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