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 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.

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 provide this environment. The accuracy of stability studies depend on the stability chamber's ability to maintain consistent temperature, humidity, and pressure conditions.

Stability Chamber Calibration in Columbia, SC

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 follow to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your needs.

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. Our calibration readings determine whether a unit is within tolerance, and allows units that are within tolerance to continue operations. Any instrument outside of tolerance will be noted, and we will immediately notify you so that your team can take the appropriate actions.

Any instruments found outside of calibration can then be calibrated using the manufacturer's 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 as necessary to ensure that it meets the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

• Temperature calibration involves verifying that temperature readings are accurate. This can be done by contrasting the readings of the stability chamber with 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 match.
• 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 verifying the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until they show the same thing.

Calibration is required to guarantee that the conditions within the chamber stay accurate 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 be performed by a qualified 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

A reliable 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) 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. This includes verifying that the instruments are in the correct spot, that it is properly connected to electrical and other services, 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 settings. 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 how a chamber works. 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 a review of the operating and maintenance processes to ensure that they will achieve the continued operation of the instruments. The PQ process may also include tracking the equipment for alarms of malfunction, to ensure that any issues are caught and addressed promptly.

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

Stability chamber calibration and validation is a critical part of ensuring the precision of stability studies in Columbia, SC. The procedures help 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 quality and effectiveness of various products.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Columbia, SC researchers for more than two decades, and our value, dependability, customer service, and expertise are second to none. All of the stability chambers we design and produce 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.