Buffalo, NY

Stability Chamber Calibration, Validation, Qualification in Buffalo, NY

Stability Chamber Calibration, Validation, Qualification in Buffalo, NY. 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 maintain your stability chambers current quality and production levels, 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 chamber calibration is a crucial aspect of ensuring that the conditions in a stability chamber are within the intended range and satisfactory 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 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 Buffalo, NY

We understand your field might have heavy oversight, which is why we use extremely precise calibration standards. Our Engineers calibrate each chamber to NIST compliance (NIST National Institute of Standards and Technology), in order to meet or exceed your specifications.

We provide several different programs to ensure that you recieve the service you need for your stability chamber in Buffalo, NY. 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 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.

Additionally, if the “as-found” readings are not within the manufacturer’s tolerance, the instrument is then calibrated using the manufacturer’s calibration procedure. 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 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 involves 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 calibrated thermometer, which is located inside the chamber. If there is a discrepancy, we'll make adjustments until the temperatures match.
• Humidity calibration follows a similar procedure as temperature calibration. A reference hygrometer is placed 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 settings in the stability chamber. In this case, we use a reference barometer, and adjustments are made until they show the same thing.

Calibration is required to ensure 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 certified and experienced technician. 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 Buffalo, NY

An expert stability chamber validation and qualification in Buffalo, NY will:

• Consist of calibration records of all instrumentation used during the qualification
• 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 adhere to the design intention. The IQ process includes an evaluation 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 validate 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) 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 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 ensure that they will support the continued operation of the chamber. The PQ process may also include observation of the equipment for indicators of malfunction, to make sure that any problems are identified and addressed promptly.

Stability Chamber Calibration, Validation, and Qualification in Buffalo, NY | Darwin Chambers

Stability chamber calibration and validation is a crucial part of ensuring the precision of stability studies in Buffalo, NY. The process helps to ensure that the stability chamber is acceptable for its intended use. Regular 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 Buffalo, NY researchers for more than two decades, and the value, reliability and expertise of our technicians are unrivaled. All of the stability chambers we manufacture meet and surpass FDA and ICH standards. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or request a free quote.