Stability Chamber Calibration, Validation, Qualification in Cambridge, MA Stability Chamber Calibration, Validation, Qualification in Cambridge, MA. It is critically important that stability chambers function as intended, and that they are also operating safely. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. To ensure that your stability chambers in Cambridge 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 or to discuss your needs with a staff member, please call Darwin Chambers now at (314) 534-3111 or contact us online. Stability chamber calibration is a crucial aspect of ensuring that the conditions in a stability chamber are within the intended range and satisfactory for carrying out stability testing. 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 store 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 Cambridge, MA 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 manufacturer’s specifications. We can also offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. 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. 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 consists of 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 involves verifying that temperature readings are accurate. This is most often completed by looking at the readings from the chamber against those from a reference thermometer, which is located inside the chamber. If there is a discrepancy, we'll make adjustments until the temperatures are the same. Humidity calibration follows a similar process as temperature calibration. A reference hygrometer is placed 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. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings match. It is important to regularly calibrate the stability chamber to ensure that the conditions 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 simple mistakes that could force you to have to carry out the study again. Calibration should only be done by a certified and experienced technician. How often you need calibration is based on the stability chamber usage and the level of precision required. Download Calibration BrochureDownload Stability Chamber Validation and Qualification in Cambridge, MA A reliable stability chamber validation and qualification in Cambridge, MA 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) is intended to provide documented verification that all key aspects of the design, procurement, and installation follow to the design intention. This includes verifying that the equipment has been installed in the correct location, that electrical components are properly connected, and that it meets the specified requirements for temperature and humidity control. 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 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 temperature, humidity, and pressure settings work in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). Where OQ validates components, PQ validates how a chamber works. The PQ process takes 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 make sure they will achieve the continued operation of the equipment. The PQ process may also include monitoring the equipment for alarms of malfunction, to make sure that any issues are caught and addressed quickly. Download Validation BrochureDownload Stability Chamber Calibration, Validation, and Qualification in Cambridge, MA | Darwin Chambers Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of stability studies in Cambridge, MA. The process helps 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 Cambridge, MA scientists for more than 20 years, 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 ask for a free quote.