Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing
Product Specifications
- Internal Cleanliness
- Pressure
- Air Flow Rate
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Product Highlights
- Class A internal clean environment, supports continuous & batch operation for sterility testing and aseptic dispensing, compliant with China GMP, EU GMP, FDA and cGMP/USP-NF standards.
- Adopts new VHP-S technology for stable decontamination; modular design with Siemens PLC+HMI control system, real-time monitoring of pressure, H2O2 concentration and other parameters.
- Equipped with wireless glove leakage detector, energy-saving air-handling system, 8-hour continuous operation, energy consumption reduced by 20%.
Product Attributes
- Customization
- Available
- Application
- Chemical Industry, Food Industry, Pharmaceutical Industry
- Certification
- CE, GMP, ISO
- Model NO.
- MY-1505
- Control System
- Fully Automatic
- Customized
- Customized
- Material
- Stainless Steel
- Differential Pressure
- +20-50PA
- Air Flow Rate
- 0.36-0.54m/S
- Internal Cleanliness
- Class a
- Temperature & Humidity
- 18-26℃, 40%-60%Rh
- Leakage Rate
- 0.5%Vol/H
- 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 Isolator for Sterility Testing & Aseptic Dispensing
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Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing -
Marya Aseptic Isolator for Sterility Testing & Aseptic Dispensing
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Product Description
MARYA Aseptic Isolator for Sterility Testing & Aseptic Dispensing
As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterility testing, sterile product dispensing and other key process operations. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of China GMP and Pharmacopoeia, EU GMP/FDA, cGMP/USP-NF, and can carry out "continuous" or "batch" operation.
Performance Features:
- New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;
- Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport;
- Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements;
- CDCV service: sterilization cycle development, validation studies and services;
- Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
- Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%;
- Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door;
- High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
- Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues;
- Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
Product Parameter:
| Parameter | ||
|---|---|---|
| 1 | Internal Cleanliness | Class A |
| 2 | Differential Pressure | +20-50Pa |
| 3 | Air Flow Rate | 0.36-0.54m/s |
| 4 | Air Flow Type | -Mainly one-way flow |
| 5 | Air flow pattern | turbulent flow |
| 6 | Sterilization Effect | log6 and above |
| 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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