Is the system compliant with GAMP5 standards?

Yes, the design and verification conform to the V-model of GAMP5 with complete verification files.

What is the minimum order quantity?

The minimum order quantity is 1 set.

What are the lead times for production?

Lead time is 1 to 3 months for both peak and off-peak seasons.

Customized Modular System Autoclavable Stainless Steel Scalable Fermentation Technology Bioreactor Machine with Factory Price

Name: Customized Modular System Autoclavable Stainless Steel Scalable Fermentation Technology Bioreactor Machine with Factory Price
Brand: Shanghai Iven Pharmatech Engineering Co., Ltd.
SKU: 2072281285

Shanghai, ChinaShanghai Iven Pharmatech Engineering Co., Ltd.

US$50,000.00-500,000.00

1 Piece

Product profile

Capacity

5L-20000L

Certification

CE, GMP, ISO

Condition

New, Field Installation, Commissioning and Training

Model NO.

Customized IVEN -11

Customized

Material

Stainless Steel, SUS304/SUS316/Red Copper

Voltage

380V

Warranty

1 year

Machinery Capacity

Machinery Capacity: 50L, to 1000L

Thickness of Tanks

3mm

Dimension(LWH)

Customized

Core Components

Motor, PLC

Key Selling Points

Automatic;Easy to Operate;

Heating

Electric Steam Generator

Heating Method

Hot Water/Steam/Electricity Heating

Advantage

Easy Operation High Efficiency

Sterilization

Auto Sterilization/Sterilization-I

Machinery Test Report

Provided

Power

0.18-1.5kw

Function

Fermentation and Reaction Process

Finished Dosage Form

Liquid

Precision

High Precision

Computerized

Transport Package

Wooden Case

Trademark

IVEN

Origin

China

Production Capacity

Customized

Key features

Modular 3D Design: Compact and elegant system architecture with 3D modular design for easy integration.

Wide Capacity Range: Scalable capacity from 5L to 20,000L to meet various production needs.

Premium Material Selection: Constructed with Stainless Steel, SUS304/SUS316, and Red Copper for durability.

Automated Control System: Features Siemens PLC and HMI touch screens for precise automatic operation.

Full GAMP5 Compliance: Design and verification conform to V-model of GAMP5 with complete documentation.

Flexible Customization: Offers full customization from samples, designs, and minor adjustments.

Multiple Heating Methods: Supports Electric Steam Generator, Hot Water, and Electricity Heating options.

Auto Sterilization: Equipped with automatic sterilization and cleaning functions for safety.

Company profile

Years of Export ExperienceLow MOQPatents AwardedProduct Certification

Shanghai Iven Pharmatech Engineering Co., Ltd.

Shanghai, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 19 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤1.47h CertifiedTerms of Payment: LC, T/T, D/P, etc.

AI-Powered supplier vetting

SummaryThe supplier is a combined company offering pharmaceutical and medical production equipment, including vial, ampoule, prefilled syringe, oral liquid, tablet, capsule, visual inspection, packaging, and logistics solutions. It provides extensive customization and integrated services such as process design, equipment selection, installation, commissioning, and validation. Export activity is substantial, with 71%–90% of sales from exports and 19 years of export experience. Quality assurance, ISO9001:2015 certification, CE capability, manufacturing contracts, and finished-product inspection instructions are documented strengths. However, the supplier lacks in-stock, overseas warehouse, overseas showroom, overseas agent or branch capabilities, and has no written procedures for service assessment, corrective actions, or complaint handling. R&D evidence is limited: no SDK, no new products in the past year, and no ODM or major-brand OEM services. No specific customer cases are provided.

CertificationsThe supplier reports an ISO9001:2015 certificate and CE certification capability, providing explicit evidence of quality-management and product-compliance credentials. However, the slices do not specify the scope, validity period, or products covered by these credentials.

After-Sales capabilityThe supplier lists installation, commissioning, validation, maintenance, debugging, repair, training, and integrated consulting services, and provides equipment installation-related offerings. Nevertheless, it has no overseas agents or branches, no overseas warehouse or showroom, and no written procedures or records for complaint handling, service assessment, or corrective and preventive actions, indicating an operational weakness in documented after-sales management.

R&D capabilityThe supplier has customization-oriented R&D services, but reports no available SDK, no new products during the past year, no ODM service, and no OEM service for popular brands. These explicit limitations indicate weak evidence of current product innovation and platform development.

Production capacityThe supplier covers multiple pharmaceutical equipment production lines, including vial and ampoule, prefilled syringe and cartridge, oral liquid, tablet and capsule, inspection, packaging, and logistics systems. It has valid manufacturing contracts with each affiliated subcontractor, follows finished-product inspection instructions uniformly, and reports quality assurance, although no quantitative production-capacity data is provided.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization. Its integrated solution includes process design, conceptual and construction design, equipment selection, model customization, installation, commissioning, and validation, demonstrating broad customization coverage.