Greenville, SC

Stability Chamber Calibration, Validation, Qualification in Greenville, SC

Stability Chamber Calibration, Validation, Qualification in Greenville, 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 Greenville 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 part of ensuring that the conditions in a stability chamber are within the specified range and acceptable 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 house and test samples of pharmaceuticals, cosmetic, food, and chemical products to determine how they hold up over time and under certain conditions.

Stability Chamber Calibration in Greenville, SC

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 needs.

We can also offer customized programs, such as single point or loop calibrations and verifications. Our service is provided as a 3-point "as-found" calibration and verification. The “as-found” readings are documented and verified to be within the manufacturer’s tolerance, if found within the tolerances the device is then returned to service. If any instrument does not meet requirements, we will promptly notify you, so that you may take the necessary steps to make note of it and fix the issue.

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.

The calibration of a stability chamber consists of verifying its performance against a set of standards and making adjustments in order to achieve the intended specifications. Most calibration procedures involve verifying 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 reference thermometer, which is placed 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 is similar to temperature calibration. A calibration hygrometer is located inside the stability chamber, and humidity readings are compared just as temperature readings are.
• Pressure calibration involves calibrating the pressure readings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until all of the readings match.

It is important to regularly calibrate the stability chamber to guarantee that the settings within the chamber stay consistent for an extended period. 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 certified and experienced technician. The frequency of calibration depends on the stability chamber usage and the level of precision required.

Stability Chamber Validation and Qualification in Greenville, SC

An expert stability chamber validation and qualification in Greenville, SC will:

• 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 intended to provide documented verification that all key aspects of the design, procurement, and installation follow to the design intention. The IQ process includes an analysis 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 consist of tests to assess 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 intended to provide documented verification that the process does what it is intended to do (normally performed with either a simulated or actual product load in the chamber). Where OQ validates components, PQ validates how a chamber works. The PQ process involves performing a series of tests and evaluations over a defined period of time, 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 procedures to ensure that they will achieve the continued operation of the equipment. The PQ process may also consist of monitoring the equipment for alarms of malfunction, to ensure that any issues are identified and addressed quickly.

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

Stability chamber calibration and validation is a crucial part of ensuring the precision of your stability chamber in Greenville, 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 validity of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Greenville, SC scientists for over 20 years, and our value, dependability, customer service, and expertise 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 inquire about a free quote.