Ampoule Washing, Drying, and Filling and Sealing Production -GMPMAX

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Ampoule Production

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Ampoule Washing, Drying, and Filling and Sealing Production

Product Details

Introduction of the production line

ALX series of ampoule washing, drying, and filling and sealing production line includes KCQ ultrasonic ampoule washing machine, ASMR sterilizing dryer, AGFA ampoule filling and sealing machine. They are developed on the advanced technology from BOSCH and B+S and IMA, they are applicable for small volume injection ampoule product production

This proudction line is used for production of type B ampoules, including ultrasonic water and gas alternating washing, high temperature hot air sterilization, multi needle liquid filling and sealing machine.

Process

Ampoules unboxing →feeding onto the conveyor belt →water rinsing → → ultrasonic washing screw feeding → cam lifting→ mechanical arm turning the ampoule mouth down→ ampoule external rinsing→ 1st flushing with circulation water with needle inserting into the ampoule→ 2nd flushing with circulation water with needle inserting into the ampoule→ 1st blowing with cleaning compressed air with needle inserting into the ampoule→1st flushing with WFI with needle inserting into the ampoule→2nd blowing with cleaning compressed air with needle inserting into the ampoule→ 3rd blowing with cleaning compressed air with needle inserting into the ampoule →ampoule external blowing with cleaning compressed air, needle withdraw out of the ampoule→ mechanical arm turning ampoule mouth up→ ampoule out→ preheating→ high temperature sterilization → cooling→ ampoule delivery→ turn table ampoule feeding → screw feeding→ filling→ nitrogen gassing→ ampoule preheating→ ampoule sealing→counting→ ampoule outlet

Parameter of the production line

Production line Model	ALX8 Ampoule Washing, Drying, Filling Production Line		ALX10 Ampoule Washing, Drying, Filling Production Line		ALX12 Ampoule Washing, Drying, Filling Production Line
Individual machine model	KCQ80 ASMR600/43 AGFA8		KCQ100 ASMR600/43 AGFA10		KCQ120 ASMR600/43 AGFA12
Applicable size	1-20ml ampoule		1-10ml ampoule		1-2ml ampoule
Production capacity	1 ml-2ml:24000pcs/hour 5m: 18000pcs/hour 10ml: 12000pcs/hour 20ml:7000pcs/hour		1 ml-2ml:28000pcs/hour 5ml: 21000pcs/hour 10ml: 16000pcs/hour		1 ml-2ml:33000pcs/hour
Filling pump accuracy	Chinese pharmacopeia compliance
Breakage rate	Ampoule washing machine≤1%, filling machine≤1%
Sterilization capacity	Ampoule internal temperature≥320℃, sterilization time≥5min
Qualified rate	≥99%
WFI	0.25 Mpa 50℃ 0.8 m3/h		0.25 Mpa 50℃ 1 m3/h		0.25 Mpa 50℃ 1.2 m3/h
Compressed air	0.4-0.6 Mpa ≈60m3/h		0.4-0.6 Mpa ≈75m3/h		0.4-0.6 Mpa ≈90m3/h
Gas consumption	coal gas: 2 m3/h LPG gas: 0.4 m3/h		coal gas: 2.5 m3/h LPG gas: 0.5 m3/h		coal gas: 3 m3/h LPG gas: 0.6 m3/h
Oxygen consumption	for coal gas: 1.2 m³/h for LPG gas: 1.8m³/h		for coal gas: 1.5 m³/h for LPG gas: 2.2m³/h		for coal gas: 1.8 m³/h for LPG gas: 2.6m³/h
Machine noise	≤70ｄB
Operator	3 persons
Air absorbtion	5360 m³/h
Power	63 kW
Dimension	8900×2600×2500 (mm)
Weight	～6600 kg	～6700 kg		～6800 kg

Ampoule ultrasonic washing machine

Introduction

Ampoule Ultrasonic washing Machine (hereinafter referred to as washing machines), this machine is mainly used in the pharmaceutical industry for small volume ampoule cleaning, it can automatically complete the production process from ampoule feeding, ultrasonic cleaning and external washing, internal washing to ampoule out.

Ampoules after the washing machine are with high purity, they comply with GMP requirements.

The machine performance is stable, reliable, low breakage, production speed can be variable controlled, easy to operate, can be used as independent machine or integrated into production line the tunnel sterilizing dryer, filling and sealing machine.

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Main Technical Parameter

Model	KCQ80	KCQ100	KCQ120
Applicable size	1-20ml ampoule	1-10ml ampoule	1-2ml ampoule
Packaging size	Paper carton or tray width B≤315, length L≤400(see the following)
capacity	1 ml-2ml:24000pcs/hour 5m: 18000pcs/hour 10ml: 12000pcs/hour 20ml:7000pcs/hour	1 ml-2ml:28000pcs/hour 5ml: 21000pcs/hour 10ml: 16000pcs/hour	1 ml-2ml:33000pcs/hour
Breakage rate	≤1%
Water Consumption	0.8 m³/h Pressure ≥0.25 MPa	1 m³/h Pressure ≥0.25 MPa	1.2 m³/h Pressure ≥0.25 MPa
Compressed Air consumption	60 m³/h Pressure ≥0.25 MPa	75 m³/h Pressure ≥0.25 MPa	90 m³/h Pressure ≥0.25 MPa
Power	10.45kW
Weight	2100kg	2200kg	2300kg
Dimension mm	2225×2165×1400

