Stability Chamber Calibration, Validation, Qualification Long Island, NY

Stability Chamber Calibration, Validation & Qualification Services

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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.

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 necessary aspect of ensuring that the conditions in a stability chamber are within the intended range and suitable 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 monitor samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Long Island, NY

We understand your field might have heavy oversight, 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 needs.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. 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 any instrument exceeds the tolerance, 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. 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 set of standards and making adjustments in order to achieve the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying the accuracy of the temperature readings in the stability chamber. This is most often completed by contrasting the readings of the stability chamber with a reference thermometer, which is put inside the chamber. If there is a difference between the two readings, we'll make adjustments until the readings 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 readings in the stability chamber. In this case, we use a calibrated barometer, and adjustments are made until all of the readings match.

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 render your results invalid.

You need a certified 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 Long Island, NY

A true stability chamber validation and qualification in Long Island, NY should:

  • Include a list of instruments used for qualifications
  • Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Qualification and validation include three different parts:

  • Installation Qualification (IQ) includes a series of tests and evaluations to confirm that the equipment has been installed according to the manufacturer's specifications and that it adheres to requirements for the intended use. This includes verifying that the instruments are in the correct spot, that electrical components are properly connected, and that it can maintain the necessary 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 empty chamber). The OQ process may also include tests to evaluate 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) 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 intended and meets the specified requirements for its intended use.

    The PQ process also includes an evaluation of the operating and maintenance procedures to ensure that they are adequate. The PQ process could also include monitoring the equipment for alarms of malfunction, to ensure that any issues are caught and addressed promptly.

Download Validation Brochure

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

Stability chamber calibration and validation is an essential aspect of ensuring the precision of stability studies in Long Island, NY. The procedures help to ensure that the stability chamber is acceptable for its intended use. Regular 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 Long Island, NY scientists for more than two decades, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we design and produce 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 ask for a free quote.

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