Piscataway, NJ

Stability Chamber Calibration, Validation, Qualification in Piscataway, NJ

Stability Chamber Calibration, Validation, Qualification in Piscataway, NJ. It is critically important that stability chambers function as intended, and that they are also operating safely. 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 Piscataway 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 learn 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.

Please note: Darwin Chambers does not provide stability testing services. We specialize in manufacturing and supplying high-quality stability chambers designed to meet your testing needs.

Stability chamber calibration is a crucial part of ensuring that the conditions in a stability chamber are within the intended range and acceptable 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 store 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 Piscataway, NJ

We understand the critical role that calibrations have in your regulated industry, which is why we use extremely precise calibration standards. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s specifications.

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 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 intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. 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 discrepancy, we'll make adjustments until the temperatures match.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is put inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
  • Pressure calibration involves verifying the pressure readings in the stability chamber. In this case, we use a calibrated barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber to guarantee that the settings within the chamber remain precise 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 certified and experienced technician to make sure the calibration is done right. How often you need calibration depends on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Piscataway, NJ

A reliable stability chamber validation and qualification in Piscataway, NJ 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) provides documented verification that key aspects of the unit follow the installation design intention. This includes verifying that the instruments are in the right location, 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) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to assess the performance of the equipment under different load conditions. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • Performance Qualification (PQ) is utilized for providing 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 a chamber's performance. 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 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 ensure that they will achieve the continued operation of the chamber. The PQ process may also include tracking the equipment for indicators of malfunction, to ensure that any issues are identified and addressed promptly.

Download Validation Brochure

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

Stability chamber calibration and validation is a critical part of ensuring the reliability of stability studies in Piscataway, NJ. The process helps to ensure that the stability chamber is acceptable for its intended use. Regular validation is essential to maintaining 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 more than two decades, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we manufacture meet and surpass FDA and ICH guidelines. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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