The newest AM-0.36 Ampoule Leak Sterilizer 1. General DescriptionThis AM series sterilizer is strictly designed and manufactured in accord with GMP technical Standard. It has passed ISO9001 quality management qualification standard and ISO13485:2003 Certificate of Quality Management System. This autoclave is applicable to sterilization of pharmaceutical products like injection products in ampoules and vials.Leakage test will be performed with vacuum to detect the leakage of ampoules.Finally, washing with pure water, which is pumped through the water pump and sprayed over the load to cool down. 2.Size & Utilities
|Working Pressure||0.22Mpa||City Water supply pressure||0.2-0.3Mpa|
|Design Temperature||139ºC||Compressed Air supply pressure||0.6-0.8Mpa|
|Working Temperature||134ºC||Steam pressure||0.4-0.6Mpa|
|Heat equilibrium||≤±1ºC||Pure Water supply pressure||0.2-0.3Mpa|
|Chamber Size L*W*H(mm)||1000*600*600|
|Pure water (kg/cycle)||100|
|Compressed Air (m³/cycle)||0.6|
|City water (kg/cycle)||200|
|Loading cart size||950(L)×550(W)×480(H)|
|Loading capacity||2ml(¢11.5×70)ampoule,3 layers,6 trays/layer,10962 bottles/cycle|
3. Structure and performance features
(1) Chamber material: the chamber adopts the SUS316L, According to mechanical and chemical treatment, the chamber surface is bright, beautiful and corrosion resistant.
(2) The insulating layer is made by aluminium silicate which is the best insulating material, and the equipment is rectangular, having stainless steel decorating cover
(3) Doors: The autoclave is designed as pass-through (double door) autoclave. The door is hinge type and automatic pneumatic locking. Both doors cannot be opened simultaneously.
Ø The door seal is the inflatable type, pressurized with compressed air, and can withstand the chamber temperature and pressure.
Ø The doors shall have a safety mechanism to prevent opening of the door when the chamber is hot or pressurized or when the autoclave is in operation.
Ø Sterilization cycle can start only after the door is fully closed and locked.
(4) Pipeline system is consisted of water pump, vacuum pump, pneumatic valve,etc.
Ø Angle type of pneumatic valve: strong switch valve, without any mistake, remote compressed gas control. with the inner chamber of interlinked valve for stainless steel clamp type seat.
Ø Water pump is connected with the sprayer which mounted at the top of the chamber to form a spraying device for cooling. The spray nozzle is produced by Spray Company,USA, and works in big water flux and wide spray angle. It assures the uniformity of the temperature and rapidly cooling down the sterilization chamber and products.
Ø Vacuum pump:The autoclave include a liquid ring vacuum pump to obtain vacuum in the chamber.
(5) Control system: PLC+ HMI control + Micro-printer. a timely data printing, should be able to default one or more sterilization cycle.Electric apparatus system adopts domestic or imported components whose performance is stable and reliable.
Ø 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.
Ø In order to maintenance, test and emergency needs, manual operation can be through the use of access control tools to complete.
Ø The master controller system: can set the user name and password, also can set up different user access. A manager, users, maintainers triple interface function. Managers can be used according to different level, set on use of a password, ensure use safety, prevent that due to improper operation or modify the program brings experiment.
Ø Touch screen: display work process parameters, control is simple, the operation is convenient. Interface has the following functions:
Display shows the process of sterilization cycle state, time,pressure,temperature,two-door airtight state, the running records, printing, etc.
(6) The system have an E-Stop mechanism designed to stop all physical movement of the equipment immediately.
(7) The GMP confirming connecter fixed can provide the GMP validation for the customer freely.