- 안정성시험챔버는 의약원료 및 의약완제에 대하여 ICH-Q1A/Q1F, Q9/10, KFDA, USFDA, cGMP-21CFR211.166 Stability Test Regulation에 따라 주로 온습도안정성시험을 위하여 설계되고 개발된 장비임
- 주장비
(1) Stability test chamber
Temp. Control Range : 15℃ to 60℃ or more
Temp. Accuracy : ±0.2℃ or less
Temp. Uniformity : ±1.0℃ or less
Humidity Control Range : 20% to 80% or more
Humidity Control Accuracy : ±2.0% or less
Air Circulation Type : Forced Air Distribution System
Access Port : 2ea or more
Exterior Dimension(WxDxH) : 1450x1000x2100mm or less
Internal Volume : 1400ℓ or more
Number of Shelf : 8ea or more
Electric Power : 208/230V, 50/60hz, 3100W or less
Controller locking system : Key pad lock
Door locking system : Door lock
HMI touchscreen controller : easy to read controller, user-friendly display
Automatic recovery system : In the event of a power failure, the chamber to return to its original setpoint when power is restored
- 부속장비
(1) Temperature & Humidity electronic recorder : Temperature & Humidity sensor, recorder with calibration certificate, SD Card, Card reader, Software(Data viewer)
(2) Water recirculating system : For Humidity supply system
(3) IQ/OQ/PQ Validation : IQ/OQ/PQ Validation & Documentation
Measuring points – Temperature 10points
– Humidity 2points
Door open & Recovery test – 2min
Mapping test(OQ 24hr & PQ 24hr)