Controlled Temperature Unit Qualification
Environmental Chamber Validation & Temperature Mapping
- Temperature, humidity, and CO2 mapping of your environmental chambers for IQ/OQ/PQ.
- Custom protocol consulting and development, or seamless execution of your own protocols.
- Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.
Ensuring Compliance by Performing your Controlled Temperature Unit Qualification
Regular temperature mapping and qualification of your environmental chambers and controlled temperature units – refrigerators, freezers, and stability chambers – ensures compliance with cGMP regulations and assures the integrity of your stored materials.
Masy BioServices performs precise environmental chamber mapping for temperature, humidity, pressure and carbon dioxide. Our turn-key solution includes writing validation protocols, executing validation protocols, and a through quality review of the final documentation.
The Correct Qualification Protocol for Your Specific Requirements
Based on your standard operating procedures (SOPs), Masy BioServices performs precise thermal, humidity, pressure, and carbon dioxide environmental chamber mapping, empty chamber thermal distribution, and load penetration studies 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 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.
Validator 2000, Premium Thermocouples, and Wireless Dataloggers
Based on your unique needs, we can use the gold-standard Kaye Validator 2000® with premium or ultra-premium thermocouples to perform your chamber validation, or we can use DataTrace wireless dataloggers. Both options offer accuracy and reliability for your temperature mapping projects.
Post-Qualification Verification of Qualification Test Equipment Confirms Accuracy
All certified validation and calibration equipment used at our customer sites are verified upon return to our NVLAP-accredited metrology laboratory. This completes the physical execution of the qualification activity that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.
Additionally, our own credentialed Quality Department will review all validation reports before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.
Quick Delivery of the Documentation Package
At the conclusion of your project, we will provide a clear, comprehensive validation report, confirming that your equipment is compliant to your standard operating procedures. Our validation reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements.
Validation reports typically include:
- Summary Report
- Executed protocol
- Real-time, hard copy, and soft copy of the raw data
- Calibration certificates for all test equipment used, noting NIST traceability
- Sensor calibration reports
- Validation personnel detailed résumé
- Electronic backup files for all studies
Fast Turnaround Time Keeps your Operations On-Schedule
We understand that your equipment being out-of-tolerance, or down for validation testing, can negatively impact your production schedules and capacity. We will supply enough personnel and equipment to complete the project within your specified timeframe.
Choose Masy BioServices for your Thermometry Calibration Needs
When you choose Masy for your environmental 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 chamber qualification needs.