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

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

We perform temperature mapping of the the loading system to demonstrate the storage area remains within the user requirement at all times. This is carried out with both the minimum and maximum LN2 fill to encompass all conditions.

Thermal 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.

The ambient temperature is also monitored throughout to confirm the units are suitably located, according to the manufacturers specification.

We perform Door Open and LN_ failure tests are 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

We confirm the correct operation of temperature alarms and record the corresponding trigger temperatures. This includes any associated facility monitoring system or building management system alarms.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary and clear conclusion.

Experience

PEV have experience of validating CBS and MVE Liquid nitrogen storeage vessels.

We can help with the generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews.

We perform Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.