Stability Chamber Calibration, Validation, Qualification Milwaukee, MI

Stability Chamber Calibration, Validation & Qualification Services

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Stability Chamber Calibration, Validation, Qualification in Milwaukee, MI

Stability Chamber Calibration, Validation, Qualification in Milwaukee, MI. Your research requires that your stability chambers in Milwaukee 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 maintain your stability chambers current quality and production levels, 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 or to discuss your needs with a staff member, 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 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 simulate this environment. The reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Milwaukee, MI

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. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We can also offer customized programs, such as single point or loop calibrations and verifications. 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 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 given tolerance 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 involves verifying the accuracy of the temperature readings in the stability chamber. This can be done by looking at the readings from the chamber against those from a reference 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 calibration hygrometer is located inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • Pressure calibration involves verifying the pressure settings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings show the same thing.

Calibration is required to guarantee that the settings 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 simple mistakes that could force you to have to carry out the study again.

Calibration should only be done 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 Milwaukee, MI

A true stability chamber validation and qualification in Milwaukee, MI should:

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

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 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) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also consist of tests to assess the performance of the equipment under different settings. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) is utilized for providing documented verification that the process does what it is intended to do (normally performed with either a simulated or actual product load in the chamber). Where OQ validates hardware and software, 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 are adequate. The PQ process may also consist of monitoring the equipment for indicators of malfunction, to ensure that any issues are caught and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Milwaukee, MI | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the accuracy of your stability chamber in Milwaukee, MI. The process helps to ensure that the stability chamber is acceptable 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 Milwaukee, MI scientists for more than 20 years, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we manufacture 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 inquire about a free quote.

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