Cryogenic Storage

Introduction

Any cell line that is likely to be used in a cGMP process should be banked as a Master Cell Bank and validated early in the research and development phases of a project. Storage of these valuable cell lines requires a Safe Deposit Facility. Custom Biogenic Isothermal storage vessels are used for the long term stable storage of such cell samples. These store the samples in liquid or vapour phase LN2 at a temperature of -196°C.

Approach

Temperature mapping the loading system demonstrates the storage area remains within the users requirements at all times this is carried out with the minimum and maximum LN2 fill to ensure all situations are validated.
The mapping is performed with an empty chamber to simulate worst case conditions and with a fixed or typical load to simulate the normal operating conditions of the unit.

The ambient temperature is also monitored throughout to confirm the units are suitably located, according to the manufacturer’s specification.
Door Open and LN_ failure tests can be performed to establish the length of time the lid can be safely opened and how long the temperature of the cell banks remain within specification if the LN2 is not refilled
The correct operation of temperature alarms are confirmed and a record made of the corresponding trigger temperatures. This includes any associated Facility Monitoring System or Building Management System alarms.

Experience

PEV have experience of validating CBS and MVE Liquid nitrogen storeage vessels.
We can provide operational resource and assistance with User Requirement Specifications (URS), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Re-qualification and Validation Reviews.