Thermolab Walk In Stability Chambers
Brand: Thermolab – India
Stability Tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities.
Stability chambers provide a stable, temperature / humidity conditioned environment for worry-free operation with a control system that is easy to use and saves you time.
- Walk in stability chamber are cost effective and a reliable solution for high volume test applications for stability studies. The chambers reproduce and closely monitor environment with a precise combination of temperature and humidity. The chamber is available in standard size and also custom made to suit the layout and requirement.
- Low Energy And Low Water Consumption Chambers
Thermolab Stability Chambers are ideal for FDA / ICH stability testing, shelf life, package testing, accelerated aging for a variety of applications including: Pharmaceutical Products / Packaging; Medical Products / Packaging; Personal Care Products; Consumer Products and Research. All stability chambers meet the FDA / ICH pharmaceutical stability guidelines for a variety of storage conditions.
Temperaure range: 20 to 60°C / Accuracy: +/- 0.2 oC / Uniformity: +/- 2oC
Humidity range: 40% to 95% RH / Accuracy: +/- 2%RH / Uniformity: +/- 3%RH
- Pre-fabricated modular panel type construction with PUF insulation to be assembled on site with floor panels having extra reinforcement to sustain the movement and sample load inside the chamber. It is provided with effective air circulation system, refrigeration system, humidity system, multi pane vacuum sealed observation glass window, chamber illumination and stainless steel racks and perforated trays
- Stand by refrigeration system and stand by humidity system is provided (as an optional feature as a redundancy)
- Microprocessor-based PID controller with auto tuning for accurate control of temperature and humidity conditions and printer interface facility to store data and to print it directly on a printer with variable print time interval.
- A multiple point (8+8) temperature and humidity scanner with printer interface and PC interface facility for online mapping purpose.
- A PLC system for an auto changeover of standby systems and other event logging and monitoring purpose.
- GSM mobile alert module to give malfunction SMS on three cell phones simultaneously.
- Door Access Security System with smart cards / bio-metrics and software to authorize and to monitor door accessibility.
- Alternatively a Advance PLC system with touch screen display with all the above features incorporated. Network connectivity via Ethernet for web based online remote monitoring
- Utility management system provided for continuous machines operations and cross checks
- Chambers are provided with safety cut offs and alarms at centrally located places including one at the security gate.
- Special door lock is provided which can be opened from inside even if locked from outside
- An emergency bell switch is also provided inside the chamber
- Dedicated Safety system to shut off the humidity system and chamber shut down in case of overshoot or undershoot of temperature or humidity with audio visual alarm.
- Thermostatic safety system is provided as an additional safety feature
- Low water level cut off for humidity system
- Door open alarm
- All the alarms and events are logged in the software
- 21 CFR part 11 USFDA compliant software with validation documents
- Secured audit Trail
- Multi level security password with aging and history
- Electronic signature
- Web based (Ethernet) online remote monitoring
- GSM alarm system (mobile alert)
- Data of door access security system in software with remote options
- All the events, utility, working status, all the alarms are logged in the software
- Records in graphical and in tabular form
- Reports of mean Kinetic Temperature Reading
- Works on 440V AC three phase 50Hz (country specific)
- Complete with extensive DQ, IQ, OQ and PQ protocols as per the International guidelines along with calibration certificates
- Standard Model(S): Inside S.S.304 with mirror polish & outside mild steel powder coated.
- GMP Model(G): Inside and outside with SS 304 matt buff
- Temp. Range /Accuracy: 20°C to 60°C /± 0.2°C
- Temp Uniformity : ± 2°C
- Humidity Range/Accuracy: 40% to 95% RH /± 2%
- Humidity Uniformity : ± 3% RH
(Thermolab Walk-in Stability Chamber installed, validated for customer in Vietnam, capacity: 8000L, Q’ty: 03pcs)