Kansas City, MO

Stability Chamber Calibration, Validation, Qualification in Kansas City, MO

Stability Chamber Calibration, Validation, Qualification in Kansas City, MO. 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 technicians have validated it's performance. To ensure that your stability chambers in Kansas City 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 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.

Please note: Darwin Chambers does not provide stability testing services. We specialize in manufacturing and supplying high-quality stability chambers designed to meet your testing needs.

Stability chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the specified range and acceptable for carrying out 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 their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Kansas City, MO

We understand your field might have heavy oversight, 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 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. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. Any instrument outside of tolerance will be recorded, and we will immediately notify you so that your team can take the appropriate actions.

If an instrument's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers 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.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance and making adjustments in order to achieve 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 is most often completed by contrasting 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 procedure as temperature calibration. A calibration 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 calibrating the pressure readings in the stability chamber. In this case, we use a calibrated barometer, and adjustments are made until they match.

Calibration is required to ensure that the conditions within the chamber stay precise over time. This helps to ensure that you can trust the results of your stability testing, and it also helps to avoid costly errors that could force you to have to carry out the study again.

You need a qualified and experienced technician to make sure the calibration is done right. How often you need calibration is based on the stability chamber usage and the level of precision required.

Stability Chamber Validation and Qualification in Kansas City, MO

A reliable stability chamber validation and qualification in Kansas City, MO 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 are 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 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 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 consist of tests to evaluate 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 the equipment, 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 processes to make sure they are adequate. The PQ process may also consist of tracking the equipment for alarms of malfunction, to ensure that any problems are identified and addressed swiftly.

Stability Chamber Calibration, Validation, and Qualification in Kansas City, MO | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the accuracy of your stability chamber in Kansas City, MO. The process helps to ensure that the stability chamber is suitable for its intended use. Annual or biannual validation is essential to maintaining the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Kansas City, MO scientists for over 20 years, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we manufacture meet and surpass FDA and ICH standards. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.