Raleigh, NC

Stability Chamber Calibration, Validation, Qualification in Raleigh, NC

Stability Chamber Calibration, Validation, Qualification in Raleigh, NC. Your research requires that your stability chambers in Raleigh are always operating as needed, and at peak capacity. 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 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 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 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 necessary part of ensuring that the conditions in a stability chamber are within the specified range and acceptable for conducting stability testing. 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 how they hold up over time and under certain conditions.

Stability Chamber Calibration in Raleigh, NC

We understand the critical role that calibrations have in your regulated industry, which is why we use extremely precise calibration standards. The use of these standards will ensure that your instruments are calibrated 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 procedure provides a 3-point “as-found” calibration 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 exceeds the tolerance, we will promptly notify you, so that you may take the necessary steps to document the event.

Any instruments found outside of calibration can then be calibrated using the manufacturer's calibration process. 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 in order to achieve the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

• Temperature calibration consists of verifying the reliability of the temperature readings in the stability chamber. This can be done by contrasting the readings of the stability chamber with a calibrated thermometer, which is put inside the chamber. If there is a difference between the two readings, the stability chamber temperature control system can be adjusted until the readings are the same.
• Humidity calibration is similar to temperature calibration. A reference hygrometer is put 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 calibrated barometer, and adjustments are made until they match.

Calibration is required to guarantee that the conditions within the chamber remain precise over time. 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 only be done by a certified and experienced technician. How often you need calibration depends on the stability chamber usage and the level of precision required.

Stability Chamber Validation and Qualification in Raleigh, NC

An expert stability chamber validation and qualification in Raleigh, NC will:

• Include a list of instruments used for qualifications
• Provide documented evidence the chamber’s instruments are in a current calibrated state

Qualification and validation are 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 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) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also include tests to evaluate 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) is intended to provide 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 components, 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 an assessment of the operating and maintenance processes to make sure they will support the continued operation of the equipment. The PQ process could also consist of observation of the equipment for alarms of malfunction, to make sure that any issues are detected and addressed swiftly.

Stability Chamber Calibration, Validation, and Qualification in Raleigh, NC | Darwin Chambers

Stability chamber calibration and validation is an essential part of ensuring the accuracy of stability studies in Raleigh, NC. The process helps 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 validity of stability study results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Raleigh, NC scientists for over 20 years, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we make 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 request a free quote.