Following ICH Stability Testing Guidelines (ICH Q1B), KamTek’s photostability chambers are precisely controlled and regularly calibrated to meet the minimum light exposure requirements:
| Parameter | Requirements (per ICH Q1B) |
|---|---|
| Total Light Exposure | ≥1.2 million lux-hours |
| Near-UV Energy | ≥200 Wh/m² |
| Temperature Monitoring | Continuous |
| Humidity control | Optional / Customizable |
We can tailor exposure protocols to include cool white fluorescent lamps, near-UV lamps (320–400 nm), or custom light profiles based on your formulation and packaging material.
Tests can be performed on unpackaged or packaged products to assess photodegradation under realistic or stress conditions.
What We Offer
We serve biopharma, research institutions, and CROs requiring GLP-level data integrity, rapid turnaround, and expert handling of light-sensitive or temperature-sensitive compounds.
Applications of KamTek’s Photostability Storage
Our services support a wide range of research, clinical, and commercial applications:
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We consult with your team to define the appropriate ICH Q1A/Q1B protocol, selecting suitable temperature, humidity, and/or light conditions.
Protocols can follow your internal SOPs or be developed by KamTek.
Products are received, inspected, and logged into our secure system with full chain-of-custody documentation.
Samples are placed in validated photostability chambers for light and UV exposure at a controlled temperature and humidity conditions. A positive and negative control are also placed to validate the process.
Each chamber is continuously logged for light, temperature, and humidity, with redundancy and alert systems in place.
KamTek can pull and package samples at predefined intervals for analytical testing at your site or ship to third-party labs under controlled conditions.
At the end of the study or in between, we provide Certificate of ICH Q1B-compliant light exposure, Environmental logs (temperature/humidity), Sample map and inventory logs. Optional interim reports upon request
Setting up ICH photostability storage requires significant capital investment in storage devices, monitoring services, documentation, and dedicated personnel. By outsourcing to KamTek, you eliminate these costs while ensuring compliance.
Our clients have the flexibility to withdraw from the study at any stage, ensuring full control over their R & D efforts.
KamTek meets ICH Q1B, cGMP, and ISO compliance, ensuring that your stability data is globally accepted by regulatory authorities like the FDA, EMA, and other health agencies
Clients can choose between-Dedicated storage (Reserve an entire chamber for your study), Shared storage (Cost-effective solution for smaller sample quantities).
Our facility has oversized backup power generator and stability chambers undergo preventive maintenance with temperature and humidity probe calibrations, and we provide round-the-clock automatic and manual monitoring to prevent disruptions.
KamTek is your one-stop partner for all associated services related to stability testing, offering secure temperature-controlled storage, shipment logistics, and additional lab testing (microbial and cell culture, assays and other tests) to streamline your workflow.
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Our team of experts can help draft protocols and determine test durations based on your product and packaging specifications.
