BOD test chambers are especially built to pass FDA and ICH compliance standards and have a reputation for reliability, quality and performance.
- Construction as per cGMP regulations.
- Consisting of refrigeration, air handling, humidification, dehumidification, temperature/humidity controlling
- Microprocessor based PID Temperature controller OR
PLC based system for chamber control and auto changeover of standby system with touch screen display. - Printer interface & PC interface for data storage
- Standard networking via Ethernet.
Data Acquisition system complying to US FDA 21 CFR Part 11
- Data records & process control systems have Electronic Signature & Electronic Record capability. The controllers have a lockout feature that permits changes through a 21CFR Part11 compliant operator station, thus providing the necessary audit trail.
- Mean Kinetic Temperature value.
- Password security for log in and door operations.
- Operators need to enter user name and password before taking any action.
- Report search option using date and sample name.
- Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
- User actions with signing and authorization.
- Access control according to authority level.
- Export conversion facility to Excel.
