Stability Chamber Calibration, Validation, Qualification Charlotte, NC

Stability Chamber Calibration, Validation & Qualification Services

Ensure Compliance with FDA, ICH, and GMP Guidelines — Get a Quote Today.

Stability Chamber Calibration, Validation, Qualification in Charlotte, NC

Stability Chamber Calibration, Validation, Qualification in Charlotte, NC. Your stability chambers need to be fully and safely operational at all times. 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 ensure that your stability chambers in Charlotte 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 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 chambers are essential pieces of laboratory equipment used to store and study the stability of products under simulated environmental conditions. These chambers are used in a variety of industries, including pharmaceuticals, cosmetics, and food, to ensure the safety and efficacy of products over a long period. To ensure that the results obtained from stability testing are reliable, stability chambers must be calibrated, validated, and qualified.

Stability Chamber Calibration in Charlotte, NC

We understand the critical role that calibrations have in your regulated industry, which is why we use extremely precise calibration standards. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s needs.

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. 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.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance and making adjustments as necessary to ensure that it meets the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration consists of verifying the accuracy of the temperature readings in the stability chamber. This is most often completed by contrasting the readings of the stability chamber with a calibrated 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 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. To read pressure, we use a calibrated 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 precise for an extended period. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could render your results invalid.

You need a qualified 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.

Download Calibration Brochure

Stability Chamber Validation and Qualification in Charlotte, NC

An expert stability chamber validation and qualification in Charlotte, NC 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 three different parts:

  • Installation Qualification (IQ) includes a series of tests and evaluations to confirm that the equipment has been installed according to the manufacturer's specifications and that it meets the requirements for the intended use. The IQ process includes an evaluation of the installation documentation, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's requirements.
  • 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 evaluate 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) ensures and documents that the unit can reach the temperature, humidity, and pressure settings as intended, either in a simulation or product load. Where OQ validates hardware and software, 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 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 could also include tracking the equipment for indicators of malfunction, to ensure that any problems are caught and addressed promptly.

Download Validation Brochure

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

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of your stability chamber in Charlotte, NC. The procedures help to ensure that the stability chamber is acceptable for its intended use. 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 Charlotte, NC scientists for more than 20 years, and the value, reliability and expertise of our services are unrivaled. All of the stability chambers we make meet and exceed FDA and ICH standards. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

Other Locations We Service

Select Reach-in Chambers IN STOCK.
Browse Available Models

Schema

5 customer service tips from LiveChat