Chapel Hill, NC

Stability Chamber Calibration, Validation, Qualification in Chapel Hill, NC

Stability Chamber Calibration, Validation, Qualification in Chapel Hill, NC. 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 engineers have validated it's performance. To ensure that your stability chambers in Chapel Hill 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 discover 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.

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 reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Chapel Hill, NC

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. The use of these standards will ensure that your instruments adhere to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s specifications.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Chapel Hill, NC. 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 does not meet requirements, we will promptly notify you, so that you may take the necessary steps to document the event.

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 set of standards and making adjustments as necessary to ensure that it meets the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This can be done 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 readings are the same.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is put 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 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 guarantee 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 qualified and experienced technician. The frequency of calibration is based on the stability chamber usage and the level of precision required.

Download Calibration Brochure

Stability Chamber Validation and Qualification in Chapel Hill, NC

An expert stability chamber validation and qualification in Chapel Hill, NC 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 in Chapel Hill, NC are usually described in terms of three different parts:

  • Installation Qualification (IQ) is utilized for providing records that the design, procurement, and installation follow to the design intention. The IQ process includes a review of the installation documentation, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's specifications.
  • Operational Qualification (OQ) is meant to provide 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 assess the performance of the equipment under different settings. 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 hardware and software, PQ validates a chamber's performance. The PQ process takes several weeks or months, to confirm that the chamber can hold up as long as you need it to.

    The PQ process also includes a review of the operating and maintenance processes to ensure that they are adequate. The PQ process may also include monitoring the equipment for indicators of malfunction, to ensure that any issues are identified and taken care of swiftly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Chapel Hill, NC | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the precision of your stability chamber in Chapel Hill, NC. The process helps to ensure that the stability chamber is acceptable for its intended use. Annual or biannual 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 Chapel Hill, NC researchers for more than two decades, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we manufacture meet and exceed 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.

Other Locations We Service

Schema

Close
Close
Close