Dallas, TX

Stability Chamber Calibration, Validation, Qualification in Dallas, TX

Stability Chamber Calibration, Validation, Qualification in Dallas, TX. 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 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 provide this environment. The accuracy of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Dallas, TX

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 manufacturer’s 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.

Any instruments found outside of calibration can then be calibrated using the manufacturer's 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 set of standards and making adjustments as necessary to ensure that it meets the intended specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

• Temperature calibration consists of verifying that temperature readings are accurate. This can be done by comparing the readings of the stability chamber with a calibrated thermometer, which is placed 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 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 calibrating the pressure settings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until all of the readings show the same thing.

Calibration is required to guarantee that the settings within the chamber remain precise over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could force you to have to carry out the study again.

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

Stability Chamber Validation and Qualification in Dallas, TX

A true stability chamber validation and qualification in Dallas, TX will:

• Include a list of instruments used for qualifications
• Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Full qualification services in Dallas, TX are generally described in terms of three different parts:

• Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. The IQ process includes an evaluation of the installation records, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's instructions.
• Operational Qualification (OQ) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also consist of tests to validate the performance of the equipment under different load conditions. 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 components, PQ validates a chamber's performance. The PQ process takes several weeks or months, to confirm that the chamber can hold up as long as you need it to.

  The PQ process also includes an evaluation of the operating and maintenance processes to ensure that they are adequate. The PQ process may also include tracking the equipment for alarms of malfunction, to ensure that any issues are caught and taken care of quickly.

Stability Chamber Calibration, Validation, and Qualification in Dallas, TX | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the reliability of your stability chamber in Dallas, TX. The procedures help to ensure that the stability chamber is acceptable for its intended use. Regular validation is necessary to maintain the validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Dallas, TX researchers for more than 20 years, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we manufacture meet and exceed FDA and ICH regulations. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.