Portland, OR

Stability Chamber Calibration, Validation, Qualification in Portland, OR

Stability Chamber Calibration, Validation, Qualification in Portland, OR. It is critically important that stability chambers operate at a peak performance level, and that they are also operating safely. 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 Portland 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 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 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 over time, and stability chambers are used to simulate 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 Portland, OR

We use precise calibration standards to ensure quality performance within every chamber. The use of these standards will ensure that your instruments adhere 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. If any instrument does not meet requirements, 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.

The calibration of a stability chamber consists of verifying its performance against a given tolerance and making adjustments as necessary to ensure that it meets the desired specifications. The most common parameters that need to be calibrated include temperature, humidity, and pressure:

• Temperature calibration consists of verifying that temperature readings are accurate. This is most often completed by comparing the readings of the stability chamber with 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 readings match.
• Humidity calibration is similar to temperature calibration. A reference hygrometer is located inside the stability chamber, and the readings are compared with the readings of the stability chamber's humidity control system.
• Pressure calibration involves verifying the pressure readings in the stability chamber. To read pressure, we use a calibrated barometer, and adjustments are made until all of the readings match.

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

You need a qualified and experienced technician to make sure the calibration is done right. 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.

Stability Chamber Validation and Qualification in Portland, OR

A reliable stability chamber validation and qualification in Portland, OR should:

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

Qualification and validation include a three-part process:

• Installation Qualification (IQ) is utilized for providing records that the design, procurement, and installation follow to the design intention. This includes verifying that the instruments are in the right spot, that electrical components are properly connected, and that it can maintain the necessary temperature and humidity control.
• Operational Qualification (OQ) provides documentation that the unit and subsystems perform to the intended, anticipated, and need operating ranges. The OQ process may also consist of tests to assess the performance of the equipment under different humidity and temperatures. 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 involves conducting 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 an evaluation of the operating and maintenance processes to ensure that they will achieve the continued operation of the instruments. The PQ process may also include observation of the equipment for alarms of malfunction, to make sure that any problems are detected and taken care of quickly.

Stability Chamber Calibration, Validation, and Qualification in Portland, OR | Darwin Chambers

Stability chamber calibration and validation is an indispensable part of ensuring the accuracy of stability studies in Portland, OR. 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 reliability of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Portland, OR scientists for more than two decades, and the value, reliability and expertise of our technicians are second to none. All of the stability chambers we design and produce meet and surpass FDA and ICH guidelines. For stability chamber calibration and qualification, call Darwin Chambers today at (314) 534-3111, contact us online, or ask for a free quote.