Infusion Line

EQP-PHL-005

IV Production Line

Technical Specification Document

1. Product Overview

The IV Production Line is an integrated system for preparing, filling, and sealing intravenous solutions, compatible with glass bottles, PVC bags, and non-PVC bags. Designed in compliance with cGMP standards, the line operates with full automation from compounding to finished product output, ensuring sterility and stability.

This production line integrates a compounding system, multi-stage filtration system, filling system, sealing system, sterilization system, and visual inspection system. It can flexibly adapt to different packaging specifications and capacity requirements, and is widely used in the production of large volume parenterals, irrigation solutions, dialysis solutions, and nutrition solutions.

The entire line design conforms to GMP, FDA, and Chinese Pharmacopoeia standards. It is equipped with an advanced PLC control system and HMI (Human-Machine Interface), enabling full-process data traceability and remote monitoring, meeting the dual requirements of modern pharmaceutical enterprises for production efficiency and product quality.

2. Working Principle

1. Compounding: Raw materials and Water for Injection (WFI) are mixed in compounding tanks according to formulation ratios. Uniform dissolution is achieved through agitation and temperature control, with the entire process enclosed.

2. Multi-stage Filtration: The solution passes through 0.45μm pre-filtration and 0.22μm sterilizing filtration sequentially, removing particles and microorganisms to ensure sterility.

3. Filling: The filtered solution is quantitatively filled into containers via peristaltic or piston pumps with filling accuracy of ±1%. The filling process is performed in a Grade A clean environment.

4. Sealing: Glass bottles are sealed with aluminum caps; PVC/non-PVC bags are sealed by thermal welding, ensuring container seal integrity.

5. Sterilization: Finished products are sterilized in water bath or steam autoclaves at 121°C/15min or 116°C/30min, achieving a Sterility Assurance Level (SAL) ≤10⁻⁶.

6. Inspection: Automatic visual inspection machines detect visible foreign matter in products. Non-conforming products are automatically rejected, ensuring quality meets pharmacopoeia standards.

3. System Classification

By Container Type

• Glass Bottle IV Production Line
• PVC Bag IV Production Line
• Non-PVC Bag IV Production Line

By Capacity

• Low-speed line: 2000-3000 bph
• Medium-speed line: 3000-4500 bph
• High-speed line: 4500-6000 bph

By Automation Level

• Semi-automatic Production Line
• Fully Automatic Production Line
• Intelligent Unmanned Production Line

4. Detailed Technical Parameters

4.1 Basic Parameters

4.2 Glass Bottle Line Parameters

4.3 Bag Line Parameters

4.4 Dimensional Parameters

4.5 Material Parameters

5. Core Component Selection

Compounding System

316L SS compounding tanks (500-5000L), equipped with agitators, temperature control, CIP/SIP connections, supporting rapid changeover for multiple products.

Filtration System

Two-stage sterilizing filtration (0.45μm + 0.22μm), SS filter housings, PES/PP filter cartridges, integrity testing capability.

Filling/Sealing System

Glass line: Rotary valve piston pump + capping machine; Bag line: Mass flow meter + thermal welder. Filling accuracy ±1%, with in-line check weighing.

Sterilization System

Water bath / steam autoclaves with real-time F0 value monitoring, supporting sterilization process validation by the overkill or survivor probability method.

Control/Inspection System

Siemens/Allen-Bradley PLC, SCADA system, 21 CFR Part 11 compliant electronic records, Automatic Visual Inspection (AVI) for visible foreign matter detection.

6. Typical Application Areas

Large Volume Parenterals (LVP)

0.9% Sodium Chloride Injection, 5% Glucose Injection, Glucose-Sodium Chloride Injection and other basic IV products. Filling volume: 100-3000ml.

Irrigation Solutions

Peritoneal irrigation solutions, wound irrigation solutions, and surgical irrigation solutions for surgical and wound irrigation. Filling volume: 500-3000ml.

Dialysis Solutions

Hemodialysis solutions, peritoneal dialysis solutions, used for dialysis treatment of acute and chronic renal failure patients. Filling volume: 1000-6000ml.

Nutrition Solutions

Amino acid injections, fat emulsion injections, carbohydrate injections, and Total Parenteral Nutrition (TPN) admixtures. Filling volume: 100-3000ml.

7. Design Standards and Certifications

GMP

Good Manufacturing Practice (2010 Revision), complying with current NMPA GMP requirements in China.

FDA

US FDA 21 CFR Part 210/211, cGMP requirements, supporting FDA on-site audits.

ISO 13485

Medical Device Quality Management System standard, covering the entire process of design, production, installation, and servicing.

CE

EU CE marking, complying with EU Medical Device Regulation (MDR 2017/745) and relevant harmonized standards.

Chinese Pharmacopoeia

Pharmacopoeia of the People's Republic of China (2025 Edition), General Chapters 0100/0101/0102 regarding injections.

8. Customizable Optional Configurations

9. Warranty Terms

Complete Machine Warranty — 12 months

From the date of equipment acceptance, 12-month warranty for the complete machine, including free repair and part replacement during the warranty period.

Critical Component Warranty — 24 months

Extended 24-month warranty for critical components including PLC controllers, servo motors, and sensors.

Process Validation Support — 6 months

Technical support for process validation within 6 months after installation, including IQ/OQ/PQ documentation preparation and execution assistance.

10. Packaging and Delivery

Packaging: Equipment is packed in wooden cases with internal shockproof and moisture-proof treatment, suitable for long-distance sea and land transport. Electrical cabinets are packed separately with desiccant.

Delivery Period: Standard configuration equipment delivery in 90-120 working days; Custom configuration equipment delivery in 120-180 working days, from the date of contract signing and receipt of advance payment.

Transport Method: FOB Shanghai/Tianjin/Guangzhou, supporting sea, land, and air freight. Inland transport is arranged by the seller to the designated factory.

Installation and Commissioning: The seller dispatches engineers to the buyer's factory for installation and commissioning, with a period of 15-30 working days. The buyer must prepare the facility, utilities, and supporting personnel in advance.

Technical Training: During installation and commissioning, the seller provides no less than 5 working days of on-site training for the buyer's operation and maintenance personnel, covering equipment operation, routine maintenance, and troubleshooting.

11. Information Required for Inquiry