Stability Chamber Calibration, Validation, Qualification Stability Chamber Calibration, Validation, Qualification. It is critically important that stability chambers operate at a peak performance level, and that they are also operating safely. Your team needs to be assured that your stability chambers are operating correctly, and that qualified engineers have validated its performance. To ensure that your stability chambers 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 Darwin Chambers' calibration, validation, and qualification services, or to speak with our team regarding other products, please call or contact Darwin Chambers now at 877-783-6774, 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 provide this environment. The accuracy and reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions. Stability Chamber Calibration 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 and exceed manufacturer’s specifications. We provide several different programs to ensure that you receive the service you need for your stability chamber. 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 noted, and we will immediately notify you so that your team can take the appropriate actions. If an instrument is "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 verification 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 desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure: Temperature calibration involves verifying the accuracy of the temperature readings in the stability chamber. This can be done by comparing the readings of the stability chamber with a reference thermometer, such as 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 readings match. Humidity calibration is similar to temperature calibration. A reference hygrometer is placed inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system. Pressure calibration involves verifying the pressure readings in the stability chamber. In this case, we use a reference barometer, such as a calibrated barometer, which is placed inside the chamber, and adjustments are made until they match. It is important to regularly calibrate the stability chamber to ensure that the conditions within the chamber remain consistent and accurate over time. This helps to ensure that the results of stability testing are reliable and accurate, and it also helps to avoid costly errors that could result in the need to repeat a stability study. Calibration should be performed by a qualified and experienced technician. The frequency of calibration depends on the stability chamber usage and the level of precision required. 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. Download Calibration BrochureDownload Stability Chamber Validation and Qualification A true stability chamber validation and qualification should: Consist of calibration records of all instrumentation used during the qualification Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards Full Qualification services are typically described in terms of a three-part process: Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. This includes verifying that the equipment has been installed in the correct location, that it is properly connected to electrical and other services, and that it meets the specified requirements for temperature and humidity control. The IQ process also includes a review of the installation documentation, such as wiring diagrams and equipment specifications, to confirm that the equipment has been installed according to the manufacturer's instructions. Operational Qualification (OQ) is utilized for providing documented verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally performed with an unloaded chamber). The OQ process may also include tests to evaluate the performance of the equipment under different conditions, such as different load conditions or different humidity and temperatures. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly. Performance Qualification (PQ) is utilized for providing documented verification that the process does what it is intended to do, in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). Where OQ validates hardware and software, PQ validates a chamber's performance. The PQ process involves conducting a series of tests and evaluations over a defined period of time, typically 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 a review of the operating and maintenance procedures to ensure that they are adequate and that they will support the continued operation of the equipment. The PQ process may also consist of monitoring the equipment for alarms and other indicators of malfunction, to ensure that any issues are detected and addressed promptly. Download Validation BrochureDownload Stability Chamber Calibration, Validation, and Qualification | Darwin Chambers Stability chamber calibration and validation is a critical aspect of ensuring the accuracy and reliability of stability studies. The validation process helps to ensure that the stability chamber is suitable for its intended use. Regular validation is essential to ensuring 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 over 20 years, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we manufacture meet and exceed FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.