Tempe, AZ

Stability Chamber Calibration, Validation, Qualification in Tempe, AZ

Stability Chamber Calibration, Validation, Qualification in Tempe, AZ. Your research requires that your stability chambers in Tempe 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 engineers have validated it's performance. To ensure that your stability chambers in Tempe are fully and safely operational, or stability chamber engineers can provide, 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 or to discuss your needs with a staff member, please call Darwin Chambers now at (314) 534-3111 or contact us online.

Stability chamber calibration is a crucial part of ensuring that the conditions in a stability chamber are within the specified range and suitable for carrying out stability testing. 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 their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Tempe, AZ

We use precise calibration standards to ensure quality performance within every chamber. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Tempe, AZ. 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. Any instrument outside of tolerance will be documented, and we will immediately notify you so that your team can take the appropriate actions.

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.

In order to perform calibration, you must verify a stability chamber's 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 contrasting the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a difference between the two readings, we'll make adjustments until the temperatures are the same.
  • Humidity calibration is similar to temperature calibration. A reference hygrometer is put inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • 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 ensure that the settings 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 qualified 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.

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Stability Chamber Validation and Qualification in Tempe, AZ

A true stability chamber validation and qualification in Tempe, AZ should:

  • 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 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 recorded verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also consist of tests to assess the performance of the equipment under different load conditions. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) is utilized for providing documented verification that the temperature, humidity, and pressure settings work in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). Where OQ validates the equipment, PQ validates a chamber's performance. 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 evaluation of the operating and maintenance processes to make sure they will support the continued operation of the chamber. The PQ process may also include monitoring the equipment for alarms of malfunction, to ensure that any problems are caught and addressed quickly.

Download Validation Brochure

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

Stability chamber calibration and validation is a critical part of ensuring the accuracy of stability studies in Tempe, AZ. The process helps to ensure that the stability chamber is acceptable for the work you need it to do. Annual or biannual validation is essential to maintaining 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 Tempe, AZ researchers for over 20 years, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we manufacture meet and exceed FDA and ICH guidelines. 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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