Madison, WI

Stability Chamber Calibration, Validation, Qualification in Madison, WI

Stability Chamber Calibration, Validation, Qualification in Madison, WI. 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 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 or to discuss your needs with a staff member, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

Stability chamber calibration is a crucial aspect 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 house and test samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Madison, WI

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

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. 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.

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 set of standards and making adjustments in order to achieve the intended specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration involves verifying the accuracy of the temperature readings in the stability chamber. This is most often completed by contrasting the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a difference between the two readings, we'll make adjustments until the temperatures match.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is placed inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • 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 consistent over time. This helps to ensure that you can trust the results of your stability testing, and it also helps to avoid simple mistakes that could force you to have to carry out the study again.

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 Madison, WI

An expert stability chamber validation and qualification in Madison, WI should:

  • Provide 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) 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. This includes verifying that the equipment has been installed in the right spot, 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 intended at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also consist of tests to evaluate 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 performs as intended, either in a simulation or with an actual product inside. Where OQ validates the equipment, PQ validates a chamber's performance. The PQ process takes 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 assessment of the operating and maintenance procedures to ensure that they will achieve 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 detected and taken care of quickly.

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Stability Chamber Calibration, Validation, and Qualification in Madison, WI | Darwin Chambers

Stability chamber calibration and validation is a critical part of ensuring the reliability of your stability chamber in Madison, WI. The process helps to ensure that the stability chamber is suitable for its intended use. Regular 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 Madison, WI scientists for more than 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 request a free quote.

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