What certifications does the machine have?

The machine meets cGMP manufacturing standards and holds CE certification.

High Performance Iven Customized Water Line Used Bfs for IV Solutions Blow-Fill-Seal (bfs) Filling Machine

Name: High Performance Iven Customized Water Line Used Bfs for IV Solutions Blow-Fill-Seal (bfs) Filling Machine
Brand: Shanghai Iven Pharmatech Engineering Co., Ltd.
SKU: 2163904335

Shanghai, ChinaShanghai Iven Pharmatech Engineering Co., Ltd.

US$50,000.00

1 Piece

Product profile

After-sales Service

Field Installation, Commissioning and Training

Warranty

1 Year

Type

Volumetric Filling Machine

Model NO.

Customized IVEN -1

Automatic Grade

Automatic

Material Type

Granular

Filling Valve Head

Multi-Head

Feed Cylinder Structure

Multi-Room Feeding

Dosing Device

Capacity Cup

Filling Principle

Pressure

Packaging Container Lifting Structure

Pneumatic Lifting

Structure

Rotary

Packaging

Box

Packaging Material

Plastic

Deflasher

Internal Punching

Power Source

3p/AC380V

Installed Power

42kw

Machine Structure

Dark Side White Side Unseperation

Packing Materials

PE/PP

Capacity (Bottle Per Hour)

The Capacity Is 3000 PCS/Hour(1ml); The Capacity I

Filling Accuracy

1.5% (Based on 5ml) with Purifie

Manufacturing Standard

cGMP

Transport Package

Stardard Packing

Specification

customized

Trademark

IVEN

Origin

China

Key features

cGMP Compliant Design: Design, manufacture, and assembly meet new GMP standards for pharmaceutical production.

High Production Capacity: Customizable output ranging from 1000 to 18000 bottles per hour based on user needs.

Integrated BFS Technology: Combines bottle making, filling, and capping in a single machine under sterile filtered air.

Energy Efficient Structure: Compact design reduces clean workshop area and lowers air conditioner energy consumption.

Advanced Servo Control: Low-speed long-screw extruder with servo motor ensures accurate preform size and reduced thermal stress.

Versatile Volume Range: Applicable for plastic bottles ranging from 0.2ml to 1000ml according to user requirements.

Safe Black/White Design: Moving parts isolated in non-clean areas (black section) ensuring safe and clean assembly.

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: ≤2.25h 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.