Philadelphia, PA

Stability Chamber Calibration, Validation, Qualification in Philadelphia, PA

Stability Chamber Calibration, Validation, Qualification in Philadelphia, PA. Your research requires that your stability chambers in Philadelphia are always operating as needed, and at peak capacity. 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 discover 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 crucial part of ensuring that the conditions in a stability chamber are within the intended range and satisfactory for conducting 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 Philadelphia, PA

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 specifications.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Philadelphia, PA. 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. 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 in order to achieve the desired specifications. The most common parameters that need to be calibrated include 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 reference thermometer, which is put inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the temperatures match.
  • 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. In this case, we use a calibrated barometer, and adjustments are made until all of the readings match.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber stay 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 result in the need to repeat a stability study.

You need a qualified and experienced technician to make sure the calibration is done right. The frequency of calibration depends on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Philadelphia, PA

A true stability chamber validation and qualification in Philadelphia, PA 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

Qualification and validation are a three-part process:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. The IQ process includes an analysis of the installation records, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's specifications.
  • 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 include tests to assess 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) 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 the equipment, PQ validates how a chamber works. The PQ process involves performing a series of tests and evaluations over a defined period of time, typically several weeks or months, to confirm that the equipment operates as intended and meets the specified requirements for its intended use.

    The PQ process also includes an evaluation of the operating and maintenance processes to ensure that they will achieve the continued operation of the chamber. The PQ process could also consist of observation of the equipment for indicators of malfunction, to ensure that any issues are detected and taken care of quickly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Philadelphia, PA | Darwin Chambers

Stability chamber calibration and validation is a critical aspect of ensuring the accuracy of stability studies in Philadelphia, PA. The process helps 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 quality and effectiveness of various products.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Philadelphia, PA scientists for more than 20 years, and the value, reliability and expertise of our services are second to none. All of the stability chambers we manufacture 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 inquire about a free quote.

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