Stability Chamber Calibration, Validation, Qualification St. Louis, MO

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in St. Louis, MO

Stability Chamber Calibration, Validation, Qualification in St. Louis, MO. Your research requires that your stability chambers in St. Louis are always functional, and at peak capacity. Your team needs to be assured that your stability chambers are operating correctly, and that qualified engineers have validated it's performance. To maintain your stability chambers current quality and production levels, our stability chamber technicians 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 fill out this form here.

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 studies are a critical aspect of ensuring the quality and effectiveness of various products, including pharmaceuticals, cosmetics, food, and chemicals. These studies require a controlled environment to test the product's stability over time, and stability chambers are used to provide this environment. The accuracy of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in St. Louis, MO

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure perfect performance. 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 offer customized programs, such as single point or loop calibrations and verifications. Our procedure provides a 3-point “as-found” calibration verification. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. If an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can take the appropriate steps necessary.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance 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 accuracy of the temperature readings in the stability chamber. This can be done by comparing the readings of the stability chamber with a calibrated thermometer, which is located inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the readings match.
  • Humidity calibration follows a similar process as temperature calibration. A reference hygrometer is located inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
  • Pressure calibration involves calibrating the pressure settings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until all of the readings match.

Calibration is required to ensure that the settings within the chamber remain precise for an extended period. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could force you to have to carry out the study again.

Calibration should only be done by a certified 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 St. Louis, MO

A reliable stability chamber validation and qualification in St. Louis, MO should:

  • Include a list of instruments used for qualifications
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Full qualification services in St. Louis, MO are generally described in terms of a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. This includes verifying that the equipment has been installed in the correct spot, that electrical components are properly connected, and that it can maintain the necessary temperature and humidity control.
  • Operational Qualification (OQ) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to validate the performance of the equipment under different load 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 the equipment, PQ validates how a chamber works. The PQ process involves performing a series of tests and evaluations over a defined period of time, typically several weeks or months, to confirm that the equipment operates as it should and meets the specified requirements for its intended use.

    The PQ process also includes an assessment of the operating and maintenance procedures to ensure that they are adequate. The PQ process could also consist of observation of the equipment for alarms of malfunction, to ensure that any issues are identified and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in St. Louis, MO | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the accuracy of your stability chamber in St. Louis, MO. The process helps to ensure that the stability chamber is suitable for its intended use. Annual or biannual validation is essential to maintaining the accuracy of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for St. Louis, MO researchers for more than 20 years, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we make meet and surpass FDA and ICH standards. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

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