Stability Chamber Calibration, Validation, Qualification Nashville, TN

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Nashville, TN

Stability Chamber Calibration, Validation, Qualification in Nashville, TN. Your applications and processes require that your stability chambers in Nashville are always operating as needed, and at peak capacity. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians 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 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 chambers are an indispensable part of any laboratory, that are used to store and study the stability of products under simulated environmental conditions. These chambers are used in a wide range of industries, including pharmaceuticals, cosmetics, and food, to ensure the safety and efficacy of products over time. To ensure that the results obtained from stability testing are reliable, stability chambers must be calibrated, validated, and qualified.

Stability Chamber Calibration in Nashville, TN

We understand your field might have heavy oversight, which is why we use extremely precise calibration standards. The use of these standards will ensure that your instruments are calibrated to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We can also offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. 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. Any instrument outside of tolerance will be noted, and we will immediately notify you so that your team can take the appropriate actions.

Any instruments found outside of calibration can then be calibrated using the manufacturer's calibration process. Once calibration is finalized, the readings of the unit will be documented to detail the units calibration and operation within the manufacturer's tolerance.

In order to perform calibration, you must verify a stability chamber's performance against a set of standards and making adjustments as necessary to ensure that it meets the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration involves verifying the accuracy of the temperature readings in the stability chamber. This can be done 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 temperatures are the same.
  • Humidity calibration follows a similar procedure as temperature calibration. A reference hygrometer is put inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • Pressure calibration involves verifying the pressure readings in the stability chamber. In this case, 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 stay consistent over time. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid simple mistakes that could force you to have to carry out the study again.

Calibration should only be done by a qualified and experienced technician. How often you need calibration is based on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Nashville, TN

A reliable stability chamber validation and qualification in Nashville, TN 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) 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 analysis of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • Operational Qualification (OQ) is meant to provide documented verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally carried out with an unloaded chamber). The OQ process may also include tests to evaluate 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) ensures and documents that the unit performs as intended, either in a simulation or product load. Where OQ validates components, PQ validates how a chamber works. The PQ process involves conducting 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 evaluation of the operating and maintenance processes to ensure that they are adequate. The PQ process might also consist of observation of the equipment for alarms of malfunction, to make sure that any issues are identified and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Nashville, TN | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the reliability of your stability chamber in Nashville, TN. The procedures help to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is necessary to maintain the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Nashville, TN scientists for over two decades, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we manufacture meet and exceed FDA and ICH regulations. 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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