Stability test chambers are especially built to pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA / ICH guidelines for long term, Intermediate and Accelerated Stability studies.
- Construction as per cGMP regulations.
- Consisting of refrigeration, air handling, humidification, dehumidification, temperature/humidity controlling
- Microprocessor based 2 channel multifunctional PID Temperature / Humidity ( RH) controller for simultaneous control of temperature and % RH. 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.
- Standard temperature & RH configuration.
25°C / 60% RH
30°C / 65% RH
40°C / 75% RH
- Specially designed chambers are available to carry out stability studies at low temperature and low humidity conditions such as
25°C / 40% RH,
40°C / 25% RH,
30°C / 35% RH,
40°C / 15% RH,
55°C / 20% RH and
55°C / 75% RH.
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.
