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