Long Island, NY

Stability Chamber Calibration, Validation, Qualification in Long Island, NY

Stability Chamber Calibration, Validation, Qualification in Long Island, NY. 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 Long Island are fully and safely operational, or stability chamber engineers can provide, our stability chamber technicians 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 fill out this form here.

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

Stability Chamber Calibration in Long Island, NY

We understand your field might have heavy oversight, which is why we use extremely precise calibration standards. 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 procedure provides a 3-point “as-found” calibration verification. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. 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.

If a chamber's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers 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 desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration consists of verifying the accuracy of the temperature readings in the stability chamber. This is most often completed by comparing the readings of the stability chamber with a calibrated 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 are the same.
  • Humidity calibration follows a similar procedure as temperature calibration. A reference hygrometer is placed inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
  • Pressure calibration involves calibrating the pressure settings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings show the same thing.

Calibration is required to ensure that the conditions within the chamber remain 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 render your results invalid.

Calibration should only be done by a qualified and experienced technician. 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 Long Island, NY

A true stability chamber validation and qualification in Long Island, NY 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 include a three-part process:

  • Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, procurement, and installation adhere to the design intention. The IQ process includes a review of the installation records, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • 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 performed with an unloaded chamber). The OQ process may also consist of tests to assess the performance of the equipment under different conditions. 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 hardware and software, PQ validates how a chamber works. The PQ process takes several weeks or months, to confirm that the equipment operates as it should and meets the specified requirements for its intended use.

    The PQ process also includes a review of the operating and maintenance processes to ensure that they are adequate. The PQ process might also include tracking the equipment for indicators of malfunction, to make sure that any issues are identified and addressed quickly.

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Stability Chamber Calibration, Validation, and Qualification in Long Island, NY | Darwin Chambers

Stability chamber calibration and validation is a critical part of ensuring the precision of your stability chamber in Long Island, 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 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 Long Island, NY scientists for more than two decades, and our value, dependability, customer service, and expertise are second to none. 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 request a free quote.

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