The production of sterile pharmaceuticals is carried out in various classes of cleanroom. The most critical operation is during aseptic preparation & filling, monitoring, recording & generating customized reports (21 CFR Part-11 Compliance System) with PC level redundancy system of all lines, sampling & dispensing and QC microbiology. Monitoring parameters like temperature, humidity and room pressure + differencial pressure and online non-viable particle counts (applicable Rooms). Generating of alert & action alarms by the system through room alarm and beacons which are mounted in all the respective rooms whenever the room parameter deviates from its pre-defined limits.

  • Communication of remote I/O modules to PLC and PLC to SCADA is routed through Profinet
  • Generating of reports in SQL Server
  • Data server path can be provided for central data storage purpose
  • Customized report generation in compliance with 21CFR Part -11 (Electronic signatures,Audit  trails, Time stamping, Backup & Restore, password management, etc..) 
  • Generating of alarms for all process critical parameters
  • Screens development as per client requirement
  • Alert and action limits for all critical parameters. Separation of critical and non-critical alarms
  • User settable delay times for generating all process alarms
  • Door open operator alert in all the rooms after completion of user settable delay time
  • Operator visual & acoustic alerting system for all EMS parameter deviations
  • Remote connectivity option for diagnostic purpose
  • System access from anywhere by LAN/Internet connectivity to the system
  • Option for adding client systems  
  • High speed communication network
  • Flexible for modification to implement your innovative idea
  • Future expansion capability and option for communicating to future central Monitoring/ Controlling system