Development↦Biobanking↦Handling of Biological Material↦Sample Storage
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
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.
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
HRO – see in particular article
- Art. 5 Storage of health-related personal data and biological material