Newtronic Stability Testing Chambers are designed to meet the regulatory requirements for stability testing in the pharmaceutical, cosmetic, and food industries. These advanced chambers provide the ideal environment for conducting real-time, intermediate, accelerated, and semi-permeable stability studies. Equipped with high-speed Ethernet communication, PLC-based control systems, and 21 CFR Part 11-compliant software, Newtronic chambers offer precise monitoring, data storage, and alarm management. With features like standby cooling, mobile alerts, and touch-screen control, Newtronic chambers ensure seamless and efficient operations while safeguarding the quality of your products. Whether you need to meet ICH guidelines or other industry-specific requirements, Newtronic provides a reliable and customizable solution for your stability testing needs.

Key Features:

Ethernet Communication:

• High-speed data transfer surpassing traditional serial communication.
• Global standard communication protocol enables remote data operations via LAN without the need for separate PC interfaces.

Standby Cooling System:

• Fully operational systems with automatic switch-over to standby cooling in case of primary system failure.
• Features like HP/LP and internal fault detection for seamless operation.
• Scheduled and manual changeovers with complete record-keeping in the system.

PLC-Based Control System:

• Complete control through Programmable Logic Controllers (PLC).
• No data loss: Stores up to 1000 readings (30-minute intervals for up to 20 days).
• Direct email notifications from the PLC for critical updates.

Touch Screen Display:

• All operations are managed through a user-friendly 4” color touchscreen display.
• Access settings like PLC IP address, system hours, standby changes, and password protection for calibration.

Documentation & Training:

• Full suite of documentation, including IQ, OQ, PQ, calibration certificates, operation manuals, GA & electrical drawings, material test certificates, and user training.

Comprehensive Alarm System:

• Temperature & Humidity Deviations, Door Opening, Water Supply Failures, Component Failures, Mains Failures, and more.
• Mobile alerts and e-mail notifications upon alarm trigger, with equipment name, alarm type, time, and limits.

21 CFR Part 11 Compliance:

• Complete e-signature and audit trail functionality for compliance with FDA standards.
• Automatic daily data backups, alarm logs, and graphical data trending.
• PDF export capabilities for report generation and data viewing.

Touch Screen Door Access System:

• Password-based access control restricts unauthorized personnel from entering.

Mobile Alert System:

• Mobile alerts for real-time notifications, including:
• Alarm transmission time
• Equipment name and alarm type
• Specific alarm limits.