Stability Chamber Calibration, Validation, Qualification Colorado Springs, CO

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Colorado Springs, CO

Stability Chamber Calibration, Validation, Qualification in Colorado Springs, CO. Your applications and processes require that your stability chambers in Colorado Springs are always operating as needed, and at peak capacity. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. To ensure that your stability chambers in Colorado Springs are fully and safely operational, or stability chamber engineers can provide, our stability chamber engineers can provide stability chamber calibration, stability chamber validation, and stability chamber qualification. To learn more about our stability chamber services, or to or to discuss your needs with a staff member, please call Darwin Chambers now at (314) 534-3111 or contact us online.

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.

Stability chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the specified range and suitable for conducting stability studies. A stability chamber is a controlled environment used to test the stability of products under specified temperature and humidity conditions. This chamber is used to house and monitor samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Colorado Springs, CO

We use precise calibration standards to ensure quality performance within every chamber. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your needs.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. Our service is provided as a 3-point "as-found" calibration and verification. The “as-found” readings are documented and verified to be within the manufacturer’s tolerance, if found within the tolerances the device is then returned to service. If any instrument exceeds the tolerance, we will promptly notify you, so that you may take the necessary steps to make note of it and fix the issue.

Any instruments found outside of calibration can then be calibrated using the manufacturer's calibration procedures. After completing the calibration, the instrument’s “as-left” readings are documented using the same three points from the calibration to ensure the instrument is reading within the manufacturer’s tolerance.

The calibration of a stability chamber involves verifying its performance against a set of standards and making adjustments as necessary to ensure that it meets the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying the reliability of the temperature readings in the stability chamber. This is most often completed by contrasting the readings of the stability chamber with a calibrated thermometer, which is located inside the chamber. If there is a discrepancy, we'll make adjustments until the temperatures are the same.
  • Humidity calibration follows a similar process as temperature calibration. A calibration hygrometer is put inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • Pressure calibration involves calibrating the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until they match.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber remain accurate for an extended period. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could result in the need to repeat a stability study.

Calibration should be performed by a qualified and experienced technician. It is recommended to calibrate a stability chamber at least once a year, or more frequently if it is used frequently or if the results of previous calibrations indicate that it may be necessary.

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Stability Chamber Validation and Qualification in Colorado Springs, CO

An expert stability chamber validation and qualification in Colorado Springs, CO should:

  • Include a list of instruments used for qualifications
  • Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Qualification and validation are a three-part process:

  • Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, procurement, and installation follow to the design intention. The IQ process includes an analysis of the installation documentation, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • Operational Qualification (OQ) is meant to provide recorded verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally carried out with an unloaded chamber). The OQ process may also include tests to validate the performance of the equipment under different conditions. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) ensures and documents that the unit can reach the temperature, humidity, and pressure settings as intended, either in a simulation or with an actual product inside. Where OQ validates hardware and software, PQ validates how a chamber works. The PQ process takes several weeks or months, to confirm that the equipment operates as intended and meets the specified requirements for its intended use.

    The PQ process also includes an assessment of the operating and maintenance processes to ensure that they are adequate. The PQ process may also include monitoring the equipment for indicators of malfunction, to make sure that any problems are identified and addressed swiftly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Colorado Springs, CO | Darwin Chambers

Stability chamber calibration and validation is an essential part of ensuring the reliability of stability studies in Colorado Springs, CO. The process helps to ensure that the stability chamber is suitable for the work you need it to do. Annual or biannual validation is essential to maintaining the quality and effectiveness of various products.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Colorado Springs, CO researchers for more than 20 years, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we manufacture meet and exceed FDA and ICH regulations. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

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