Pharma Refrigerators 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.

Temperature Data Logger :

4 channel or 8 channel , calibrated data logger to print date, time, temperature set and process values for mapping and auto validation. Features like printer and PC interfacing provided.

Standby Systems :

Standby refrigeration and sensor

Mobile Alert :

• Different Alarm indication through Mobile SMS Alert (from single to multi user)
• Process value indication through Mobile SMS Alert (from single to multi user)

Validation :

DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.