Rochester, NY

Stability Chamber Calibration, Validation, Qualification in Rochester, NY

Stability Chamber Calibration, Validation, Qualification in Rochester, NY. Your research requires that your stability chambers in Rochester are always functional, and at peak capacity. You want the assurances that the process and products you trust with your stability chambers are safe, and that your business investment is protected. To maintain your stability chambers current quality and production levels, 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 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 under a variety of conditions, 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 Rochester, NY

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure they function reliably for a long period of time. 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 customized programs, such as single point or loop calibrations and verifications. 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. If any instrument exceeds the tolerance, we will promptly notify you, so that you may take the necessary steps to make note of it and fix the issue.

If a chamber's "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 to ensure the instrument is reading within the manufacturer’s tolerance.

The calibration of a stability chamber consists of verifying its performance against a set of standards and making adjustments in order to achieve the intended specifications. Most calibration procedures involve verifying 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 difference between the two readings, we'll make adjustments until the readings are the same.
• Humidity calibration is similar to temperature calibration. A reference hygrometer is placed inside the stability chamber, and humidity readings are compared just as temperature readings are.
• Pressure calibration involves calibrating the pressure readings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until all of the readings show the same thing.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber stay accurate 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.

You need a certified and experienced technician to make sure the calibration is done right. 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 Rochester, NY

A reliable stability chamber validation and qualification in Rochester, NY should:

• Provide a list of instruments used for qualifications
• 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 follow the installation design intention. The IQ process includes an analysis of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's requirements.
• Operational Qualification (OQ) is utilized for providing 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 include tests to validate the performance of the equipment under different settings. The OQ process also validates that safety measures and alarms are operating as they should.
• Performance Qualification (PQ) is utilized for providing 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 takes several weeks or months, to confirm that the equipment operates as it should and meets the specified requirements for its intended use.

  The PQ process also includes an assessment of the operating and maintenance processes to make sure they are adequate. The PQ process may also consist of tracking the equipment for indicators of malfunction, to make sure that any issues are caught and addressed swiftly.

Stability Chamber Calibration, Validation, and Qualification in Rochester, NY | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the reliability of stability studies in Rochester, NY. The procedures help to ensure that the stability chamber is suitable for its intended use. Regular validation is essential to maintaining the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Rochester, NY researchers for more than 20 years, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we design and produce meet and exceed FDA and ICH regulations. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.