Features of walk-in stability chamber
Stability studies are an essential component of Pharmaceutical development & marketing authorization, allowing evaluation of Active Pharmaceutical Ingredients’ (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established. Today, other than Pharma and Bio-pharma products, stability studies are required for Alternative medicines, Food & Beverages, Cosmetics and any other commodities where expiry dates are mandated.
Thermolab Stability testing chambers are designed to meet, if not exceed, stringent quality standards recognized internationally. Offering all temperature and relative humidity conditions specified in ICH guidelines, each Thermolab Chamber is warranted to provide unparalleled control accuracy and superior air flow uniformity. Fully automated control systems and HMI complement the chamber performance with highly rated data acquisition, storage and retrieval software. 21 CFR Part 11 requires that all appropriate electronic records are attributable, legible, contemporaneous, original, and accurate and maintained with integrity. We guarantee just that. Thermolab Chambers seamlessly blends modern engineering designs with aesthetics.
Standard features
· Pre-fabricated modular wall, floor and ceiling panels with PUF insulation.
· Interior Stainless Steel and Exterior PPGI/PCGI/Stainless Steel.
· Floor panels having extra reinforcement to sustain the movements and sample loads inside the chamber.
· Adequate illumination at working areas
· Double glass view panel on specially designed leak proof door.
· Racks & trays made of Stainless steel with adjustable tray heights.
· Validation port with seal to introduce sensors.
· Air processing Unit (APU) with Integrated Cooling, Heating and Humidifying systems.
· Hydronic Cooling System with CFC free refrigerants: This unique design enables maintenance of optimum cooling coil temperatures depending on the chamber conditions and resultant dew point. Enormous savings accrue due to reduced and intermittent operation of condensing unit, air heater and humidifier.
· Smart air distribution system: Recognizing air flow patterns as a major parameter in maintaining temperature and RH uniformity, we have custom designed the supply and return air pathways particularly for chambers having larger storage volume.
· PLC based control system with touch screen display coloured screen — 5.7” HMI with Ethernet.
· Web based online monitoring
· Complete with IQ, OQ, PQ, documents, Operations and maintenance manuals
· Works on 230/415 volts 50 Hz or 60 Hz.
· Safety & Alarms
Ø Safety controller sensor to cut off the supply in case of overshoot and undershoot of Temperature and Humidity giving audio visual alarm.
Ø Low water level alarms
Ø Door Opening alarms
Ø Emergency bell switch provided inside the chamber
Ø Special door lock provided to open the door from inside.
Ø All the alarms and events are logged in the software
Optional features:
· Support for 21 CFR Part 11 compliance: Window based communication software for data management.
· Stand by refrigeration system & Stand by humidity system.
· 8 point temperature and relative humidity scanners
· Printer interface and data storage facility, Door Access Security system and mobile alert system.
· 80 Col. Dot Matrix printer along with stainless steel stand.
· Flame Proof Chambers :
Ø Flame proof Rockwool panels
Ø Flame proof components
Specifications
· Temperature Range: 20°C to 60°C
· Temp Uniformity : ± 2°C
· Humidity Range : 40% to 95 % RH
· Humidity Uniformity : ± 3% RH
For more information about walk in stability chamber, contact Thermolab Scientific Equipments.
