Miami, FL

Stability Chamber Calibration, Validation, Qualification in Miami, FL

Stability Chamber Calibration, Validation, Qualification in Miami, FL. It is critically important that stability chambers function as intended, and that they are also operating safely. You want the assurances that the process and products you trust with your stability chambers are safe, and that your business investment is protected. To ensure that your stability chambers in Miami 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 speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

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 Miami, FL

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure they function reliably for a long period of time. 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. 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 an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can take the appropriate steps necessary.

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. Most calibration procedures involve verifying temperature, humidity, and pressure:

  • Temperature calibration consists of verifying that temperature readings are accurate. This can be done by contrasting the readings of the stability chamber with 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 are the same.
  • Humidity calibration is similar to temperature calibration. A reference 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. In this case, we use a reference barometer, and adjustments are made until they match.

Calibration is required to guarantee that the conditions within the chamber remain precise 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 force you to have to carry out the study again.

Calibration should be performed by a qualified and experienced technician. The frequency of calibration depends on the stability chamber usage and the level of precision required.

Download Calibration Brochure

Stability Chamber Validation and Qualification in Miami, FL

An expert stability chamber validation and qualification in Miami, FL will:

  • Consist of calibration records of all instrumentation used during the qualification
  • Provide documented evidence the chamber’s instruments are in a current calibrated state

Full qualification services in Miami, FL are usually described in terms of 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 an analysis 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 meant to provide recorded verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally performed with an empty chamber). The OQ process may also include 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) 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 the equipment, PQ validates a chamber's performance. 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 ensure that they are adequate. The PQ process may also consist of tracking the equipment for alarms of malfunction, to make sure that any problems are caught and addressed swiftly.

Download Validation Brochure

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

Stability chamber calibration and validation is a critical part of ensuring the reliability of your stability chamber in Miami, FL. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is necessary to maintain the accuracy of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Miami, FL scientists for more than two decades, 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.

Other Locations We Service

Schema