Waco, TX

Stability Chamber Calibration, Validation, Qualification in Waco, TX

Stability Chamber Calibration, Validation, Qualification in Waco, TX. Your stability chambers need to be fully and safely operational at all times. Your team needs to be assured that your stability chambers are operating correctly, and that qualified technicians have validated it's performance. To maintain your stability chambers current quality and production levels, 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 or to discuss your needs with a staff member, please call Darwin Chambers now at (314) 534-3111 or fill out this form here.

Stability chambers are essential pieces of laboratory equipment used to store and study the stability of products under simulated environmental conditions. These chambers are used in a variety of fields, including pharmaceuticals, cosmetics, and food, to ensure the safety and efficacy of products over a long period. To ensure that the results obtained from stability testing are accurate, stability chambers must be calibrated, validated, and qualified.

Stability Chamber Calibration in Waco, TX

We understand the critical role that calibrations have in your regulated industry, 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 provide several different programs to ensure that you recieve the service you need for your stability chamber in Waco, TX. Our procedure provides a 3-point “as-found” calibration 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 document the event.

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.

In order to perform calibration, you must verify a stability chamber's performance against a given tolerance and making adjustments in order to achieve the intended specifications. Most calibration procedures involve verifying temperature, humidity, and pressure:

• Temperature calibration consists of verifying that temperature readings are accurate. This can be done by contrasting the readings of the stability chamber with a calibrated 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 are the same.
• Humidity calibration follows a similar procedure as temperature calibration. A reference hygrometer is located inside the stability chamber, and humidity readings are compared just as temperature readings are.
• Pressure calibration involves calibrating the pressure settings in the stability chamber. To read pressure, we use a reference barometer, and adjustments are made until they show the same thing.

It is important to regularly calibrate the stability chamber 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 result in the need to repeat a stability study.

You need a certified 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 Waco, TX

An expert stability chamber validation and qualification in Waco, TX should:

• Consist of calibration records of all instrumentation used during the qualification
• Deliver documented evidence detailing the instruments adherence to correct calibrated state and standards

Full qualification services in Waco, TX are usually described in terms of three different parts:

• Installation Qualification (IQ) is intended to provide documented verification that all key aspects of the design, procurement, and installation adhere to the design intention. The IQ process includes a review of the installation records, 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 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 a chamber's performance. 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 a review of the operating and maintenance processes to make sure they will support the continued operation of the equipment. The PQ process may also include monitoring the equipment for indicators of malfunction, to ensure that any problems are detected and addressed quickly.

Stability Chamber Calibration, Validation, and Qualification in Waco, TX | Darwin Chambers

Stability chamber calibration and validation is an indispensable aspect of ensuring the reliability of stability studies in Waco, TX. The procedures help to ensure that the stability chamber is suitable for the work you need it to do. Regular validation is necessary to maintain the accuracy of stability testing results.

Trust in Darwin Chambers for your stability calibration, validation and qualification. We have been an industry leader for Waco, TX researchers for more than 20 years, and the value, reliability and expertise of our technicians are unmatched. All of the stability chambers we design and produce meet and exceed FDA and ICH guidelines. For stability chamber calibration and validation, call Darwin Chambers today at (314) 534-3111, contact us online, or inquire about a free quote.