Ampoule Tunnel Sterilization Dryer

Introduction

Ampoule tunnel sterilization dryer is designed and manufactured by our factory on the base of importing, digesting and absorbing foreign advanced technology. It is mainly used on the injection linked production line of pharmaceutical factories. It can continuously dry, sterilize and remove pyrogen of the washed ampoule or big / small glass medicine ampoule. Due to using heating of “Hot air laminar flow”, the heating is constant and even, the sterilization time is short with good sterilization effect, and the production capability is high. The machine is tunnel structure, includes preheating zone, high temperature sterilization zone, cooling zone, it uses the hot circulation air to sterilze the product within a short period, it is applicable for ampoule, antibiotic vial, oral liquid production.

Main Technical Parameter

Model	ASMR600/43 Tunnel type Sterilization drier
Applicable size	1-20ml ampoule
Production capacity	1 ml-2ml 33000pcs/hour 5ml 20000pcs/hour 10ml 16000pcs/hour 20ml 10000pcs/hour
Delivery belt width	560mm
Tunnel air cleaning class	100 class(US standard 209E)
Power Consumption	Installation power: 48.57kw Electric heating power: 43.2kw
Power	380V　50Hz　( three phase five wire)
Noise	Less than 70dB
Sterilization temperature	≥320℃
Sterilization time	≥ 5 minutes
Ampoule internal temperature	320℃ ±5℃
Sterilization quality	Particle and Endotoxin comply with “Chinese pharmacopeia”
Breakage rate	＜0.0１%
Ampoule temperature after cooling	< room temperature+＋15℃
HEPA Filter	99.997%
Particle test	100 class
Air suction	5000 m3/h
Machine dimension (LWH)	3180×1560×2350(mm)
sterilzation zone length	800mm
Weight	About 2000 kg

Ampoule Filling and Sealing Machine

Introduction

Ampoule (antibiotic ampoule) dual-purpose machine is researched and manufactured by our factory, it is a new type dual-purpose machine with world leading technical level for ampoule filling and sealing (antibiotic ampoule filling, stopper adding or semi stopper adding). The ampoule medicine liquid filling and sealing are mainly applicable for 8-needle filling-sealing of 1ml - 20ml; 10-needle filling and sealing is mainly applicable for 1ml - 5ml (antibiotic ampoule medicine liquid filling, stopper adding and semi stopper adding is mainly applicable for 2ml - 15ml, 8-needle filling). Only need to change a little of parts, you can change the production of antibiotic ampoule to ampoule, or vice versa. The machine is composed of transmission part, ampoule inlet part, filling part, stopper adding part, ampoule outlet part and hopper frame, the machine has a compact and simple structure for easy maintenance. This machine can be either for single machine production, or for linked production line with ampoule washing machine and dryer. It is one of the ideal equipment for pharmaceutical factory GMP reformation and realizing the modernized production.

The table of the filling machine is step type for easy washing, it has optional peristaltic pump, glass pump and ceramic piston pump for customer to choose. The application of the servo motor driving, PLC, frequency converting speed regulation and the technology coordinating each functional mold with servo motor makes the control system reach the world advanced level. The ampoule inlet system of this machine has mesh-belt transition, rotary plate and screw rod structure. This structure can reduce the ampoule breakage due to direct ampoule inlet to reduce ampoule contamination; it can efficiently control the ampoule inlet speed to reach front-rear synchronization; it can reduce screw rod’s friction, raise ampoule inlet efficiency, ensure reaching the designed production rate.

Main Technical Parameter

Model	AGFA8 Ampoule filling and sealing machine	AGFA10 Ampoule filling and sealing machine	AGFA12 Ampoule filling and sealing machine
Applicable size	1-20ml Ampoule	1-10ml Ampoule	1-2ml Ampoule
Production capacity	1 ml-2ml:24000pcs/hour 5m: 18000pcs/hour 10ml: 12000pcs/hour 20ml:7000pcs/hour	1 ml-2ml:28000pcs/hour 5ml: 21000pcs/hour 10ml: 16000pcs/hour	1 ml-2ml:33000pcs/hour
Gas consumption	coal gas: 2 m3/h LPG gas: 0.4 m3/h	coal gas: 2.5 m3/h LPG gas: 0.5 m3/h	coal gas: 3 m3/h LPG gas: 0.6 m3/h
Oxygen consumption	for coal gas: 1.2 m³/h for LPG gas: 1.8m³/h	for coal gas: 1.5 m³/h for LPG gas: 2.2m³/h	for coal gas: 1.8 m³/h for LPG gas: 2.6m³/h
Sealing qualification rate	99%
No ampoule no filling rate, ampoule falling, equipment stop rate	100%
Filling pump accuracy	Comply with Chinese Pharmacopeia
Qualification rate	≥98%
Breakage rate	≤1%
Noise	＜70dB
Air suction	360 m3/h
Power	Ac380V/50Hz
Overall power	2.4kW
Main quality	About 2500 kg
Dimension mm (LWH)	3600×2100×2450