree of the isolator?
- The isolator maintains a Class A cleanliness degree, ensuring high-precision tasks are performed in a sterile environment.
- Can the size of the isolator be customized?
- Yes, the standard inner compartment is 1800*710*850mm, but the size can be customized according to specific requirements.
- What materials are used in the construction?
- The main body is made of 316L stainless steel wire drawing board, and manufacturing materials include 316L or PTFE.
- Is the isolator suitable for hazardous drugs?
- Yes, it is specifically designed for handling high-activity and sensitizing drugs, ensuring absolute containment of potent powders and aerosols.
- Does the isolator support explosion-proof functionality?
- Yes, optional explosion-proof functionality is available to ensure safe operation in specific environments.
- 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.
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