Boston, MA

Stability Chamber Calibration, Validation, Qualification in Boston, MA

Stability Chamber Calibration, Validation, Qualification in Boston, MA. It is critically important that stability chambers operate at a peak performance level, and that they are also operating safely. Your team needs to be assured that your stability chambers are operating correctly, and that qualified engineers have validated it's performance. To ensure that your stability chambers in Boston 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 find out 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.

Stability chambers are essential pieces of laboratory equipment used to store and study the stability of products under controlled 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 a long period. To ensure that the results obtained from stability testing are accurate, stability chambers must be calibrated, validated, and qualified.

Stability Chamber Calibration in Boston, MA

We use precise calibration standards to ensure quality performance within every chamber. 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 manufacturer’s needs.

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

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. This is most often completed by looking at the readings from the chamber against those from a reference thermometer, which is located 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 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. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings match.

Calibration is required to ensure that the conditions within the chamber remain consistent over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could render your results invalid.

You need a qualified and experienced technician to make sure the calibration is done right. The frequency of calibration depends on the stability chamber usage and the level of precision required.

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Stability Chamber Validation and Qualification in Boston, MA

A true stability chamber validation and qualification in Boston, MA should:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are within the intended tolerance levels

Full qualification services in Boston, MA are typically described in terms of a three-part process:

  • Installation Qualification (IQ) is intended to provide records that the design, procurement, and installation follow 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 requirements.
  • 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 humidity and temperatures. The OQ process also validates that safety measures and alarms are operating as they should.
  • Performance Qualification (PQ) ensures and documents that the unit performs as intended, either in a simulation or with an actual product inside. Where OQ validates components, PQ validates a chamber's performance. 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 make sure they will support the continued operation of the instruments. The PQ process may also include tracking the equipment for alarms of malfunction, to ensure that any issues are identified and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Boston, MA | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of your stability chamber in Boston, MA. The procedures help to ensure that the stability chamber is suitable for its intended use. 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 Boston, MA researchers for over two decades, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we design and produce meet and surpass FDA and ICH regulations. 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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