Photostability testing in accordance with ICH Q1B using POL-EKO KKS ICH chambers

Photostability testing in accordance with ICH Q1B using POL-EKO KKS ICH chambers

Photostability testing is a critical area of pharmaceutical development and quality assurance. The ICH Q1B guideline precisely defines the light-exposure conditions under which the stability of preparations/products must be tested.

The POL-EKO KKS ICH series is a photostability climate chamber solution specifically designed to meet these requirements.

ICH Q1B compliance in practice

KKS ICH chambers are designed to enable complete photostability testing in accordance with ICH Q1B under controlled conditions. According to the documentation, the system can deliver the required light exposure within as little as 29 hours, enabling time- and energy-efficient operation.

The chambers:

• use a combined UVA and visible-light (VIS) system
• provide uniform illumination through an optimised optical design
• use premium lighting components (Osram, Philips)

The light has a near-natural spectrum (CRI > 90, 6500K), which is particularly important for reproducibility.

Environmental control and temperature protection

KKS ICH chambers are not merely lighting systems; they are fully functional climate chambers. The temperature range is 10–50 °C, while relative humidity can be controlled within the 10–90% RH range.

The system has temperature protection class 3.3 in accordance with DIN 12880, which is an important safety parameter in pharmaceutical environments.

The combination of uniform illumination and stable climate control ensures that test results meet ICH Q1B requirements.

SMART PRO control and data management

The KKS ICH series is available with SMART PRO control and a 7” colour touchscreen

This enables:

• precise parameter management
• programmable test cycles
• detailed data logging

Of particular importance in pharmaceutical environments, the system can be integrated with LabDesk CFR software, which supports 21 CFR Part 11 requirements.

Who is the KKS ICH series recommended for?

POL-EKO KKS ICH photostability chambers are a purpose-designed solution primarily for:

• pharmaceutical development laboratories
• stability testing laboratories
• quality control departments

where testing in accordance with ICH Q1B is not optional but mandatory.

Summary

The POL-EKO KKS ICH series is not a general-purpose climate chamber but a system specifically optimised for photostability testing. UVA and VIS lighting technology, uniform illumination, precise climate control and SMART PRO control work together to ensure compliance with ICH Q1B.

In regulated environments, the reliability and traceability of test results are crucial. A properly configured system provides genuine added value in this respect.

This blog post was prepared based on the official manufacturer documentation for POL-EKO KKS ICH photostability chambers.