Denver, CO

Stability Testing Chambers & Rooms for ICH and FDA Compliance

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Stability Testing Denver, CO

Stability Testing Denver, CO. Medical and pharmaceutical advancement cannot exist without stability testing, and stability testing cannot be accomplished without exact, high-quality stability chambers for the pharmaceutical industry. As Darwin Chambers, we are an established leader in chambers for stability testing, FDA/ICH pharmaceutical storage, and many other uses in pharmaceuticals, medical device storage, and many other industries in Denver, CO. Trust none other than Darwin Chambers to provide you with top-of-the-line environmental chambers and stability testing equipment you can rely upon.

Please note: Darwin Chambers does not provide stability testing services. We specialize in manufacturing and supplying high-quality stability chambers designed to meet your testing needs.

Contact Darwin Chambers today to get a quote or discuss your stability testing needs with an expert. Request a quote for the right Denver, CO stability chamber model for your work, select your fully customized walk-in stability testing chamber for you Denver, CO location, or speak to one of our knowledgeable associates about the right stability testing products for you.

Denver, CO Stability Testing

In the pharmaceutical industry, stability testing is a type of testing used to establish how long a drug or product remains effective and safe for use at specific storage conditions. The process of stability testing is achieved by storing the substance at specified conditions and testing its properties periodically. This task would not be possible without access to reliable and accurate Denver, CO stability chambers. Darwin Chambers is your source for pharmaceutical stability chambers.

What To Look For from a Stability Testing Chamber?

Whether you work in pharmaceuticals, other medical devices, or any FDA-regulated products in Denver, CO, stability testing is essential. To execute stability testing in Denver, CO that adheres to strict industry standards and regulations, your organization must have two things: qualified personnel and performance stability chambers and stability rooms. Your team may have access to the best minds in your field, but that is irrelevant without facilities with quality stability chambers that exceed the stringent stability testing standards laid forth by the FDA and ICH.

Purchasing stability chambers and other equipment in order to handle stability testing at your Denver, CO facility is a big investment. Your operation and ability to conduct Denver, CO stability testing depend upon your stability chambers; you must choose the best product available that meets your exact needs. Whether you need a small bench-top model for small batch stability testing or need a completely customized stability chamber room for high-volume stability testing in Denver, CO, Darwin Chambers has the right product for you.

Consider the following characteristics when selecting stability chambers for your Denver, CO stability testing operations:

  1. Control - A chamber is useless to you for stability testing if its control of conditions does not adhere to ICH requirements. Typically that means control of ± 2°C and ± 5% RH. Darwin Chambers' designs 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 are quipped with easy-to-use precision controls or optional virtual touchscreen technology.
  2. Conditioning - Your chamber must have a consistent temperature and humidity conditions throughout the interior of the chamber and should be able to recover conditions quickly after open doors or loss of power. Darwin Chambers' stability chambers are regulated with ultrasonic humidity and thermoelectric cooling technologies, of hot spots. Equipped with multiple, independent cooling units for cooling redundancy, the conditions within our stability chambers will remain as steady as possible for your Denver, CO stability testing application.
  3. Construction - Look for quality construction to ensure that your stability chamber has the ability to operate without fail for years to come. Our stability testing chambers are designed with the best materials and designs, including stainless steel exteriors, positive seal self-closing doors, and foamed-in-place high-density insulation. The majority of the components on our chambers are simple and easy to access and service.

Denver, CO Stability Testing You Can Do With Our Chambers

Stability testing in Denver, CO can and should be done on many different substances and should test a variety of characteristics based on a range of specific environmental conditions. Our chambers are designed, engineered, constructed, installed, and tested to fulfill your Denver, CO stability testing needs. Choose from our line of stability chambers with a number of standard and customized reach-in and walk-in chambers.

Darwin Chambers stability chambers will allow you to carry out stability testing in Denver, CO to measure:

  • Physical Characteristics
    • Appearance
    • Melting point
    • Water content
    • Color or clarity
    • pH
    • Dissolution
    • Disintegration
    • Viscosity
    • Crystal modification
    • Particle size
  • Chemical Characteristics
    • Assay
    • Degradation
    • Related substances
    • Residual solvents
    • Radioactive decay
    • Packaging and interaction
  • Microbial
    • Sterility
    • The efficacy of antimicrobial preservatives
    • Antioxidants
    • Growth in microorganisms
    • Environmental control
  • Therapeutic Characteristics
  • Toxicological Characteristics
  • Biocompatibility

We offer environmental chambers to meet your every need. Learn more about some of our popular services and products below.

ICH Guidance Stability Testing

Our stability chambers are engineered and built to provide acute control of environmental conditions, allowing you to conduct Denver, CO stability testing that is accepted by 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

Denver, CO Stability Testing Chambers: Darwin Chambers

When you need to do important Denver, CO 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 superior accuracy, control, customability, and powerful systems, our stability chambers make stability testing possible in Denver, CO. Get a look at which products are right for you or speak to an experienced associate about your Denver, CO stability testing chamber needs now at 877-783-6774 or reach us online.

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