What is it? Why is it important?

Prior to analysis, collected Biological Material (BM) is stored for a given period of time. Based on required storage temperature, different storage options exist:

  • Cabinets (room temperature)
  • Fridge (2°C to 10°C)
  • Freezer (-35 to -18°C)
  • Ultra-freezer (-85 to -60°C)
  • Cryogenic storage (< -135 °C)

 

Safeguarding the quality and integrity of BM, requires that storage equipment is continuously supervised. Storage equipment should be:

  • Serviced to ensure optimal performance
  • Protected against unauthorized access (e.g. prevents unacceptable handling of storage equipment resulting in damage or loss of BM)
  • Monitored on an ongoing basis with 24hours / 7 days a week surveillance (e.g. temperature- and humidity control, protected from light exposure)
  • Equipped with emergency procedures in the event required storage conditions deviate (e.g. a drop or rise in temperature)

More

Large biobanks (>2 million samples), have automated storage systems. Robots take over sample storage and retrieval processes. Even though quite costly, these solutions allow for efficient and high quality storage of BM (e.g. rapid error-free BM storage and retrieval).

What do I need to do?

Based on the planned collection and storage of BM, inform yourself about required:

  • Storage conditions (e.g. temperature / humidity control)
  • Infrastructure (e.g. access protected premises, integration into the local alarm logistics)
  • Storage guidelines for infectious (e.g. HIV / HCV), radioactive, or genetically modified BM
  • Criteria towards equipment manufacturers (e.g. minimum attainable temperature, temperature stability, available storage space, inbuilt alarm, locking system, cost)

 

Before activating an equipment:

  • Add the apparatus to your equipment inventory (e.g. labeled with an identifier number)
  • Write an SOP/WI and define:
    • A maintenance plan (e.g. add a logbook that tracks equipment maintenance history)
    • An emergency plan (e.g. implemented in the event of equipment failure)
    • Access guidelines (e.g. restrict access to storage and removal of BM to biobanking staff)
  • Train biobanking staff on equipment SOP/WI

More

Additional questions to ask when buying new storage equipment:

  • What is the storage capacity / volume?
  • How is the storage content organized (e.g. number of drawers or shelves, type of racks)?
  • What is the expected temperature stability (e.g. expected maximum range when in operation)?
  • What is the temperature recovery performance after opening / closing storage doors?
  • Equipment footprint (e.g. chest vs. shelf freezer)?
  • Level of automation (e.g. robot support)
  • What is the price performance ratio?

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.

SBP Documents

SOPs, Forms and Templates – see in particular

  • Equipment management SOP
  • Equipment Inventory

References

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular sections

  • 6.5 Equipment
  • 7.7 Storage of biological material
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HIV – Human Immunodeficiency Virus
  • HCV – Hepatitis C Virus
  • ISO – International Organization for Standardization
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Biobank Set-Up ↦ Storage Equipment
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

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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

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Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Biobank Set-Up ↦ Storage Equipment

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