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Photostability chamber KKS ICH 750

Photostability chamber KKS ICH 750

The POL-EKO KKS ICH 750 is the ultimate solution for laboratories managing high volumes of light-sensitivity assessments. While standard chambers focus on general stability, the KKS ICH 750 is specifically engineered to determine the effects of light exposure on drug substances and finished products. Its 923-liter internal volume (with a working capacity of 702L) provides unmatched space, while the steam humidification system ensures a silent, vibration-free environment?critical for preserving the physical integrity of samples during intense light exposure.

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SKU: KKS ICH 750 Categories: , Brand: Product ID: 21643

Description

The POL-EKO KKS ICH 750 is the ultimate solution for laboratories managing high volumes of light-sensitivity assessments. While standard chambers focus on general stability, the KKS ICH 750 is specifically engineered to determine the effects of light exposure on drug substances and finished products.6 Its 923-liter internal volume (with a working capacity of 702L) provides unmatched space, while the steam humidification system ensures a silent, vibration-free environment?critical for preserving the physical integrity of samples during intense light exposure.7+1Advanced Lighting & Speed:The chamber utilizes a sophisticated dual-module system to satisfy the “Option 2” requirements of the ICH Q1B guideline:VIS Module: High-intensity LED lighting (6500K, CRI > 90) simulating natural visible light.8UVA Module: Specialized UVA fluorescent lamps (320?400 nm) for ultraviolet exposure.9Rapid Cycles: The high-efficiency system can reach the required 10$1.2 text{ million lux-hours}$ and 11$200 text{ watt-hours/m}^2$ in approximately 29 hours, significantly shortening the time to market for new formulations.12Smart PRO: Intelligence and Compliance:Managed by a 7-inch color touchscreen, the Smart PRO controller serves as a comprehensive data management hub:13Automatic Dosing: The system tracks cumulative light exposure and automatically concludes the test once the ICH targets are met.CFR Readiness: When paired with optional LabDesk CFR software, the unit supports 21 CFR Part 11 compliance with electronic signatures and full audit trails.14Connectivity: Integrated Wi-Fi, LAN, and USB ports allow for remote monitoring and seamless data transfer to laboratory LIMS systems.15Robust and Reflective Construction:The chamber features a white powder-coated, acid-proof stainless steel interior (DIN 1.4301) to maximize light uniformity and reflection across all sample levels.16 The double-door system (solid outer for safety, glass inner for inspection) ensures that users are never exposed to UV radiation while allowing for visual monitoring of the test progress.

Specifications

Photostability Chamber KKS ICH 750 Specifications

The KKS ICH 750 is a large-capacity, high-performance photostability chamber engineered to meet the stringent requirements of ICH Q1B (Option 2) guidelines. It combines a massive internal volume with precise environmental control, enabling high-throughput testing of pharmaceuticals, cosmetics, and packaging in a single cycle.

 

Technical Parameters

  • Chamber Capacity: 923 Liters

     

  • Working Capacity: 702 Liters

     

  • Temperature Range (Light Off): 0 to 60C

  • Temperature Range (Light On): +10 to +50C

     

  • Humidity Range (Light Off): 10% to 90% RH

     

  • Humidity Range (Light On): 10% to 80% RH

  • Temperature Resolution: 0.1C

     

  • Humidity Resolution: 0.1%

     

  • Visible Light Source: LED modules, 6500K, CRI > 90

     

  • UV Light Source: UVA fluorescent lamps (320 – 400 nm)

     

  • ICH Q1B Test Duration: Approx. 29 hours (20.5h VIS / 8.5h UVA)

     

  • Temperature Protection: Class 3.3 according to DIN 12880

     

  • Nominal Power: 3100 W

     

  • Voltage: 230V 50/60 Hz

     

Physical and Material Data

  • Internal Dimensions (W x H x D): 1040 x 1200 x 600 mm

     

  • Overall Dimensions (W x H x D): 1270 x 1990 x 1010 mm

     

  • Internal Material: Acid-proof stainless steel (DIN 1.4301)

     

  • Housing Material: Powder-coated sheet (Smart PRO) or Stainless steel linen finish (IG Smart PRO)

     

  • Unit Weight: 275 kg

     

  • Shelves (Standard / Max): 2 / 2 (specific to light modules)

     

  • Max. Shelf Workload: 30 kg (100 kg for reinforced version)

  • Max. Unit Workload: 140 kg

     

Functional and Safety Features

  • Advanced Lighting System: Uses high-efficiency Osram/Philips components to ensure maximum uniformity and the fastest possible testing times.

     

  • Automatic Dose Integration: The Smart PRO controller monitors and calculates cumulative exposure, automatically terminating the light cycle once ICH thresholds (1.2 million Lux-hours / 200 Wh/m²) are reached.

  • Steam Humidification: Utilizes a steam generator for rapid and stable humidity control without the vibrations of ultrasonic systems.

     

  • Smart PRO Controller: Features a 7-inch color touch screen with alphanumeric keyboard, 40-program memory, and 100 segments per program.

     

  • Integrated Data Management: Features internal memory for up to 1 year of data, Wi-Fi/LAN connectivity, and LabDesk software for full documentation.

     

  • Mobile Design: Standard heavy-duty castors allow for easier positioning of the large-scale unit.

  • Double Door System: Full external solid doors with internal glass doors for safe sample viewing during active cycles.

Datasheet

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