Montreal, QC

Stability Chamber Calibration, Validation, Qualification in Montreal, QC

Stability Chamber Calibration, Validation, Qualification in Montreal, QC. It is critically important that stability chambers function as intended, and that they are also operating safely. 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 Montreal 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 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.

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 Montreal, QC

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 needs.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Montreal, QC. 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. 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 process. 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 intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This is most often completed by looking at the readings from the chamber against those from a calibrated thermometer, which is put inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the temperatures match.
  • Humidity calibration follows a similar process as temperature calibration. A reference hygrometer is put inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
  • Pressure calibration involves verifying the pressure settings in the stability chamber. In this case, we use a calibrated barometer, and adjustments are made until all of the readings match.

Calibration is required to guarantee that the settings within the chamber remain accurate over time. 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 result in the need to repeat a stability study.

Calibration should only be done by a certified 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 Montreal, QC

An expert stability chamber validation and qualification in Montreal, QC 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

Full qualification services in Montreal, QC are usually described in terms of a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. The IQ process includes an analysis of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's requirements.
  • Operational Qualification (OQ) is utilized for providing recorded verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally carried out with an empty chamber). The OQ process may also include tests to evaluate 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) 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 a review of the operating and maintenance processes to ensure that they will achieve the continued operation of the instruments. The PQ process may also consist of monitoring the equipment for alarms of malfunction, to ensure that any problems are identified and addressed promptly.

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Stability Chamber Calibration, Validation, and Qualification in Montreal, QC | Darwin Chambers

Stability chamber calibration and validation is a critical aspect of ensuring the accuracy of stability studies in Montreal, QC. The procedures help to ensure that the stability chamber is suitable for its intended use. Annual or biannual validation is necessary to maintain the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Montreal, QC scientists for more than two decades, and our value, dependability, customer service, and expertise are unmatched. 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 ask for a free quote.

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