Jacksonville, FL

Stability Chamber Calibration, Validation, Qualification in Jacksonville, FL

Stability Chamber Calibration, Validation, Qualification in Jacksonville, FL. 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 technicians have validated it's performance. To ensure that your stability chambers in Jacksonville 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 learn 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 necessary part of ensuring that the conditions in a stability chamber are within the specified 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 Jacksonville, FL

We understand the critical role that calibrations have in your regulated industry, 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 provide several different programs to ensure that you recieve the service you need for your stability chamber in Jacksonville, FL. 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. 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. 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 as necessary to ensure that it meets the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration involves verifying that temperature readings are accurate. This is most often completed by comparing the readings of the stability chamber with a reference thermometer, which is placed inside the chamber. If there is a difference between the two readings, we'll make adjustments 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. To read pressure, we use a calibrated barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber to guarantee that the conditions within the chamber stay accurate for an extended period. This helps to ensure that you can rely on the results of your stability testing, and it also helps to avoid costly errors that could render your results invalid.

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

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Stability Chamber Validation and Qualification in Jacksonville, FL

An expert stability chamber validation and qualification in Jacksonville, FL 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) provides documented verification that key aspects of the unit adhere to the installation design intention. This includes verifying that the instruments are in the right location, that it is properly connected to electrical and other services, 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 assess the performance of the equipment under different humidity and temperatures. The OQ process also includes verifying that the chamber's alarms and safety systems are functioning correctly.
  • 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 how a chamber works. The PQ process takes 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 processes to ensure that they will achieve the continued operation of the equipment. The PQ process may also include monitoring the equipment for indicators of malfunction, to ensure that any issues are identified and taken care of promptly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Jacksonville, FL | Darwin Chambers

Stability chamber calibration and validation is a crucial aspect of ensuring the reliability of stability studies in Jacksonville, FL. 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 Jacksonville, FL researchers for over 20 years, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we design and produce meet and exceed 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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