Stability tests performed on biocidal products are carried out in 3 different ways, depending on the product. Stability tests are carried out as Accelerated Stability, Long Term Stability and Open Package Stability tests.
If the physical and chemical tests for the biocidal product are carried out and the results are appropriate, all stability tests should be started at the same time without waiting for the product.
Along with all stability tests, the initial physical test and chemical tests must be performed in the same laboratory. In the stability test results, the acceptable tolerance limit value is accepted as a maximum of "±10%" over the initial value.
If there is an easily perishable active substance such as liquid chlorine in the content of the biocidal product, the tolerance limit for the active substance can be accepted as "±35%" in stability tests, provided that it is proved that the microbiological activity of the product does not decrease.
Accelerated stability tests
Accelerated stability tests are carried out for 14 days at a temperature of "54±2ºC".
If the biocidal product is a product that can be damaged above 50ºC, the time and temperature values specified in "Table-2" can be used.
Open package stability tests For stability tests in open packaging, the biocidal product is stored at a temperature of "25±2ºC" at a temperature of "25±2ºC" for the duration of use after the product is opened, as indicated on the label, in air-conditioning cabinets, with open packaging, and analyzed and reported in 3-month periods from the date of production until the 12th month.
For biocidal products with an open package lifetime of more than 12 months, after these periods are completed, the product is analyzed every 6 months and the results are reported.
If the biocidal product is in the "Type-19 biocidal product" class, the maximum period of use after opening the biocidal product is specified as one year. For ready-to-use biocidal products applied by spraying in stability tests, whether the sprayer works successfully before and after stability should be tested.
During this test, the amount of spray sprayed each time and the spray pattern and obstructions on the nozzle should be examined.
Considering the necessity of performing all stability tests in the same laboratory and on the same batch, the manufacturer should provide the laboratory with a sufficient number of samples, including the witness sample.
If the number of samples is not sufficient, analyzes should not be started. The first physical and chemical tests performed based on the stability tests to be carried out are considered as the "0th day test".
When the suitability of physical and chemical tests is determined, the product is placed in the air-conditioning/stability cabinet and stability tests are started.
In stability tests, after the products are removed from the air-conditioning cabinet, physical and chemical tests are carried out without waiting.
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