Kesar Control Systems
Stability chamber
What is a Stability Chamber?
Every expiry date on a drug label is backed by a stability study. No stability data, no regulatory submission. No submission, no market clearance. A stability chamber maintains precise temperature and relative humidity at set points for weeks, months, or even years at a stretch, while your product sits inside. Every deviation is recorded. Every parameter is logged. The result is the kind of reproducible stability data that regulators such as CDSCO, USFDA, and WHO require before a product is approved. At its core, a stability chamber controls two things: temperature and relative humidity. But doing that accurately, for 12 to 36 months without interruption, is what separates a good chamber from one that ruins a study. Kesar stability chambers are used across pharmaceuticals, food & beverage, cosmetics, biotechnology, agrochemicals, and medical device manufacturing. Depending on the application, for large-scale pharmaceutical manufacturers running concurrent studies across multiple batches, a Walk-in Stability Chamber provides the same ICH-validated conditions at room scale.
Construction
- Body fabricated on fully automatic CNC machines for dimensional precision and consistent quality across every unit.
- Interior made of high-grade stainless steel (SS 304 or SS 316, depending on model) with a dull finish, easy to clean, corrosion-resistant, and built for long-term cGMP use.
- Exteriors with model options of Stainless steel and G.I. Powder Coating.
- Exterior options: GI powder-coated (STD model), SS 304 dull finish (GMP and cGMP models); suitable for cleanroom and production environments.
- Illuminated interior with multi-pane insulated glass door, which prevents condensation so you can inspect samples without opening the chamber.
- Heavy-duty hinges and latches with full-perimeter silicone rubber gaskets on both inner and outer doors maintain a uniform airtight seal even after years of daily use.
- Adjustable electro-polished wire mesh trays rated for up to 30 kg per tray (uniformly distributed), easy to clean, and repositionable for different sample sizes.
Technical Specification
Kesar stability chambers are factory-configured to support all ICH Q1A(R2) test conditions, including long-term (25°C/60%RH), intermediate (30°C/65%RH), and accelerated (40°C/75%RH), with accuracy well within regulatory tolerance limits.
| Temperature Range | 20 ℃ to 60 ℃ |
|---|---|
| Humidity Range | 40%RH to 95%RH |
| Accuracy | ±0.2 ℃ & ±2.0% RH |
| Uniformity | ±2.0 ℃ & ±3.0% RH |
| Test Suitable For | 25 ℃ & 60% RH, 30 ℃ & 65% RH 40 ℃ & 75% RH, 30 ℃ & 75% RH |
| Specially designed chambers for Low Humidity conditions such as 25 ℃ 40% RH, 40 ℃ 25% RH, 30 ℃ 35% RH | |
| Control System | PLC or PID Based |
Material of Construction
| Models | Material Of Construction | |
|---|---|---|
| Interior | Exterior | |
| STD | S.S.304 Dull Finish | G.I Powder Coated |
| GMP | S.S.304 Dull Finish | S.S.304 Dull Finish |
| CGMP | S.S.316 Dull Finish | S.S.304 Dull Finish |
Sizes
| Models | Capacity (in ltrs.) | Dimensions (W X D X H) | Max No. of Trays | |
|---|---|---|---|---|
| Internal Width X Depth X Height (mm) |
External Width X Depth X Height (mm) |
|||
| KGOS-90 | 90 LTR | 450 X 450 X 450 | 600 X 1030 X 1060 | 2 |
| KGOS-227 | 227 LTR | 600 X 630 X 600 | 750 X 1210 X 1210 | 2 |
| KGOS-325 | 325 LTR | 600 X 630 X 900 | 750 X 1210 X 1510 | 5 |
| KGOS-400 | 400 LTR | 600 X 630 X 1060 | 750 X 1210 X 1670 | 6 |
| KGOS-500 | 500 LTR | 600 X 630 X 1330 | 750 X 1210 X 1940 | 8 |
| KGOS-600 | 600 LTR | 800 X 800 X 950 | 950 X 1380 X 1560 | 5 |
| KGOS-800 | 800 LTR | 800 X 800 X 1250 | 950 X 1380 X 1860 | 7 |
| KGOS-1000 | 1000 LTR | 800 X 800 X 1570 | 950 X 1380 X 2180 | 10 |
How It Maintains Accuracy
What Makes Stability Testing Accurate
Regulatory guidelines are precise about what's acceptable: temperature must not deviate beyond ±2°C from the setpoint, and humidity must stay within ±5% RH throughout the study period. Kesar chambers achieve ±0.2°C temperature accuracy and ±2% RH humidity accuracy well inside these limits.
