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守肯包裝材料(上海)有限公司

守肯包裝材料(上海)有限公司——包裝機器、配件供應和維修服務、配套環保材料

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守肯包裝材料(上海)有限公司
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德國AUDION歐迪昂

醫療(醫用)腔體式真空封口機

Validatable vacuum chamber


On a bi-active vacuum chamber it is possible to add the option: " validatable". This option includes validation on temperature, seal pressure, vacuum pressure, gas pressure and seal time.
 
Base models:
Validatable version is available on all the vacuum chamber models with bi-active seal option.
Table top model: VMS 163B Single chamber model: VM 203, VMS 233, VM 303, VMS 333
Double chamber model: VM 243, VMS 253, VMS 263, VM 273, VMS 283, VMS 503, VMS 883
 
The pictures are of a VM 203 and VMS163B validatable vacuum chamber.
   
Features & Specifications
Audion validatable vacuum chamber complies with the validation processes for sealing required in ISO11607-2. (*1)
Process parameters (seal temperature, seal time, seal pressure, vacuum pressure and gas pressure) can be controlled and monitored. (*2)
The machine gives an alarm and aborts the cycle if one of the parameters goes beyond the predetermined tolerances.
Parameter log data can be exported to PC with USB memory stick.
Touch panel controller
Controlled access level with password
Sensor controlled vacuum chamber pressure
Bi-active seal (8mm width)
Seal temperature: Max.180 ºC
Seal time: Max. 20 sec.
Seal pressure: Max. 1500 N
(*1) Packaging of terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
(*2) Seal time is not monitored as it is consistently and precisely controlled inside PLC and is not supposed to deviate.
Options & Accessories:
Gas flush with multi cycle
Temperature measurer ATM
IQ/OQ procedure
Calibration executed by Audion: certificate by Audion, on temperature, time, seal pressure, vacuum pressure, gas pressure
Calibration executed by an accredited laboratory: calibration like above but realised by an accredited laboratory
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