Shelf life test, also known as stability test, is performed in cosmetics and medical products.
Stability Test; the physical, chemical, microbiological quality standards of cosmetic products during their shelf life, as well as their sustainability when stored under appropriate conditions. Stability Test; 1, 28 and 90. products are subjected to color, odor, appearance, pH, weight change, viscosity, microbial load and anti-microbial efficacy and packaging tests according to international European Pharmacopoeia analysis methods. Breaking, cracking and sealing tests of packaging materials are just as important as product tests.
Cosmetic products cannot be a standard stability test procedures because they are very diverse. Test protocols can be determined by establishing scientific foundations depending on the products. The type of lot to be tested is determined (eg laboratory, pilot, or production sample), which may be a representative sample of the product to be commercially available.
When the stability test is performed in real time or under accelerated conditions;
· Odor, color, appearance
· Changes in packaging
· PH
· Viscosity
· Weight change
· Other specific tests, if necessary, and microbial testing demonstrating the ability of the product to inhibit microbiological growth during normal use
· For special product types, analytical data should be evaluated according to other parameters.
It should also be based on scientific data at higher temperatures and times or at the specified temperature, by selecting the appropriate criteria for each product type. These parameters and procedure should be evaluated by experts and on the basis of experience.
We can support you at raw material quality control stage and to prove the safety of your finished products.
Stability tests are generally tests to determine / verify the shelf life of the product. Stability tests are expected not to deteriorate the physicochemical structure of the product and to be suitable for microbiological aspects.
Stability tests can be performed both by holding the product for normal shelf life and by changing the ambient conditions (such as increasing the temperature to accelerate). Stability tests by increasing the temperature are also called accelerated aging tests.
In the accelerated aging test, the test time is shortened by exposing it to temperatures higher than the normal shelf life temperature and results are obtained in a shorter time.
Stability tests are generally performed in two stages.
- Isothermal stability tests at constant temperature:
Long term stability tests (UST),
Accelerated stability tests (HST) (Stress Tests),
The difference between these two tests is that the operating temperatures are different than 15 ° C. That is, the temperature used in the HST should be 15 ° C higher than the temperature used in the UST. In both methods, the activation energy is calculated and the shelf life of the product is determined.
Stress Test:
Storage conditions are determined according to the type of active substance and pharmaceutical form,
Storage conditions are changed;
Working at high temperatures such as 50 ° C, 60 ° C, 70 ° C, Humidity conditions higher than 75% are provided, Exposure to oxidation, Hydrolysis event observed at different pHs, Exposure to light (Photostability).
Identification of degradation products, Validation of analytical method, can be done in a single batch.
Amacıyla Stability Tests ”are performed to ensure product safety of cosmetics, which are an integral part of our daily life. Stability Tests are indicative of any changes in the physical, chemical and microbiological criteria of the product during the specified shelf life.
Apart from the functional uses of cosmetics, it is extremely important that they are stable. Stability tests enable us to learn about the physical, microbial and chemical quality of the product as well as the adequacy of the packaging during the storage, transportation, sales and consumption of the end user.
Stability tests are carried out in two ways: “Real Time and Accelerated Aging Tests..
In the real-time stability test, the product is kept in an environment that meets the normal sales conditions and the physical, microbiological and chemical changes in the product are monitored. Since there are difficulties in performing real-time stability tests in products with shelf life of 1-2, which are covered by durable consumer goods, “Accelerated Aging Tests ılan which are commonly used in mathematical modeling are applied today.
Accelerated aging tests are carried out in artificial environments containing temperature and humidity outside normal sales and consumption conditions. After accelerated aging tests, physical, microbial and chemical analyzes of the product are required to ensure that we have prior knowledge of the stability of the product.
Shelf life of medical products:
Rapid aging tests in medical products are performed as accelerated aging test. The method used for shelf life testing in medical products is the ASTM F 1980 standard. It also determines the strength of the product and how long it can take us.
According to this standard, the fast aging time of the product is calculated by taking into account the temperature and real-time shelf life time that the product can withstand according to the structure and packaging characteristics of the product.
An example calculation is given below.
