College Station, TX

Stability Chamber Calibration, Validation, Qualification in College Station, TX

Stability Chamber Calibration, Validation, Qualification in College Station, TX. 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 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 discover more about our stability chamber services, or to speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

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 College Station, TX

We understand the critical role that calibrations have in your regulated industry, which is why we use extremely precise calibration standards. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s needs.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in College Station, TX. Our service is provided as a 3-point "as-found" calibration and 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 address the problem promptly.

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.

The calibration of a stability chamber involves verifying its performance against a set of standards and making adjustments in order to achieve the intended specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This can be done by looking at the readings from the chamber against those from a calibrated thermometer, which is put inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the readings match.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is located inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • Pressure calibration involves verifying the pressure settings in the stability chamber. In this case, we use a reference barometer, and adjustments are made until they match.

Calibration is required to ensure that the conditions within the chamber remain consistent over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could render your results invalid.

Calibration should be performed by a qualified and experienced technician. 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 College Station, TX

A true stability chamber validation and qualification in College Station, TX should:

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

Full qualification services in College Station, TX are typically described in terms of a three-part process:

  • 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 correct location, that electrical components are properly connected, 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 load conditions. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • Performance Qualification (PQ) is intended to provide documented verification that the process does what it is intended to do (normally performed with either a simulated or actual product load in the chamber). Where OQ validates hardware and software, PQ validates how a chamber works. The PQ process takes several weeks or months, to confirm that the chamber can hold up as long as you need it to.

    The PQ process also includes an assessment of the operating and maintenance procedures to make sure they will support the continued operation of the chamber. The PQ process may also consist of observation of the equipment for alarms of malfunction, to ensure that any problems are identified and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in College Station, TX | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the precision of stability studies in College Station, TX. The procedures help to ensure that the stability chamber is acceptable for the work you need it to do. Regular validation is necessary to maintain the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for College Station, TX scientists for more than two decades, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we design and produce meet and surpass FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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