If you wish to get a brief understanding of the working and the use of the stability chamber, this blog will provide you with answers, read on to see if your stability chamber is meeting all these requirements.
What is the use of stability testing in the chamber?
Placing samples in environmentally controlled chambers to determine their quality and product value over a period of time under the influence of various environmental changes such as temperature difference, humidity, and light changes tests the performance of the sample. This data is useful in the research and development stage of any product before it is introduced to the market. The industries that greatly rely on this testing format are pharmaceutical manufacturers, medical device manufacturers those in the food manufacturing industry, dealing with life science samples, etc.
What is the reason for stability studies?
Stability studies are a must for certain industries such as those dealing with drug development. The stability testing results reveal the influence of physical, chemical, and microbiological reactions on a sample, the test reveals the efficacy of the sample and the integrity that the final product shows when the testing period is over. A stability study program ensures the commercialization of the product sample determining its shelf life and helping manufacturers take the next step to the product's development.
How is the stability testing done?
The sample is stored in environmentally controlled chambers as a part of the stability study program. The samples are kept for a time frame after which they are removed and tested to see if temperature, humidity, and light changes have impacted the physical, chemical, or microbiological characteristics of the sample.
What is the length of stability testing?
Stability testing is done according to the guidelines recommended by the ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Broadly classifying stability in long-term testing extending for a minimum of 12 months at 25°C/60%RH, the long-term testing allows product degradation under conditions of recommended storage, intermediate testing is done at 30°C/65%RH. Accelerated testing is done for a minimum of 6 months at 40°C/75%RH. The product goes through a short-term testing period.
Retain testing is done on products that will be marketed from a batch of finished products defining market authorization, labels and packaging, and pharmacy vigilance report.
Thermal cycling testing mimics conditions like marketplace storage and the reaction it will have when it is transported to the market, on loading and offloading, etc.
How is accelerated testing done?
Storage for stability testing follows 40°C +/- 2 degrees and Relative Humidity (RH) of 75% +/- 5% according to the ICH guidelines. This testing is based on the final formulation of the established manufacturing process. The test determines shelf life and storage conditions in real-time studies.
How is long terms testing done?
Also called the room temperature stability storage, this testing condition follows storage parameters measuring according to ICH guidelines. This is a forced degradation study that provides more knowledge on the drug development process, the degradation chemistry, of drug substances and products. The finding is an authority that builds the foundation of drug formulation and packaging development. The ICH does not state any guidelines for forced degradation, but 5-20% is the recommended degradation limit.
What is photostability testing?
This testing is a must for ensuring quality especially for manufacturing pharmaceutical drugs. If the drug is not tested adequately it will result in additional cost failure of the drug and loss of revenue. The selected drugs go through single batch testing, if the batch cites variations then the studies are repeated.
Reference samples are used for analytical testing of fully finished products.
Retention samples are used for identification purposes that include presentation, packaging, labeling, patient information leaflet, batch number, expiry date.
Both reference and retention samples are considered before a finished product is made ready for the market.
Conclusion
There is more to the stability chamber that those using it must know. You can go into greater details on the product from our website https://www.igenels.com/ and also purchase your stability testing device from us for the best results.
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