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Marya GMP-Compliant Sterility Testing Isolator Sterile Isolation System for Pharmaceutical Aseptic Testing
US$14,000.00
1 Piece

Product profile

Customization

Available

Certification

GS, RoHS, CE, ISO9001

Noise

>100db

Application

Industrial

Control Mode

Touch

Usage

Fragrance, Dust Removal, Smoke Removal, Adding Negative Ion, Humidification, Formaldehyde Formaldehyde, Adding Oxygen, Sterilization

Material

Stainless Steel 316L

Power Supply

380V 50Hz

Design

Modular Design

Control System

Siemens PLC+Ipc Control System;

Transport Package

Wooden Package

Specification

Customized

Trademark

Marya

Origin

Shanghai, China

Key features

GMP & FDA Compliance: Conforms to Class A environment, FDA 21 CFR Part 11, and GMP standards for aseptic testing.
Advanced VHPS Technology: Controls H2O2 concentration and saturation for reproducible sterilization and shorter cycle times.
Modular Design: Includes transfer chamber, operation chamber, and bacteria collector for easy installation and transport.
Intelligent Control System: Siemens PLC+IPC with multi-level access control and intelligent alarms for pressure, temperature, and humidity.
Energy Saving: Optimized airflow design reduces energy consumption by 20% during eight-hour continuous operation.
Real-Time Monitoring: Monitors door status online and continuously checks the airtight seal of the door for safety.
OEM/ODM Customization: Offers full customization and flexible options for material, power supply, and design.

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: ≤3.23h

AI-Powered supplier vetting

SummaryThe supplier, Marya, is a combined type company with extensive experience in pharmaceutical and medical industries. It lacks certain service capabilities, such as effective after-sales service and overseas infrastructure. While it excels in customization and maintains strong R&D capabilities, it does not introduce new products frequently. The company has significant export trade capacity, but lacks formal contracts and warehouse facilities.
Supplier typeThe supplier is described as a combined type company with three factories and extensive experience in the pharmaceutical and medical industries.
CertificationsThe company has expertise in securing GMP and FDA certifications for factory construction.
After-Sales capabilityThe supplier lacks written procedures or records for corrective and preventive actions, as well as for handling customer complaints.
Production capacityThe supplier lacks valid contracts for manufacturing capacity and has no in-stock service capacity.
Customization capabilityThe supplier offers full and flexible customization in design services.
Client casesThe supplier has a proven track record since 2014, maintaining relationships with major pharmaceutical companies such as Novartis and Novo Nordisk.

Product Q&A

Q:What certifications does the isolator have?
A:
The system is certified with GS, RoHS, CE, and ISO9001, and complies with FDA 21 CFR Part 11 requirements.
Q:What is the power supply requirement?
A:
Standard power supply is 380V 50Hz. Other voltages require a transformer.
Q:Is customization available?
A:
Yes, full customization and flexible customization are available, including material, power supply, and design.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 1 Set.
Q:What is the lead time for production?
A:
Peak season lead time is 1-3 months, while off-season lead time is one month.

Send Inquiry

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