In the climatic chambers' field, alongside the most common climate tests about temperature and humidity, many materials demand testing for solar radiation.
However, when we talk about photostability chamber and photostability test we mean something specific that has to do with a particular category of products: drugs and cosmetics.
What is Photostability?
By photostability, we mean the capacity of a compound to keep its active ingredients unaltered when exposed to sunlight.
The principle of photostability also applies to paints, for example, which must demonstrate that they do not discolour easily due to the sun but, by convention, in our sector, we are used to talking about photostability tests in relation to drugs and cosmetics.
The sunlight resistance of these products is important for two reasons.
In the first place because they come into direct contact with our body and our organism and every alteration factor of the compound must be carefully examined.
Secondly, because some of these products have the precise purpose of being exposed to sunlight, we think of all skin creams and especially tanning creams. Any degradation caused by sunlight must therefore be sought and eliminated through the appropriate photostability test in a climatic chamber.
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How does the Camera for the Photostability test work?
The photostability test in a climatic chamber is carried out by means of lighting capable of simulating sunlight. For this purpose, a set of phosphorescent and UV lamps is implemented that emits both visible light and ultraviolet radiation. Exposure to visible light and ultraviolet radiation can be performed simultaneously or separately.
The chambers for the photostability test can be chambers built specifically for the test or climatic chambers to which the set of lamps necessary for carrying out the tests is mounted.
The specific chambers for the photostability test are usually small due to the nature of the head products, ie drugs and cosmetics.
What rules regulate the Photostability Test in the Climatic Chamber?
International standards for the safety of drugs and cosmetics are governed by the ICH, abbreviation for International Conference for the Harmonization of Technical Requirements for the Registration of Medicines for Human Use.
The specific standard that regulates the photostability test in a climatic chamber is the ICH-Q1B.
As specified in the document, the test can be divided up into a maximum of four phases: first by exposing the compound directly to light and then inside the various boxes and packaging that accompany its circulation and sale.
The standard also establishes what type of lamps a climatic chamber must mount to perform the photostability test, and they are:
- White phosphorescent lamps as established by ISO 10977
- UV lamps having a spectral distribution from 320 nm to 400 nm, with a maximum energy emission between 350 nm and 370 nm.
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The FDM Climatic Chamber for the Photostability Test
All FDM climatic chambers can be equipped with the aforementioned sets of lamps and made suitable for carrying out the photostability test.
In addition, FDM is pleased to discuss with the customer to build a customized photostability chamber that meets all the needs of the end-user.
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