San Diego, CA

Stability Chamber Calibration, Validation, Qualification in San Diego, CA

Stability Chamber Calibration, Validation, Qualification in San Diego, CA. Your research requires that your stability chambers in San Diego are always functional, and at peak capacity. Your team needs to be assured that your stability chambers are operating correctly, and that qualified engineers have validated it's performance. To ensure that your stability chambers in San Diego 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 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 San Diego, CA

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 can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. 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. If an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can take the appropriate steps necessary.

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.

In order to perform calibration, you must verify a stability chamber's performance against a set of standards and making adjustments in order to achieve 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 contrasting 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, we'll make adjustments until the temperatures match.
  • Humidity calibration follows a similar process as temperature calibration. A reference hygrometer is located inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
  • Pressure calibration involves calibrating the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until they show the same thing.

Calibration is required to guarantee that the settings within the chamber stay 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 simple mistakes that could render your results invalid.

You need a certified 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 San Diego, CA

A reliable stability chamber validation and qualification in San Diego, CA should:

  • 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 are 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. 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 requirements.
  • Operational Qualification (OQ) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to assess 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) is intended to provide documented verification that the process does what it is intended to do (normally performed with either a simulated or actual product load in the chamber). 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 it should and meets the specified requirements for its intended use.

    The PQ process also includes an assessment of the operating and maintenance processes to ensure that they are adequate. The PQ process might also consist of tracking the equipment for indicators of malfunction, to make sure that any problems are identified and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in San Diego, CA | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the precision of stability studies in San Diego, CA. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is necessary to maintain the validity of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for San Diego, CA researchers for more than 20 years, and the value, reliability and expertise of our services are second to none. All of the stability chambers we design and produce meet and surpass 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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