In the pharmaceutical industry, stability testing refers to the process that tests how well a product retains its properties over the lifetime of the product. This type of testing offers a highly flexible and compliant way to conduct tests during the development phase of almost any pharmaceutical product.
A small-scale stability testing unit can be set up in minutes and can allow for the simulated exposure of the effects of various environmental conditions, including weather, temperature and humidity, on a pharmaceutical product. It is important to note that there are many small-scale testing units available. When selecting a testing unit, it is important to conduct extensive research in order to find the product that is best suited to the needs of a particular project.
A Step-by-Step Guide
Professionals have established what stability testing is but what does it entail? The next section of this article will give a brief example of how stability testing can be used to test how the properties of a pharmaceutical product reacts to different levels of humidity.
1) A humidity capsule will be used to generate the required humidity. This humidity capsule needs to be pierced and placed in the stability testing unit. Humidity capsules can provide relative levels of humidity in the range 0-95% are available in 5% increasing increments. The appropriate humidity capsule should be selected based on the objectives of the test.
2) Place a sample of the pharmaceutical product in a separate compartment of the stability testing unit.
3) Seal the testing unit with a sensor cap. The sensor cap will measure the level of humidity within the unit for the duration of the test.
4) Dock a logger cap onto the base of the testing unit. Connect the logger cap to a computer via a USB cable to collect and record the humidity readings for the duration of the test. If the initiated tests are outside wireless range for communication with the basestation then cabling and aerials can be used to ensure wireless communication.
5) Incubate tests at the required temperature. When the tests are complete dispose of the humidity capsule and test chamber.
Benefits of Small-scale Stability Testing Units:
Using small-scale testing to conduct tests during the development of a pharmaceutical product allow for a variety of practical benefits.
These benefits include:
• The need for environmental chambers is eliminated
• Each test is monitored in its own micro-humidity chamber
• A full range of humidity and temperature conditions are available
• Continuous data is collected throughout the study for each test
• Improved sample integrity and less risk of cross contamination
• Sensors can be easily calibrated
• Only a small amount of space is requirement
• There isn't a need for salt solutions or desiccators
• It is easy to set-up
• It is ideal for use with toxic materials
• The system can be used for monitoring and mapping applications
• Data can be automatically backed up
Amebis is a technology company offering innovative and compliant Stability testing products and services to the healthcare and food industries.
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