Cryogenic Storage Qualification
Proper Storage Conditions to Ensure Cell Viability
- Proper storage conditions ensuring biological activity does not occur at temperatures below the glass transition temperature of water.
- 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 Cryogenic Storage Qualification
The cryogenic storage of biological material is a crucial component of many biopharmaceutical processes. To ensure cell viability, proper storage conditions must be maintained. Biological activity does not occur at temperatures below the glass transition temperature of water, or -135°C. Biological samples kept below this temperature can be safely stored for years.
The Correct Qualification Protocol for Your Specific Requirements
Cryogenic units operate under either liquid phase or vapor phase conditions. In vapor phase units, heat introduced at the chamber lid is conducted along a heat fin to a liquid nitrogen reservoir below the storage envelope. Nitrogen vapor is boiled off and freezes the stored material. Although this method greatly reduces the risk of sample contamination, it causes a vertical temperature gradient to form within the unit. Proper material loading, liquid level monitoring and preventative maintenance can ensure that the highest temperatures within the storage envelope are kept within acceptable operating ranges. Masy BioServices can perform temperature mapping of the storage envelope to ensure the temperature gradient is within acceptable limits. Material stored in liquid phase cryogenic units is submerged in liquid nitrogen, ensuring a storage temperature of -196°C, but there is some risk of contamination if the packaging material is compromised. 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 cryogenic vessel is properly and safely installed.
- OQ Protocols: Verifies that the cryogenic vessel consistently meets operational specifications such as alarms, controls, and operates as intended.
- PQ Protocols: Verifies that the cryogenic vessel consistently meets performance specifications under dynamic conditions.
- RQ/CQ Protocols: Verifies that the cryogenic vessel consistently meets operational specifications while the cryogenic vessel is in use, ensuring a robust compliance posture for your company’s continuous qualification efforts.
Unparalleled Experience in Cryogenic Storage Qualification
Whether vapor or liquid phase, Masy BioServices can assist in all steps of your cryogenic storage unit installation, operational and performance qualification, from authoring the validation protocol and executing the study through to a quality review of the finished validation report.
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 cryogenic vessel 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 cryogenic vessel 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 cryogenic vessel qualification needs.