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IV Bag Form Fill Seal Machine Manufacturer
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IV Bag Form Fill Seal Machine Manufacturer for Aseptic IV Solutions

Everheal is a professional IV Bag Form Fill Seal Machine Manufacturer and FFS Machine Manufacturer based in China, providing OEM pharmaceutical equipment solutions for global brand owners, wholesalers, and sterile solution producers.

Founded in 2013 and located in Xiangshan, Ningbo, Everheal brings together 100+ experienced professionals across engineering, production, validation, and international sales. We specialize in IV Bag Form Fill Seal Machines, purified water systems, pure steam generators, liquid filling and sealing machines, and turnkey pharmaceutical production lines.

Our IV Bag Form Fill Seal Machine solutions are engineered to meet the most demanding EU GMP Annex 1, FDA, and global pharmacopeia standards, enabling safe, efficient, and sustainable large-volume parenteral (LVP) manufacturing.
IV Bag Form Fill Seal Machine

Pharmaceutical Filling Equipment

An IV Bag Form Fill Seal Machine (FFS Machine) is an advanced aseptic packaging system designed for the production of sterile infusion bags. The machine integrates film forming, sterile filling, and hermetic sealing into a single automated process within an ISO Class 5 critical zone.
Compared with conventional preformed bag filling lines, an IV Bag Form Fill Seal Machine offers:
  • Lower contamination risk
  • Higher production efficiency
  • Reduced material waste
  • Improved compliance with Annex 1
  • Lower total cost of ownership
As an experienced FFS Machine Manufacturer, Everheal designs systems that balance regulatory compliance, operational efficiency, and long-term reliability.

Eco-Friendly Material Processing for Modern IV Bags

Everheal IV Bag Form Fill Seal Machines are optimized for non-PVC infusion bag materials, supporting the industry’s transition toward safer and more sustainable packaging.
1. Non-PVC Film Compatibility
  • Compatible with EVA films
  • Compatible with PP multilayer barrier films
  • Designed for sensitive formulations requiring low extractables
 
2. Precise Heat & Thickness Control
  • Film thickness range: 150–300 μm
  • Intelligent thermal control prevents film distortion
  • Ensures consistent bag geometry and sealing integrity
3. Regulatory Compliance
  • Meets USP <661>
  • Meets EP 3.1.7
  • Suitable for critical injectable and nutritional solutions
 

Fully Automated IV Bag Form Fill Seal Production

As a leading IV Bag Form Fill Seal Machine Manufacturer, Everheal focuses on scalable production.

1. High-Speed Multi-Lane Output
Output speed up to 3,600 bags/hour
Multi-lane configuration for higher throughput
Stable performance during long production runs

2. Wide Bag Size Flexibility
Bag volume range: 50 ml to 3,000 ml
Quick format changeover in <15 minutes
Ideal for multi-SKU production environments

3. Integrated Bag Assembly Functions
Simultaneous port welding
Automatic tube attachment
Eliminates downstream manual operations

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Typical Use Scenarios for Everheal IV Bag Form Fill Seal Machines

 
Everheal BFS Machines are equipped with advanced automation and intelligent control systems to ensure consistent filling accuracy and full process traceability.
Large Volume Parenterals (LVP)
Glucose, saline, compound infusions
High-volume, continuous production environments
Emphasis on sterility and cost efficiency
 
 
Electrolyte & Dialysis Solutions
Tight conductivity and concentration control
Large batch consistency requirements
Strong demand for Annex 1 compliance
 
 
Nutritional Emulsions & Sensitive Formulations
Heat- and shear-sensitive APIs
Cold Seal Technology minimizes degradation
Vision inspection ensures particulate control
OEM & Export-Oriented Manufacturers
Flexible formats for different markets
Supports multiple pharmacopeia standards
Ideal for companies serving EU, US, and emerging markets

Precision Control System for First-Pass Quality

1. Servo-Driven Filling Accuracy
Filling accuracy: ±0.75%
Pharmacopeia-grade dosing performance
Suitable for electrolytes, emulsions, and dialysis fluids

2. Vision Inspection & Defect Detection
Detects particulates and defects down to 50 μm
Continuous inspection without line stoppage
Automated reject handling for non-conforming bags

