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Sterile Testing Isolator for Testing Isolator
US$30,000.00
1 Piece

Product profile

Customization

Available

After-sales Service

Engineers Available to Service Machinery Overseas

Analysis Speed

High Throughput

Application

Food Safety, Pharmaceutical Industry, Chemical, Medical, Food

Certification

CE, GMP, ISO

Condition

New

Customized

Customized

Detection Range

Proteins

Material Compatibility

Capsules, Granules, Herbs, Liquid, Powder, Tablets

Portability

Benchtop

Power Source

Electric Operated

Sensitivity

High Sensitivity

Technology

Ultraviolet-Visible Spectroscopy

User Interface

Touchscreen

Voltage

220V

Driven Type

Electric

Certificate

CE, ISO, SGS

Capacity

Cutomized

Machine Power

1 Kw

Precision

High Precision

Computerized

Computerized

Type

Pharmaceutical Workshop

Finished Dosage Form

Pharmaceutical Workshop

Transport Package

Inner Water Proof Bag, Outer Sea Worth Case

Specification

Customized

Trademark

Marya

Origin

China

HS Code

8409919100

Production Capacity

300 PCS/Year

Key features

VHPS Sterilization Technology: Controls H2O2 concentration and saturation for good reproducibility and shorter sterilization time.
FDA 21 CFR Part 11 Compliance: Siemens PLC+IPC system with multi-level access control and intelligent alarms for regulatory compliance.
Energy Saving Design: Optimized airflow handling reduces energy consumption by 20% during eight-hour continuous operation.
Modular Design: Includes transfer chamber, operation chamber, and bacteria collector for easy installation and transport.
Real-Time Door Monitoring: Online monitoring of door opening and continuous tracking of airtight seal integrity.
Decomposition Filter Option: Equipped with decomposition filter to shorten H2O2 degradation time and reduce residue concentration.
Full Customization Available: Supports full customization and flexible customization options for specific user requirements.

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: ≤3.10h

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 is the sterilization technology used?
A:
It uses new VHPS technology to control H2O2 concentration and saturation, ensuring good sterilization reproducibility and shortened cycle time.
Q:Is the system compliant with FDA regulations?
A:
Yes, the intelligent control system complies with FDA 21 CFR Part 11 requirements and features multi-level access control.
Q:Can the isolator be customized?
A:
Yes, full customization and flexible customization options are available to meet specific production needs.
Q:What is the power supply requirement?
A:
Standard power supply is 380V 50Hz. Other voltages require a transformer.
Q:Is energy consumption reduced?
A:
Yes, the optimized airflow handling system reduces energy consumption by 20% during eight-hour continuous operation.

Send Inquiry

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