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Stability Studies

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Stability Studies

Stability is “The limit to which a product or medical device retains, within the specified extent of time, or throughout its period of storage and use, i.e. termed as, its life span or self-life, the same properties and characteristics that it possessed at the time of manufacturing of product or device.”

The purpose of the stability study is to give information on how the quality of products does not vary with time under the influence of a variety of environmental factors such as temperature and humidity.

There are internationally accepted standards for assessing medical device stability in general and also certain product specific standards based on the product type. Applicable standards have to be identified before initiating the studies.

The stability of product can be demonstrated in 2 ways:

  • Accelerated
  • Real-Time

Accelerated stability:In accelerated stability tests, a product is kept at elevated stress conditions (such as temperature, humidity, and pH) for a shorter period of time.

Real-time Stability:

In real-time stability testing, a product is kept at recommended storage conditions and tested at periodic intervals until it fails the specification.

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While determining the stability of Medical devices following are also considered:

  • Storage conditions, e.g. temperature variations, relative humidity, ventilation, air pressure, air-borne contamination, visible light, and other radiation, etc.
  • The type of the device and intended use
  • The components or materials used for the manufacturing of the device
  • Method of manufacture
  • Packaging, e.g., products that are packaged in different sizes of packages may each have different stability or shelf life due to the difference in packaging area coming in the contact with the product.
  • Transportation conditions; e.g., vibration, shock, temperature, humidity, pH, etc.

The following criteria are used to evaluate the stability of medical devices:

  • Chemical
  • Physical
  • Microbiological
  • Therapeutic, and
  • Toxicological.

Verifying the stability/shelf life of medical device include:

  • Storage Plan for medical device
  • Sampling plan – that defines the frequency of sampling and test to be performed at each interval
  • testing during various phases of stability study
  • Evaluating the packaging of the medical device
  • Simulation of shipping and handling stress

On-going stability Studies:

The product can be released in the market based on the data of accelerated stability study, however, real-time stability studies shall be carried out simultaneously.

After a marketing authorization has been granted, the stability of the products should be appropriately monitored according to a continuous Programme that will permit the detection of any stability issue (e.g. changes in levels of degradation products)

Maven helps you to design a Stability study Plan and reduce errors.

FAQ:

Written test protocol specifying the accelerated aging conditions (test temperature, humidity, cycle, ambient temperature), rationale for selection of samples, time frame, sample sizes, package description, time for sampling interval, and specific tests at each time interval must be developed before testing.

Document the temperature of the stability chamber used

Document the test standard references and methods used for packaging evaluation.

Accelerated aging studies provide alternate means in a case where the product becomes obsolete in a short time due to market conditions and there is a need to get a new product to the market in the shortest possible time.

  • Select the Q10 value and define the expected shelf life of the package, such as, marketing needs, product needs, etc.
  • Define aging test time intervals, including time zero.
  • Expected test conditions, room temperature (TRT), and accelerated aging temperature (TAA).
  • Evaluate the test duration using the Q10, TRT, and TAA.
  • Explain the package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria
  • Age samples at TAA. In parallel, age samples at real-time aging conditions (TRT).
  • Assess the package performance after accelerated aging relative to the initial package requirements, for example, package seal strength, package integrity.
  • Assess the package, or package performance, or both, after real-time aging relative to the initial package requirements.
  • The estimated AAF method is a simple and conservative technique for evaluating the long-term performance of a package; however, like all accelerated aging techniques, it must be confirmed by real-time aging data

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