What is it? Why is it important?

During the handling of BM, staff may be exposed to biological agents (e.g. bacteria, viruses, parasites, fungi and their associated toxins), including harmful chemical reagents.


Biological agents carry the risk of:

  • Contracting infectious diseases (e.g. HIV, hepatitis, tuberculosis)
  • Contracting respiratory diseases (e.g. COVID-19)
  • Becoming ill due to toxins (e.g. diphtheria toxin, pertussis toxin)
  • Developing cancers (e.g. aflatoxins cause oesophageal and liver cancer, hepatitis C cause liver cancer)


Consumables and chemicals used during the processing of BM carry health risks such as:

  • The exposure to toxic, corrosive or flammable substances
  • The development of allergies (e.g. to laboratory latex gloves)

What do I need to do?

Based on the set-up of your biobank:

  • Define potential risks to your biobanking staff. Make a list of risk areas and include:
    • Biological- and lab reagents
    • Infectious organisms (e.g. FOEN classification of organisms).
    • Laboratory equipment
    • Hazardous storage material such as Liquid Nitrogen
  • Define risk control-measures to reduce risks such as to ensure that:
    • Equipment remains in optimal condition (e.g. regular equipment maintenance checks, followed by applicable repairs)
    • Staff has access to safety information and are aware of safety warnings (e.g. warning labels on laboratory equipment / chemical reagents, safety instruction sheets on how to safely process BM)
    • Staff remains up-dated and trained on safety procedures
  • Document risk management procedures in a SOP/WI, or in a project/study relevant Risk Assessment Form


For the definition of safety procedures and the training of biobank staff, do not hesitate to consult biosafety- or alternative safety experts. These experts can support and confirm the correct assessment and implementation of your risk management strategy.

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

  • Personnel management SOP
  • Personnel file


FOEN – see in particular

  • Topics / biotechnology/publications-studies/ Managing biological risks in contained systems
  • Topics / biotechnology/publications-studies/ Classification of Organisms


  • BM – Biological Material
  • COVID-19 – Coronavirus disease
  • CTU – Clinical Trials Unit
  • FOEN – Federal Office for the Environment
  • HIV – Human Immunodeficiency Virus
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Safety ↦ Biobanking Staff

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 ↦ Safety ↦ Biobanking Staff

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