STABILITY CHAMBER

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 and humidity 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.

Features
  • Temp. Control: Microprocessor-based PID Control with Auto-tune, CE Marked
  • Temp. Sensor: PT-100 RTD, Class "A"
  • Humidity Sensor: HUMIREL, Capacitance level, - High reliability and long term stability
  • Temp. Display: Digital LED, 3½ digit
  • Heating: U-shaped Nichrome wire heater in SS Sheathing
  • Cooling: CFC Free compressor utilizing R134-a eco friendly refrigerant, with condenser, motor and relay. Complete Unit – Copeland Make.
  • Steam Injection: Boiler with reservoir made of thick stainless steel, with heater, water inlet control,low water level safeguard and insulation
  • Air Circulation: Flange motor with Impeller/ Blower
  • Chamber Illumination: Fluorescent light with door switch
  • Feet: Castor Wheels
  • Trays: SS Wire Mesh, Heavy Duty
  • Construction: Double-walled with Poly Urethene (PUF) insulation provided with outer stainless steel metal door and inner glass viewing door
  OSC S/G-4 OSC S/G-8 OSC S/G-12 OSC S/G-16 OSC S/G-21 OSC S/G-28 OSC S/G-34
Temperature Range 10°C to 60°C
Humidity Range 40% to 95% RH
Temp. Resolution ±0.1°C ±0.1°C ±0.1°C ±0.1°C ±0.1°C ±0.1°C ±0.1°C
Temp. Accuracy ±0.2°C ±0.2°C ±0.2°C ±0.2°C ±0.2°C ±0.2°C ±0.2°C
Temp. Uniformity ±1°C ±1°C ±1°C ±1°C ±1°C ±1°C ±0.7°C
Humidity Resolution 1% 1% 1% 1% 1% 1% 1%
Humidity Accuracy ±2% RH ±2% RH ±2% RH ±2% RH ±2% RH ±2% RH ±2% RH
Humidity Uniformity ±3% RH ±3% RH ±3% RH ±3% RH ±3% RH ±3% RH ±3% RH
Internal Size (W x D x H) cm 45 x 45 x 60 60 x 60 x 60 60 x 60 x 90 60 x 60 x 125 60 x 80 x 125 80 x 80 x125 80 x 80 x 155
External Size (W x D x H) cm 65 x 114 x 130 79 x 121 x 130 79 x 121 x 165 79 x 121 x 199 76 x 141 x 199 96 x 141 x 199 96 x 141 x 225
Capacity (Litres) 120 200 324 450 600 800 1000
Shelves (S.S.) 2 2 3 4 5 5 5
Shipping Weight - kg (lb) 200 (440) 240 (528) 250 (550) 265 (583) 295 (649) 325 (715) 375 (825)
Input Voltage 230 Volts AC, 50 Hz
Material Inner Chamber: SS 304 Grade/ Mirror finish
  Outer Chamber: Mild Steel Powder Coated/ SS 304 Grade

 

Installation Mandatory Requirement
  1. Continuous supply of Distilled water or DM water with a tap for boiler input of ½” BSP at 3 feet height
  2. Room temperature around machine preferably at 25°C with air conditioning or a well-ventilated room with an exhaust fan. The surrounding temperature should not exceed 30°C
  3. Stabilized input voltage of 230V AC, 20 Amps. Use of Servo Controlled Stability Chamber is recommended
  4. Water drain line with ½” nozzle to be provided at floor level.
Safety Features
  • High temperature safety cut-off
  • Low water level boiler cut-off
  • Electrical overload cutoff relay for compressor
  • Time delay for compressor switch ON
Calibration / Validation
i) Calibration
  • Temperature sensor probe calibration with traceability to ERTL
  • Temperature controller calibration with traceability to ERTL
ii) Validation
  • IQ, OQ and PQ documentation and protocols shall be provided with equipment.
  • Documentation prepared / developed for Osworld by Premier Validation Ltd. – Ireland, one of Europe’s leading validation consultants
  • Performance Qualification with Temperature Mapping on site. The Performance Validation Test consists of one cycle at any one temperature point for an 8-hour period. Data is collected in printed format from up to six different points within the chamber. Temperature uniformity is considered acceptable if the deviation is less than ±1°C of set temperature.
Optional Extras / Accessories :
  • Oslog Data Storage Device and Oslog 21 CFR Part 11 Compliant Software - Both have been developed exclusively for Osworld by M/s Godrej & Boyce Mfg. Co. Ltd.
  • Additional high-temperature safety system to cut off all heaters with audio-visual alarm
  • PLC-based system: PLC with HMI 3.7” touch screen grey monitor with 21 CFR Part 11 features (OSLOG) software.
  • Servo controlled voltage stabilizer
  • GSM System: Alarms sent to predefined mobile numbers
  • HMI: 5.7" touch screen grey in lieu of 3.7"
  • Controller with printer interface to connect to EPSON Dot Matrix line printer. Date, time and temperature can be printed whereas print interval can be set between 1 to 99 minutes
  • Imported RH sensor European make, Rotronic – Switzerland for higher accuracy
  • Standby Humidity Control Chamber System
  • Standby Refrigeration system
  • Data Logger: 4 point temp. Data logger with sensors placed at specific points in chamber with printer interface and memory
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