Austin, TX

Stability Chamber Calibration, Validation, Qualification in Austin, TX

Stability Chamber Calibration, Validation, Qualification in Austin, TX. It is critically important that stability chambers function as intended, and that they are also operating safely. 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 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.

Stability chamber calibration is a necessary aspect of ensuring that the conditions in a stability chamber are within the intended range and suitable for conducting 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 store and monitor samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Austin, TX

We understand the critical role that calibrations have in your regulated industry, which is why we use extremely precise calibration standards. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s needs.

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

  • Temperature calibration involves verifying that temperature readings are accurate. 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 difference between the two readings, we'll make adjustments until the readings are the same.
  • Humidity calibration is similar to temperature calibration. A reference 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. In this case, we use a calibrated barometer, and adjustments are made until all of the readings match.

Calibration is required 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 costly errors that could result in the need to repeat a stability study.

Calibration should be performed by a certified 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 Austin, TX

A reliable stability chamber validation and qualification in Austin, TX 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

Qualification and validation are a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. The IQ process includes an analysis of the installation documentation, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's specifications.
  • 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 assess 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) 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 hardware and software, PQ validates a chamber's performance. The PQ process involves performing a series of tests and evaluations over a set period, typically 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 evaluation of the operating and maintenance processes to ensure that they are adequate. The PQ process might also include monitoring the equipment for alarms of malfunction, to ensure that any issues are identified and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Austin, TX | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the accuracy of your stability chamber in Austin, TX. The process helps to ensure that the stability chamber is acceptable for the work you need it to do. Annual or biannual validation is necessary to maintain the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Austin, TX scientists for more than 20 years, and the value, reliability and expertise of our technicians 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 request a free quote.

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