Which certifications does the product have?

The product is certified with CE, GMP, and ISO.

What is the working pressure inside the vessel?

The working pressure inside the vessel is 0.25MPa.

What is the voltage requirement?

The equipment operates at 380V.

Factory Price Bio Engineering Pharmaceutical Machine/Equipment with ISO

Name: Factory Price Bio Engineering Pharmaceutical Machine/Equipment with ISO
Brand: Shanghai Iven Pharmatech Engineering Co., Ltd.
SKU: 2066371255

Shanghai, ChinaShanghai Iven Pharmatech Engineering Co., Ltd.

US$50,000.00-500,000.00

1 Piece

Product profile

Material

Wet Part Is SS316L(Alltank Body)and Other Is SS304

Warranty

1 Year

Working Pressure Inside Vessel

0.25MPa

Model NO.

Customized IVEN -11

Working Pressure Inside Jacket

0.3MPa

PLC

Self-Developing PLC/Siemens PLC

Basic Functions

Culture Microorganism, Adjust pH, Do, Temp.Antifoa

Optional Functions

Weigh, Pressflow, Discharged Gas Detect, Multi-Fee

Capacity

50L-500L

Type

Preparation Machinery

Finished Dosage Form

Liquid

Precision

High Precision

Certification

CE, GMP, ISO

Voltage

380V

Computerized

Customized

Condition

New

After-sales Service

Field Installation, Commissioning and Training

Transport Package

Wooden Case

Trademark

IVEN

Origin

China

Production Capacity

Customized

Key features

GMP & ASME-BPE Compliant: Design and manufacture strictly follow GMP regulations and ASME-BPE requirements.

Full Customization Options: Offers customization from samples, designs, full customization, and flexible options.

S88 & GAMP5 Compliant Control: Self-control program complies with S88 standard and GAMP5 for data management.

CFR 21 Part 11 Audit Trail: Features electronic record and electronic signature functions compliant with CFR 21 Part 11.

Wide Capacity Range: Available in capacities ranging from 50L to 500L for various production scales.

High Precision SS316L Material: Wet parts constructed from SS316L for high precision and corrosion resistance.

Comprehensive After-Sales Service: Includes field installation, commissioning, and training services.

Versatile Cell Culture Support: Suitable for suspension, sheet carrier, and microcarrier culture of biological drugs.

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: ≤1.46h 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.