Stability Chamber Calibration, Validation, Qualification Charleston, SC

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Charleston, SC

Stability Chamber Calibration, Validation, Qualification in Charleston, SC. It is critically important that stability chambers operate at a peak performance level, and that they are also operating safely. 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 engineers can provide stability chamber calibration, stability chamber validation, and stability chamber qualification. To discover more about our stability chamber services, or to speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

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 satisfactory 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 Charleston, SC

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 manufacturer’s needs.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. Our procedure provides a 3-point “as-found” calibration 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 noted, 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.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance and making adjustments in order to achieve the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. This can be done by comparing the readings of the stability chamber with a reference thermometer, which is located inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the temperatures are the same.
  • Humidity calibration is similar to temperature calibration. A reference hygrometer is located 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 calibrated barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber to guarantee that the conditions within the chamber stay consistent for an extended period. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid costly errors that could result in the need to repeat a stability study.

Calibration should only be done by a certified and experienced technician. 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 Charleston, SC

An expert stability chamber validation and qualification in Charleston, SC will:

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

Full qualification services in Charleston, SC are generally described in terms of three different parts:

  • Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, procurement, and installation follow to the design intention. This includes verifying that the equipment has been installed in the right location, that electrical components are properly connected, and that it meets the specified requirements for 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 consist of 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) 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 components, 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 achieve the continued operation of the instruments. The PQ process could also include monitoring the equipment for alarms of malfunction, to make sure that any problems are identified and addressed swiftly.

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Stability Chamber Calibration, Validation, and Qualification in Charleston, SC | Darwin Chambers

Stability chamber calibration and validation is a critical aspect of ensuring the reliability of your stability chamber in Charleston, SC. The procedures help to ensure that the stability chamber is acceptable 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 Charleston, SC researchers for over two decades, and the value, reliability and expertise of our services are second to none. All of the stability chambers we make meet and surpass FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

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