Product real-time shelf life: 3 years (1095 days)
Temperature of the product to be analyzed: 65 ° C
Stability Test Analysis Time: 56 days
As a result of this calculation performed with the Arrhenius equation, the fast aging time of the product is calculated. At the end of this period, performance tests and physicochemical and microbiological tests are performed.
After the stability test in medical products, the starilite test and the leak test are the main tests.
Shelf life of cosmetic products
It is extremely important that cosmetics are stable in addition to their functional uses. Stability tests enable us to learn about the physical, microbial and chemical quality of the product as well as the adequacy of the packaging during the storage, transportation, sales and consumption of the end user.
Stability tests are carried out in two ways: “Real Time and Accelerated Aging Tests..
Manufacturers should demonstrate that there are no unacceptable changes in cosmetic products within the prescribed lifetime.
It is a test to verify that the minimum durability of cosmetic products under specified storage conditions and to maintain their reliability during this time.
At the end of the stability test, it should be shown that the product is microbial safe and there is no change in physicochemical aspect by analysis.
Guidance on the microbiological control of cosmetic products Article 5.2 states that “The manufacturer shall have the knowledge to support the microbiological stability of the product. The manufacturer shall demonstrate that there are no unacceptable changes in the product within the prescribed lifetime. ”Indicates the necessity of shelf life studies.
Accelerated aging tests are carried out in artificial environments containing temperature and humidity outside normal sales and consumption conditions. After accelerated aging tests, physical, microbial and chemical analyzes of the product are required to ensure that we have prior knowledge of the stability of the product.
Before starting the accelerated aging tests, all the necessary information about the content, packaging and physical structure of the product must be obtained and the information must be notified by the manufacturer in advance. Aging tests of cosmetic products
37, 40, 45, 1, 2,% 3,% 6,% 10,% 55,% 75,% XNUMX, XNUMX ° C, XNUMX ° C, XNUMX ° C, XNUMX ° C, XNUMX ° C varies. Some products are also applied at low temperatures.
At the end of the holding period, the products are subjected to color, odor, appearance, pH, weight change, viscosity, microbial load and, if necessary, antimicrobial efficacy and packaging tests performed according to international pharmacopoeia analysis methods and examined physically, microbiologically and chemically. Breaking, cracking and sealing tests of packaging materials are just as important as product tests.
In accelerated aging studies, it should be understood that the analysis parameters determined according to the type of product cannot maintain the stability of the products during the predicted shelf life if the test results show any negativity and the manufacturer should make the necessary changes in both the content and packaging of the product.
For example, for a wet wipe that has a shelf life of 2 years, X Accelerated Aging Test X is applied at 40 and 50 degrees. The waiting time of a product at 2 grade for 40 annual shelf life is 210 days. 2 year shelf life of the same product is at 50 degrees and 105 days. As you can see, the “Accelerated Aging Test süre is inversely proportional to the temperature. The higher the temperature, the shorter the time. However, it should be noted that at the end of this period, there should be no physical, chemical and microbiological problems. Therefore, when determining this temperature, the softening temperature of the packaging of the product, the decomposition temperature of the product content, and so on. parameters should be considered.
At the end of the holding period, the products are subjected to color, odor, appearance, pH, weight change, viscosity, microbial load and, if necessary, antimicrobial efficacy and packaging tests performed according to international pharmacopoeia analysis methods and examined physically, microbiologically and chemically. Breaking, cracking and sealing tests of packaging materials are just as important as product tests.
In accelerated aging studies, it should be understood that the analysis parameters determined according to the type of product cannot maintain the stability of the products during the predicted shelf life if the test results show any negativity and the manufacturer should make the necessary changes in both the content and packaging of the product.
As a result, Accelerated Aging Tests are the tests that should be performed to prevent potential problems that may occur in the product and to prevent material and moral damages such as the collection and recall of the product.
As a result, shelf life tests (Stability Tests / Accelerated Aging Tests) are necessary tests to prevent potential problems that may occur later in the product and to prevent material and moral damages such as the collection and recall of the product.
You can get shelf life and stability tests from our laboratory EUROLAB.