What is it? Why is it important?
Sample packaging refers to the material used to wrap and protect Biological Material (BM) during shipment.
Its aim is to protect:
- Transport vesicle(s) containing BM (and its solutions) from breakage
- Staff safety and environment from:
- Injuries due to broken tubes
- Sample integrity from being:
- Exposed to less than optimal temperatures
- Lost to analysis
Required packaging depends on:
- The hazard classification of the BM
- Required temperature needed to preserve BM stability (e.g. cold chain maintenance)
- Whether it is an international shipment
Sample packaging usually includes 3 layers:
- A primary airtight container (e.g. cryovial or leak-proof tube)
- A secondary leak-proof packaging device (e.g. plastic box, sealed plastic pouch)
- An external packaging device that:
- Protects the content
- Ensures the maintenance of the cold chain (e.g. transport case in hard plastic, isothermal box)
Packaging is adapted to ensure required temperature is maintained during shipment, also called the shipment cold chain.
Sample temperature can be monitored and documented using:
- A temperature measuring device that tracks potential temperature excursions (e.g. deviations from required)
- A temperature controlling device (e.g. a thermometer that logs temperature during shipment)
Special packaging and documentation requirements exist for international shipment (e.g. custom declaration papers). Based on country of destination, special guidelines may apply (e.g. country required packaging guidelines, labelling requirements such as content and hazards sticks).
For international shipments, relevant staff must have IATA training and have acquired an IATA certificate.
What do I need to do?
Based on the planned shipment:
- Define the BM risk class (e.g. not dangerous, infectious substances to humans and or animals, genetically modified material)
- Define shipment temperature required to maintain BM integrity
- Based on risk and temperature requirements acquire packaging material, such as:
- External tubes to store frozen tube samples
- Sealed pouches to store tubes
- Absorbent material needed to absorb potential spillage
- Isothermal boxes that supports temperature maintenance
- Ice packs for transport at 2-8°C
- Dry ice for transport below -18°C
- Dry shipper for transporting BM stored in liquid nitrogen
- Temperature monitors (e.g. thermometer)
- Applicable labels for content and risk classifications
- Cardboard box for external wrapping
- Transport case in hard plastic
- Prepare shipment documents
- For air transport ensure to comply with IATA standards. For international shipments, relevant staff must be in the possession of an IATA certificate.
- Train staff on shipment requirements and procedures
Specialized transport companies can provide for external shipment services. They deliver external packaging material with dry ice or cold packs, and can support you with the shipment logistics (e.g. waybill, shipment tracking, filling in custom declaration papers, means to ensure low temperature is maintained even when package is on hold at custom).
If you decide to use an external shipment company, make sure to set-up and sign a service level agreement or contract that defines expected tasks 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
- Shipping Form
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
SECB – see in particular
- Topics / Transport of biological substances
IATA - Source for the regulation, standard and best practice in air transport