This is possible because of how temperature and humidity interact. Warm air holds more moisture than cool air. As the temperature rises, the relative humidity drops. A well-designed stability chamber controls both simultaneously, not independently, using PID or PLC logic that makes continuous micro-adjustments based on sensor feedback, not periodic corrections.
ICH Q1A(R2) defines three standard test conditions every pharmaceutical product must pass before regulatory approval:
- Long-Term: 25°C ± 2°C / 60% ± 5% RH: Minimum 12-month study, required for all drug registrations
- Intermediate: 30°C ± 2°C / 65% ± 5% RH: Triggered when a significant change appears during the accelerated study; also, the primary condition for Zone IVb countries, including India
- Accelerated: 40°C ± 2°C / 75% ± 5% RH: 6-month study designed to fast-track shelf-life prediction
Kesar Chambers also supports specialized low-humidity conditions: 25°C/40%RH, 40°C/25%RH, and 30°C/35% RH—for hygroscopic formulations and specific stability protocols.
Full View Glass Door
The door is where most chambers lose temperature and humidity during a study, either through poor insulation, gasket degradation, or condensation that signals heat loss. Kesar Chambers uses a multi-pane insulated glass door that keeps the inner glass surface warm enough to prevent condensation at all times. The full perimeter of both inner and outer doors is sealed with silicone rubber gaskets. QC managers can visually inspect every shelf without opening the door, without disturbing conditions, and without generating a door-open event in the data log.
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Features
- Heavy-duty stainless steel construction, SS 304 or SS 316 depending on model, built to withstand continuous 24/7 operation for the full duration of multi-year stability studies.
- LED-illuminated interior for clear visibility of all shelf positions without opening the door.
- Multi-pane condensation-free viewing door. Inspect product condition at any time without affecting the test environment.
- Electro-polished wire mesh trays. Hygienic, easy to clean, and adjustable to accommodate different product sizes and loading configurations.
Optional Features
- Standby humidity system: automatic switchover if the primary humidity system trips; study continues without interruption or manual intervention.
- Standby refrigeration system: redundant cooling ensures the chamber holds temperature even if the primary compressor requires maintenance.
- Multi-channel scanner: simultaneous monitoring across multiple chambers from a single interface.
- GSM alert system: sends SMS notifications to up to 6 registered numbers the moment any alarm condition is triggered, such as temperature deviation, power failure, door open, or low water level.
- Security alarm system: unauthorized access protection with password-controlled door entry and audit trail.
- Microprocessor based PID controller with auto tuning for accurate control of temperature and humidity conditions.
- Rotronic make 4-20mA sensors for better accuracy/ Pt100 Sensor for Temperature & Direct % RH electronic capacitor type humidity.
- Data Storage unit facility to store data and to print directly on printer or transfer to software with Date, Time, SV, PV, Door Open/ Close, Power On/Off remarks.
- Safety: Temperature & Humidity High / Low Alarm, Temperature very High / Low cut off, Water level low cut off.
- 7″ HMI with TFT LCD Colour touch screen with password protection for all parameter actual status monitoring of utilities like Sensor, Heating & Cooling System, and Humidity System.
- Rotronic make 4-20mA sensors for better accuracy.
- PLC with auto tuning facility for accurate control of temperature and humidity conditions.
- PLC system for an auto changeover of standby systems.
- Data Storage unit facility to transfer the data to software via Ethernet for web based online remote monitoring with Date, Time, SV, PV, Door Open/ Close, Power On/Off remarks. Also transfer the data through USB.
- Safety/Alert: Temperature & Humidity High / Low alarm, Temperature & Humidity High / Low cut off, Low water level cut off, Auto change over for standby systems
Safety Features
- Multi-level password-protected door access, which restricts unauthorized operation and logs every access attempt with user ID and timestamp.
- Temperature and RH deviation alarms, which triggered immediately if actual values drifted beyond configured tolerance limits.
- Power failure alarm with date and time stamp, complete record of any power interruption during the study period.
- Continuous open-door alarm, audible and data-logged alert if the door remains open beyond a set duration.
- Extreme temperature and RH cut-off, hard protection that shuts down heating or humidification if values exceed safe operating limits, protecting both product and equipment.
- Low water level cut-off prevents the humidity generator from running dry, which can cause component damage and humidity control failure.
- Automatic changeover for standby RH generator and cooling system, zero manual intervention required during a fault condition.
- Heavy-duty door hinges and latches with full-perimeter silicone rubber gaskets on inner and outer doors, a uniform seal maintained across the full lifespan of the equipment.
