Ramping Chamber Qualification

Maintaining Set Temperatures at a Specific Rate for a Specific Length of Time

  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.

 

Choose Masy for Accurate Calibration

Ensuring the Performance of your Ramping Chamber Qualification

Ramping chambers, also known as cycling chambers, approach a set temperature at a specified rate and maintain that temperature for a specified length of time. Profiles can be set up within the controller of the unit to define cycling programs that can ramp through an array of different temperatures at predetermined periods of time. These chambers are typically used for the stability testing of drug product, as specified in 21 CFR Part 211, to determine appropriate product storage conditions, simulate logistical studies, etc.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy BioServices can perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) services to validate your ramping chamber performance, and employ trained validation engineers to provide a program setup and a full-scale validation service, from protocol generation to final report review. We can work with you to create a custom protocol, or we will follow your Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP) and other cGxP guidelines. We can help you develop:

  • IQ Protocols: Establishes that the chamber is properly and safely installed.
  • OQ Protocols: Verifies that the lchamber consistently meets operational specifications such as alarms, controls, and operates as intended.
  • PQ Protocols: Verifies that the chamber consistently meets performance specifications under dynamic conditions.
  • RQ/CQ Protocols: Verifies 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.

Pre-Qualification Services Improve Efficiency and Cost-Effectiveness

As a cost-saving measure we apply our experience with instrumentation and controls, recommending and implementing essential modifications to bring your chamber into compliance. Over time, nearly all chambers will require tuning to maintain optimal performance. Masy BioServices can assess your chamber’s performance before qualification begins, and if possible, tune the chamber to reach optimal performance. Through pre-qualification, we can determine if the chamber will likely pass or fail validation – helping you make the best decisions before you spend time and money on chamber qualification.


Contact Masy for Calibration

Choose Masy BioServices for your Ramping Chamber Qualification Needs

When you choose Masy for your ramping chamber qualification projects, you can enjoy the confidence that comes with knowing that your critical equipment is qualified to the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.


Contact Masy BioServices today for your ramping chamber qualification needs

 

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