Stability Chamber Calibration, Validation, Qualification New York, NY

Stability Chamber Calibration, Validation & Qualification Services

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

Stability Chamber Calibration, Validation, Qualification in New York, NY. Your stability chambers need to be fully and safely operational at all times. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. To ensure that your stability chambers in New York 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 discover more about our stability chamber services, or to or to discuss your needs with a staff member, 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 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 under a variety of conditions, and stability chambers are used to simulate this environment. The reliability of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in New York, 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 follow to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

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. Any instrument outside of tolerance will be recorded, and we will immediately notify you so that your team can take the appropriate actions.

Any instruments found outside of calibration can then be calibrated using the manufacturer's calibration process. 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 that temperature readings are accurate. This can be done by looking at the readings from the chamber against those from a calibrated thermometer, which is put inside the chamber. If there is a discrepancy, 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 calibration hygrometer is located 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. In this case, we use a reference barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber to ensure that the settings within the chamber stay precise for an extended period. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could force you to have to carry out the study again.

Calibration should be performed by a qualified and experienced technician. 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 New York, NY

A true stability chamber validation and qualification in New York, NY should:

  • Provide a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Full qualification services in New York, NY are usually described in terms of a three-part process:

  • 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 meets the requirements for the intended use. This includes verifying that the instruments are in the correct location, 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 include tests to validate the performance of the equipment under different settings. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) is utilized for providing documented verification that the temperature, humidity, and pressure settings work in the correct and anticipated manner (normally performed with either a simulated or actual product load in the chamber). Where OQ validates components, 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 assessment of the operating and maintenance procedures to make sure they are adequate. The PQ process may also include observation of the equipment for indicators of malfunction, to make sure that any problems are identified and taken care of swiftly.

Download Validation Brochure

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

Stability chamber calibration and validation is a crucial aspect of ensuring the precision of your stability chamber in New York, NY. The process helps to ensure that the stability chamber is acceptable for the work you need it to do. 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 New York, NY scientists for more than 20 years, and the value, reliability and expertise of our services are unrivaled. All of the stability chambers we manufacture meet and surpass FDA and ICH standards. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.

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