Drug stability test chamber

Constant Climete Chambers ICH-Complaint Light Source and Light dos Control

Constant Climete Chambers ICH-Complaint Light Source and Light dos Control

STIK Instrument Equipment Co., Ltd.

  • Characteristics
  • technical parameter
  • Options and accessories

 

Features:

 

-Achieve temperature -10~100 degrees, humidity 10%rh~95%rh

-5-level automatic defrosting function, stable and non-fluctuating temperature and humidity, meeting GMP, FDA-required frost-free operation (20 degrees or more)

- Manual defrost function

- Logging, audit trail function and export function (USB encryption export or host computer serial port export)

- Wind speed adjustable control function

- Total illumination and UV intensity control function (based on the total amount of 1.2 million LUX glare and near-ultraviolet light 200W.hr/m2 total)

- Have an electronic signature function that meets FDA requirements to ensure that test data is more objective

- Data real-time recording and export function (USB encryption export or host computer serial port export)

- Fault monitoring, alarm, recording and export functions (USB encryption export or host computer serial port export)

-4 level password function: login password, operator password, administrator password, advanced administrator password

- Three power-off mode selection functions: power failure recovery, stop or restart

- Historical data and historical curve query and download functions

- Maximum support for expanding 32GTF memory cards, which can store at least 10 years of data;

- Ambient temperature detection function

-PDF data export function (exported by PC software)

- PC software monitoring and synchronization control functions, supporting up to 32 devices for simultaneous control.

- Network function for remote monitoring.

- Mobile APP remote monitoring function.

-GPRS SMS alarm function

- Water level monitoring and automatic water replenishment

-Provide communication code, access and drug enterprise integrated equipment management platform

 

 

Lighting system:

Meeting the ICH (Q1A and Q1B) guidelines and meeting the guidelines of the National Pharmacopoeia Drug Stability Test.

Visible light (VS) D65 light source, 4500±500 lux, near-ultraviolet light (UV) with a wavelength of 320-400 nm; adjustable light intensity, illumination and ultraviolet radiation test can be completed simultaneously.

 

 

Visible/ultraviolet light detection sensor:

 

 

Computer monitoring software

Optional computer monitoring software, the device is compatible with the data interface of the comprehensive equipment management platform of the pharmaceutical company, and can provide data access, audit trail and electronic signature for review requirements.

 

 

Temperature and humidity range:

 

Compliance with the pharmacopoeia drug stability test guidelines 40 degrees / 75% RH or 30 degrees / 60% RH 180 days

25 degrees / 60% RH or 30 degrees / 60% RH365 days

 

 

Easy to operate and use:

 

 

 

0
Effective size / model PP-LQC series PP-LQC series H-LQC series TH-LQC series
150liter PMT-150L PMT-150LT IMT-150L IMT-150LT
250liter PMT-250L PMT-250LT IMT-250L IMT-250LT
450liter PMT-450L PMT-450LT IMT-450L IMT-450LT
750liter PMT-750L PMT-750LT IMT-750L IMT-750LT
1100liter PMT-1100L PMT-1100LT IMT-1100L IMT-1100LT
Temperature control range

0~70℃

(Plus light source plus 10 ℃)

0~70℃

(Plus light source plus 10 ℃)

0~70℃

(Plus light source plus 10 ℃)

-10~100℃

(Plus light source plus 10 ℃)

Humidity country 25~80%RH 20~95%RH 10~95%RH 10~95%RH
Humidity fluctuation ±3%RH ±3%RH ±1.5%RH ±1.5%RH
Display LCD display LCD display 7 inch touch screen 7 inch touch screen
Log, audit trail function No No Have Have
Electronic signature No No Have Have
Mobile APP No No Have Have
Curve display function No No Have Have
Level 4 permissions No Have Have Have
Adjustable wind speed No No Have Have
Data logging and export No No Have Have
Printer (micro) Optional Optional Optional Standard
Computer monitoring software Optional Optional Optional Standard
Program control Fuzzy intelligent P.l.D control
Humidity Sensor Imported electronic
Frost-free area Frost-free operation above 20 degrees

Light intensity (visible light)

6000Lux±500Lux 
light source D65,6500K
Visible light sensor Not configurable Not configurable Optional Optional
UV lamp sensor Not configurable Not configurable Optional Optional
Near ultraviolet wavelength 320~400nm
Near-ultraviolet fluorescent lamp intensity 0~5W/m2
Standards compliant Meets GMP, FDA, ICH (Q1A and Q1B) guidance requirements, cool white fluorescent light is greater than or equal to 1.2x10⁶Lux.hr, near ultraviolet light> /200w.hr/m²
Safety equipment Compressor overheat protection, over temperature protection, water shortage protection, overload protection, fan overheat protection
Operating temperature 5~35 degrees (It is recommended that the ambient temperature be lower than 30°C for long-term operation)

 

 

Volume (liter) 150 250 450 750 1100
Liner size (W * D * H) mm 540*400*700 640*440*890 750*500*1200 1250*500*1200 1250*735*1200
Dimensions (W * D * H)mm 700*830*1300 800*870*1470 910*930*1785 1410*950*1705 1430*1195*1800
Shelf Three floors Three floors Four floors Four floors Four floors
Cooling power 500W 750W 800W 1000W 1000W
Temperature uniformity(40℃) ±0.5℃ ±0.5℃ ±0.5℃ ±0.8℃ ±0.8℃
Heating tube power 1100W 1500W 2000W 2500W 3000W
Humidification tube power 750W 1000W 1200W 2000W 2000W
product weight About 115kg About 138kg About 216kg About 266kg About 310kg

 

-The test technical data is only applicable to the test results under the no-load condition of the equipment and the ambient temperature is 25 degrees!


-The appearance and parameters of the product are subject to change without notice. The appearance of the product may vary due to photography and printing. Please understand!

Computer monitoring software                         3Q
Paperless recorder                                               partition light
SMS alarm                                                             password lock
Power failure alarm                                             visible light / ultraviolet light total control system