All you need to know about photostability test chambers

Definition

What is a photostability test chamber?

A photostability test chamber is a climate chamber with light which generates defined light conditions in addition to temperature and humidity. Light climate chambers are used for stability testing to determine the shelf life of products. They are used in different sectors, such as the pharmaceutical, cosmetics, and food industries. Photostability tests examine the influence of temperature, humidity, and exposure to light on a product. The test materials are first stored in a climate chamber under defined conditions (constant temperature, constant relative humidity, and constant light intensity) for a specified period of time before the shelf life is checked. The test materials are exposed to light using both visible light (VIS) and ultraviolet radiation (UV), which is considerably more aggressive than VIS radiation.

Structure

Structure and function of a photostability test chamber

A light climate chamber features an interior (usable space) in which the required light and climate conditions are generated and maintained over a predefined period of time.

The test materials are sequentially irradiated with UV light and VIS light in the usable space. When using the light-dosage measurement option, the corresponding light source is automatically switched off once the preset light dosage has been reached.

The UV fluorescent tube technology ensures standard-compliant irradiation with the specified standard spectrum according to ICH guideline Q1B.

The VIS light unit with three different types of LED perfectly simulates daylight according to standardized light D65.

Photostability test chamber applications

Photostability tests according to guideline ICH Q1B

Extensive stability testing must be performed as part of the approval process for drugs. According to the guidelines from the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) the photostability of drugs must also be tested. The test materials are exposed to both visible light (VIS) and ultraviolet radiation (UV). If the drug proves to be sensitive to light during testing, the manufacturer must provide separate instructions for storage. 

BINDER photostability test chambers ensure reproducible light and climate conditions as well as the perfect distribution of light, temperature, and humidity. The light systems used fulfill the requirements of ICH guideline Q1B, Option 2. They can be used to carry out a complete ICH photostability test in just three days.

Accelerated shelf-life testing in the food industry

In the food industry, shelf-life testing is carried out to determine the shelf life of a product under different storage conditions and therefore calculate the exact best-before date. To achieve meaningful results quickly, food manufacturers perform accelerated shelf-life testing (ASLT). This involves using a constant climate chamber to simulate temperature, humidity, and light at predefined values. The test also evaluates changes in color (fading) which can be caused by exposure to light. The samples are stored at different temperatures, such as 20 °C, 30 °C, and 40 °C, and exposed to a defined light intensity. Finally, color loss is measured as changes in hue (ΔH) as a function of different time intervals. Chemical, microbiological, physical, and gustatory changes are measured at regular intervals and the best-before date of the products is established in this way.

Standards for working with photostability test chambers

In the pharmaceutical industry, the ICH Q1B guideline regulates stability testing under the influence of light. 

The exact irradiation dose with both visible and UV light and complying with the light spectra specified in ICH Q1B is of crucial importance. BINDER photostability test chambers reliably meet these criteria.

With the aid of optional, network-enabled APT-COM GLP Edition software, the test parameters can be reliably recorded and documented according to Good Laboratory Practice (GLP) and in compliance with FDA Regulation 21 CFR Part 11.

You can read all about ICH photostability testing and everything to consider before purchasing a climate chamber in our whitepaper “Stability testing according to ICH Q1A (R2): Basics and technical solutions.” 
 

Selection criteria when buying a photostability test chamber

For photostability tests according to ICH Q1B, the light sources and illuminance levels are crucial. The light spectra and illuminance doses are precisely specified. The visible light (VIS similar to ISO 10977 (1993)) must reach a VIS light dosage of at least 1.2 million lux hours and the near ultraviolet (320 nm to 400 nm) dosage must be at least 200 Wh/m². There are illumination cassettes providing flexible placement, so homogeneous light distribution is guaranteed in the interior. In terms of the irradiation by UV light, according to ICH guideline Q1B, a significant proportion of the UV radiation must be in the range of 320 to 360 nm as well as in range of 360 to 400 nm. The BINDER photostability test chambers meet this requirement in full.

 

A distinction is made between systems that use an illumination cassette for UV and VIS and those that use a separate UV illumination cassette and VIS illumination cassette. Separate illumination cassettes for VIS and UV light are used in the BINDER photostability test chambers. After half the test time, the samples are swapped and exposed to the other light source.

