What is it? Why is it important?

Sample storage is the sample-workflow step where collected or processed Biological Material (BM) is designated for short or long-term storage.


The aim is to guarantee:

  • Sample quality by preserving BM characteristics of interest to the downstream analysis
  • Sample identification and traceability during the entire storage duration (e.g. documentation in BIMS, sample coding, donor identification-log)
  • Sample safety (e.g. access control, optimal storage conditions)


To prevent a loss in BM quality requires:

  • Optimal facilities and storage equipment, that guarantee required storage conditions (e.g. provision of stable temperature, humidity, CO2 concentrations)
  • Ongoing monitoring of storage facilities (e.g. freezers with temperature control and alarm)
  • Access control to storage premises (e.g. access with badge including time stamp)
  • Biobank Information Management System (BIMS):
    • Tracking (e.g., sample storage location)
    • Status (e.g. surveillance of sample inventory, sample stored or distributed)
    • Duration (e.g. maximum acceptable storage duration)

What do I need to do?

Define sample storage procedures with the aim to ensure BM of high quality.


Adapt storage conditions based on:

  • BM of interest (e.g. PBMC, RNA, tissue cells)
  • BM stability (e.g. RNA is stable for 14 days at 4°C and up to 1 year at -80°C)
  • Planned analysis (e.g. RNA is stored at -80°C as analysis is planned 6 month after BM collection)


Provide facilities and materials, such as:

  • Temperature controlled freezer
  • Access control premises
  • Required material (e.g. freezer compatible cryolabels/cryostickers)
  • Back-up system (e.g. LN2 emergency cooling system in case of a power or mechanical failure)
  • Back-up storage units (e.g. emergency freezer)



  • Storage start-date and time
  • BM location in the storage unit (e.g. BIMS)
  • Monitoring of storage conditions (e.g. temperature log)
  • Storage non-conformities (e.g. sub-optimal temperature fluctuations)



  • Emergency plans are in place (e.g. freezer/electricity breakdown)
  • Staff is properly trained


Write a SOP and/or WI describing BM storage requirements, and ensure staff is properly trained.


Once optimal storage time has been exceeded, BM might be of lesser quality. Upon analysis, this can lead to unexpected or false test results. In the SOP, describe how to proceed once optimal storage conditions are exceeded.

Options might include:

  • To perform a quality test that confirms that the BM of interest still complies with pre-defined quality expectations
  • To follow BM destruction procedures (e.g. destruction means and documentation)

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

  • Biological Material SOP


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

  • 7.7 Storage of biological material

Swiss Law

HRO – see in particular article

  • Art. 5 Storage of health-related personal data and biological material
  • BM – Biological Material
  • BIMS – Biobank Information Management System
  • CO2 – Carbon Dioxide
  • CTU – Clinical Trials Unit
  • FFPE – Formalin-Fixed Paraffin-Embedded
  • HRO – Human Research Ordinance
  • LN2 – Liquid Nitrogen
  • PBMC – Peripheral Blood Mononuclear Cells
  • RNA – Ribonucleic Acid
  • ISO – International
  • SBP – Swiss Biobanking Platform
  • SOP – Standards Organisation
  • WI – Working Instruction
Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Storage

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Storage

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