Memphis, TN

Stability Chamber Calibration, Validation, Qualification in Memphis, TN

Stability Chamber Calibration, Validation, Qualification in Memphis, TN. Your stability chambers need to be fully and safely operational at all times. 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 ensure that your stability chambers in Memphis 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 find out 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 Memphis, TN

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. The use of these standards will ensure that your instruments follow to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s 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. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. If an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can take the appropriate steps necessary.

If an instrument's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers calibration procedures. 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 involves verifying its 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 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 put inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the readings 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 readings in the stability chamber. To read pressure, we use a reference 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 remain consistent 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 qualified 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 Memphis, TN

An expert stability chamber validation and qualification in Memphis, TN should:

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

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 adhere to the design intention. This includes verifying that the instruments are in the right location, that it is properly connected to electrical and other services, and that it meets the specified requirements for temperature and humidity control.
  • Operational Qualification (OQ) is utilized for providing documented 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 include 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 can reach the temperature, humidity, and pressure settings as intended, either in a simulation or product load. 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 assessment of the operating and maintenance procedures to make sure they will support the continued operation of the instruments. The PQ process may also consist of tracking the equipment for alarms of malfunction, to make sure that any problems are caught and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Memphis, TN | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the reliability of your stability chamber in Memphis, TN. The process helps to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is necessary to maintain the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Memphis, TN scientists for over 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 regulations. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

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