Through shelf life and stability testing, you can discover how environmental conditions may affect your product’s potency, contamination, color, odor, and moisture. More information about our Privacy Policy, DDL is an ISO 17025 accredited laboratory. The following sections will discuss these approaches, all of which have a common goal of getting reliable deterioration data in a short period and selecting the proper model to use for predicting the shelf life of the product.

All these questions will be dealt with in relation to the different ASLT methods that are discussed in the following sections. For example, more rapid changes will occur at −18°C compared with normal long-term storage temperatures of below −25°C, still faster changes will occur at −10°C. The resulting ‘expiration date’ or shelf life from accelerated aging testing is considered a conservative estimate. Certain forms of deterioration, such as ice crystal growth and freezer burn (i.e., sublimation of ice as water vapor from the surface of the frozen food), will also be accelerated if the temperature is made to fluctuate while the food remains frozen.18, Cycling the product between 0°C and room temperature will accelerate watery separation in starch-thickened foods. An oxidative reaction (loss of Vitamin E, A, C or linoleic acid) can decrease in rate if oxygen availability is the limiting factor. In the interim, we adhere to the FDA’s previous stability testing standards, At a state level in Florida, The Department of Health determined that.

At ACS Laboratory, we conduct real-time and accelerated shelf life and stability testing at 3 months, 6 months and 12 months so you can accurately define the life of your product. If the temperature-accelerating factor is given, then extrapolation to lower temperatures, such as those found during distribution, may be used to predict expected product shelf-life.

A calculator is provided below to easily explore difference test scenarios. Recommended replicates: You may age as many samples as you need. Singh, K.R.

“expiration date” means the month and year as determined by the manufacturer, packer, or distributor on the basis of tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will contain not less than the quantity of each ingredient as set forth on its label.”. The principles of ASLT are covered in detail by Mizrahi (2000 and 2004).

This process is performed using the Q10 value. Exposure to north light (in the northern hemisphere) or a light box with appropriate wavelength light of the required intensity may be used for color-sensitive products, but the majority of accelerated testing is carried out at increased temperature, typically 35–40°C.

Final step is that a kinetic study of the deterioration process at such levels of the accelerating factors is run.

Real time aging must be performed in conjunction with any accelerated aging study to correlate the results found during accelerated aging.

An alternative way of expressing temperature dependence which has been extensively used by the food industry is the Q10 approach. ANSI/AAMI/ISO 11607-1:2006 2. Currently there are no federal standards related to stability and shelf life testing for cannabis because marijuana is still federally outlawed.

For example, at 55°C using an ambient temperature of 25°C, 6.5 weeks is equivalent to 1 year on the shelf.

During a, we analyze products at the recommended environmental conditions and monitor for them for the full duration of the requested shelf life test.

Copyright © 2020 Elsevier B.V. or its licensors or contributors.

In practical terms, those concerned with the storage and deterioration of soft drinks and fruit juices will often use storage at ambient temperature (in the range of 15–20°C) as typical of normal conditions and a warm room of 35–40°C to give an indication of the accelerated effects. Brea, CA 92821 Accelerated aging may be regarded as sufficient evidence for the claimed shelf life on the introduction of new products. Temperature selection for an accelerated aging study should be determined by the temperature that avoids unrealistic failure conditions such as deformation due to melting.

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It is used to simulate real shelf-life aging and is conducted to validate shelf-life claims and document expiration dates. This section will cover the important aspects of accelerated shelf-life testing. It is recognized that in some cases products are technologically obsolete before a real time aging project can be completed. ... electrical, and physicochemical testing. Finally, although ASL is intended to model long-term storage, samples should be analyzed as frequently as feasible, not just once a week or month, to observe detailed patterns of change. There are a number of approaches to ASLT but all are concerned with how to get reliable deterioration data in a short period, what model to use and how eventually to predict the actual shelf-life of the product. Real time aging is performed in parallel with accelerated aging in order to support and verify accelerated aging conclusions. Upon freezing, such as used for storage of control samples, reactants are concentrated in the unfrozen liquid, creating a higher rate of quality loss at certain temperatures, which is unaccounted for by the Q10 value and will cause prediction errors.

As discussed earlier in this chapter, packaging is an important factor to consider in any shelf-life test. ASL studies serve an important purpose but not without detriments. Shelf-life studies can come in many different forms, including accelerated studies. P.J. Accelerated aging testing is based on a thermodynamic temperature coefficient formulated by J.H. Accelerated aging is optional, but real-time aging is required when establishing an expiration date. Another term used by Robertson to discuss the response of biological systems to the effects of heat is the temperature quotient. This is the principle behind ASLT.

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, Predicting Product Shelf Life Through Accelerated Studies. In case of proper packaging, the cost-effective packages are used except the effect of packaging materials is concerned. This test enables manufacturers to get their product to market faster. However, if the rate of deterioration is too fast or too slow, then the frequency of sampling can be increased or decreased as appropriate. At the elevated temperature, an approximate guide is that deterioration proceeds about 3–4 times faster than at ambient. You can’t!’. Although ASLTs are extremely useful and have their place, there are many limitations which need to be considered in using these tests (Robertson, 1991). This model may follow the changes in a shelf life expressing the value of a marker of deterioration or the extent of product failure under a given storage and handling history. The use of Van’t Hoff’s Theory for medical device products and packaging materials is supported by the following references: Hemmerich, Karl J., “General Aging Theory and Simplified Protocol for Accelerated Aging of Medical Devices” Proceedings MDM-West, January, 1997, Clark, Geoffrey, “Shelf Life of Medical Devices” Guidance Document, Division of Small Manufacturers Assistance, CDRH, FDA, April 1991.

However, most of the studies on ASLT have been done on chemical deterioration of foods and therefore the examples in this chapter will be based on them.

To catch all that is going on, you need to cast your analytical nets broadly and measure as many products as can be handled accurately.

Documented shelf life evidence must exist to substantiate shelf life claims made by the manufacturer.

As described previously, ASLT involves the use of higher testing temperatures in food quality loss and shelf-life experiments and extrapolation of the results to regular storage conditions through the use of the Arrhenius equation, which cuts down testing time substantially. Like all consumable goods, cannabis and hemp quality can degrade over time due to conditions such as temperature, lighting, air and humidity. Please contact us to request a quote, or talk to one of our engineers.

Four variables are used in calculating the accelerated aging test duration.