What is it? Why is it important?

A freezer Emergency Plan (EP) describes procedures to follow in the event of freezer malfunction or breakdown.

 

The aim is to guarantee:

  • The quality and integrity of Biological Material (BM)
  • Optimal storage conditions all times

 

This requires that:

  • Temperatures remain stable during the entire storage duration
  • Freezer temperatures are monitored and documented on an ongoing basis (24 hours / 7 days a week)
  • A power back-up circuit takes over in the event of electricity failure
  • Freezers are equipped with an emergency alarm system connected to a response team (e.g. institution or hospital security system, active 24 hours / 7 days a week)
  • Compatible reserve freezers are available for the transfer of BM during freezer breakdown, or a backup system of CO2 or LN2 is in place to maintain temperature at baseline levels
  • Implemented emergency events are diligently documented to prove the ongoing integrity of BM during storage

More

A power back-up circuit takes over in the event electricity failure. Large biobanks (>2 million samples) have automated storage systems. Robots take over the sample storage and retrieval process, eliminating the risk of temperature fluctuations compared to people managed freezers. Still, also robot driven biobanks have ongoing temperature surveillance and EP in place.

What do I need to do?

Set-up an EP and describe procedures in a SOP or WI. Include important processes such as how to:

  • Provide the response team with biobanking contact details (e.g. place an emergency contact sheet on the freezer with staff name and phone number)
  • Document activities performed by the response team (e.g. timing of the alarm, first contact with biobank responsible staff)
  • Document the handling of an emergency event (e.g. date, time, reasons for the alarm, temperature excursions, implemented interventions, responsible staff)
  • Document freezer breakdown and transfer of BM to a reserve freezer, such as:
    • Inventory check of transferred BM
    • Reserve freezer ID and temperature (e.g. ensure ongoing temperature surveillance)
    • Relocation of BM back to original freezer, if applicable

 

If you are responsible for the storage of BM belonging to external projects / customers, define how to communicate the occurrence of an emergency event.

More

Other events that carry the risk of exposing BM to less than optimal temperatures are:

  • BM retrieval from freezer: in order to retrieve samples, the freezer is opened exposing not only required samples but also all other stored BM. Set-up sample retrieval procedures that limit freezer exposure to higher temperatures and consequently unwanted temperature fluctuations

 

  • Selective retrieval of BM from a storage box or storage of BM in a box already containing BM: a storage box might contain additional not retrievable samples. These samples carry the risk of being exposed, for a given amount of time, to less than optimal temperatures. Ensure to place the box on dry ice in order to protect samples that must be returned to the freezer

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

References

ISO 20387:2018 General Requirements for Biobanking (access liable to costs)

 

Swiss Law

ClinO – see in particular article

  • Art. 18 Storage of health-related personal data and biological material

HRO – see in particular article

Art. 5 Storage of health-related personal data and biological material

Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • CO2 – Carbon Dioxide
  • EP – Emergency Plan
  • ID – Identity
  • LN2 – Liquid Nitrogen
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Biobank Set-Up ↦ Freezer Emergency Plan
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
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Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
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Current Path (click to copy): Development ↦ Biobanking ↦ Biobank Set-Up ↦ Freezer Emergency Plan

Please note: the Easy-GCS tool is currently under construction.