Stability Chamber
Precision Environmental Control for Reliable Stability Studies. 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 re 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.
Our goal is to deliver thermal and laboratory equipment solutions that are reliable, operationally safe, energy efficient and built to provide long-term performance.
Key Highlights
Engineered for precise temperature and humidity control, compliance, and long-term stability studies.
- ICH & FDA COMPLIANT
- ACCURATE & UNIFORM CONTROL
- RELIABLE & DURABLE
- IDEAL FOR LONG TERM STUDIES
Technical Specifications
| 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 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 viewing 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 cut off 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
Pharmaceutical Stability Studies
Reliable testing for drug stability under regulated guidelines.
Drug Substance & Product Testing
Assessing shelf-life and degradation patterns.
R&D and QC Laboratories
Essential quality control testing environments.
Accelerated / Intermediate / Long Term Studies
Full compliance with ICH climatic zone requirements.
FDA / ICH Compliance Testing
Meeting stringent regulatory standards.
Life Science & Biotech Research
Advanced controlled temperature and humidity applications.
Models & Dimensions
| Model No. | Capacity | Dimension in CMS | Shelves | Wt in Kg | Power | ||||
|---|---|---|---|---|---|---|---|---|---|
| Cu. Ft | Litres | Chamber (W x D x H) | Over All (W x D x H) | Unit | Packed in Wooden Case | VAC Hz | Watts | ||
| PIS042S-3 | 3 | 90 | 45x45x45 | 60x95x110 | 2 | 110 | 165 | 230, 50 | 1500 |
| PIS042S-4 | 4 | 120 | 45x45x60 | 60x95x125 | 2 | 150 | 225 | 230, 50 | 2000 |
| PIS042S-8 | 8 | 200 | 60x60x60 | 80x110x125 | 2 | 220 | 300 | 230, 50 | 2500 |
| PIS042S-12 | 12 | 324 | 60x60x90 | 80x110x155 | 3 | 230 | 320 | 230, 50 | 2500 |
| PIS042S-16 | 16 | 450 | 60x60x125 | 80x130x175 | 4 | 340 | 430 | 230, 50 | 4000 |
| PIS042S-21 | 21 | 600 | 60x80x125 | 80x130x195 | 5 | 365 | 465 | 230, 50 | 4000 |
| PIS042S-28 | 28 | 800 | 80x80x125 | 100x130x210 | 5 | 390 | 500 | 230, 50 | 4500 |
| PIS042S-34 | 34 | 1000 | 80x80x155 | 100x130x220 | 5 | 430 | 525 | 230, 50 | 4500 |
