The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, Pharmaceutical Stability Chamber serves as an important quality attribute for the product.
- Construction-: Double walled construction. With backside triple.
- Insulation-: 3 inch Thick PUF Insulation ensures stable temperature with humidity & reduced energy consumption.
- Observation Door-: Full view observation Acrylic door with gasket to observe sample inside the chamber.
- Heating System-: High quality U shape S.S. Tubular Heaters are used for better heating.
- Air Circulation – : Motorized Blower at back side of the chamber develops unique air flow system which ensures maximum uniform temperature humidity condition inside the chamber.Unique air flow assures quick recovery after door openings.
- Humidity System -: Steam injection system (Non condensing type) & reservoir tank with water level arrangement with indicator.
- Blower Motor -: 1/12 HP, TEFC, F-class insulation, Single Phase, 1440 RPM, 230 Volts.
- Control Condition-: As per ICH guidelines to control following conditions.
At 25◦C: RH = 60%
At 30◦C:RH = 65%
At 40◦C:RH = 75%
- Safety Features-:
1) Additional safety thermostat to cut of dry heater supply in case temperature of overshoot.
2) Float switch to cutoff the wet heater supply in case of low water level in the reserve tank.
Audio & Visual alarm.
3) Compressor ON delay timer (2min) to safe guard the compressor.
4) In built over load protector provided for hermetically sealed compressor.
- Refrigeration System -: By means of CFC Free hermitically sealed Emerson Copland make compressor with R 134 A for better cooling with ECO friendly refrigerant with time delay to safe guard compressor system.
- Validation Port-: 50 mm validation port hole with silicone rubber seal to insert sensors for validation.
- Lighting-: Interior illumination for working area.
- Supply -: 230 V AC, Single Phase , 50 Hz
- Trays -: Specially designed Stainlesssteel Rod trays ensure uniform temperature distribution.
- Standard Model -: Inside S.S.304 mirror finish & Outer Mild steel (CRCA) sheet with powder coated.
- Temperature Range -: 20° C above ambient to 60°C
- Temperature Accuracy -: ± 0.2° C.
- Temperature Uniformity -: ±1° C.
- Humidity Range -: 40% to 90%
- Humidity Accuracy -: ± 2%
- Humidity Uniformity -: ± 3%
- Temperature Control System-: Imported Microprocessor based auto tuned PID controller with CE mark & dual display of set value & process value.
- Humidity Control System-: Imported Microprocessor based auto tuned PID controller with CE mark & dual display of set value & process value with direct % RH. Direct RH electronic capacitor type humidity sensor, avoid wick cup & water.
REQUIREMENT FOR INSTALLATION
- Place the chamber where ventilation is good.
- The chamber must be operated in an ambient of 22◦ C ~ 30◦ C.
- Leave minimum 300 mm. Space from the sides and leave 600 mm. Space from the backside.
- Place the chamber horizontally levelled.
- Give stabilized electric supply (230V ±5%, 50Hz, 1 Phase, 20Amp). It is recommended to use a voltage stabilizer (KVA).
- Proper grounding of the chamber to get satisfactory operation of chamber.
- Do not use pump water, pressured water or hot water for water connection. Water supply from an overhead water tank where the water pressure should not be more than 15 PSI is recommended.
- Use of soft water or D.M. water for humidity formation is recommended. Use of hard or salty water will damage the boiler heater.
Do not test any product in the chamber, which is capable of generating combustible mixtures.