Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments
Product Specifications
- Customized
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Product Highlights
- Customizable Test Port: Test port can be customized to match the isolator's operating port.
- Comprehensive Compliance: Software complies with 21CFR Part 11, FDA, GMP, and ISO 14644-7 standards.
- High Pressure Detection: Pressure detection range reaches 2500Pa, covering all glove detection pressures.
- Chip Tracking Technology: Automatically identifies glove number and records it in test results.
- Dual Mode Testing: Supports online testing with isolator and offline testing with glove bracket.
- Positive Pressure Operation: Operates in positive pressure mode, eliminating the need for manual operation.
- Modular Design: Features repeatable and verifiable test procedures per ISO 14644-7 requirements.
- Full Customization Service: Offers full and flexible customization options for ODM and OEM services.
Product Attributes
- Customization
- Available
- After-sales Service
- Video Online, Field Installation
- Warranty
- 1 Year
- Loading Method
- Dynamic Load
- Display
- Digital
- Control
- Computer Control
- Weight
- 0-100Kg
- Power Source
- AC220V
- Transport Package
- Customized
- Specification
- Customized
- Trademark
- Marya
- Origin
- China
Product Images of Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments
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Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments -
Marya Pharmaceutical Glove Leak Tester for Vaccine Production / Cell Therapy Aseptic Environments
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Product Description
Marya Wireless Glove Leak Tester for Sterile Cleanroom China Manufacturer
Introduction
The Glove Leak Tester is a specialized instrument used to test the integrity of cuffs/gloves of isolator/RABS system or one-piece gloves. The test plate and frame are made of engineering plastic, and the test port can be customized to match the isolator's operating port. It can operate in positive pressure mode, eliminating the need for manual operation. The display automatically displays the test results throughout the process, thereby determining the sealing integrity of the tested gloves.
Characteristics
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Control system: Connected to the isolator control system, test data can be transmitted with delay. With chip tracking technology, automatically identifying the glove number and recording it in the test results. The glove leak detector supports online testing, which can simultaneously test the seal of the gloves and their fixing flanges without removing the gloves. It also supports offline testing with glove testing bracket.
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Detection range: The pressure detection range can reach 2500Pa, covering all glove detection pressures.
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System Adaptation: The glove leak detector is developed in accordance with GB/T25915.7-2010/ISO14644-7:2004 standards. Its software complies with 21CFR part 11 electronic record and electronic signature certification requirements. It complies with FDA/GMP and other regulations and computer system validation requirements, capable of performing IOQ and PQ validation. It has modular design of repeatable and verifiable test procedures in accordance with ISO 14644-7 requirements.
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Easy maintenance: The maintenance surface is the back, and the space requirement for the laboratory is not high.
Product ParametersControl System Fully Automatic Power Supply AC220V Material Stainless Steel Pressure detection range -2500Pa
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
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Business Type
- Manufacturer/Factory & Trading Company
- Address
- No211, North Fute Road, Pudong Area, 200131, Shanghai, China
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Plant Area
- 3210 square meters
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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
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Average Lead Time
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Peak Season Lead Time: 1-3 months
Off Season Lead Time: one month -
Nearest Port
- Shanghai Port; Ningbo Port
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Minimum Order Quantity
- 1 Set
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Supply Chain Partners
- 150
Our Production Capability & Technical Expertise
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Main Products
- Pharmaceutical Filling Line, Cleanroom Project
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Production Lines
- 6
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Production Machines
- Welding Machine, Lathe, Milling Machine, Bench Drill
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QA/QC inspectors
- 3 people
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Inspection Type for Finished Products
- 100% inspection(Visual inspection & Function inspection)
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Inspection Method for Finished Products
- Have instructions and uniformly followed
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Customization Options
- Full Customization, Flexible customization
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ODM Service Available
- Yes
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OEM Service Available
- Yes
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R&D Engineers
- 30 people
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Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
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Year of Establishment
- 2014-03-10
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Export Year
- 12 Years
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
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Repeat Buyers Choice
- 10%~30%
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Number of Foreign Trading Staff
- 16
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Overseas Agent/Branch
- No
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New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
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Product Certification
- CE
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Cooperated with Fortune 500
- Yes
FAQ
- What is the warranty period?
- The product comes with a 1-year warranty.
- Can the test port be customized?
- Yes, the test port can be customized to match the isolator's operating port.
- What is the maximum pressure detection range?
- The pressure detection range can reach 2500Pa.
- What power supply does the device require?
- The device requires an AC220V power supply.
- Is the device suitable for sterile cleanrooms?
- Yes, it is designed for sterile cleanrooms and can operate in positive pressure mode.
- What after-sales services are provided?
- We provide video online support and field installation services.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- Does the device support glove tracking?
- Yes, it uses chip tracking technology to automatically identify and record glove numbers.
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