Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling
Product Specifications
- Negative pressure
- Filter Type
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Product Highlights
- Stable negative pressure control of -20Pa ~ -50Pa prevents pollutant leakage, protects operators during weighing, dispensing and feeding of high active, toxic and sensitized materials, fully compliant
- Equipped with HEPA / ULPA high-efficiency filters and 10-30 air changes per hour, effectively intercept fine particles and lower cross-contamination risk
- Corrosion-resistant stainless steel main body with high-transparency viewing window, built-in multi-condition safety alarm system
- 300-500lux soft working lighting for reliable and convenient operation.
Product Attributes
- Customization
- Available
- Application
- Chemical Industry, Food Industry, Pharmaceutical Industry
- Certification
- CE, GMP, ISO
- Model NO.
- MY-1504
- Control System
- Fully Automatic
- Customized
- Customized
- Material
- Stainless Steel
- Working Lighting
- 300 ~ 500 Lux
- Air Exchange Rate
- 10 ~ 30 Times Per Hour
- Transport Package
- Plywood Export Wooden Case
- Specification
- Negative pressure: -20Pa ~ -50Pa
- Trademark
- Marya
- Origin
- China
- Production Capacity
- 15-20 Sets / Year
Product Images of Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling
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Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling -
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling
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Product Description
Marya Aseptic Negative Pressure Isolator for Pharmaceutical Liquid Handling
Marya aseptic 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;
- Automatic regulation and emergency system: when leakage occurs, the isolator automatically gives an alarm and adjusts the fan frequency to ensure that the air speed of crack is greater than 0.5m/s.
- Various material transfer: configurable RTP (Rapid transfer ports) and online waste discharge port (bagging system);
- Safe filter replacement: PUSH-PUSH filters of the air handling system can be replaced safely to protect personnel's safety.
- Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the inflatable sealing of the door;
- CDCV service: sterilization cycle development, validation studies and services;
- High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm; the brands of all key components are international first-class such as Camfil, EBM, SIEMENS, etc.
Product Parameter:
| Parameter | ||
|---|---|---|
| 1 | Cavity material | Stainless steel sus316 |
| 2 | Temperature and humidity | Conventional 18-26ºC/45%-65%, can be customized according to the pharmaceutical process |
| 3 | Protection grade | OEB4 or OEB5 |
| 4 | Chamber pressure | -20-50pa |
| 5 | Air flow pattern | turbulent flow |
| 6 | Ventilation frequency | >20 times/h |
| 7 | Leakage rate | 0.5%vol/h |
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 is the warranty period?
- The system comes with an 180-day warranty.
- Can the system be customized?
- Yes, full customization and flexible customization options are available.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- Does it support CIP & SIP automatic cleaning and sterilization?
- Yes, fully automatic CIP/SIP function is available.
- What certifications does the product have?
- The product holds CE, ISO, and GMP certifications.
- What is the lead time for production?
- Lead time is one month during off-peak season and 1-3 months during peak season.
- What after-sales services are provided?
- Online support and video technical support are available.
- What documents will you provide?
- Usually we will provide DQ,IQ,PQ,OQ, FAT, SAT, operation manual, maintenance instruction,layout drawing.etc.
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