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De Lama Sterilizzatori
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DE LAMA CONTROL SYSTEM

De Lama's Control Systems are designed to satisfy the plants automation requirements granting the working cycle complete repeatability. The control systems have an intuitive and usable interface and they don't need a particular basic skill. All the design documents are conforming to the last GAMP Guidelines and to the procedures of the UNI EN ISO 9001:2000 and UNI EN ISO 13485:2004 Quality Management Systems Manual.

De Lama's control systems run on a Windows (Windows Xp PRO and Windows XP EMBEDDED) platform and have all the functionalities of a windows-based operating system.

 

HIGHLIGHTS
  • industrial standard architecture based on SCADA + PLC with CPU
  • PC based systems compliant to FDA CFR 21-Part 11 (electronic records and electronic signature)
  • user_ID continuous logging to allow traceability of all operations performed by the Users
  • easily configurable for full integration with complex distributed IT architectures (database and PC)
  • easily configurable for LAN connection to remote control room for remote desktop, data storage and network printing
  • equipment can be fitted with an independent recording system (EN 285 compliant) to provide fully independent recording from the one performed by the main control system
  • S/W life cycle and design according to cGAMP
  • complete range of cycles to suit the widest variety of sterilization processes and cycles full reproducibility
  • built-in utility applications such as probes calibration and I/O test
  • PC based systems featuring Microsoft Windows® Operating System
  • cycles management through lethality factors with integrated calculation
  • CE marking: compliant with European Directive EMC 89/336 (electromagnetic compatibility)

 

MAIN FEATURES
  • Friendly Human Machine Interface
  • Ethernet Connection
  • Data Security
  • Data Protection (Audit Trails, reports, etc..)
  • easy Cycle Editing & Integrated Management of all process parameters and sequences
  • integrated UPS for power back-up
  • cycle report storage in both encrypted and Adobe Acrobat® PDF format
  • local & remote printing

 

UTILITY PROGRAMS
  • I/O TEST
  • Integrated Calibration Tools application
  • Maintenance Calendar

De Lama S.p.A. Control System