Software (21 CFR Part-11 Compliance)
For pharmaceutical companies submitting stability data to the USFDA, EMA, or CDSCO, 21 CFR Part 11 compliance is not optional; it's a prerequisite for regulatory acceptance. Kesar's data acquisition software is built to meet these requirements out of the box:
- Multi-level alphanumeric password protection with configurable password ageing
- Secured audit trail, where every parameter change logged with user ID, old value, new value, and timestamp
- Electronic records (e-Records) and electronic signatures (e-Signatures) as required by 21 CFR Part 11
- Complete event log: door open/close, power on/off, alarm triggers, and system changeovers
- Graphical and tabular data analysis with export to standard formats
- Mean Kinetic Temperature (MKT) calculation for any selected date range
- Multi-chamber monitoring on a single software dashboard
- LAN/Ethernet connectivity for server-based storage and web-based remote monitoring
- GSM mobile alerts to up to 6 registered numbers for any alarm condition
- USB data transfer and direct printer output
Trays
All chambers are supplied with heavy-duty electro-polished wire mesh trays. The wire mesh design allows for maximum airflow around samples, critical for uniform temperature and humidity distribution at every shelf level. Trays are adjustable in height, rated for up to 30 kg uniformly distributed load, and designed to be removed and cleaned quickly without tools.
Industries We Supply
Kesar stability chambers are in use across regulated and quality-driven industries, wherever shelf life, product degradation, or regulatory approval depends on documented environmental testing:
Pharmaceuticals: ICH Q1A long-term, intermediate, and accelerated studies for APIs, finished dosage forms, and primary packaging materials. Required for CDSCO new drug applications and USFDA ANDA/NDA submissions.
Biotechnology: Stability studies for biologics, biosimilars, vaccines, and recombinant proteins under ICH Q1A and Q5C guidelines.
Food & Beverage: Accurate best-before date determination under simulated real-world storage conditions for FSSAI and export compliance.
Cosmetics: Physical and chemical stability validation supporting shelf-life claims and Bureau of Indian Standards compliance.
Agrochemicals: Pesticide and fertilizer formulation stability under tropical climate conditions as per CIB&RC registration requirements.
Medical Devices: Packaging material compatibility and device stability data for CDSCO MD-15 submissions.
Why Pharma Companies Across India Choose Kesar
NABL-Accredited Calibration: Calibration certificates from an NABL-accredited lab, not outsourced to a third party. Traceable, regulator-accepted, and issued by your chamber. No separate calibration vendor, no coordination delay before your study starts.
IQ/OQ/PQ Validation Documentation: Full Installation Qualification, Operational Qualification, and Performance Qualification documentation is available as a packaged option. The complete validation bundle your regulatory affairs team needs for CDSCO, USFDA, or EU-GMP facility audits.
AMC — Annual Maintenance Contracts: Stability studies run for years. So do our service commitments. AMC plans cover scheduled preventive maintenance, annual NABL calibration, and emergency response, so a compressor issue at month 10 of a 12-month study doesn't become a crisis.
Manufactured in India: Two manufacturing units in GIDC Vatva, Ahmedabad. Faster delivery across India, local service engineers, and immediate spare parts availability without the lead times and import complications of foreign equipment.
Clarifying Your Doubts
Frequently Asked Questions
A stability chamber is environmental testing equipment that holds temperature and relative humidity at defined setpoints for weeks, months, or years, while products are stored inside. It's used to generate the shelf-life data that regulatory bodies like CDSCO, USFDA, and WHO require before a product is approved for sale.
A stability chamber is designed for long-duration shelf-life studies with tight tolerances (±2°C / ±3% RH), primarily for pharmaceutical and food applications under ICH or similar guidelines. An environmental chamber simulates a broader range of harsh conditions like thermal shock, vibration, altitude, and extreme humidity and is more commonly used for electronics, automotive, and industrial product stress testing.
Kesar chambers support all ICH Q1A(R2) conditions: Long-term (25°C/60%RH), Intermediate (30°C/65%RH and 30°C/75%RH for Zone IVb), and Accelerated (40°C/75%RH). They also support low-humidity protocols: 25°C/40%RH, 40°C/25%RH, and 30°C/35%RH.
For R&D labs testing small batches, 90–227 litre chambers (KGOS-90 or KGOS-227) are typically sufficient. Mid-sized QC departments testing multiple products simultaneously usually need 325–500 litres. Large pharmaceutical manufacturers running concurrent long-term, intermediate, and accelerated studies should consider 800–1000 litre chambers or a walk-in stability chamber.
Yes. Kesar provides Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation as an optional package, the full validation package required for regulated pharmaceutical facilities undergoing CDSCO, USFDA, or EU-GMP audits.
At least once a year, with mapping studies at installation and after any major maintenance or relocation. Kesar's AMC (Annual Maintenance Contract) plans include scheduled preventive maintenance and NABL-accredited calibration with traceable calibration certificates.
