Tuson, AZ

Stability Chamber Calibration, Validation, Qualification in Tuson, AZ

Stability Chamber Calibration, Validation, Qualification in Tuson, AZ. It is critically important that stability chambers function as intended, and that they are also operating safely. Your team needs to be assured that your stability chambers are operating correctly, and that qualified engineers have validated it's performance. To ensure that your stability chambers in Tuson 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 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.

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 fields, 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 Tuson, AZ

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. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We can also offer customized programs, 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 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.

If an instrument'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.

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. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying the accuracy 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, we'll make adjustments until the temperatures are the same.
  • 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 verifying the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until they match.

It is important to regularly calibrate the stability chamber to ensure 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 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.

Download Calibration Brochure

Stability Chamber Validation and Qualification in Tuson, AZ

A reliable stability chamber validation and qualification in Tuson, AZ will:

  • Consist of calibration records of all instrumentation used during the qualification
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation include a three-part process:

  • Installation Qualification (IQ) is intended to provide documented verification that all key aspects of the design, procurement, and installation follow to the design intention. The IQ process includes an analysis of the installation records, such as wiring diagrams, 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 intended at all anticipated operating ranges (normally performed with an unloaded chamber). The OQ process may also consist of tests to assess the performance of the equipment under different settings. 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 performs as intended, either in a simulation or with an actual product inside. Where OQ validates the equipment, PQ validates how a chamber works. 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 an assessment of the operating and maintenance processes to ensure that they are adequate. The PQ process could also include observation of the equipment for alarms of malfunction, to make sure that any issues are caught and addressed swiftly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Tuson, AZ | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the precision of your stability chamber in Tuson, AZ. The procedures help to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is necessary to maintain the validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Tuson, AZ researchers for over two decades, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we design and produce 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 inquire about a free quote.

Other Locations We Service

Schema