The stability test chambers are used in the pharmaceutical, food and cosmetics sector, able to store the products, such as biological samples, reagents, sera, vaccines, insulin, some antibiotics, eye drops and eye ointments, to be stored at 2°C to 8°C, and not lose their properties, through temperature conservation, with advanced technology, as part of a production or regulatory process.
The stability test chamber is distinguished by its ability to handle complex environmental conditions, extreme temperatures and adequate humidity levels. In fact, it is developed to maintain controlled temperature conditions for a very long period of time.
Functions of the Stability Test Chamber
This equipment complies with the stability control of different materials. In a test chamber, it simulates the values of temperature and humidity. On the other hand, the stability test chambers use tools based on constant and variable climates, capable of prolonging the fixity of the products to a defined level. In addition, they are used for sample stress testing, material justifications, expiration testing, long-term stability testing and for fixed storage.
It should be noted that the stability conditions of the products depend on the shelf life of the active substances and of the excipients or adjuvants, which is ultimately conditioned by their structure and chemical and physicochemical properties. As well as external factors such as temperature, humidity, air and light, which induce or accelerate reactions that devalue the quality or activity of the product.
Factors involved in stability testing
The stability of the products, influences through the factors and active principles, manufacturing processes, dosage form, type of container, coating, closure and environmental conditions, when the drugs are subjected to temperatures higher than the appropriate, and can be affected by the following properties:
- Chemical: oxidation, reduction, hydrolysis, solvent evaporation, polymerization, volatilization of essential oils and destruction of heat labile substances (proteins) are caused.
- Physical: Original properties are altered, such as appearance, uniformity, and so on.
- Therapeutic: therapeutic effects are altered.
- Toxicological: changes in toxicity due to formation of toxic products occur.
In this sense, as a result of this structure, the products need specific storage conditions, should remain at all times within the range of temperatures between 2°C and 8°C, these products are commonly called heat labile.
Both the efficacy and the stability of the preservative agents are very sensitive to a variety of factors and should be monitored in all stability studies.
Components for Product Stability in the Climate Chamber
It is necessary to recognize the importance of components, such as diluents, lubricants, binders and disintegrants, on the stability of products, as well as the influence of inactive excipients on the stability of solutions, emulsions, ointments, etc. The intervention of these, often accelerate the chemical degradation of the active ingredient, modifying its pharmacokinetic characteristics, such as time separation, dissolution time, friability, hardness, among others, otherwise influence the biological availability of the drug and modify its absorption possibilities, causing undesirable organoleptic changes.
Climate Chamber of Stability Study in Kalstein
At Kalstein, we are able to offer you the best medical equipment, capable of meeting all the requirements of our clients. We offer the best technology, as is the case of the YR model stability study climate chamber, which provides all the benefits for the preservation of medicines. For this reason, our medical team has attractive features such as: LCD screen with integrated dots matrix, subtitles in Chinese and English, design for maximum operational comfort. Display parameters: temperature, humidity, cycle, run time, run time and stop time. The adaptive PID controller, precisely controls temperature and humidity, prevents temperature from rising, keeps ambient temperature stable and uniform. User password protection, built-in multi-functional memory menu, multi-device connection (up to 16 drives), real-time monitoring.
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