Piscataway, NJ

Stability Chamber Calibration, Validation, Qualification in Piscataway, NJ

Stability Chamber Calibration, Validation, Qualification in Piscataway, NJ. Your applications and processes require that your stability chambers in Piscataway are always functional, 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 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 contact us online.

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 provide 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 Piscataway, NJ

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

We can also offer programs that are tailored to fit your needs, 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. If any instrument does not meet requirements, we will promptly notify you, so that you may take the necessary steps to document the event.

If an instrument's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers 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.

The calibration of a stability chamber involves verifying its performance against a given tolerance and making adjustments in order to achieve the intended specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration involves verifying the reliability of the temperature readings in the stability chamber. This can be done by looking at the readings from the chamber against those from a reference thermometer, which is placed 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 follows a similar process 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. In this case, we use a reference 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 over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could force you to have to carry out the study again.

Calibration should only be done by a certified 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 Piscataway, NJ

An expert stability chamber validation and qualification in Piscataway, NJ will:

  • Provide a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Full qualification services in Piscataway, NJ are generally described in terms of three different parts:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. The IQ process includes an evaluation 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) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to validate the performance of the equipment under different conditions. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • Performance Qualification (PQ) ensures and documents that the unit performs as intended, either in a simulation or with an actual product inside. Where OQ validates hardware and software, PQ validates how a chamber works. 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 assessment of the operating and maintenance processes to make sure they are adequate. The PQ process could 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 Piscataway, NJ | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of your stability chamber in Piscataway, NJ. The process helps to ensure that the stability chamber is acceptable for its intended use. Regular validation is necessary to maintain the reliability of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Piscataway, NJ scientists for over two decades, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we manufacture meet and exceed FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.

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