New York, NY

Stability Chamber Calibration, Validation, Qualification in New York, NY

Stability Chamber Calibration, Validation, Qualification in New York, NY. 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 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 speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or contact us online.

Stability chambers are an indispensable part of any laboratory, that are used to store and study the stability of products under simulated environmental conditions. These chambers are used in a variety of fields, including pharmaceuticals, cosmetics, and food, to ensure the safety and efficacy of products over time. To ensure that the results obtained from stability testing are reliable, stability chambers must be calibrated, validated, and qualified.

Stability Chamber Calibration in New York, NY

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 your needs.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in New York, NY. 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 take the appropriate steps necessary.

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.

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

  • Temperature calibration consists of verifying the reliability of the temperature readings in the stability chamber. This is most often completed 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, 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 reference barometer, and adjustments are made until they show the same thing.

Calibration is required to ensure that the settings within the chamber stay consistent for an extended period. This helps to ensure that you can trust the results of your stability testing, and it also helps to avoid simple mistakes 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. It is recommended to calibrate a stability chamber every 6 months to 1 year, depending on how often it is used.

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Stability Chamber Validation and Qualification in New York, NY

An expert stability chamber validation and qualification in New York, NY should:

  • Consist of calibration records of all instrumentation used during the qualification
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Full qualification services in New York, NY 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 equipment has been installed in the right spot, that electrical components are properly connected, and that it can maintain the necessary 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 consist of tests to assess the performance of the equipment under different settings. 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 components, 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 make sure they are adequate. The PQ process might also consist of observation of the equipment for indicators of malfunction, to make sure that any problems are detected and taken care of swiftly.

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Stability Chamber Calibration, Validation, and Qualification in New York, NY | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the reliability of your stability chamber in New York, NY. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Annual or biannual validation is essential to maintaining 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 New York, NY researchers for more than two decades, and the value, reliability and expertise of our services are unrivaled. All of the stability chambers we design and produce 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 ask for a free quote.

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