Stability Chamber Calibration, Validation, Qualification St. Paul, MN

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in St. Paul, MN

Stability Chamber Calibration, Validation, Qualification in St. Paul, MN. Your applications and processes require that your stability chambers in St. Paul are always functional, and at peak capacity. 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 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 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 crucial part of ensuring that the conditions in a stability chamber are within the intended range and acceptable for carrying out 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 test samples of pharmaceuticals, cosmetic, food, and chemical products to determine how they hold up over time and under certain conditions.

Stability Chamber Calibration in St. Paul, MN

We use precise calibration standards to ensure quality performance within every chamber. 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 specifications.

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. Any instrument outside of tolerance will be recorded, and we will immediately notify you so that your team can take the appropriate actions.

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 consists of 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 looking at the readings from the chamber against those from a calibrated thermometer, which is located inside the chamber. If there is a discrepancy, we'll make adjustments until the readings are the same.
  • Humidity calibration is similar to temperature calibration. A calibration 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 readings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until all of the readings show the same thing.

It is important to regularly calibrate the stability chamber 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 simple mistakes that could render your results invalid.

You need a certified and experienced technician to make sure the calibration is done right. The frequency of calibration depends on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in St. Paul, MN

A true stability chamber validation and qualification in St. Paul, MN should:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Qualification and validation include three different parts:

  • 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 it is properly connected to electrical and other services, 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 evaluate the performance of the equipment under different humidity and temperatures. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • 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 a chamber's performance. 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 chamber can hold up as long as you need it to.

    The PQ process also includes an assessment of the operating and maintenance processes to ensure that they will achieve the continued operation of the instruments. The PQ process could also consist of monitoring the equipment for indicators of malfunction, to make sure that any problems are caught and taken care of swiftly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in St. Paul, MN | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the accuracy of your stability chamber in St. Paul, MN. The procedures help to ensure that the stability chamber is suitable for its intended use. Regular 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 St. Paul, MN researchers for over 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 qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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