San Antonio, TX

Stability Chamber Calibration, Validation, Qualification in San Antonio, TX

Stability Chamber Calibration, Validation, Qualification in San Antonio, TX. Your applications and processes require that your stability chambers in San Antonio 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 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 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 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 accuracy of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in San Antonio, TX

We use precise calibration standards to ensure quality performance within every chamber. 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. 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 set of standards and making adjustments as necessary to ensure that it meets the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

• Temperature calibration involves verifying that temperature readings are accurate. This is most often completed by comparing the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the readings are the same.
• Humidity calibration follows a similar process 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 verifying 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 remain consistent for an extended period. This helps to ensure that you can trust the results of your stability testing, and it also helps to avoid simple mistakes 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 depends on the stability chamber usage and the level of precision required.

Stability Chamber Validation and Qualification in San Antonio, TX

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

• Consist of calibration records of all instrumentation used during the qualification
• Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation include a three-part process:

• 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 right location, 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 documented 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 load conditions. 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 the equipment, PQ validates a chamber's performance. The PQ process involves performing a series of tests and evaluations over a set period, 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 an evaluation of the operating and maintenance procedures to make sure they will achieve the continued operation of the chamber. The PQ process could also include tracking the equipment for alarms of malfunction, to make sure that any issues are detected and addressed promptly.

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

Stability chamber calibration and validation is a crucial aspect of ensuring the precision of stability studies in San Antonio, TX. The procedures help to ensure that the stability chamber is acceptable 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 San Antonio, TX researchers for more than two decades, and our value, dependability, customer service, and expertise 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 inquire about a free quote.