Columbia, SC

Stability Chamber Calibration, Validation, Qualification in Columbia, SC

Stability Chamber Calibration, Validation, Qualification in Columbia, SC. Your stability chambers need to be fully and safely operational at all times. 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 Columbia are fully and safely operational, or stability chamber engineers can provide, 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 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 crucial aspect 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 house 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 Columbia, SC

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 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 an instrument is found to be outside of the allowed tolerance, we will inform you of the findings so that you can address the problem promptly.

If a chamber's "as-found" readings are outside of the recommended tolerance level, the instrument can be calibrated using the manufacturers calibration procedures. 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.

The calibration of a stability chamber involves verifying its performance against a set of standards and making adjustments in order to achieve the desired specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

• Temperature calibration involves verifying the accuracy of the temperature readings in the stability chamber. This is most often completed by contrasting 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 are the same.
• Humidity calibration is similar to temperature calibration. A calibration hygrometer is put inside the stability chamber, and humidity readings are compared just as temperature readings are.
• Pressure calibration involves verifying 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.

Calibration is required to ensure that the conditions within the chamber remain precise over time. This helps to ensure that the results of stability testing are reliable, and it also helps to avoid simple mistakes that could render your results invalid.

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 Columbia, SC

An expert stability chamber validation and qualification in Columbia, SC should:

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

Qualification and validation include three different parts:

• Installation Qualification (IQ) is utilized for providing documented verification that all key aspects of the design, procurement, and installation follow to the design intention. This includes verifying that the instruments are in the correct spot, that electrical components are properly connected, and that it meets the specified requirements for temperature and humidity control.
• Operational Qualification (OQ) is meant to provide documented verification that the systems and subsystems perform as they need to at all anticipated operating ranges (normally carried out with an unloaded chamber). The OQ process may also include tests to evaluate the performance of the equipment under different load conditions. 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 a chamber's performance. The PQ process takes 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 a review of the operating and maintenance procedures to make sure they are adequate. The PQ process may also include monitoring the equipment for alarms of malfunction, to make sure that any problems are identified and addressed quickly.

Stability Chamber Calibration, Validation, and Qualification in Columbia, SC | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the precision of stability studies in Columbia, SC. The procedures help to ensure that the stability chamber is acceptable for its intended use. Annual or biannual validation is necessary to maintain the validity of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Columbia, SC scientists for more than two decades, and our value, dependability, customer service, and expertise are unmatched. All of the stability chambers we make 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.