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Aditya Bhardwaj
Aditya Bhardwaj
Senior Manager Quality at ARKRAY Healthcare Pvt Ltd.
Published Sep 12, 2019
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Shelf life studies are used to determine how long a product can reasonably be expected to maintain its quality, safety, and character. These studies take into account not only products’ functional qualities such as safety and effectiveness, but also cosmetic qualities such as color and texture that make them appealing to customers. An acceptable shelf life for a product is one that allows its desired end of shelf life parameters (EOSLs) to be maintained; these include a product’s sensory, chemical, functional, microbiological, and physical properties. Since the EOSLs are different for every product, the test procedure for conducting a shelf life study will be unique for each product.
A tool used in accelerated studies is “the rule of ten,” or Q10, which is the factor by which the rate of spoil-age increases when the temperature is raised by 10C. Q10 allows for the prediction of a product’s shelf life under real-life conditions based on the results of testing conducted at high temperatures. It is unitless and can be calculated with the equation Q10 = (R2/R1)(10/(T2-T1)), where R is the time it takes for a product to spoil and T is the temperature at which the testing is conducted. For most products the Q10 value is 2.0, which means that for every increase of 10C, the rate of a chemical reaction will double. In an example, a product was tested at three different temperatures to obtain the time to spoilage. Q10 values were obtained by comparing T2/T1 with R2/R1 and T3/T2 with R3/R2.
Applying these numbers to the equation:
The actual Q10 for this product is approximately 1.6, not the value of 2.0 that is generally assumed. If this product started to spoil after eight weeks, to determine the shelf life at 20C the time to spoilage would be multiplied by the Q10 value twice, once for each 10C change in temperature. When calculating the shelf life of this product using a Q10 value of 2.0, the predicted shelf life is 32 weeks (8 months), but with a Q10 value of 1.6 the predicted shelf life is 20.48 weeks (5.2 months).
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5 Comments
Dr. Hitesh Chauhan
Biologist, Nanotechnology, Materials Science, Physicist, IVD, Medical Device
1y
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Prakash RANA
Rapid Diagnostic Test Design, QC, QA, Regulatory compliance and Production
2y
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Reference?
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AiYing Ch'ng
Laboratory Operations Manager at ALS Technichem (M) Sdn Bhd
2y
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I would like to ask for clarification, R is the rate or R is the time. As if it is referring to Time, it is unlikely that time to spoil is increasing when Temperature is increased.
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