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Ampoule Filling Line

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Ampoule Filling Line

BRIEF INTRODUCTION

The JKAFL series provides a comprehensive solution for ampoule processing in pharmaceutical production. This system integrates the JKQX series vertical ultrasonic washer, JKRX series hot-air circulation sterilization tunnel, and JKAF series filling and sealing machine. Whether operated as a complete line or as a single machine, the equipment performs excellently in critical production steps, including water spray filling, ultrasonic cleaning, internal and external water and air rinsing, preheating, drying, high-temperature sterilization for pyrogen removal, cooling, nitrogen purging, sealing preheating, and final sealing. The JKAFL production line is compatible with ampoules ranging from 1 mL to 20 mL and is an ideal choice for pharmaceutical applications requiring precise cleaning, drying, pyrogen removal, filling, and sealing processes.

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Product Positioning

Designed to meet GMP-grade production requirements for sterile pharmaceutical preparations, covering the complete process of ampoule washing → sterilization → filling → sealing.

Applicable Packaging Type & Specifications

Packaging Type: Ampoules

Fill Volume Range: 1 mL – 20 mL

Maximum Output: Up to 24,000 ampoules/hour
(verified under 2 mL ampoule, liquid product conditions)

Process Flow

Infeed → Washing (Ultrasonic washing: 20–43 kHz, water temperature approx. 50 °C) → Sterilization (Dry heat 320 °C, laminar airflow 0.6 m/s, ≥5 min exposure) → Filling (Servo-driven filling, ±0.5% accuracy) → Sealing (Nitrogen pre-flushing protection, rotary flexible flame sealing)

Core Modules

Module	Key Function	Main Configuration	GMP Highlights
Ampoule Washing Machine	Ultrasonic + three-water/three-air washing	Vertical rotary structure, PU grippers, POM screw conveyor	No ampoule breakage, dead-zone-free cleaning
Sterilization Tunnel	Dry heat sterilization & depyrogenation	320 °C hot air laminar flow, three-zone independent control	HEPA H14 filtration, temperature control ±3 °C
Filling & Sealing Machine	Nitrogen pre-flushing + high-precision filling + flame sealing	Servo-driven ceramic pumps, dual nitrogen protection, 6-head flame sealing	High-precision ceramic pump filling, carbonization control

Control System & Data Integrity

The machine is equipped with a Siemens PLC and industrial touch-screen HMI, supporting 21 CFR Part 11–compliant audit trails.

Recipe Management: ≥100 recipes stored, one-touch changeover

Batch Record Management: Automatic generation with electronic signatures, PDF export, and MES connectivity via OPC UA

Washing & Sterilization Strategy

The piping system supports WFI recovery, circulation, and filtration, with independent pipelines for WFI and compressed air, eliminating the risk of cross-contamination.

Sterilization Cycle: Dry heat at 320 °C for 5 minutes, endotoxin reduction ≥3 log

Filters: HEPA filters supporting DOP testing and resistant to temperatures up to 400 °C

Utility Requirements

Item	Requirement	Interface Standard
Power Supply	AC 380 V ±10%, 50 Hz	Industrial connector
Purified Water	≥0.3 MPa, ambient temperature, USP <645>	Tri-clamp
Water for Injection (WFI)	≥0.3 MPa, 70–80 °C	Tri-clamp
Compressed Air	Oil-free & dry, 0.6–0.8 MPa	ISO 8573-1:2010 [1:3:2]
Vacuum	–0.08 MPa	Tri-clamp
Exhaust Air	1,000–1,500 m³/h	Negative pressure system