Cleveland, OH

Stability Chamber Calibration, Validation, Qualification in Cleveland, OH

Stability Chamber Calibration, Validation, Qualification in Cleveland, OH. Your applications and processes require that your stability chambers in Cleveland are always operating as needed, and at peak capacity. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. To maintain your stability chambers current quality and production levels, our stability chamber technicians can provide stability chamber calibration, stability chamber validation, and stability chamber qualification. To learn 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 chamber calibration is a necessary part of ensuring that the conditions in a stability chamber are within the intended range and suitable for conducting 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 house and test samples of pharmaceuticals, cosmetic, food, and chemical products to determine how they hold up over time and under certain conditions.

Stability Chamber Calibration in Cleveland, OH

We use precise calibration standards to ensure quality performance within every chamber. We use these standards to ensure NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

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. If any instrument does not meet requirements, we will promptly notify you, so that you may take the necessary steps to make note of it and fix the issue.

Any instruments found outside of calibration can then be calibrated using the manufacturer's 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 as necessary to ensure that it meets the intended 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 calibrated thermometer, which is placed inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the readings match.
  • Humidity calibration is similar to temperature calibration. A calibration hygrometer is placed inside the stability chamber, and humidity readings are compared just as temperature readings are.
  • 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.

It is important to regularly calibrate the stability chamber to ensure that the conditions within the chamber remain 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 result in the need to repeat a stability study.

Calibration should only be done by a certified and experienced technician. 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 Cleveland, OH

A true stability chamber validation and qualification in Cleveland, OH will:

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

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 meets the requirements for the intended use. The IQ process includes a review of the installation documentation, such as equipment specifications, to confirm that the equipment has been installed according to the manufacturer's instructions.
  • Operational Qualification (OQ) is utilized for providing recorded verification that the systems and subsystems perform as intended at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also include tests to validate 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) ensures and documents that the unit performs as intended, either in a simulation or product load. Where OQ validates hardware and software, PQ validates a chamber's performance. The PQ process involves performing a series of tests and evaluations over a set period, 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 procedures to make sure they will achieve the continued operation of the equipment. The PQ process might also consist of tracking the equipment for indicators of malfunction, to make sure that any problems are detected and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Cleveland, OH | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the precision of stability studies in Cleveland, OH. The procedures help to ensure that the stability chamber is acceptable 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 Cleveland, OH scientists for over 20 years, and the value, reliability and expertise of our services are unrivaled. All of the stability chambers we design and produce meet and exceed 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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