Charlotte, NC

Stability Testing Charlotte, NC

Stability Testing Charlotte, NC. Stability testing is a vital part of the pharmaceutical and medical development process and is not possible without precise, top of the line stability chambers for pharmaceutical use. Darwin Chambers has been the leader in the design and construction of chambers for stability testing, FDA/ICH pharmaceutical storage, and a wide range of other uses in pharmaceuticals, medical device storage, and many other industries in Charlotte, NC. When you need stability testing equipment you can trust 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 you. Request a quote for the best Charlotte, NC stability chamber model for your application, design a completely customized walk-in stability testing chamber for you Charlotte, NC location, or discuss your precise needs with an expert to determine the right stability testing products for you.

Charlotte, NC Stability Testing

Pharmaceutical stability testing is the process for determining 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 material at defined conditions and testing its properties periodically. This task would not be possible without access to consistent and accurate Charlotte, NC stability chambers such as the wide range of chambers available from Darwin Chambers.

What To Look For from a Stability Testing Chamber?

Whether you work in pharmaceuticals, other medical devices, or any FDA-regulated products in Charlotte, NC, stability testing is essential. In order to perform stability testing in Charlotte, NC 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 highly accurate and powerful stability chambers that exceed the stringent stability testing standards laid forth by the FDA and ICH.

Getting stability chambers and other equipment in order to handle stability testing at your Charlotte, NC facility is no small investment. Your operation and ability to conduct Charlotte, NC stability testing depend upon the performance of your stability chambers and it is important that you select a quality product for your precise requirements. 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 in Charlotte, NC, Darwin Chambers has the right product for you.

Consider the following factors when selecting stability chambers for your Charlotte, NC stability testing operations:

  1. Control - You cannot use a chamber for stability testing in the US unless it meets 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 fitted with precise and simple controls or optional virtual touchscreen technology.
  2. Conditioning - Your chamber must have a even distribution of temperature and humidity throughout the interior of the chamber and should be able to recover conditions quickly after open doors or loss of power. The stability chambers we engineer use ultrasonic humidity and thermoelectric cooling technologies, which both allow for superior uniformity and eliminate the presence of hot spots. In addition, our stability chambers are cooled using a redundant design of multiple, independent cooling units to keep the inside as consistent as possible for your Charlotte, NC stability testing work.
  3. Construction - Look for quality construction to ensure that your stability chamber has the ability to serve you reliably for years to come. Our stability testing chambers are constructed with the best materials and designs, including stainless steel exteriors, 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.

Charlotte, NC Stability Testing Our Chambers Accommodate

Stability testing in Charlotte, NC can and should be done on many different substances and should 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 Charlotte, NC 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 carry out stability testing in Charlotte, NC 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

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 constructed to give you tight manipulation of environmental conditions, allowing you to conduct Charlotte, NC 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

Charlotte, NC Stability Testing Chambers: Darwin Chambers

When you need to do important Charlotte, NC stability testing, count on Darwin Chambers. Our line of reach-in and walk-in stability chambers allow you to do your stability testing work. WIth superior accuracy, control, customability, and efficient systems, our stability chambers make stability testing possible in Charlotte, NC. Get a look at which products are right for you or speak to an experienced associate about your Charlotte, NC stability testing chamber needs now at 877-783-6774 or reach us online.

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