Denver, CO

Stability Chamber Calibration, Validation, Qualification in Denver, CO

Stability Chamber Calibration, Validation, Qualification in Denver, CO. Your applications and processes require that your stability chambers in Denver are always operating as needed, and at peak capacity. 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 Denver 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 speak with our team regarding other products, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

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 aspect of ensuring that the conditions in a stability chamber are within the intended 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 how they hold up over time and under certain conditions.

Stability Chamber Calibration in Denver, CO

Calibrations play a critical role in every stability chamber, and our engineers use precise calibrations to ensure perfect performance. The use of these standards will ensure that your instruments follow to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed manufacturer’s specifications.

We can also offer programs that are tailored to fit your needs, such as single point or loop calibrations and verifications. Our procedure provides a 3-point “as-found” calibration verification. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. If any instrument exceeds the tolerance, we will promptly notify you, so that you may take the necessary steps to document the event.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. After completing the calibration, the instrument’s “as-left” readings are documented using the same three points from the calibration to ensure the instrument is reading within the manufacturer’s tolerance.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance and making adjustments as necessary to ensure that it meets 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 looking at the readings from the chamber against those from a reference 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 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 settings in the stability chamber. To read pressure, we use a reference 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 consistent over time. 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 be performed by a qualified and experienced technician. How often you need calibration is based on the stability chamber usage and the level of precision required.

Stability Chamber Validation and Qualification in Denver, CO

A reliable stability chamber validation and qualification in Denver, CO 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 Denver, CO are usually described in terms of three different parts:

• Installation Qualification (IQ) provides documented verification that key aspects of the unit follow the installation design intention. This includes verifying that the instruments are in the correct spot, that electrical components are properly connected, and that it can maintain the necessary temperature and humidity control.
• 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 carried out with an empty chamber). The OQ process may also consist of tests to validate 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) ensures and documents that the unit performs as intended, either in a simulation or product load. Where OQ validates hardware and software, 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 equipment operates as it should and meets the specified requirements for its intended use.

  The PQ process also includes an assessment of the operating and maintenance processes to make sure they will support the continued operation of the instruments. The PQ process could also include tracking the equipment for indicators of malfunction, to ensure that any issues are caught and addressed promptly.

Stability Chamber Calibration, Validation, and Qualification in Denver, CO | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the accuracy of your stability chamber in Denver, CO. The process helps to ensure that the stability chamber is suitable for its intended use. Annual or biannual validation is necessary to maintain 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 Denver, CO scientists for over two decades, and our value, dependability, customer service, and expertise are unrivaled. All of the stability chambers we design and produce meet and surpass 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.