What is it? Why is it important?
- Sample processing site (e.g. BM handling prior to long or short-term storage), or
- Sample storage site, where BM is kept until analysis (e.g. freezer storage at -80°C)
The aim is to preserve the integrity of BM during transport.
- Rapid delivery: once collected BM becomes negatively impacted if exposed to sub-optimal conditions and temperatures (e.g. RNA/DNA/protein degradation or alteration, decrease in cell viability)
- Transport conditions: Temperature fluctuations, vibrations, and accelerations (in hospital transport system: pneumatic systems), threaten optimal BM properties (e.g. degradation of cells or molecules of interest)
- Documentation: For subsequent down-stream analysis, traceability of BM handling during transport provide important BM quality information
IATA certificate: dry ice used during sample transport is considered a dangerous substance. Consequently, staff responsible for sample transport require the acquisition of an IATA certificate.
What do I need to do?
Define sample transport processes. Aspects to consider include:
- The trajectory, which reflects the expected time-laps between BM collection and processing or storage site
- Required transport temperature (TT)
- Required packaging material and safety requirements:
- Ensure optimal TT (e.g. secondary container, dry ice, ice pack)
- Prevent unwanted damage to BM (e.g. shake and/or light proof container)
- Protect staff from unwanted BM contamination. Define an emergency process for unwanted BM spillage
- Required documentation:
- Person(s) responsible for BM transport (e.g. study staff, logistics, couriers, pneumatic system), including an IATA certificate
- Transport date, reception time, and temperature
- Unexpected events impacting sample quality (e.g. non-conformities such as, transport delays, sub-optimal handling or shaking of BM)
In addition to an SOP/WI:
- Create applicable forms to be filled-in by staff responsible for BM transport (e.g. date & time of BM transport, transport conditions, unexpected events)
- Ensure staff is properly trained and adhere to required transport conditions (e.g. IATA, safety measures, unexpected events with potential impact on BM characteristics and quality)
In the event BM transport is outsourced to an external partner ensure:
- Transport processes are comply with internal standards
- Set-up a service level agreement (e.g. contract) that defines expected services and responsibilities
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
- 7.4 Transport of biological material and associated data
- Giavarina, et al. “Blood venous sample collection: Recommendations overview and a checklist to improve quality”
- Lippi et al. "Preanalytical quality improvement: in quality we trust"
- Ellervik et al. “Preanalytical variables affecting the integrity of human biospecimens in biobanking”
- Betsou et al. “Standard PREanalytical Code Version 3.0