Stability Chamber
Pharmaceutical Stability Chamber for Precise Temperature & Humidity Control
The purpose of Stability Chamber is to provide evidence on the how the quality of drug substances or drug product varies with time under the influence of environmental factors such as temperature, humidity and light and to establish a test period for the drug substance or product under recommended storage conditions.
PIS Make GMP Stability test chambers are especially built to pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA/ICH guidelines for long term, intermediate and accelerated Stability studies.
Key Features & Benefits
- ICH & FDA compliant
- Accurate & uniform control
- Reliable & durable
- Ideal for long term studies
- Microprocessor based PID controller with auto tune facility
- Temperature and humidity control
- Dedicated safety controller with audio visual alarm
- 21 CFR Part 11 compliant software with audit trail
- Online & offline data storage
- Multi chamber data acquisition
- Tabular and graphical reports
- Mean kinetic temperature report
- Alarm report & attractive graphs
Technical Specifications
| Parameter | Specification |
|---|---|
| Temperature Range | 5.0 °C to 60.0 °C (Accuracy ±0.1 °C, Uniformity ±1.0 °C) |
| Humidity Range | 25% to 95% RH (Accuracy ±3% RH, Uniformity ±3% RH) |
| Temperature Display | Digital LED 3 ½ digit, Resolution 0.1 °C |
| Humidity Display | Digital LED 3 ½ digit, Resolution 0.1% RH |
| Heating System | U shaped Nichrome wire heater in SS sheathing |
| Cooling System | Hermetically sealed CFC free Emerson compressor with R 134a refrigerant |
| Humidity System | Non condensing type steam injection system with water level arrangement with insulation to save heat energy |
| Air Circulation | Flange motor with impeller and blower |
| Interior Illumination | Provided for working area |
| Blowers | Two nos. of blower from 450 Ltr onwards |
Construction
- Double walled, gap filled with PUF insulation.
- Standard Model: SS mirror polished chamber & powder coated CRC exterior.
- GMP Model: SS mirror polished chamber & dull finish SS exterior.
- Double door: inner full view door & outer insulated door with lock.
- 50mm validation port with silicon rubber seal.
- 3″ thick CFC free PUF insulation.
- SS trays with adjustable height.
- Unit mounted on castor wheels with front lock.
Control Panel
- Microprocessor based PID controller with auto tune facility.
- Temp. Sensor: PT-100, RH sensor: capacitance type.
- Dedicated safety controller with audio visual alarm.
- Recorder with data bank (optional).
- PC interface with RS 485 (hardware only) (optional).
- Alarm for temperature deviation.
Safety Features
- Over heat & humidity cutoff with alarm.
- Low temperature & humidity alarm.
- Low boiler water level safeguard.
- Electrical overload compressor cutoff.
- Time delay for compressor switch on.
- Electrical short circuit breaker.
Data Record
- 21 CFR Part 11 compliant software with audit trial.
- Multi level passwords.
- Online & offline data storage.
- Multi chamber data acquisition.
- Tabular and graphical reports.
- Mean kinetic temperature report.
- Alarm report & attractive graphs.
Applications & Industries
- Pharmaceutical Stability Studies
- Drug Substance & Product Testing
- R&D and QC Laboratories
- Accelerated / Intermediate / Long Term Studies
- FDA / ICH Compliance Testing
- Life Science & Biotechnology Research
Models & Size Range
| Model | Capacity | Chamber | Overall | Shelves | Unit Wt. | Packed Wt. | VAC / Hz | Watts |
|---|---|---|---|---|---|---|---|---|
| PIS042S-3 | 3 Cu. Ft. / 90 L | 45 × 45 × 45 cm | 60 × 95 × 110 cm | 2 | 110 kg | 165 kg | 230, 50 | 1500 |
| PIS042S-4 | 4 Cu. Ft. / 120 L | 45 × 45 × 60 cm | 60 × 95 × 125 cm | 2 | 150 kg | 225 kg | 230, 50 | 2000 |
| PIS042S-8 | 8 Cu. Ft. / 200 L | 60 × 60 × 60 cm | 80 × 110 × 125 cm | 2 | 220 kg | 300 kg | 230, 50 | 2500 |
| PIS042S-12 | 12 Cu. Ft. / 324 L | 60 × 60 × 90 cm | 80 × 110 × 155 cm | 3 | 230 kg | 320 kg | 230, 50 | 2500 |
| PIS042S-16 | 16 Cu. Ft. / 450 L | 60 × 60 × 125 cm | 80 × 130 × 175 cm | 4 | 340 kg | 430 kg | 230, 50 | 4000 |
| PIS042S-21 | 21 Cu. Ft. / 600 L | 60 × 80 × 125 cm | 100 × 130 × 195 cm | 5 | 365 kg | 465 kg | 230, 50 | 4000 |
| PIS042S-28 | 28 Cu. Ft. / 800 L | 80 × 80 × 125 cm | 100 × 130 × 210 cm | 5 | 390 kg | 500 kg | 230, 50 | 4500 |
| PIS042S-34 | 34 Cu. Ft. / 1000 L | 80 × 80 × 155 cm | 100 × 130 × 220 cm | 5 | 430 kg | 525 kg | 230, 50 | 4500 |
Utilities — At Buyer’s Scope
- Distilled water or DM water line. (Consumption 20 ltrs/24 hrs upto 450 Ltr model)
- Room temperature preferably 25°C.
- Stabilised input voltage of 230V AC, 50 Hz, 20 Amps.
- Water drain line with ½” nozzle at floor level.
Why Choose Phoenix India Solutions (PIS)
- Application-focused selection of pharmaceutical chambers based on your stability testing and environmental control requirements.
- Support for selecting stability chambers according to temperature, humidity, capacity and application requirements.
- Technical assistance for pharmaceutical stability studies, R&D and quality-control applications.
- Support for documentation, technical discussions and quotations.
- Complete coordination with the manufacturer.
- Responsive after-sales assistance and service coordination.
Interested in This Stability Chamber?
Get in touch with Phoenix India Solutions for Stability Chamber specifications, technical discussions, capacity selection, pricing and quotation.