Fort Collins, CO

Stability Chamber Calibration, Validation, Qualification in Fort Collins, CO

Stability Chamber Calibration, Validation, Qualification in Fort Collins, CO. 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 engineers 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 find out 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.

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 reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Fort Collins, CO

We understand your field might have heavy oversight, which is why we use extremely precise calibration standards. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s needs.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. 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. 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.

The calibration of a stability chamber consists of verifying its performance against a given tolerance and making adjustments as necessary to ensure that it meets the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. This is most often completed by comparing the readings of the stability chamber with a calibrated thermometer, which is located inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the readings are the same.
  • Humidity calibration follows a similar process as temperature calibration. A reference 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. To read pressure, we use a reference barometer, and adjustments are made until they match.

Calibration is required to ensure that the conditions within the chamber remain consistent for an extended period. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid costly errors that could render your results invalid.

You need a qualified 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 Fort Collins, CO

An expert stability chamber validation and qualification in Fort Collins, CO will:

  • Include a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation are a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. The IQ process includes a review of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's specifications.
  • Operational Qualification (OQ) is utilized for providing documented verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally performed with an unloaded chamber). The OQ process may also include tests to evaluate the performance of the equipment under different load conditions. 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 product load. Where OQ validates the equipment, 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 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 will achieve the continued operation of the instruments. The PQ process might also consist of monitoring the equipment for alarms of malfunction, to make sure that any issues are caught and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Fort Collins, CO | Darwin Chambers

Stability chamber calibration and validation is an essential part of ensuring the accuracy of stability studies in Fort Collins, CO. The procedures help to ensure that the stability chamber is acceptable for its intended use. Regular validation is necessary to maintain the reliability of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Fort Collins, CO scientists for over 20 years, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we manufacture meet and exceed FDA and ICH standards. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

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