Controlled Temperature Unit Validation

Validate Refrigerators, Freezers and Stability Chambers to Meet cGMP Regulations

Life sciences companies of all sizes choose and stay with Masy to validate environmental chambers or controlled temperature units, i.e., refrigerators, freezers, and stability chambers. Our highly specialized team understands the critical nature of ensuring these units are in compliance with cGMP regulations. When these units are out of compliance, the integrity and efficacy of the stored products are jeopardized, potentially impacting everything from the research and patient safety to the bottom line. To avoid costly disasters, successful temperature mapping and qualification testing of these units is crucial.

The Correct Qualification Protocols for Your Specific Requirements

Part of the reason we have a reputation for being quality-driven and customer-focused is our flexibility. Masy BioServices performs precise thermal, humidity, and carbon dioxide environmental chamber mapping, empty chamber thermal distribution, and load penetration studies with in-depth analysis based on your standard operating procedures (SOPs). We can also work with you to create custom qualification protocols to suit your needs.

We can help you develop:

  • IQ Protocols- Establish that the chamber is properly and safely installed.
  • OQ Protocols- Verifies that the chamber consistently meets operational specifications such as alarms and controls and operates as intended.
  • PQ Protocols- Verifies that the chamber consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols- Verify that the chamber consistently meets operational specifications while the chamber is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.

In some cases, we may even make suggestions not to move forward with the qualification, as the chamber will not pass. However, when we do move forward, you’ll be impressed to see how quickly we work, often exceeding timelines to keep your schedule on track. In the end, you’ll receive a comprehensive report reviewed by a credentialed professional and complete with easy-to-read graphs, audits, NIST calibration certifications for all our equipment, and personnel credentials.

Industry-Leading Controlled Temperature Unit Validation Practices

Our validation process is aimed at saving you money in the long run and throughout the testing process. We leverage our deep knowledge of instrumentation and controls, so we can recommend and implement modifications to bring your chamber into compliance. We can also determine if the chamber will likely fail validation during the pre-qualification process, helping you make the best decisions before you spend time and money on failed validation testing. At Masy, we aren’t focusing on closing a deal; we’re focusing on bringing our clients the highest possible quality of care and service. If you have a single-chamber project or a large-scale laboratory build-out, we are ready and well-equipped to exceed your expectations.

Time is valuable in a high-demand, fast-paced industry. Masy creates time and money-saving efficiencies in the validation process by conducting pre-qualification procedures before beginning a project. Pre-qualification assesses your equipment’s performance before validation begins and determines if the equipment will likely pass or fail validation – helping you make the most informed decision before moving forward with further testing.

All certified validation and calibration equipment used at customer sites is verified upon return to our NVLAP accredited metrology laboratory to confirm accuracy (NVLAP lab code 200904-0). We complete your project by providing a clear, comprehensive validations report, confirming your equipment is fit for use for your requirements. 

Reducing equipment downtime is critical to meeting the needs of patients. Masy is fully-equipped with an in-house validation team and the largest validation equipment inventory to consistently meet or exceed your project and time-frame requirements, while never sacrificing quality or accuracy.

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CASE STUDY

Learn more about how Masy qualified 54 controlled temperature and humidity unites (CTUs). 

Masy can be your pharma support provider for any need.

Over time, nearly all chambers will require tuning to maintain optimal performance. Customers continually return to us for their validation needs because they recognize our ability to deliver and do so in record time. In our case study, we share the example of a time when our team completed validation of -80 freezer in just five short days, and the final invoice came in under the estimated quote. That customer now continues to call Masy for their validation needs.

Masy is the trusted name when your controlled chamber needs to be validated for compliance. Our cost-effective, tailored approach has allowed us to build long-term client relationships. Our customers recognize that when they use Masy, they have a validation partner with expert industry knowledge that adds value for the life of the chamber and cGMP resource unlike any other.

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