What is a pharmaceutical stability chamber?

A pharmaceutical stability chamber is a laboratory instrument that enables to carry out the so-called stability tests of drugs, these devices allow to control, monitor and document parameters such as temperature, humidity, differential pressure, illumination, gas levels and other environmental conditions.

These chambers are specialized incubators that can be programmed to simulate environmental conditions, to perform such tests where a batch of medicinal products can be placed inside a stability chamber for a selected period of time (e. g. one month / one year) and periodically analyzed to evaluate the impact on the quality of the product. These devices can also be used in studies of accelerated aging and to determine the shelf life and expiration date of pharmaceuticals.

What are pharmaceutical stability tests?

Pharmaceutical stability tests are tests done in pharmaceutical industries to assess how a drug will be affected by different environmental conditions over time. They are considered a mandatory requirement to introduce new products to the market and thus legalize their trade. Thus, this type of tests is an integral part of many processes of manufacturing products in the pharmaceutical industry, since they show first that there was no error in the final product and secondly that the product works correctly.

Such testing can take up to weeks or even months or years according to the product requirement and allow pharmaceutical companies to expose the product (drug) to conditions that could occur along the supply chain, for example temperature, humidity, and exposure to light, as these conditions can cause a drug to deteriorate or lose its effectiveness. Stability tests are used not only for chemical pharmaceuticals but also for biologicals such as proteins, polypeptides, and conjugates.

What is the purpose of pharmaceutical stability testing?

The purpose of pharmaceutical stability testing is to document changes in the physicochemical and microbiological characteristics of a pharmaceutical product when exposed to different environmental conditions, such as temperature, humidity or light. The purpose of these tests is to define precisely the storage conditions of the product, the type of packaging most appropriate for it, and to establish its shelf life or expiry date.

The stability of pharmaceutical products will depend on key environmental factors such as temperature, humidity and ambient light, as well as other factors that are specific to the product: the physical and chemical properties of the active substance it contains and also of the excipients used, the manufacturing process for its transformation, as well as the closure system of the used container, the properties of all the materials with which the containers have been manufactured and the compatibility between the container and the product.

How do the pharmaceutical stability chambers work?

The pharmaceutical stability chambers work simulating relative humidity and temperature conditions, this is achieved thanks to its structure, since they are closed systems that allow recreating, maintaining and controlling a constant temperature and relative humidity in its interior, simulating the conditions of the destination of the products to be able to check the efficacy of the same during their useful life.

Different pharmaceutical products require different types of conditions for stability testing, but it is practically impossible to move around to achieve the different climatic conditions to which they will be subjected. This is where stability chambers come into play, making the job much easier. They are also able to assess the changes that these conditions could cause in product quality in situations of alternative environmental exposure.

What does Kalstein offer you?

Kalstein is a company MANUFACTURER of medical and laboratory equipment of the highest quality and the best technology at the best PRICES in the market, so you can make your PURCHASE confidently with us, knowing that you have the service and advice of a company specialized in the field and committed to provide you with safe, economical and effective options to perform your functions in the right way.

This time we present you our Strong Lighting Stability Test Chamber YR053283 // YR053285. It consists of a new lighting stability testing chamber for pharmaceutical companies for the evaluation of drug failures, accelerated testing and long-term testing of special equipment. Among its main characteristics are:

  • World-famous compressor: Balanced cooling technology, automatic thawing, multiple safety system, long-term operation, environmental protection, high efficiency and energy saving.
  • Automatic thawing function: original rapid thawing technology with heat pump, for continuous operation, effectively prevents frosts due to continuous evaporator operation.
  • Manual control system of cooling effect: meets the customer’s terrible working environment. HERE

For more information we invite you to take a look: HERE