3. OEE & Data Transparency
Real-time OEE dashboard
Production KPIs visible at a glance
Supports continuous improvement programs
factory

What Truly Differentiates Everheal from Other FFS Machine Manufacturers

1. Patented Cold Seal Technology
Prevents thermal degradation of sensitive APIs
Improves long-term product stability

2. AI-Powered Defect Prevention
Predictive parameter adjustment
Reduces deviations before defects occur

3. Complete Annex 1 Validation Package
URS, DQ, IQ, OQ, PQ support
Documentation aligned with EU GMP inspections

GMP-Ready Architecture by a Trusted FFS Machine Manufacturer

FFS Machine Manufacturer
1. Hygienic Mechanical Design
All product-contact surfaces in 316L stainless steel
Surface roughness Ra ≤ 0.38 μm
Fully sanitary, cleanroom-friendly construction

2. No Dead Legs Design
Self-draining pipework with <1° slope
Eliminates residue and microbial risk
Supports fast and validated cleaning cycles

3. Data Integrity Compliance
21 CFR Part 11 compliant
Electronic batch records
Secure electronic signatures and audit trails

Key Advantages of Everheal IV Bag Form Fill Seal Machines

Higher Efficiency, Lower Cost
  • 40% less energy consumption vs traditional PVC lines
  • Optimized thermal and servo control architecture
 
Enhanced Sterility Assurance
  • Zero human contact in critical zones
  • Reduced risk of contamination and batch rejection
 
Superior Production Yield
  • First Pass Yield >99.5%
  • Consistent sealing and filling accuracy
 
 
Material Savings
  • 30% material reduction
  • Intelligent sealing algorithms minimize film waste
 
 

Maintenance & Lifecycle Support

1. Self-Diagnostic System
90% fault pre-detection
Reduces unplanned downtime

2. Modular Machine Design
Component replacement in <30 minutes
Simplified maintenance and spare parts management

3. Remote Monitoring & Analytics
Cloud-based performance tracking
Remote technical support and optimization
1. ISO Class 5 Critical Zone
Class 100 (ISO 5) aseptic environment
Fully enclosed filling and sealing area
No human intervention during production
2. Double HEPA Filtration System
0.3 μm particle retention
99.99% filtration efficiency
Stable airflow and pressure cascade control
3. VHP Compatibility
Ready for vaporized hydrogen peroxide (VHP) cycles
Supports bio-decontamination between batches
Aligned with modern Annex 1 expectations

Technicaal Specifications Overview

Parameter Specification
Filling Method Peristaltic pump (time-pressure optional)
Filling Accuracy ±0.75%
Seal Strength ≥4.5 N / 15 mm (ASTM F88)
Compressed Air 6 bar, oil-free ISO 8573-1 Class 0
Floor Space 4.2 m × 3.5 m (dual-lane)
 

Driven Design Philosophy of Everheal IV Bag FFS Machines

Unlike generic equipment suppliers, Everheal designs every IV Bag Form Fill Seal Machine from the perspective of EU GMP Annex 1 inspection logic, not just basic compliance. This approach positions Everheal not just as an FFS Machine Manufacturer, but as a compliance-oriented engineering partner. How Everheal Aligns with Annex 1 Expectations:
1. Contamination Control Strategy (CCS) Support
  • Clear segregation of critical and non-critical zones
  • Defined airflow direction and pressure differentials
  • Risk-based design documentation for inspectors
2. Human Intervention Elimination
  • Fully automated forming, filling, sealing, and port welding
  • Remote operation interfaces outside the aseptic zone
  • Reduced gowning-related contamination risk
 
 
3. Data Integrity & Traceability
  • 21 CFR Part 11–compliant batch records
  • Alarm logs, deviation tracking, and audit trails
  • Supports FDA, EMA, and WHO inspections
 
 
 
 

Frequently Asked Questions

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Looking for a reliable IV Bag Form Fill Seal Machine Manufacturer or FFS Machine Manufacturer?
Contact Everheal today to receive a customized solution, technical consultation, and competitive quotation for your IV solution production line.
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E-mail: info@everhealgroup.com
Mobile: +86 188 5843 2776
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Add.: No. 5, Jinhai Avenue, Dongchen Binhai Industrial Zone, Xiangshan County, Ningbo City, Zhejiang Province
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