Storage and Shelf Life Testing

In the dynamic and highly competitive food industry, ensuring the safety, quality and longevity of food products, maintaining consumer confidence and meeting regulatory standards has become a necessity. Food storage and shelf life testing is a critical process that helps manufacturers determine how long their products remain safe and of high quality under specified storage conditions.

This process is meticulously structured to guarantee the safety of consumed food and to provide manufacturers, distributors and consumers with clear information about the life of a product. Conducting systematic assessments is crucial as it guides informed decision-making throughout the food supply chain, from the earliest stages of production to the moment the product reaches consumers.

Storage and shelf life tests are important for both food and cosmetic products for the following reasons:

• Ensuring safety: it is crucial to prevent potential illnesses by ensuring that products remain safe for consumption throughout their shelf life.
• Preservation of quality: Preservation of desired sensory qualities such as taste, texture, aroma and durability is essential for consumer satisfaction.
• Compliance with regulations: Food and cosmetic safety is essential for compliance with various regulations and industry standards. Shelf life studies ensure accurate expiration dates, protect human health and provide reliable product information.
• Building brand reputation and trust: Consistently high-quality products build consumer trust and brand loyalty.
• Reducing waste: Accurate shelf-life estimates can minimize product waste and optimize inventory management.

The main factors affecting the shelf life of food and cosmetic products are:

• Intrinsic factors: These are pH value, water activity, nutrient content and natural enzymes and the like.
• External factors: These include external conditions such as temperature, humidity, light exposure, and oxygen levels.
• Packaging: The type of packaging material and its barrier properties significantly affect shelf life by providing protection against environmental factors.
• Microbial growth: The presence and growth of microorganisms can cause spoilage and affect safety and quality.

In general, storage and shelf life tests include:

• Microbiological tests: Evaluate the presence and growth of microorganisms such as bacteria, yeast and mold that can cause spoilage and decay in food and cosmetic products.
• Chemical tests: Evaluate changes in chemical composition, such as pH measurement, oxidation testing, moisture content and nutrient levels.
• Accelerated shelf life testing (ASLT): Accelerates the aging and deterioration process of products using elevated conditions such as temperature and humidity, allowing for quicker estimation of shelf life.
• Real-time shelf life testing: Evaluates product quality by continuously monitoring a product over an extended period of time while it is stored under consistent conditions, typically room temperature.
• Sensory evaluation: Uses sight, smell, taste, touch, and similar senses to evaluate the quality of a food product over time.

Storage and Shelf Life Testing for Medical Products

Storage and shelf life testing is a critical step in preparing a medical device for market and is mandatory for all products. If this testing is not carried out correctly, the company may be forced to recall products and risk significant damage to its market profile.

Medical device shelf life testing is generally carried out in accordance with the standard “EN ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems”, which is a British standard and published by the International Organization for Standardization (ISO). This standard describes the requirements for the selection of packaging materials used and their required performance. In addition to this standard, there are other standards that are referenced where relevant.

Shelf life testing for medical devices focuses on the performance of the device and the performance of the product packaging over time – that is, how long the packaging keeps the product sterile and how long the device performs according to specification.

For established medical devices, shelf life testing can be based on existing performance data. However, for new products, there is no existing data on which to base testing, which presents a challenge for manufacturers looking to quickly bring new products to market. To overcome this challenge, manufacturers are allowed to use simulated test data and real-time test data in parallel. However, if there are multiple parts in the device, the part with the lowest known shelf life determines the overall shelf life.

There are two primary types of shelf-life testing for medical devices:

• Real-time aging
• Accelerated obsolescence (this plays an important role in shelf life testing for new medical devices)

Real-time aging is the real-time shelf life testing of medical devices. Zero-day testing is performed to provide baseline performance data, and then the device is tested at key points and compared to the initial data. However, product performance may improve over time, it would be wrong to assume that a product will always fail.

Accelerated ageing requires specialist equipment and expertise. As a result, it is often outsourced. A device is placed in a temperature and humidity controlled ageing oven that simulates conditions where one month is approximately equal to one year. A full box of product is placed in the oven and a full box is removed at each time point. Once all time points and tests have been completed, the data can be trended and compared to the zero-end results. If all tests pass as expected, a product shelf life estimate can be obtained. Real-time data as collected always takes precedence and should be performed together.

