The shelf life of a product begins from the time the food is prepared or manufactured. Its length is dependent on many factors including the types of ingredients, manufacturing process, type of packaging and how the food is stored. It is indicated by labelling the product with a date mark.

How long is accelerated stability testing?

Testing frequency At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g. 0, 3 and 6 months), from a six- month study is recommended.

How long is shelf life testing?

Such tests normally last at least as long as the required shelf life of the product. In some cases this may be as long as a year or more. Obviously, such a long test does not coincide with a 3-month product development cycle. The amount of sample required can be substantial, as well as the costs of the analysis.

What is the temperature in accelerated storage stability test?

How do you test accelerated stability? Most commonly, it is storage at 40°C +/- 2 degrees and Relative Humidity (RH) of 75% +/- 5% when the long-term stability storage condition for the product is 25°C +/- 2 degrees and RH of 60% +/- 5%.

How do you test accelerated shelf life?

To run an accelerated shelf life study, the most common method used is the kinetic model approach. Its process involves: Selection of kinetic factors for acceleration of deteriorative process. Running study of deterioration process at such levels of accelerating factors that deterioration is fast enough.

How does accelerated shelf life testing work?

In accelerated shelf life tests, the chemical, biochemical and microbiological changes may be induced in shorter time, that it would not otherwise occur. … The shelf life is then the amount of time in which a food product is considered acceptable for consumption when stored at the appropriate storage conditions.

How is accelerated stability testing calculated?

t90 : Time required to reduce the concentration to 90% of its initial concentration. stability of formulation can be determined by shelf life. …

STABILITY STUDY STORAGE CONDITIONS TESTING FREQUENCY (MONTHS)
Accelerated 40 ± 2ºC & 75 ± 5% RH 0,1,2,3 & 6
Intermediate 30 ± 2ºC & 65 ± 5% RH 0,3,6,9,12,18,24 & 36

What are the limitations of accelerated stability testing?

The following are some of these limitations: 1. High temperatures used in accelerated stabil- ity models may result in a change in pH of the reagent and consequently may result in stabili- zation or destabilization of analytes or active ingredients and inaccurate stability predictions.

What is accelerated stability analysis?

accelerated stability testing Studies designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing programme. … The results of accelerated testing studies are not always predictive of physical changes.

How long is shelf life of food?

High-acid canned foods (tomatoes, fruits) will keep their best quality for 12 to 18 months; low-acid canned foods (meats, vegetables) for 2 to 5 years. Sell by date is a less ambiguous term for what is often referred to as an expiration date. Most food is still edible after the expiration date.

What is shelf life of food?

The shelf life of food is the period during which the food retains an acceptable quality from a safety and organoleptic point of view, and depends on four main factors, namely formulation, processing, packaging and storage conditions.

Why do we do shelf life testing?

Why is shelf life testing important? By conducting food product shelf life testing, it helps you identify the causes of reduced shelf life and improve your products, processes and ultimately profitability. With accurate dates for your food products, you can ensure quality and safety for your consumers.

Why accelerated stability testing is important?

1. Main aim of accelerated stability study to predict the stability profile of a drug product that prediction of self life of the product before launching into market. 3. Prediction of shelf life, which is the time a product will remain satisfactory when stored under expected or directed storage condition.

How do you predict shelf life?

The food system uses four main methods (other than static testing) to predict shelf life. … Most measure the internal status and external conditions of fresh produce.

  1. Spectroscopy. Spectroscopy uses light to analyze the internal status of fruits and vegetables. …
  2. Imaging. …
  3. Chemical Analysis. …
  4. Temperature.

How shelf life of a product is determined by accelerated stability studies?

Accelerated shelf life takes the climatic conditions to more extreme levels in order to compress required test time. This is done by applying the Arrhenius equation to determine the rate of acceleration of time based on increased temperatures.

How much does shelf life testing cost?

A shelf life study for 1 product generally costs $1,200. Pricing does decrease if 1 study includes multiple varieties (flavors) of the same product. The following questionnaire should take about 20 minutes to complete.

How is the shelf life of food products determined in the UK?

The methods most used today to estimate the shelf life of foods are:

  1. Direct method. …
  2. Challenge Test. …
  3. Predictive microbiology. …
  4. Accelerate shelf life tests. …
  5. Survival method.

How do you perform a stability test?

7 Steps for Stability Testing

  1. Step 1: Batch Production. …
  2. Step 2: Product Container Filling. …
  3. Step 3: Initial Test (Time Point Zero). …
  4. Step 4: Product Storage. …
  5. Step 5: Product Evaluation. …
  6. Step 6: Determine Stability. …
  7. Step 7: Conclusion Report.

What is the accelerated stability study conditions?

Accelerated Stability Testing is done to determine the shelf life of finished products. As per the result, the expiry date of a particular product is fixed. Pharmaceutical products are kept under accelerated conditions. The changes under extreme conditions like temperature, light intensity and humidity are monitored.

What is the time period required for long term and accelerated stability studies?

The accelerated stability testing data at 40°C / 75% for minimum six months and long term stability testing data at 30°C / 65% for minimum 12 months should be available at the time of submission for new drug application and can be continued further.

Which is the correct accelerated stability conditions for refrigerated product?

For example, for a product to be stored long term under refrigerated conditions, accelerated testing should be conducted at 25°C ± 2°C/60 percent RH ± 5 percent RH.

What is shelf life of drug?

The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer.