Darwin Chambers
stability-testing-pharmaceuticals

Stability Testing

Stability Testing

Stability Testing. Stability testing is a vital part of the pharmaceutical and medical development process and cannot be accomplished without reliable, top of the line environmental chambers for pharmaceutical use. Darwin Chambers has been the leader in environmental chambers for stability testing, FDA/ICH pharmaceutical storage, and a wide range of other applications in pharmaceuticals, medical device storage, and many other industries. When you need stability testing equipment you can count on or any type of environmental chamber that performs without fail, turn to Darwin Chambers.

Contact Darwin Chambers today to speak to a qualified specialist about your stability testing needs and the best products for your needs. Request a quote for the best reach-in stability testing chamber for your application, design a fully customized walk-in stability testing chamber, or discuss your precise needs with an expert to determine the right stability testing products for you.

Stability Testing

Pharmaceutical stability testing is the process for determining how long a substance or product remains effective and safe for use at specific storage conditions. The process of stability testing is done by storing the substance at defined conditions and testing its properties periodically. In order to achieve this critical task, researchers and manufacturers of pharmaceuticals and other medical products must have access to reliable and accurate stability chambers such as the wide range of chambers available from Darwin Chambers.

What Do You Need from a Stability Testing Chamber?

Whether you work in pharmaceuticals, other medical devices, or any FDA-regulated products, stability testing is essential. In order to perform stability testing that adheres to strict industry standards and regulations, your operation needs qualified personnel in addition to precise stability chambers and stability rooms. Your team may have access to the best minds in your field, but that is irrelevant without access to quality stability chambers that are designed especially for FDA and ICH stability testing.

Purchasing equipment like stability chambers for your operation to fulfill your stability testing needs is no small investment. Your stability testing work and entire operation depend upon the performance of your stability chambers and it is important that you select a quality product that meets your precise needs. Whether you need a small bench-top model for supplemental stability testing or need a completely customized walk-in stability chamber for high-volume stability testing, Darwin Chambers has the right product for you.

When selecting the stability chambers for your stability testing work, it is important to evaluate your options on the following criteria:

  1. Control – A chamber is useless to you for stability testing if its control of conditions does not adhere to ICH requirements. This is generally ± 2°C and ± 5% RH. Our products far exceed these specifications, with standard controls with a range of ±0.2°C and ±0.3% RH. Our line of stability chambers, refrigerators, and freezers come standard with easy-to-use precision controls or optional virtual touchscreen technology.
  2. Conditioning – Your chamber must have a uniform distribution of temperature and humidity throughout the interior of the chamber and must be able to recover from open doors or loss of power. Darwin Chambers’ stability chambers are regulated with ultrasonic humidity and thermoelectric cooling technologies, which both allow for superior uniformity and eliminate the presence of hot spots. Equipped with multiple, independent cooling units for cooling redundancy, the conditions within our stability chambers will remain as consistent as possible for your stability testing application.
  3. Construction – Look for quality construction to ensure that your stability chamber is prepared to serve you without fail for years to come. Our chambers designed for stability testing are constructed with stainless steel exteriors, positive seal self-closing doors, and foamed-in-place high-density insulation. The majority of the components on our chambers can be serviced quickly and simply.

Stability Testing Our Chambers Accommodate

Stability testing can and should be done on many different substances and should test and measure a variety of characteristics based on a range of specific environmental conditions. Darwin Chambers engineers, manufactures, and installs stability chambers and other environmental chambers that are perfect for your stability testing needs. Choose from our line of stability chambers with a number of standard and customized reach-in and walk-in chambers.

You can count on Darwin Chambers’ stability chambers to allow you to conduct stability testing to measure:

  • Physical Characteristics
    • Appearance
    • Melting point
    • Water content
    • Clarity and color of the solution
    • pH
    • Dissolution
    • Disintegration
    • Viscosity
    • Crystal modification
    • Particle size
  • Chemical Characteristics
    • Assay
    • Degradation
    • Related substances
    • Residual solvents
    • Radioactive decay
    • Packaging and interaction
  • Microbial
    • Sterility
    • Antimicrobial preservatives’ effectiveness
    • Antioxidants
    • Growth in microorganisms
    • Environmental control
  • Therapeutic Characteristics
  • Toxicological Characteristics
  • Biocompatibility

ICH Guidance Stability Testing

Our stability chambers are engineered and constructed to provide acute control and precise manipulation of environmental conditions so that you can conduct the stability testing you need that conforms to ICH stability testing guidance.

With our stability chambers, you can perform:

  1. Real time/long term stability testing – testing is usually done every three months during the first year, every six months during the second year, and once a year after that for the duration of the study
  2. Intermediate stability testing – for a 12 month study, it is recommended that testing is conducted a total of four times including the initial and final tests
  3. Accelerated stability testing – for a six month study, it is recommended that tests are done a total of three times at regular intervals, including the initial and final tests

Get Chambers for Stability Testing: Darwin Chambers

When you need to do important stability testing, count on Darwin Chambers. Our line of reach-in and walk-in stability chambers allow you to perform the stability testing your work requires. WIth precision, control, customization, and efficient systems, our stability chambers make stability testing possible. Learn more about our products or speak to an expert about your stability testing chamber needs now at 877-783-6774 or reach us online.