Phoenix, AZ

Stability Chamber Calibration, Validation, Qualification in Phoenix, AZ

Stability Chamber Calibration, Validation, Qualification in Phoenix, AZ. 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 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 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 fill out this form here.

Stability chamber calibration is a crucial aspect of ensuring that the conditions in a stability chamber are within the specified range and acceptable for conducting 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 house and test samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Phoenix, AZ

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 or exceed manufacturer’s needs.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. Our service is provided as a 3-point "as-found" calibration and 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 noted, 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.

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. Most calibration procedures involve verifying 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 calibrated thermometer, which is placed inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the temperatures 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 calibrating the pressure settings 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 ensure that the conditions within the chamber remain consistent over time. 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. 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.

Stability Chamber Validation and Qualification in Phoenix, AZ

A true stability chamber validation and qualification in Phoenix, AZ will:

• Provide a list of instruments used for qualifications
• Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Qualification and validation include three different parts:

• Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, procurement, and installation follow to the design intention. The IQ process includes an evaluation of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's specifications.
• Operational Qualification (OQ) is utilized for providing recorded verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally carried out with an empty chamber). The OQ process may also consist of tests to evaluate the performance of the equipment under different conditions. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
• 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 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 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 monitoring the equipment for indicators of malfunction, to make sure that any problems are detected and taken care of swiftly.

Stability Chamber Calibration, Validation, and Qualification in Phoenix, AZ | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the reliability of stability studies in Phoenix, AZ. The process helps to ensure that the stability chamber is acceptable for the work you need it to do. 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 Phoenix, AZ scientists for more than 20 years, and the value, reliability and expertise of our services are second to none. All of the stability chambers we design and produce meet and surpass FDA and ICH guidelines. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.