Seattle, WA

Stability Chamber Calibration, Validation, Qualification in Seattle, WA

Stability Chamber Calibration, Validation, Qualification in Seattle, WA. Your stability chambers need to be fully and safely operational at all times. 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 Seattle 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 find out 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 fill out this form here.

Stability chamber calibration is a crucial aspect of ensuring that the conditions in a stability chamber are within the intended range and acceptable 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 Seattle, WA

We use precise calibration standards to ensure quality performance within every chamber. 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 offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. 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. 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.

In order to perform calibration, you must verify a stability chamber's 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 the reliability of the temperature readings in the stability chamber. This is most often completed by looking at the readings from the chamber against those from a calibrated thermometer, which is placed inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the temperatures are the same.
• Humidity calibration is similar to temperature calibration. A calibration 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 readings in the stability chamber. In this case, 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 stay consistent over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could result in the need to repeat a stability study.

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.

Stability Chamber Validation and Qualification in Seattle, WA

A true stability chamber validation and qualification in Seattle, WA 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 Seattle, WA are typically described in terms of 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. This includes verifying that the instruments are in the right spot, that it is properly connected to electrical and other services, and that it meets the specified requirements for 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 consist of tests to validate 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) 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 assessment of the operating and maintenance procedures to ensure that they will achieve the continued operation of the chamber. The PQ process might also consist of observation of the equipment for indicators of malfunction, to ensure that any issues are detected and taken care of quickly.

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

Stability chamber calibration and validation is a critical aspect of ensuring the reliability of your stability chamber in Seattle, WA. The procedures help to ensure that the stability chamber is acceptable for the work you need it to do. Regular validation is necessary to maintain the quality and effectiveness of various products.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Seattle, WA scientists for more than 20 years, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we make meet and surpass FDA and ICH regulations. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.