Cryopreservation plays a key role in many Good Manufacturing Practice (GMP) cell and gene therapy workflows, allowing precious samples frozen in the laboratory to be stored for extended periods. However, given the sensitive nature of cell and gene therapy products, precise control of the freezing rate is necessary to minimize the detrimental effects of undercooling and heat liberation during the phase change from water to ice, which can compromise cell viability.
Thanks to advances in cold storage technology, modern controlled-rate freezer (CRF) systems are providing manufacturers with precise, repeatable freezing capabilities to protect sample quality and safety. At the same time, these innovative solutions are enhancing data traceability to support GMP and 21 Code of Federal Regulations (CFR) Part 11 regulations, which require cell and gene therapy manufacturers to ensure the authenticity, integrity and traceability of electronic data generated by laboratory equipment.
A trusted partner for 21 CFR Part 11 compliance in cell and gene therapy workflows
The 21 CFR Part 11 regulations are the U.S. Food and Drug Administration’s guidelines for the replacement of paper documents by electronic information. In summary, the 21 CFR Part 11 regulations designate that electronic records and signatures are as valid as paper records and handwritten signatures, and set out the requirements for laboratories and organizations to maintain the highest standards of public health by assuring electronic data is secure, traceable and unalterable.
When it comes to the use of electronic records and signatures in the GMP environment, the burden of compliance applies to both GMP equipment manufacturers and end users. To ensure GMP cold storage and sample preservation workflows align with the 21 CFR Part 11 regulations, it is, therefore, important to partner with the right equipment vendor.
CryoMed Controlled-Rate Freezers: Safeguarding sample integrity, traceability and 21 CFR Part 11 compliance
Thermo Scientific CryoMed Controlled-Rate Freezer (CRF) systems are an advanced solution for cell cryopreservation. The systems provide precise and repeatable freezing capabilities, while enhancing traceability to support GMP and 21 CFR Part 11 requirements.
CryoMed CRF systems protect sample safety and integrity by applying Type T thermocouples and real-time monitoring of chamber and sample temperatures. The freezers’ dual solenoid valves are capable of balancing liquid nitrogen (LN2) injection volumes, and together with their advanced air-handling systems, enable precise temperature control, temperature uniformity and accelerated freezing. CryoMed CRF systems also feature remote alarm capabilities to notify users of thermocouple failures, heater malfunction, power failures and breach of high/low temperature limits, which can be used to prompt corrective action and ensure ideal conditions are always maintained. Additionally, the freezers’ preventative maintenance indicator for LN2 solenoid replacement provides advance notice to minimize unscheduled downtime.
These advanced cold storage solutions feature built-in functionality to support GMP and 21 CFR Part 11 requirements, making it easier for laboratories to maintain regulatory compliance. Thanks to an intuitive touchscreen user interface that facilitates data traceability, the systems enable easy set-up, operation and review of freezing runs, as well as events monitoring. The freezers also offer three levels of accessibility to authorized personnel only, for optimal protection of freezing profiles and data. For added convenience, run and event logs can be exported as PDF files onto a USB stick.
CryoMed CRF systems are available in three capacities to suit varying application needs, and offer six pre-set and up to 14 user-defined custom freezing profiles. To further support ease-of-use, a “run last” feature allows the same profile to be run consecutively at the touch of a button.
Want to learn more about using CryoMed CRF systems to meet GMP and 21 CFR Part 11 requirements?
Watch our on-demand webinar to discover how CryoMed CRF systems can help cell and gene therapy manufacturers address GMP and 21 CFR Part 11 requirements.
CryoMed Controlled-Rate Freezers: Safeguarding sample integrity, traceability and 21 CFR Part 11 compliance
Thermo Scientific CryoMed Controlled-Rate Freezer (CRF) systems are an advanced solution for cell cryopreservation. The systems provide precise and repeatable freezing capabilities, while enhancing traceability to support GMP and 21 CFR Part 11 requirements.
CryoMed CRF systems protect sample safety and integrity by applying Type T thermocouples and real-time monitoring of chamber and sample temperatures. The freezers’ dual solenoid valves are capable of balancing liquid nitrogen (LN2) injection volumes, and together with their advanced air-handling systems, enable precise temperature control, temperature uniformity and accelerated freezing. CryoMed CRF systems also feature remote alarm capabilities to notify users of thermocouple failures, heater malfunction, power failures and breach of high/low temperature limits, which can be used to prompt corrective action and ensure ideal conditions are always maintained. Additionally, the freezers’ preventative maintenance indicator for LN2 solenoid replacement provides advance notice to minimize unscheduled downtime.
These advanced cold storage solutions feature built-in functionality to support GMP and 21 CFR Part 11 requirements, making it easier for laboratories to maintain regulatory compliance. Thanks to an intuitive touchscreen user interface that facilitates data traceability, the systems enable easy set-up, operation and review of freezing runs, as well as events monitoring. The freezers also offer three levels of accessibility to authorized personnel only, for optimal protection of freezing profiles and data. For added convenience, run and event logs can be exported as PDF files onto a USB stick.
CryoMed CRF systems are available in three capacities to suit varying application needs, and offer six pre-set and up to 14 user-defined custom freezing profiles. To further support ease-of-use, a “run last” feature allows the same profile to be run consecutively at the touch of a button.
Want to learn more about using CryoMed CRF systems to meet GMP and 21 CFR Part 11 requirements?
Watch our on-demand webinar to discover how CryoMed CRF systems can help cell and gene therapy manufacturers address GMP and 21 CFR Part 11 requirements.
This product is intended for General Laboratory Use. It is the customer’s responsibility to ensure that the performance of the product is suitable for customer’s specific use or application.