Description
Overview
The RDS series is WSHLab’s pharmaceutical stability platform: a chamber qualified to hold the ICH Q1A(Q2) long-term, intermediate and accelerated setpoints — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH — continuously, and to prove it held them. Five capacities, 155L to 1025L, carry stability programmes from early development batches to full production scale.
The specification is written for inspectors: ±0.5°C and ±3% RH uniformity across the loaded chamber, recovery after door openings verified at the factory, an audit trail of setpoint changes and user actions, alarm history with excursion duration, and three years of onboard data behind a 7-inch touchscreen with USB/RS485 export. IQ/OQ documentation and sensor calibration certificates are available for GMP-regulated laboratories.
Photostability runs on the same chamber: a qualified light bank delivers up to 60,000 lux for ICH Q1B dosing, integrated with the climate programme and logged alongside temperature and humidity, so routine photostability work needs no second cabinet.
Key features
- ICH Q1A(Q2) by design. long-term, intermediate and accelerated setpoints held within defined tolerances, with recovery and uniformity verified at the factory
- Photostability to 60,000 lux. ICH Q1B light dosing on the same chamber, integrated with the climate programme and logged together with it
- GMP documentation layer. audit trail of setpoint changes and user actions, alarm history with excursion duration, calibration certificates, optional IQ/OQ
- Three-year data integrity. onboard logging with USB CSV export and RS485 for central monitoring — the study record leaves the chamber directly
- ±0.5°C / ±3% RH uniformity. verified across the loaded chamber at the ICH setpoints, mapped in the factory test report
- 7-inch touchscreen, 100 segments. study protocols run as profiles; constant conditions hold for the life of the programme
- Five capacities, one platform. 155L, 255L, 455L, 725L and 1025L — scale the study without revalidating procedures or retraining operators
Specifications
| Model range | RDS 155L / 255L / 455L / 725L / 1025L |
|---|---|
| Capacity options | 155L · 255L · 455L · 725L · 1025L |
| Temperature range | 10-65°C, resolution 0.1°C, uniformity ±0.5°C |
| Humidity range | 40-95% RH, uniformity ±3% RH |
| ICH conditions | 25°C/60% RH long-term, 30°C/65% RH intermediate, 40°C/75% RH accelerated |
| Photostability | Up to 60,000 lux, ICH Q1B dosing, integrated with climate programme |
| Controller | 7-inch touchscreen, 100-segment programming, audit trail |
| Chamber | 304 stainless steel, rounded corners, tempered glass viewing window |
| Data | 3-year onboard logging, USB CSV export, RS485 remote monitoring |
| Alarms | Over-temperature, over-humidity, sensor failure — logged with duration and recovery |
| Power | 220V/50Hz standard; 110V/60Hz available |
| Documentation | Factory test report, calibration certificates, IQ/OQ available |
| Compliance | ICH Q1A(Q2), GMP, CE certified |
Where you would install it
- Long-term stability. 25°C/60% RH programmes to 1025L scale for drug shelf-life studies
- Accelerated stability. 40°C/75% RH studies running unattended behind alarm protection
- Photostability. ICH Q1B light dosing to 60,000 lux without a separate cabinet
- Medical device aging. controlled temperature and humidity exposure for product and packaging aging
Frequently asked questions
What sizes are available?
155L, 255L, 455L, 725L and 1025L. Development batches usually start at 155L; production programmes run at 455L to 1025L.
Does it meet ICH Q1A(Q2)?
Yes — the RDS series is specified and factory-qualified against the ICH Q1A long-term, intermediate and accelerated conditions, with recovery verification and IQ/OQ documentation available.
What is the maximum illumination?
60,000 lux from the qualified photostability light bank, dosed per ICH Q1B and logged with the climate data.
How is data exported?
USB CSV export plus RS485 for central monitoring, with three years of onboard logging and a full audit trail.
Is it GMP compliant?
Yes — audit trail, alarm and operation records, calibration certificates and optional IQ/OQ documents support GMP-regulated use.
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