Princeton, NJ

Stability Chamber Calibration, Validation, Qualification in Princeton, NJ

Stability Chamber Calibration, Validation, Qualification in Princeton, NJ. 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 Princeton are fully and safely operational, or stability chamber engineers can provide, 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 Princeton, NJ

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 needs.

We can also offer customized programs, 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 make note of it and fix the issue.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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 set of standards 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 accuracy of the temperature readings in the stability chamber. This can be done by contrasting the readings of the stability chamber with a reference thermometer, which is located 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 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 they match.

It is important to regularly calibrate the stability chamber to guarantee that the settings within the chamber remain accurate over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could force you to have to carry out the study again.

You need a qualified and experienced technician to make sure the calibration is done right. How often you need calibration is based on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Princeton, NJ

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

  • Provide a list of instruments used for qualifications
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Full qualification services in Princeton, NJ are typically described in terms of three different parts:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. This includes verifying that the instruments are in the right spot, that it is properly connected to electrical and other services, and that it meets the specified requirements for temperature and humidity control.
  • 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 carried out with an unloaded chamber). The OQ process may also consist of 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 product load. 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 chamber can hold up as long as you need it to.

    The PQ process also includes an evaluation of the operating and maintenance processes to make sure they are adequate. The PQ process may also include monitoring the equipment for alarms of malfunction, to make sure that any problems are identified and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Princeton, NJ | Darwin Chambers

Stability chamber calibration and validation is an essential part of ensuring the precision of stability studies in Princeton, NJ. The procedures help to ensure that the stability chamber is suitable for its intended use. Regular validation is necessary to maintain the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Princeton, NJ researchers for over 20 years, and the value, reliability and expertise of our services are unmatched. All of the stability chambers we make meet and surpass FDA and ICH regulations. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

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