Photostability Chamber Qualification

  • Validating the critical conditions required for accurate photostability testing.
  • 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 Compliance by Performing your Photostability Chamber Qualification

Temperature and light mapping and qualification of your environmental photostability chambers ensures compliance with cGMP regulations and assures the integrity of your stored materials.
 
Masy BioServices performs precise environmental photostability chamber mapping for temperature and light (Cool White and Ultraviolet). Our turn-key solution includes writing validation protocols, executing validation protocols, and a thorough quality review of the final documentation.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Based on your standard operating procedures (SOPs), Masy BioServices performs precise thermal and light mapping, at multiple settings or conditions with in-depth analysis. 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 chamber 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 a pre-qualification evaluation, 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 Photostability Chamber Qualification Needs

When you choose Masy for your photostability 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 photostability chamber qualification needs.

 

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