Chicago, IL

Stability Chamber Calibration, Validation, Qualification in Chicago, IL

Stability Chamber Calibration, Validation, Qualification in Chicago, IL. 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 Chicago 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 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 chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the intended range and satisfactory 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 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 Chicago, IL

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 specifications.

We can also offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. 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. Once calibration is finalized, the readings of the unit will be documented to detail the units calibration and operation 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. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This is most often completed by contrasting the readings of the stability chamber with a calibrated thermometer, which is put 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 calibrating the pressure settings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until they match.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber remain precise over time. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid simple mistakes that could render your results invalid.

You need a certified and experienced technician to make sure the calibration is done right. It is recommended to calibrate a stability chamber every 6 months to 1 year, depending on how often it is used.

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Stability Chamber Validation and Qualification in Chicago, IL

A true stability chamber validation and qualification in Chicago, IL 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 are a three-part process:

  • 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 meets the requirements for the intended use. The IQ process includes a review of the installation documentation, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's specifications.
  • Operational Qualification (OQ) is meant to provide documented verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally performed with an unloaded 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) 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 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 an assessment of the operating and maintenance procedures to make sure they are adequate. The PQ process might also include monitoring the equipment for alarms of malfunction, to make sure that any problems are identified and taken care of swiftly.

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Stability Chamber Calibration, Validation, and Qualification in Chicago, IL | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of stability studies in Chicago, IL. The procedures help to ensure that the stability chamber is acceptable for the work you need it to do. Regular 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 Chicago, IL scientists for more than two decades, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we design and produce 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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