TECHNICAL SPECIFICATION

 NAME: AMPOULE LEAK STERILIZER 

MODEL:AM-0.36(360 liters)

1.GENERAL

This AM series sterilizer is strictly designed and manufactured in accord with GMP technical Standard. It has passed ISO9001 quality management qualification standard.

This autoclave is applicable to sterilization of pharmaceutical products like injection products in ampoules and vials.

Leakage test will be performed by color water to detect the leakage of ampoules.

Finally, washing by pure water, which is pumped through the water pump and shower from the top nozzle to clean the products.

2.SIZE & UTILITIES

3.STRUCTURE AND PERFORMANCE FEATURES

Sterilization chamber: The pressure vessel of the sterilizer is constituted by a double-walled chamber.The internal chamber is made of SS316L which is mirror-finished (Ra δ 0.5 µm) in order to ensure that it can be cleaned and sterilized and in order to increase its resistance to corrosion.

The insulating layer is made by aluminium silicate which is the best insulating material, and the equipment is rectangular, having stainless steel decorating cover

Doors: The autoclave is designed as pass through type. The doors are hinge type and automatic pneumatic locking.

The door seal is the inflatable type, pressurized with compressed air, and can withstand the chamber temperature and pressure.

● Sterilization cycle can start only after the door is fully closed and locked.

● Supply with instrument-grade compressed air: thanks to the special cross-section, the compression fluid cannot escape toward the sterilization chamber, compromising the sterility of the chamber and of its contents.

● No vacuum: thanks to the specifically designed cross-section and to the mechanical characteristics of the material of the gasket (silicone rubber), the door can be opened simply by discharging the compression fluid, as this makes the gasket retract uniformly into its seat.

● Simple  maintenance:  no  periodic  lubrication  or maintenance is required, except for ordinary cleaning of the surfaces and removal of any foreign objects that might be squashed between the gasket and the door;

● Safety: electromechanical and electronic safety interlocks managed by the process controller prevent the opening of the door if the gasket is still pressurized and/or if there are conditions entailing danger for the operator and/or the load

Pipeline system:It is consisted of pneumatic valves,vacuum system,water pump,etc.

●Valve:The valves used are of the pneumatic type. Ten years’experience in designing these components for the specific application has allowed to optimize system solutions related to the hydraulic system, providing solutions characterized by minimal dimensions, optimum functionality, and minimum and easy maintenance.

●Water pump:It is connected with the nozzle which fixed at the top of the chamber to form a spraying device for cooling and clean. It assures the uniformity of the temperature and rapidly cooling down and clean the ampoules.

●Vacuum pump: the water ring pump continues to aspirate through an adjustable intake even

during the steam injection and sterilization phases. The steam releases heat by condensing, consequently releasing latent heat. By constantly draining the condensate that forms in the chamber through a valve that has a small cross-section, a dynamic condition is ensured which allows a more uniform (indirect) adjustment of the sterilization temperature, which leads to extremely small temperature differences and prevents the accumulation inside the chamber of condensate and of any incondensable gases present in the steam.

Control system: PLC+ HMI + Micro-printer + Data logger.

●When automatic controller in the failure of the circumstances, the security device makes the sterilization indoor pressure safety in the pressure of the atmosphere to the back of the state, and allow the loading door can be opened.

●In order to maintenance, test and emergency needs, manual operation can be through the use of access control tools to complete.

●The master controller system:3 level password.The adminstrator can set the user(engineer and operator) name and password.

●Touch screen: display work process parameters and sterilization cycle state, the operation is convenient.The engineer can modify the parameters,including the temperature,time,program name,vacuumize times,etc.

4.PROCESS FLOW

The autoclave control with optional automatic operation or manual operation.

CYCLE 1- Glass ampoule and vial sterilization –115 °C / 30 min or 121 °C / 15 min

Loading→Chamber vacuumize→ Heating and Sterilizing→Cooling(pure water spraying)→Detect the leakage of ampoules (by chamber vacuumize or color water)→Washing (pure water spraying)→End.

CONFIGURATION LIS