Baltimore, MD

Stability Chamber Calibration, Validation, Qualification in Baltimore, MD

Stability Chamber Calibration, Validation, Qualification in Baltimore, MD. 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 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 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 Baltimore, MD

We use precise calibration standards to ensure quality performance within every chamber. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Baltimore, MD. 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 recorded, 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 the accuracy of the temperature readings in the stability chamber. This is most often completed by comparing the readings of the stability chamber with a calibrated thermometer, which is located inside the chamber. If there is a discrepancy, we'll make adjustments until the readings are the same.
  • Humidity calibration follows a similar procedure as temperature calibration. A calibration hygrometer is put 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 calibrated barometer, and adjustments are made until all of the readings show the same thing.

Calibration is required to guarantee that the settings within the chamber remain precise for an extended period. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid simple mistakes that could render your results invalid.

Calibration should only be done by a qualified and experienced technician. 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 Baltimore, MD

An expert stability chamber validation and qualification in Baltimore, MD will:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Full qualification services in Baltimore, MD are generally described in terms of a three-part process:

  • 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 a review of the installation records, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • Operational Qualification (OQ) is meant to provide documented verification that the systems and subsystems perform as they need to 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 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 temperature, humidity, and pressure settings work in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). 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 an evaluation of the operating and maintenance procedures to make sure they will achieve the continued operation of the equipment. The PQ process might also consist of tracking the equipment for indicators of malfunction, to ensure that any problems are caught and taken care of swiftly.

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Stability Chamber Calibration, Validation, and Qualification in Baltimore, MD | Darwin Chambers

Stability chamber calibration and validation is an essential aspect of ensuring the accuracy of stability studies in Baltimore, MD. The process helps to ensure that the stability chamber is acceptable for its intended use. Regular validation is necessary to maintain the validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Baltimore, MD 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 make meet and exceed FDA and ICH guidelines. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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