The rationale behind the framework of shelf life testing is based on both accuracy and efficiency.

Storage and Shelf Life Testing for Food Products

The most direct way to estimate the shelf life of a food product is to conduct simulation tests, which are time-consuming and expensive. Conversely, accelerated shelf life tests can be used successfully for stable products with a long expected shelf life.

All sectors of the food and beverage industry are under pressure to rapidly develop and launch new and innovative products to maintain market share. Part of the product development cycle is to determine an appropriate shelf life. For ambient stable products with a long shelf life, it is rarely possible to complete full shelf life assessments prior to product launch.

For the refrigerated food sector, although shelf lives are much shorter, they can extend up to weeks and it is demanded that the shelf life be determined in a very short time. In accelerated shelf life tests, chemical, biochemical and microbiological changes can be brought about in a shorter time that would not otherwise occur. All foods consist of biological material that deteriorates after a certain period of time. This deterioration belongs to processes that cannot be completely prevented. Shelf life is the time during which the product remains safe and suitable for use under defined storage conditions after production and packaging.

The food product should maintain its chemical, physical, microbiological and sensory characteristics during this period and, where appropriate, comply with any label declaration containing nutritional information when stored in accordance with recommended conditions. Shelf life is the amount of time a food product is considered acceptable for consumption when stored under appropriate storage conditions.

According to the Consumer Food Information Regulation No. 1169/2011/EN, the minimum durability date is replaced by the "expiration date" for foods that are extremely perishable from a microbiological point of view and therefore likely to pose an immediate risk to human health after a short period of time. Therefore, the shelf life called the minimum durability date is valid for foods that do not deteriorate extremely quickly and do not pose an immediate risk to human health.

Storage and Shelf Life Testing for Cosmetic Products

Routine stability testing provides cosmetic manufacturers with critical data about the safety and shelf life of their products and can help ensure that products comply with the Food and Drug Administration (FDA) cosmetic stability testing regulations. The FDA has not yet mandated stability testing of cosmetic products before they are commercially marketed, but such testing is considered good manufacturing practice.

The information obtained from stability testing is seen as beneficial to companies both externally and internally because it provides useful information for product development, material procurement and management, and life cycle management.

Stability testing is essentially a testing method where a formula is created and placed in different environmental conditions for a period of time. These conditions vary in temperature and humidity and aim to simulate what happens to the product throughout its life cycle.

In the pharmaceutical industry, both the FDA and the European Medicines Agency require stability testing of products before they are sold to consumers. The primary goal is to measure and document the effectiveness of drugs up to their intended expiration date. For both pharmaceutical and cosmetic manufacturers, product recalls are not only expensive and labor-intensive, but can also damage brand image.

Like medicines, cosmetics naturally deteriorate over time, and stability tests performed by manipulating storage temperature and other factors can reveal the extent to which they have deteriorated by measuring:

• Natural degradation rate of basic components
• The ability of a product to resist microbial invasion
• Product response to packaging materials
• Increased pollution during the production process
• Product response to heat, moisture and light

The purpose of stability testing is to ensure that a product maintains its intended physical, chemical and microbiological qualities (as well as functionality and aesthetics) when stored under appropriate (room temperature) conditions. It is also to collect data predicting the stability of the cosmetic product throughout its lifespan and compatibility between the formulation and the container material.

There are three basic forms of stability testing:

• Physical and chemical integrity: These evaluate colour, odour or flavour, pH, viscosity, texture, flow and emulsion stability or signs of separation.
• Microbiological stability: Evaluates the degree of contamination with bacteria, mold and yeast.
• Packaging stability: These assess the impact of the packaging on the product inside.

Stability testing for cosmetics is typically performed when:

• When a new product is developed
• When an existing product on the market is reformulated
• When the production method is changed or production is moved to a new facility or supplier
• When the packaging method changes

Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides storage and shelf life testing services with its trained and expert staff and advanced technological equipment.