Stability Chambers manufactured by Vishwakarma Industries are designed as per ICH, WHO, & international Stability guidelines & standards with the help of several years of experience to meet the requirements of Studies.
Application:
- Stability Testing is an essential part of R&D, Q.C, Q.A departments, and formulation development.
- It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances and products and recommended storage conditions.
- Stability data are required to be submitted as a part of the record to the regulatory agencies for licensing approval.
Construction Features:
- Thick Puff insulated panels for less heat & cooling loss.
- Distributed a unique airflow system for maximum uniformity of temperature and humidity throughout the chamber.
- Full Glass Door View & chamber illumination.
Control Features:
- Microprocessor-based PID controller (Temperature & Humidity controller) with high accuracy of ± 0.2°C & +2%RH.
- Three wire RTD sensor & direct output capacitance type RH sensor.
- Safety Controller system for temperature overshoot & undershoot with buzzer & LED in case of temperature controller fails.
- An additional Safety thermostat is provided to prevent the temperature overshoot in case if safety controller fails.
- Low water level safety cut off for humidity boiler heater.
- CFC-free eco-friendly cooling systems.
- Printer/PC interface for online/offline print of data on 80 col. Dot matrix printer or on PC with data storage capacity of 2500 readings & print interval settable from 1-255 mins.
- Vishwakarma Industries Data Management 21 CFR Part 11 compliance Software.
- Power off, Power resumed remark in software.
- Complete IQ, OQ, and PQ documentation & operating manual.
Technical Specifications:
- Available in GMP and Standard Models.
- GMP model: Inside S.S316 Matte finish and outside S.S 304 Matte finish.
- Standard model: Inside S.S 304 Matte Finish and outside mild steel powder coated.
- The below-mentioned chambers are manufactured for ICH conditions like:
- 25°C/60% RH, 30°C / 65% RH, 40°C/75% RH.
- Other sizes are available as per requirement.
- Also, Low RH Stability chambers are manufactured for conditions like:
- 25°C/40% RH, 40°C/25% RH, 30°C/35% RH etc.
Optional Accessories:
- Scanner (Data logger) with 4+4 or 8+8 sensors for continuous scanning of temperature humidity uniformity.
- Standby Cooling System.
- Standby Humidity System.
- Mobile alert through GSM.
- Door Access Security System.
- PLC for auto change overcooling system and humidity system.
- Imported linear-type Temperature Humidity sensors.
