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Marya GMP Standard Glove Integrity Testing System for Pharmaceutical Industry
US$4,000.00
1 Piece

Product specifications

Customized

Product profile

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

Key features

GMP & FDA Compliance: Software complies with 21CFR Part 11 and meets FDA/GMP regulations for electronic records.
Customizable Test Port: Test port can be customized to match the isolator's operating port specifications.
High Pressure Detection: Pressure detection range reaches 2500Pa, covering all glove detection pressures.
Online & Offline Testing: Supports simultaneous online testing of gloves and flanges, plus offline testing with bracket.
Chip Tracking Technology: Automatically identifies glove number and records it in test results via chip tracking.
ISO 14644-7 Standard: Developed in accordance with GB/T25915.7-2010/ISO14644-7:2004 standards.
Full Customization Options: Offers full and flexible customization options for specific requirements.
1-Year Warranty Coverage: Comprehensive 1-year warranty provided for the Glove Integrity Testing System.

Company profile

Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
Flexible CustomizationProduct CertificationYears of Export ExperienceR&D Capabilities
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization, Flexible customization CertifiedExport Year: 12 Years CertifiedNearest Port: Shanghai Port; Ningbo PortAverage Response Time: ≤4.38h

About Our Factory & Business Background

AddressNo211, North Fute Road, Pudong Area, 200131, Shanghai, China
Plant Area3210 square meters
Number of Employees69
Terms of PaymentLC, 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 TimePeak Season Lead Time: 1-3 months Off Season Lead Time: one month
Minimum Order Quantity1 Set
Supply Chain Partners150

Our Production Capability & Technical Expertise

Main ProductsPharmaceutical Filling Line, Cleanroom Project
Production Lines6
Production MachinesWelding Machine, Lathe, Milling Machine, Bench Drill
QA/QC inspectors3 people
Inspection Type for Finished Products100% inspection(Visual inspection & Function inspection)
Inspection Method for Finished ProductsHave instructions and uniformly followed
R&D Engineers30 people
Traceability of Raw MaterialsYes

Our Industry Experience & Global Business Record

Year of Establishment2014-03-10
Main MarketsNorth America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
Repeat Buyers Choice10%~30%
Number of Foreign Trading Staff16
Overseas Agent/BranchNo
New Products Launched in Last yearYes

Our Certifications, Standards & Industry Recognition

Product CertificationCE
Cooperated with Fortune 500Yes

Product Q&A

Q:What is the warranty period for this system?
A:
We provide a 1-year warranty for the Glove Integrity Testing System.
Q:Can the test port be customized?
A:
Yes, the test port can be customized to match the isolator's operating port.
Q:What is the maximum pressure detection range?
A:
The pressure detection range can reach 2500Pa, covering all glove detection pressures.
Q:Does the system support online testing?
A:
Yes, it supports online testing to simultaneously test the seal of gloves and their fixing flanges without removing them.
Q:Is the system compliant with GMP and FDA regulations?
A:
Yes, the software complies with 21CFR Part 11 and meets FDA/GMP and computer system validation requirements.

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