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Photostability chamber KKS ICH 240

Photostability chamber KKS ICH 240

POL-EKO KKS ICH 240 Photostability Chamber The KKS ICH 240 is a 315-liter professional climatic chamber purpose-built for high-speed photostability testing in pharmaceutical and cosmetic laboratories. It features two dedicated light modules (UVA and VIS) that allow for a complete ICH Q1B compliant test in as little as 29 hours. With a temperature range of +10?C to +50?C and humidity control from 10% to 90% RH, it provides the stable, vibration-free environment required for light-sensitivity assessments. Managed by the Smart PRO controller, it ensures full data integrity and audit-readiness for regulated industries.

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SKU: KKS ICH 240 Categories: , Brand: Product ID: 21642

Description

The POL-EKO KKS ICH 240 is designed to determine if light exposure results in unacceptable changes to drug substances or finished products.6 While standard climatic chambers focus on heat and humidity, the ICH version integrates advanced lighting systems to simulate the “Option 2” light source specified by the International Council for Harmonisation (ICH).7 Its vibration-free steam humidification system ensures that even the most delicate samples are not physically disturbed during long exposure cycles.ICH Q1B Compliant Lighting System:The chamber is equipped with two specialized lighting modules that work in tandem to achieve the required exposure levels:8VIS Light Module: LED light (6500K, CRI > 90) providing high-quality visible light close to natural conditions.9UVA Light Module: UVA fluorescent lamps specifically for the 320?400 nm range.Speed & Efficiency: The system is capable of delivering the required 10$1.2 text{ million lux-hours}$ of visible light and 11$200 text{ watt-hours/m}^2$ of UV energy in roughly 29 hours for flat samples.12Smart PRO Controller & Compliance:The unit features the Smart PRO 7-inch touchscreen, which acts as the command center for stability protocols.13 It provides:Integrated Light Dosing: The controller tracks the cumulative light dose and can automatically end the program once the ICH threshold is reached.1421 CFR Part 11 Readiness: When used with the optional LabDesk CFR software, the system provides electronic signatures, audit trails, and secure data logging required for FDA/EMA compliance.15Connectivity: Standard Wi-Fi, LAN, and USB ports allow for remote monitoring and effortless data export.16Design and Reliability:The interior is finished in white powder-coated acid-proof stainless steel to maximize light reflection and uniformity.17 A double-door system (solid outer, glass inner) allows for safe viewing without exposing the user to UV radiation or disrupting the internal temperature and humidity.18

Specifications

Photostability Chamber KKS ICH 240 Specifications

The KKS ICH 240 is a specialized climatic chamber designed to meet the requirements of ICH Q1B (Option 2) for photostability testing. It provides integrated control over temperature, humidity, and light (UV and Visible), ensuring precise and reproducible conditions for pharmaceutical stability studies.

 

Technical Parameters

  • Chamber Capacity: 245 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: 1.0%

     

  • Light Source: Fluorescent lamps according to ICH Q1B Option 2

  • UV Spectrum: 320 – 400 nm

  • Visible Spectrum: 400 – 800 nm

  • Light Control: Automatic dose control (Lux-hours and Watt-hours/m2)

  • Temperature Protection: Class 3.3 according to DIN 12880

     

  • Nominal Power: 3150 W

Physical and Material Data

  • Internal Dimensions (W x H x D): 600 x 800 x 510 mm

  • Overall Dimensions (W x H x D): 820 x 1140 x 1030 mm

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

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

     

  • Unit Weight: 160 kg

  • Shelves (Standard / Max): 3 / 10

  • Max. Shelf Workload: 10 kg

  • Access Port: 30 mm diameter on left wall

     

Functional and Safety Features

  • ICH Q1B Compliance: Specifically designed to fulfill photostability guidelines with independent monitoring of UV and Visible light intensity.

     

  • Ultrasonic Humidifier: Provides precise humidity control using demineralized water.

  • Smart PRO Controller: Features a 7-inch color touch screen for programming complex test cycles and monitoring dose accumulation.

     

  • Automatic Light Shut-off: The system automatically turns off the lamps once the predefined dose (Visible or UV) is reached.

  • Data Logging: Internal memory for recording temperature, humidity, and light intensity with export via USB or LAN.

  • Double Door System: Includes an outer solid door and an inner glass door to minimize environmental disturbance.

     

  • LabDesk Software: Included for advanced data management, reporting, and 21 CFR Part 11 compliance.

Datasheet

Download Photostability chamber KKS ICH 240 Datasheet

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