ALXI-I Model Ampoule Washing-Drying-Filling-Sealing Production Line

SMALL VOLUME INJECTABLES FILLING SOLUTIONS

OVERVIEW

The ALX-I model ampoule washing-drying-filling-sealing production line is composed of the QCL series vertical ultrasonic washing machine, ASMR series depyrogenation tunnel and AGF series vertical filling-sealing machine, whilst the three machines can also be used independently. Suitable for production of ampoules of 1-20ml, it can complete more than 20 work procedures such as ultrasonic bathing, three-time WFI and recycled water washing, three-time compressed air flushing, exterior wall water washing and compressed air flushing, preheating, drying, sterilizing, depyrogenation, cooling, pre-fill gas purging, filling, post-fill gas purging, heating and sealing. This production line is a new-type processing line which is researched and developed by Xin Weisheng through its own patented technologies based on its deep understanding of the regulatory requirements and customer needs.

The whole processing line adopts PLC control, frequency converter and HMI control technology to make the production process stable and reliable. The touch screen can display running dynamics of each single machine, with water pressure, air pressure and temperature to be shown at each control point. The display of each on-off status and faults, fault self-diagnosis, fault analysis and eliminating ways will realize the automatic control for the whole production process. The production line is provided with the automatic three-machine balancing control device to ensure the even and reliable production.

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FEATURES

The washing machine adopts the mechanical arms to clamp the ampoules of 1-20ml;

The water-air spray nozzles adopt the reciprocating tracking insertion method for washing, featured by excellent washing effect and energy saving. It is also provided with a device that prevents the nozzle holder from shaking to enhance the accuracy of the spray nozzle's insertion into the ampoule and reduce the occurrence of nozzle breakage;

The water and air pipes are totally separable from the spray nozzles, so that cross contamination is avoided and cGMP requirements are satisfied;

The buffer block is installed before the ampoule out-feed scroll for the washing machine to protect the scroll and reduce ampoule breakage;

Ampoule out-feed is realized by the integral imported synchronous belt that is connected to the ampoule pushing block to convey ampoules, a structure that ensures stable and reliable transmission;

The depyrogenation tunnel adopts the hot air circulation heating method with even temperature and energy saving;

The depyrogenation tunnel is provided with the function of protecting against sudden power-off to ensure safe running;

The depyrogenation tunnel can be equipped with the water cooling device that does not consume air volume in the room, which can reduce the risk of unbalanced differential pressure in the room and achieve good cooling effect;

The depyrogenation tunnel can be equipped with the differential pressure automatic balancing and regulating system to eliminate the issues of deviation at the high temperature section caused by unbalanced differential pressure in the room and tunnel, and the temperature rise in the filling room and washing-drying room;

The depyrogenation tunnel is provided with the PAO inspection ports (including inspection ports for air pressure, air velocity and dust particles);

The cooling section in the tunnel is provided with the sterilization function (specially chosen by FDA)- optional;

The depyrogenation tunnel mesh belt can be equipped with the ultrasonic and CIP cleaning systems;

The depyrogenation tunnel chamber can be subject to all-round, multi-angle high pressure water washing;

In the vertical filling-sealing machine, ampoule in-feed is carried out by using the constant speed pushing wheel instead of the sector pushing block to reduce the ampoule breakage rate;

The filling-sealing machine adopts the imported synchronous belt and ampoule turning gearbox, featured by low wear and reliable running;

The vertical filling-sealing machine is provided with sufficient gas purging work stations to ensure one-off purging. The completion of the procedures of pre and post fill nitrogen purging and drug filling fully guarantees the filling quality;

The filling-sealing machine is equipped with the nozzle holder and clamping stand automatic locking device;

The filling-sealing machine can be equipped with ceramic pump, piston pump or peristaltic pump based upon product nature and characteristic;

The filling-sealing machine can be equipped with the servo filling system.

OPTIONAL ADD-ONS

According to customer requirements, it can also be equipped with the following:

Control system of brands such as Siemens, Schneider, Allen Bradley, Mitsubishi and Delta;

Online particle counting, alarm system, recording and printing systems;

ORABS, CRABS, or aseptic isolator system.

TECHNICAL PARAMETERS

Product Model	QCL100+ASMR620+AGF8/1-20	QCL100+ASMR620+AGF10/1-20	QCL120+ASMR620+AGF12/1-20	QCL120+ASMR620+AGF12/1-20	QCL160+ASMR620+AGF16/1-3	QCL160+ASMR620+AGF16/1-5
Applicable specifications (ml) (GB Standard Ampoule)	1-20	1-20	1-20	1-20	1-3	1-5
Capacity (pcs/h)	1-2ml: 22,000	1-2ml: 24,000	1-2ml: 28,000-30,000	12,000-30,000	36,000-42,000	30,000-42,000
	5ml: 16,000	5ml: 18,000
	10ml: 11,000	10ml: 15,000	5-10ml: 18,000-20,000
	20ml: 6,000	20ml: 8,000
Clarity (%)	>99
Qualified Rate (%)	>99
Fresh Water Cosumption (m³/h) and Pressure (mpa)	Consumption: 0.4-1.0 Pressure: 0.2
Purified Compressed Air Cosumption (m³/h) and Pressure (mpa)	Consumption: 30-75 Pressure: 0.15
Sterilizing Temperature (°C)	300-500
Exhaust volume (m³/h)	4,100
Gas Fuel Consumption (m³/h) and Pressure (mpa)	Consumption: 1.5-2.5 Pressure: 0.2-0.3
Oxygen Consumption (m³/h) and Pressure (mpa)	Consumption: 1.2-2.5 Pressure: 0.2-0.3
Dimension (LxWxH) (mm)	9,940 × 2,003 × 2,445	10,000 × 2,260 × 2,455				10,600 × 2,260 × 2,455
Weight (kg)	7,500
Power capacity	380V/50hz, 71kw