The air movement is a constant climate chamber is crucial for climate homogeneity inside the unit. Only homogeneous climate conditions, both in terms of space and time, provide reliable results. Double-sided horizontal air flow allows for particularly homogeneous conditions. The air is extracted via a perforated rear wall and returned back into the usable space after reconditioning. The air is distributed evenly into the chamber via small perforations in the side walls and therefore flows evenly over the test materials from both sides.

  • Type of water supply and disposal: 
    The water can be supplied and disposed of via a connection to the on-site water supply or via large-volume water canisters for fresh water supply and collecting condensed water that are mounted directly on the climate chamber.
  • Type of humidification:
    The most common types of humidification are steam and ultrasonic humidification systems. Climate chambers from BINDER feature steam humidification systems, as these ensure quick and accurate humidification and this technology prevents condensation in the interior.
  • Water quality:
    Fully desalinated water with a conductivity between 1 µS/cm and max. 20 µS/cm is the prerequisite for reliable continuous operation of the unit. If the water quality is inadequate, the tap water must be treated. The BINDER PURE AQUA SERVICE water treatment system can be used here as an accessory, both when using via the mains water connection and when the units are supplied via canisters.

  • As many components as possible in the unit should be made from corrosion-resistant stainless steel.
  • A triple door gasket guarantees maximum reliability.
  • Long-life steam humidifiers have been proven to have a very low failure rate of less than one percent in the first five years of continuous operation.

Photostability test chambers for testing according to ICH Q1B

ICH light system

When combined with the new ICH light modules, our latest generation of climate chambers become photostability test chambers. 

The light spectra fulfill the requirements of ICH guideline Q1B, Option 2. Modern LED technology is used for visible light. However, the UVA range cannot be covered with the current LED technology in accordance with ICH, which explains the use of fluorescent tubes.

The irradiance levels are designed so that a complete test can be carried out in three days. The light intensities were deliberately limited to this level to avoid thermal effects during the photostability test.

The ICH light modules are available with or without light-dose control (LQC) and in two sizes.  They can be combined with climate chambers from the KBF and KBF PRO series in sizes 260, 470, and 720. For ICH photostability tests without humidity, the light modules can be combined with units from the KB PRO series.

  • ICH 260/470 without light-dose control for unit sizes of 260 and 470 liters
  • ICH 720 without light-dose control for a unit size of 720 liters
  • ICH-LQC 260/470 with light-dose control for unit sizes of 260 and 470 liters
  • ICH-LQC 720 with light-dose control for a unit size of 720 liters

Scope of delivery for ICH light modules:

  • VIS illumination cassette
  • UVA illumination cassette
  • For the ICH-LQC variant, two additional light sensors (VIS and UVA) for light-dose control
  • Supply unit with ballasts / power supply units
  • Cabling 

Controller functions

  • The ICH light system is connected to the unit controller via data cables
  • Time-segment programming for lighting control via unit controller
  • Light-dose control via unit controller

Units without humidity control

KB PRO 260 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

With a temperature range of +18°C to +32°C

 

KB PRO 470 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

With a temperature range of +18°C to +32°C

KB PRO 720 with ICH light module

Light module ICH 720 or ICH-LQC 720

With a temperature range of +18°C to +32°C

Units with humidity control

KBF 260 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

 With a climate range of +20°C to +50°C  and 20% to 50% RH

 

KBF 470 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

With a climate range of +20°C to +50°C and 20% to 50% RH

KBF 720 with ICH light module

Light module ICH 720 or ICH-LQC 720

With a climate range of +20°C to +50°C and 20% to 50% RH

Units with humidity control and extended temperature range

KBF PRO 260 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

With a climate range of +10°C to +50°C and 10% to 80% RH

 

KBF PRO 470 with ICH light module

Light module ICH 260/470 or ICH-LQC 260/470

With a climate range of +10°C to +50°C and 10% to 80% RH

KBF PRO 720 with ICH light module

Light module  ICH 720 or ICH-LQC 720

With a climate range of +10°C to +50°C and 10% to 80% RH