Stability Chamber Calibration, Validation, Qualification Kansas City, MO

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Kansas City, MO

Stability Chamber Calibration, Validation, Qualification in Kansas City, MO. Your research requires that your stability chambers in Kansas City are always operating as needed, and at peak capacity. 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 Kansas City 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 learn 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.

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 suitable for conducting 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 Kansas City, MO

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

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Kansas City, MO. 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. If any instrument does not meet requirements, we will promptly notify you, so that you may take the necessary steps to document the event.

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.

The calibration of a stability chamber consists of 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 the accuracy of the temperature readings in the stability chamber. This is most often completed by looking at the readings from the chamber against those from a reference thermometer, which is placed inside the chamber. If there is a difference between the two readings, we'll make adjustments until the readings 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.

It is important to regularly calibrate the stability chamber to ensure that the conditions within the chamber stay precise 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. It is recommended to calibrate a stability chamber at least once a year, or more frequently if it is used frequently or if the results of previous calibrations indicate that it may be necessary.

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Stability Chamber Validation and Qualification in Kansas City, MO

A reliable stability chamber validation and qualification in Kansas City, MO will:

  • Provide a list of instruments used for qualifications
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Full qualification services in Kansas City, MO 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. The IQ process includes an analysis of the installation documentation, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • Operational Qualification (OQ) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to evaluate 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 involves conducting a series of tests and evaluations over a defined period of time, typically 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 equipment. The PQ process could also consist of observation of the equipment for indicators of malfunction, to make sure that any issues are identified and taken care of promptly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Kansas City, MO | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the reliability of stability studies in Kansas City, MO. The process helps to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is essential to maintaining the validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Kansas City, MO scientists for over 20 years, and the value, reliability and expertise of our technicians are unrivaled. All of the stability chambers we make meet and surpass 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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