What is it? Why is it important?

Biobank facilities include:

  • Premises or spaces dedicated to the management of the biobank (e.g. laboratory space, offices, storage rooms)
  • Equipment for the processing and storage of biological material (BM) (e.g. laboratory processing hoods, centrifuges, pipets, freezers, fridges)

 

Biobank materials are consumables used during sample workflow (e.g. collection tubes, storage containers, processing solutions, freezer compatible labels and pens). Example: for tracking purposes, biological samples are allotted and labelled with personalised identifiers. Types of labels and pens used are crucial as they must withstand low temperatures.

 

The provision of facilities and materials:

  • Facilitate daily operations and reduce the likelihood of unwanted sample workflow incidents
  • Guarantee the harmonised handling of BM, by providing samples comparable in nature needed for the downstream analysis (e.g. the use of collection / storage containers, centrifugation speed and duration, stable storage temperatures)

More

In biobanking it is important to define a strategy on how to handle materials (consumables). Aspects to consider include:

  • Keep an inventory. Ensure to order/re-order consumables in due time. This will avoid shortage, potentially affecting daily business
  • Log purchasing and expiration date, and ensure only non-expired consumables remain in circulation (e.g. if applicable, follow required destruction procedures)
  • Store consumables according to specifications provided by the manufacturer (e.g. temperature, light protected)
  • Perform regular quality checks to ensure consumables perform as intended
  • Provide an SOP/WI describing how to handle consumables

What do I need to do?

Based on planned sample workflow activities, guarantee the following:

  • Material durability: containers and labels are suited for low temperature:
    • Verify the instruction for use
    • As applicable, test durability before use
  • Equipment compatibility: freezers offer adequate required storage space and optimal stable temperature and ventilation
  • Monitoring systems: premises are temperature and humidity controlled; freezers are connected to an alarm that is activated once temperature becomes unacceptable. LN2 rooms are in line with the strict regulation of working with nitrogen
  • Equipment quality control: oversee manufacturer/service provider qualifications and equipment installation
  • Equipment maintenance: perform:
    • Periodic calibrations, if applicable by manufacturer (e.g. pipets, centrifuges)
    • Annual defrosting of freezers, filter changes
    • Cleaning of equipment
    • Decommissioning of defective equipment and replacement
  • Restricted access: doors have key or access-badge, freezers have locks, access to BM storage is tracked and documented manually or electronically
  • Special conditions: RNase or germ free work zone, BM packaging and shipment space
  • Safety: Procedures protecting:
    • Biobanking staff (e.g. handling of contaminated BM (HIV, HCV), use of toxic solutions (e.g. acids, radioactive material)
    • The environment (e.g. safety guidelines)
    • The Biological Material (e.g. biosecurity)

More

Ensure staff is qualified and trained on the management of biobank facilities, such as:

  • To purchase and track biobanking material, and to perform regular inventory checks and document ongoing consumption
  • To monitor and if applicable purchase required biobanking equipment. Implement ongoing quality controls and facility maintenance
  • To implement ongoing quality controls and facility maintenance

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 calibration record
  • Equipment maintenance record
  • Expiring consumables
  • Equipment Inventory

References

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

  • 6.3 Facilities / dedicated areas and environmental conditions
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HIV – Human Immunodeficiency Virus
  • HCV – Hepatitis C Virus
  • ISO – International Organization for Standardization
  • LN2 – Liquid Nitrogen
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Biobank Set-Up ↦ Facilities and Materials
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
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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