Best Practices for Controlled Biobanking and Biorepositories
The Guardian of Vaccine Vials: SenseAnywhere Saves the Day!
Before any components or products can be delivered to a new destination, proper packaging and transportation protocols must be met to assess whether the components and products will remain viable during transit.
One key factor of assessment is the container in which they’re shipped in. This must undergo strict validation processes that evaluate potential hazards, ensuring that validation is fully compliant with ISBT guidelines.
Product preservation during transit
There are a number of occasions in the life sciences, healthcare and biorepository sectors that result in the need to transport blood products or components. These include:
- To increase the availability of blood components in emergency situations
- To maximise geographical accessibility of blood products between medical facilities
- To store quantities of rare blood products for medicinal or research purposes
- To ensure any long-term stored products maintain their quality and safety
- To solidify disaster preparedness of the medical sector
Much like many other biological samples, blood components and products must be stored in appropriate conditions to maintain cell viability, product function and prevention of bacterial contamination. One such parameter that must be protected is the precise temperature range at which they’re stored.
This is a challenge to the blood supply cold chain, as transportation is a difficult environment to simulate the highly accurate temperature conditions of static storage.
For example, red cells (a blood part) are required to be stored between +2C and 6C and must not go below 1C. This differs to platelets, plasma and cryoprecipitates, which can require maintained temperatures of -25C during transit.
The two main components of stabilised temperature
This is a useful tool to validate the suitability of a container for blood transportation. With our temperature mapping service and rental equipment, we can validate all the crucial zones of individual transit containers, vehicles, and storage facilities to map a thorough landscape of where the temperature of blood products is likely to be most vulnerable to fluctuations.
There are a number of parameters that affect the temperature of transported blood products. Logging and safeguarding temperature is one such example in which Withnell Sensors can assist, as our range of brand partnerships provides access to loggers which have been purposely designed for life science and medical applications.
Transportation validation in accordance with ISBT blood transport container validation guidelines is a field of familiarity to our team of experts. To view a copy of the guidelines click below. If you’re looking for support in understanding the realm of temperature surrounding any transportation container's upcoming journey. Speak to our team today.
We’ve also compiled the key factors to account for to effectively validate your containers of choice:
Securing product integrity with blood transport validation testing
Validating whether a container and its respective packaging is suitable for protecting blood vials and components starts with the requirements of the goods themselves. This is a crucial stage for long-distance transportation especially.
In accordance with ISBT blood transport container validation guidelines, taking an estimate of the geographical temperature range the transport container will be exposed to during transit, in both controlled and uncontrolled environments, will assist with identifying the most suitable container.
Total transit weight
Next, the weight and security of a container must be assessed. In order to comply with local health and safety requirements, there will be a maximum weight allowed in transit, therefore the weight of the components or products, plus the weight of the packaging and containers must all be accounted for.
As sustainability ambitions also increase, ISBT guidelines encourage carbon reduction transport methods as well as plastic alternative materials for day-to-day consumables.
Like many others in the technical and scientific fields, distribution centres, processing facilities and blood collection centres are all working towards using re-usable materials where possible. The transportation of such crucial bioproducts however does mean that any reusable container must be returned to the distribution centre for shedding of any material particles prior to being utilised again.
Managing pre, post and in-transit temperature fluctuations
Fluctuation management before transit
Although these blood products are hardly trekking Mount Everest or the Sahara Desert, there will be degree fluctuations in the external ambient temperatures. If ambient temps cause even a 1C fluctuation, the viability, function and safety of such products can be drastically affected.
The starting temperature of the blood products and components is also paramount. The product will be stored at an exact temperature range before it is contained for transport. This means all coolant packs and additional packaging must also be brought to these temperatures prior to the assembly of the container.
ISBT guidelines require that all container materials are stabilised at the desired temperature for at least 24 hours prior to transit.
Temperature control whilst in transit
Finally, a data logger or sensor should be placed on the surface of the blood products as well as in the expected hot spots and cool positions inside. These are usually the top centre and bottom of the containers, however, performing temperature mapping will highlight the single points of recording that are required during transportation, to give an accurate overview of the internal temperature range.
For blood component and product safety, a data logger such as the SenseAnywhere AiroSensor, will provide accurate measurements and readings during transportation with all operations backed by cloud storage.
Temperature fluctuation alerts can also be received remotely via SMS or MMS, which means that stakeholders can find out immediately if the products are at risk during transit.
Validation process which mitigate post transit effects
Validation testing must be conducted to ensure there is accurate monitoring of the temperature throughout the transportation journey length. This is where ambient seasonal conditions must be accounted for.
External temperatures will fluctuate during the summer and winter seasons. Any testing can reflect the summer ambient temperature through the use of an incubator simulator, meanwhile, winter ambient temperatures can be simulated in a cold room.
Calculating the time of which the containers will be exposed to ambient temperature fluctuations can also be performed using the desired destination. Calculating the maximum journey time required to reach the endpoint is crucial as this holds the key to knowing the testing time of validation.
Validation testing should be conducted for 150% - 200% of the maximum journey time. This ensures the transported components or products are safeguarded for much longer than the journey actually requires. Acting as a safety buffer should any transportation setbacks occur; this process will offer effective evidence of validation.
An alternative route, which gathers the same intel, is to validate the container until a notable change in temperature range. This highlights the truest maximum time a container can be in transit.
You can reference the full ISBT guidelines for further details or talk to a member of our team and we can assist during your validation processes.