Bellingham, WA

Stability Chamber Calibration, Validation, Qualification in Bellingham, WA

Stability Chamber Calibration, Validation, Qualification in Bellingham, WA. 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 Bellingham are fully and safely operational, or stability chamber engineers can provide, our stability chamber engineers 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 fill out this form here.

Stability chamber calibration is a crucial part of ensuring that the conditions in a stability chamber are within the intended range and satisfactory for conducting stability studies. 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 Bellingham, WA

We understand the critical role that calibrations have in your regulated industry, 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 your specifications.

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. 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.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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 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 consists of verifying that temperature readings are accurate. 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 difference between the two readings, we'll make adjustments until the readings match.
  • Humidity calibration follows a similar procedure 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 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 show the same thing.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber remain precise 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 simple mistakes that could force you to have to carry out the study again.

You need a qualified and experienced technician to make sure the calibration is done right. 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 Bellingham, WA

A reliable stability chamber validation and qualification in Bellingham, WA will:

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

Full qualification services in Bellingham, WA are usually described in terms of three different parts:

  • Installation Qualification (IQ) is utilized for providing records that the design, procurement, and installation follow to the design intention. This includes verifying that the instruments are in the correct location, that it is properly connected to electrical and other services, and that it can maintain the necessary temperature and humidity control.
  • Operational Qualification (OQ) is meant to provide 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 includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • 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 equipment operates as intended and meets the specified requirements for its intended use.

    The PQ process also includes an evaluation of the operating and maintenance procedures to ensure that they will support the continued operation of the chamber. The PQ process could also include observation of the equipment for indicators of malfunction, to ensure that any issues are detected and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Bellingham, WA | Darwin Chambers

Stability chamber calibration and validation is an essential part of ensuring the precision of stability studies in Bellingham, WA. The process helps to ensure that the stability chamber is acceptable for the work you need it to do. Regular 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 Bellingham, WA researchers for over 20 years, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we make meet and exceed FDA and ICH regulations. 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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