Chicago, IL

Stability Chamber Calibration, Validation, Qualification in Chicago, IL

Stability Chamber Calibration, Validation, Qualification in Chicago, IL. Your stability chambers need to be fully and safely operational at all times. You want the assurances that the process and products you trust with your stability chambers are safe, and that your business investment is protected. To ensure that your stability chambers in Chicago 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 discover 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 reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Chicago, IL

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure they function reliably for a long period of time. The use of these standards will ensure that your instruments adhere 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 procedure provides a 3-point “as-found” calibration 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 process. 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 consists of verifying its performance against a given tolerance and making adjustments in order to achieve the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. This is most often completed by comparing the readings of the stability chamber with a reference thermometer, which is located inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the temperatures match.
  • Humidity calibration follows a similar process as temperature calibration. A calibration hygrometer is put 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 readings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until they show the same thing.

Calibration is required to guarantee that the conditions within the chamber stay precise over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could result in the need to repeat a stability study.

You need a certified and experienced technician to make sure the calibration is done right. It is recommended to calibrate a stability chamber every 6 months to 1 year, depending on how often it is used.

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Stability Chamber Validation and Qualification in Chicago, IL

An expert stability chamber validation and qualification in Chicago, IL will:

  • Provide a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation include three different parts:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. This includes verifying that the equipment has been installed in the right location, that it is properly connected to electrical and other services, and that it meets the specified requirements for 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 consist of tests to validate the performance of the equipment under different humidity and temperatures. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) is intended to provide documented verification that the temperature, humidity, and pressure settings work in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). Where OQ validates hardware and software, PQ validates a chamber's performance. The PQ process involves performing a series of tests and evaluations over a set period, typically several weeks or months, to confirm that the chamber can hold up as long as you need it to.

    The PQ process also includes a review of the operating and maintenance procedures to ensure that they are adequate. The PQ process could also include observation of the equipment for indicators of malfunction, to ensure that any issues are identified and addressed promptly.

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Stability Chamber Calibration, Validation, and Qualification in Chicago, IL | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the accuracy of stability studies in Chicago, IL. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is essential to maintaining the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Chicago, IL researchers for over two decades, and the value, reliability and expertise of our services are unrivaled. All of the stability chambers we manufacture meet and exceed FDA and ICH guidelines. 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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