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Sterile Eye Drop Filling Line

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Sterile Eye Drop Filling Line

BRIEF INTRODUCTION

The Sterile Eye Drop filling Line is designed to ensure a seamless process for filling or eye drops. This line consists of several key components, including a bottle unscrambling and feeding unit, ion air washing, filling, stoppering, and capping units. It is engineered to handle a variety of bottle sizes through easy mold changes, allowing for flexible production without the need for specialized tools for disassembly.

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Product Positioning

Designed to meet GMP-compliant production requirements for pharmaceuticals such as sterile preparations, covering the entire process of bottle unscrambling / filling / stoppering / capping / laminar airflow protection.

Applicable Packaging Type & Specifications

Container type: Eye drop bottles
Filling volume range: 5 – 30 mL
Maximum output: 7,200 bottles/hour
(Measured under operating conditions of 5 mL ophthalmic solution bottles filled with aqueous solution)

Process Flow

Bottle infeed →
Filling: accuracy ±0.5 – 1%, ceramic piston pump →
Stoppering: accuracy ≥ 99%, fiber optic detection and control →
Capping: constant torque control, qualified rate ≥ 99.8% →
Laminar airflow hood (local Class 100 / ISO 5, with glove ports)

Core Modules

Module	Key Functions	Main Configuration	GMP Highlights
Filling / Stoppering / Capping Main Unit	Integrated filling, stoppering & capping	Ceramic pumps, silicone tubing, stoppering device, constant-torque capping	No bottle–no fill / no stopper / no cap, with dust-proof enclosure
Bottle Unscrambler	Automatic bottle unscrambling	Equipped with buffer hopper	Ensures orderly bottle feeding into the main unit
Laminar Flow Hood	Local Class 100 protection	Glove ports	Provides clean operating environment and reduces contamination risk
Buffer Tank	Stabilized liquid supply	Optional jacket, agitator, etc.	Product-contact parts in 316L stainless steel
Nitrogen System	Nitrogen purging protection	Pre- and post-filling nitrogen flushing	Reduces oxidation and improves product stability

Control System & Data Integrity

Equipped with Siemens PLC and HMI touchscreen.
Supports recipe storage and rapid changeover.
Backup available for both PLC and HMI programs.

Cleaning & Sterilization Strategy

Fully automatic CIP/SIP with cleaning coverage ≥ 99% and residue ≤ 0.1 ppm.
Filter integrity testing: online PALL integrity tester with automatic report printing.