Stability Chamber Calibration, Validation, Qualification Bellingham, WA

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Bellingham, WA

Stability Chamber Calibration, Validation, Qualification in Bellingham, WA. 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 engineers can provide stability chamber calibration, stability chamber validation, and stability chamber qualification. To learn 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 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 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 simulate 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 Bellingham, WA

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 follow to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your needs.

We can also offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. 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 does not meet requirements, we will promptly notify you, so that you may take the necessary steps to document the event.

If a chamber's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers 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 desired 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 looking at the readings from the chamber against those from a calibrated thermometer, which is placed 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 placed 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. In this case, we use a reference barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber to guarantee that the conditions 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 simple mistakes that could result in the need to repeat a stability study.

Calibration should be performed 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 Bellingham, WA

A true stability chamber validation and qualification in Bellingham, WA will:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Full qualification services in Bellingham, WA are typically described in terms of a three-part process:

  • Installation Qualification (IQ) includes a series of tests and evaluations to confirm that the equipment has been installed according to the manufacturer's specifications and that it adheres to requirements for the intended use. The IQ process includes an evaluation 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) 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 assess the performance of the equipment under different 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 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 make sure they will support the continued operation of the chamber. The PQ process may also consist of tracking the equipment for indicators of malfunction, to ensure that any issues are identified and taken care of quickly.

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Stability Chamber Calibration, Validation, and Qualification in Bellingham, WA | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the accuracy of your stability chamber in Bellingham, WA. The process helps to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is necessary to maintain 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 Bellingham, WA researchers for over two decades, and the value, reliability and expertise of our technicians are unrivaled. All of the stability chambers we make meet and surpass FDA and ICH guidelines. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

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