Stability Chamber Calibration, Validation, Qualification Pittsburgh, PA

Stability Chamber Calibration, Validation & Qualification Services

Ensure Compliance with FDA, ICH, and GMP Guidelines — Get a Quote Today.

Stability Chamber Calibration, Validation, Qualification in Pittsburgh, PA

Stability Chamber Calibration, Validation, Qualification in Pittsburgh, PA. It is critically important that stability chambers function as intended, 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 Pittsburgh 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 discover 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 contact us online.

Please note: Darwin Chambers does not provide stability testing services. We specialize in manufacturing and supplying high-quality stability chambers designed to meet your testing needs.

Stability chamber calibration is a crucial part of ensuring that the conditions in a stability chamber are within the specified 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 store and test samples of pharmaceuticals, cosmetic, food, and chemical products to determine their shelf-life and effectiveness over a period of time.

Stability Chamber Calibration in Pittsburgh, PA

We use precise calibration standards to ensure quality performance within every chamber. 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 provide several different programs to ensure that you recieve the service you need for your stability chamber in Pittsburgh, PA. 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 a chamber'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 involves verifying its performance against a given tolerance and making adjustments in order to achieve the intended 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 looking at the readings from the chamber against those from a reference thermometer, which is put inside the chamber. If there is a discrepancy, the stability chamber temperature control system can be adjusted until the temperatures are the same.
  • Humidity calibration follows a similar process as temperature calibration. A reference hygrometer is put 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 they show the same thing.

It is important to regularly calibrate the stability chamber to guarantee that the settings within the chamber stay 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 force you to have to carry out the study again.

Calibration should only be done by a certified and experienced technician. It is recommended to calibrate a stability chamber at least once a year, or more frequently if it is used frequently or if the results of previous calibrations indicate that it may be necessary.

Download Calibration Brochure

Stability Chamber Validation and Qualification in Pittsburgh, PA

An expert stability chamber validation and qualification in Pittsburgh, PA will:

  • Provide a list of instruments used for qualifications
  • Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Full qualification services in Pittsburgh, PA are generally 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 documentation, such as wiring diagrams, to confirm that the equipment has been installed according to the manufacturer's requirements.
  • Operational Qualification (OQ) is meant to provide 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 settings. 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 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 components, 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 a review of the operating and maintenance processes to ensure that they will support the continued operation of the instruments. The PQ process might also include tracking the equipment for alarms of malfunction, to ensure that any issues are detected and taken care of promptly.

Download Validation Brochure

Stability Chamber Calibration, Validation, and Qualification in Pittsburgh, PA | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the precision of your stability chamber in Pittsburgh, PA. The process helps to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is essential to maintaining the accuracy of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Pittsburgh, PA scientists for over two decades, and the value, reliability and expertise of our technicians are unmatched. All of the stability chambers we manufacture meet and exceed FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.

Other Locations We Service

Pass Thru Refrigerators – HUGE SALE!
Request a Quote

Schema

5 customer service tips from LiveChat