Milwaukee, MI

Stability Chamber Calibration, Validation, Qualification in Milwaukee, MI

Stability Chamber Calibration, Validation, Qualification in Milwaukee, MI. Your stability chambers need to be fully and safely operational at all times. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. 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 discover 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 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 Milwaukee, MI

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure perfect performance. 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 customized programs, 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 any instrument exceeds the tolerance, we will promptly notify you, so that you may take the necessary steps to document the event.

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.

The calibration of a stability chamber involves verifying its performance against a set of standards 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 can be done by contrasting the readings of the stability chamber with a calibrated thermometer, which is placed inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the temperatures are the same.
  • Humidity calibration is similar to temperature calibration. A calibration 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. 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 guarantee that the conditions within the chamber stay precise for an extended period. This helps to ensure that you can trust the results of your stability testing, and it also helps to avoid simple mistakes that could render your results invalid.

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 Milwaukee, MI

An expert stability chamber validation and qualification in Milwaukee, MI will:

  • Consist of calibration records of all instrumentation used during the qualification
  • 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 adheres to requirements for the intended use. This includes verifying that the instruments are in the right spot, that electrical components are properly connected, and that it can maintain the necessary 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 evaluate the performance of the equipment under different conditions. 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 product load. Where OQ validates the equipment, 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 evaluation of the operating and maintenance processes to ensure that they will support the continued operation of the equipment. The PQ process might also include tracking the equipment for alarms of malfunction, to make sure that any problems are identified and addressed promptly.

Download Validation Brochure

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

Stability chamber calibration and validation is a critical part of ensuring the reliability of your stability chamber in Milwaukee, MI. 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 testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Milwaukee, MI researchers for over 20 years, and the value, reliability and expertise of our services are second to none. All of the stability chambers we make meet and exceed FDA and ICH guidelines. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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