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
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?
- 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.
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
ISO 20387:2018 General Requirements for Biobanking (access liable to costs)
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