Gainsville, FL

Stability Chamber Calibration, Validation, Qualification in Gainsville, FL

Stability Chamber Calibration, Validation, Qualification in Gainsville, FL. 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 engineers 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 fill out this form here.

Stability chamber calibration is a necessary aspect of ensuring that the conditions in a stability chamber are within the intended range and satisfactory 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 monitor samples of pharmaceuticals, cosmetic, food, and chemical products to determine how they hold up over time and under certain conditions.

Stability Chamber Calibration in Gainsville, FL

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure perfect performance. 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 manufacturer’s needs.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Gainsville, FL. 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 recorded, and we will immediately notify you so that your team can take the appropriate actions.

If a chamber's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers calibration procedures. 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 involves verifying its performance against a given tolerance and making adjustments as necessary to ensure that it meets the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This can be done by looking at the readings from the chamber against those from a calibrated thermometer, which is put inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the temperatures are the same.
  • Humidity calibration follows a similar process as temperature calibration. A calibration hygrometer is put 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. In this case, we use a reference barometer, and adjustments are made until they match.

Calibration is required to ensure that the conditions within the chamber stay precise for an extended period. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could render your results invalid.

Calibration should only be done by a qualified and experienced technician. How often you need calibration is based on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Gainsville, FL

An expert stability chamber validation and qualification in Gainsville, FL will:

  • Consist of calibration records of all instrumentation used during the qualification
  • 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 adheres to requirements for the intended use. This includes verifying that the equipment has been installed in the right spot, that electrical components are properly connected, and that it meets the specified requirements for temperature and humidity control.
  • 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 validate 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 performs as intended, either in a simulation or product load. Where OQ validates hardware and software, PQ validates how a chamber works. 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 a review of the operating and maintenance procedures to ensure that they are adequate. The PQ process may also include tracking the equipment for alarms of malfunction, to make sure that any issues are detected and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Gainsville, FL | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of your stability chamber in Gainsville, FL. The process helps to ensure that the stability chamber is suitable for the work you need it to do. Annual or biannual validation is essential to maintaining the reliability of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Gainsville, FL scientists for over 20 years, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we manufacture 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 ask for a free quote.

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