Columbus, OH

Stability Chamber Calibration, Validation, Qualification in Columbus, OH

Stability Chamber Calibration, Validation, Qualification in Columbus, 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 ensure that your stability chambers in Columbus are fully and safely operational, or stability chamber engineers can provide, 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 speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

Stability chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the specified range and suitable 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 test samples of pharmaceuticals, cosmetic, food, and chemical products to determine how they hold up over time and under certain conditions.

Stability Chamber Calibration in Columbus, OH

We use precise calibration standards to ensure quality performance within every chamber. 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 your specifications.

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. 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. If an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can address the problem promptly.

Any instruments found outside of calibration can then be calibrated using the manufacturer's 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 given tolerance and making adjustments in order to achieve the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration consists of verifying the reliability of the temperature readings in the stability chamber. This can be done by comparing the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a discrepancy, we'll make adjustments until the readings are the same.
  • Humidity calibration is similar to temperature calibration. A calibration 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 calibrated barometer, and adjustments are made until they match.

Calibration is required to guarantee that the conditions within the chamber stay precise over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could render your results invalid.

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.

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Stability Chamber Validation and Qualification in Columbus, OH

A true stability chamber validation and qualification in Columbus, OH 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 include 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 adheres to requirements for the intended use. The IQ process includes a review of the installation documentation, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's requirements.
  • Operational Qualification (OQ) is meant to provide recorded verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally carried out with an unloaded chamber). The OQ process may also consist of tests to validate the performance of the equipment under different load conditions. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) is intended to provide 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 components, PQ validates how a chamber works. 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 are adequate. The PQ process may also include observation of the equipment for alarms of malfunction, to make sure that any issues are caught and taken care of promptly.

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

Stability chamber calibration and validation is an indispensable part of ensuring the accuracy of your stability chamber in Columbus, OH. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Annual or biannual validation is necessary to maintain the accuracy of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Columbus, OH scientists for over 20 years, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we design and produce meet and surpass FDA and ICH guidelines. 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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