Charleston, SC

Stability Chamber Calibration, Validation, Qualification in Charleston, SC

Stability Chamber Calibration, Validation, Qualification in Charleston, SC. Your research requires that your stability chambers in Charleston 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 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 contact us online.

Stability studies are a critical aspect of ensuring the quality and effectiveness of various products, including pharmaceuticals, cosmetics, food, and chemicals. These studies require a controlled environment to test the product's stability over time, and stability chambers are used to provide this environment. The accuracy of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure 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 your 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. 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 documented, 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.

The calibration of a stability chamber consists of verifying its 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 consists of verifying the reliability of the temperature readings in the stability chamber. This is most often completed by comparing the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a discrepancy, we'll make adjustments until the temperatures match.
  • Humidity calibration follows a similar process as 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 all of the readings match.

Calibration is required to ensure that the settings within the chamber stay accurate over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could render your results invalid.

Calibration should be performed by a qualified and experienced technician. How often you need 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

A true stability chamber validation and qualification in Charleston, SC should:

  • Include a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation include a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. This includes verifying that the equipment has been installed in the correct spot, that electrical components are properly connected, and that it meets the specified requirements for temperature and humidity control.
  • Operational Qualification (OQ) is meant to provide recorded verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also include tests to validate 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 with an actual product inside. Where OQ validates components, PQ validates how a chamber works. 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 a review of the operating and maintenance procedures to ensure that they are adequate. The PQ process could also include tracking the equipment for indicators of malfunction, to make sure that any issues are detected and taken care of swiftly.

Download Validation Brochure

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

Stability chamber calibration and validation is an indispensable aspect of ensuring the accuracy of stability studies in Charleston, SC. The process helps to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is essential to maintaining the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Charleston, SC scientists for over two decades, 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 validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

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