Anaheim, CA

Stability Chamber Calibration, Validation, Qualification in Anaheim, CA

Stability Chamber Calibration, Validation, Qualification in Anaheim, CA. 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 engineers have validated it's performance. To maintain your stability chambers current quality and production levels, 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 chamber calibration is a crucial part of ensuring that the conditions in a stability chamber are within the intended range and acceptable 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 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 Anaheim, CA

We understand your field might have heavy oversight, which is why we use extremely precise calibration standards. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s specifications.

We can also fit our services to meet your needs, whether this be calibrations, qualifications, or verificatiopns. Our service is provided as a 3-point "as-found" calibration and verification. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. If any instrument does not meet requirements, 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.

The calibration of a stability chamber consists of verifying its performance against a given tolerance and making adjustments as necessary to ensure that it meets the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

  • Temperature calibration consists of verifying the reliability of the temperature readings in the stability chamber. This can be done by looking at the readings from the chamber against those from a reference thermometer, which is put inside the chamber. If there is a discrepancy, we'll make adjustments until the readings match.
  • Humidity calibration is similar to temperature calibration. A reference hygrometer is located 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 reference 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 stay consistent over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid costly errors that could force you to have to carry out the study again.

Calibration should be performed by a certified 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 Anaheim, CA

An expert stability chamber validation and qualification in Anaheim, CA 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

Full qualification services in Anaheim, CA are generally described in terms of three different parts:

  • Installation Qualification (IQ) provides documented verification that key aspects of the unit adhere to the installation design intention. The IQ process includes an analysis of the installation documentation, 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 carried out with an empty chamber). The OQ process may also include tests to validate the performance of the equipment under different load conditions. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • Performance Qualification (PQ) is utilized for providing 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 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 a review of the operating and maintenance procedures to ensure that they are adequate. The PQ process could also include tracking the equipment for alarms of malfunction, to ensure that any problems are caught and taken care of promptly.

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Stability Chamber Calibration, Validation, and Qualification in Anaheim, CA | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the reliability of stability studies in Anaheim, CA. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is essential to maintaining the validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Anaheim, CA scientists for over 20 years, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we design and produce meet and surpass FDA and ICH guidelines. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

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