Cincinnati, OH

Stability Chamber Calibration, Validation, Qualification in Cincinnati, OH

Stability Chamber Calibration, Validation, Qualification in Cincinnati, OH. 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 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 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 contact us online.

Stability chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the intended 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 how they hold up over time and under certain conditions.

Stability Chamber Calibration in Cincinnati, OH

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure perfect performance. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your needs.

We can also offer customized programs, 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 documented, and we will immediately notify you so that your team can take the appropriate actions.

If a chamber'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 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 looking at the readings from the chamber against those from a calibrated thermometer, which is located inside the chamber. If there is a difference between the two readings, we'll make adjustments until the temperatures are the same.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is placed inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • Pressure calibration involves verifying the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings match.

Calibration is required to ensure that the settings within the chamber remain precise for an extended period. This helps to ensure that you can trust the results of your stability testing, 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 every 6 months to 1 year, depending on how often it is used.

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Stability Chamber Validation and Qualification in Cincinnati, OH

An expert stability chamber validation and qualification in Cincinnati, OH will:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Full qualification services in Cincinnati, OH are usually described in terms of a three-part process:

  • 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 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 they need to at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also consist of tests to validate 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 can reach the temperature, humidity, and pressure settings as intended, either in a simulation or with an actual product inside. Where OQ validates components, PQ validates a chamber's performance. The PQ process involves conducting a series of tests and evaluations over a defined period of time, typically 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 will support the continued operation of the chamber. The PQ process may also include monitoring the equipment for indicators of malfunction, to ensure that any problems are identified and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Cincinnati, OH | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the precision of stability studies in Cincinnati, OH. The procedures help to ensure that the stability chamber is suitable 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 Cincinnati, OH researchers for more than 20 years, and the value, reliability and expertise of our technicians are unmatched. All of the stability chambers we design and produce 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 ask for a free quote.

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