How to prove that vaccine insulation CSTR eligibility
In the past 20 years, has a good distribution practice specifically for new regulatory focus, which regulates how to transport the regulated products.Fortunately, the emergence of the GDP has created a mighty cold chain, can be processed in a timely manner to fight COVID - 19 needed to transport a large number of temperature control vaccine.
For example, Pfizer vaccine storage for sizes - 70 ° C, this is a new challenge for the temperature distribution in one of the striking examples.The current distribution channels do not have the ability to handle - 70 ° C product.Most of the distribution center no ultra-low temperature freezer, our truck and airplane also can't keep such a low temperature.This brings to the need of ultra-low temperature conditions of vaccine distribution problems.
When the outbreak in cryogenic transportation solutions
Heat transport box successfully solved the problem.
In simple terms, heat transport box is shipping carton and combination of ice box with ice packs, can keep contents at the right temperature.Pfizer is ingeniously the transport of heat preservation box design, equipped with efficient vacuum insulation board and dry ice packs.The carrying case is also equipped with a support temperature data recorder, GPS to track temperature and location.These parts are not cheap.But given the critical nature of the vaccine, effective low temperature CSTR is necessary.
A transport box up to nearly 5000 doses of vaccine, each agent price is about $20.Compared to $100000 each product value, data recorder, the cost of insulation board and ice bag is trivial.
However, if the recorder technology problems, or deployment of human error, data recorder is likely to fail.This uncertainty leads to need to transport to heat preservation box eligibility for confirmation, in order to prove that they are suitable for its intended use.
Heat transport box section
To understand how to prove that heat transport box eligibility, check the basic sections can be helpful.It is the outermost layer of a durable cardboard boxes;Usually for three layers of cardboard and waterproof.Due to the cost could be as high as $100 for each of the incubator, so box must be strengthened, so that you can reuse.
The next layer is the insulating layer, in our figure in white board.For ordinary frozen cargoes, this layer will use the polystyrene foam.For cryogenic transportation, Pfizer adopted vacuum insulation board.
The next layer containing ice packs, in our figure in silver plate.For ordinary refrigerated transport, it will be built in some alcohol mixture of ice bag, its design, the product of the target temperature phase change, from solid to liquid) will happen.Phase transition temperature is important, because ice packs will remain in the phase change temperature, until the phase change is complete.For example, plain old ice at 0 ° C phase transition happens, and before all the ice melting temperature will not increase.For Pfizer cryogenic transportation tank, ice bag is made from dry ice, ice when - 78 ° C, from solid to gas.
Transport box products is the most inner box.Please note that the actual product can take up only a small part of the available space.In general, the carefully designed and used in traditional refrigerated transport the transport of heat preservation box, used to store the product in the space usually only less than 20% of its volume.
Confirmed: prove effective
Validation to prove that a process achieved the expected results.Confirmation is the terminology used in the validation of a piece of equipment.Therefore, when we make confirmation on the thermal transport box in, is also in the validation of the packing and shipping box operating procedure.
Let us suppose that carrying case to illustrate the validation process, will be in the summer of a four-day trip, used to transport frozen products.Products acceptable temperature range in between - 10 ° to 30 ° C - C.
First of all, according to the SOP insulation assembly carrying case.SOP 中会包括规格，例如冰袋的类型以及冰袋在组装前所需的调节时间和温度。放置经过调节的冰袋，并在产品装运箱中放入经过调节的对照产品。接下来，因为我们在对运输箱进行确认，所以我们将在产品区域中添加一个温度传感器。请记住，这些箱子里的空间很珍贵；因此，我们将使用电缆上的远程探头，而不是把整个数据记录仪放到箱子里。热敏电阻探头是此应用的理想选择，因为它们体积小、精度高，可用于不同的工作范围和校准测量范围。一个很好的例子是维萨拉 VL-1416，而不是像维萨拉 VL-1000 那样带有内部传感器的数据记录仪。
Carrying case confirmed packing box, the key is in accordance with the SOP as the actual shipment.Is different, the inside is controlled products, and we added a temperature sensor in the loading space.
Put packaging good shipping box can simulate may encounter in the process of transportation tank temperature environment.Because we simulated the summer not refrigerated trucks, so environmental compartment temperature can be set to 40 ° C, the last 12 hours to on behalf of the sunny day, and at night the temperature down to 15 ° C.Repeat the cycle of the last four days, to simulate a four-day transport.
In environmental compartment after a four-day challenge, examine the temperature data in the data recorder.Pay attention to control products in the sensor is to keep all four days at the required temperature range (- 10 ° to 30 ° C - C).If this is the case, you can be sure that when carried out in accordance with the SOP for packaging packaging, the highest temperature during the day to 40 ° C in the summer, the incubator can will products in a four-day trip to keep the required temperature range.A study is not enough, so we repeated the process, completed two four-day period.The results of three test success, all demonstrate that heat transport box.
Challenge test duration and temperature based on the choice of transport routes, and is expected to forecast weather pattern analysis.You may need to confirm a thermal insulation in summer, carrying case and SOP for winter to confirm a different transport box and SOP.
Confirm with confidence
If the end result is transportation qualified, then you can make sure the product at the right temperature in the transport process.Even if the transport vehicle equipped with temperature sensors, Pfizer still needs qualified carrying case.They must prove his single sensor accurately represents the entire product area.They also need to make sure that, if the transport of sensor malfunction or loss of data, transport box can maintain the required temperature.Less important products mentioned in the more traditional, scenario, after confirm shipping crate eligibility, its monitoring of the distribution process can be reduced.We can see the weather forecast and make sure that the goods arrive within the prescribed time limit, instead of using expensive recorder to monitor the temperature of the goods.
The attention to good distribution practice brings a stronger cold chain, and the new technology to support it.Now, many transit can use cheap one-time data recorder for directly monitoring, although the accuracy is not high, but for such application scenario is sufficient.However, the basic knowledge of transport time and temperature sensitive products without change.We in the development of transportation to heat preservation box for the Pfizer will no doubt to see it.
Low temperature COVID - 19 vaccine is proved qualified temperature transportation role and its continued relevance of a good example.In terms of Pfizer, even if they joined in the carrying case support GPS temperature sensor, still need to be confirmed.They need to prove that the transport box in the effectiveness of the temperature sensor failure occurs.Through validation, people can be sure that the rationality of the design of insulation carrying case.They need to make sure that the packing SOP is suitable for the intended use and dry ice recharging process effectively.
In North America, SoftBox Systems built the insulation is suitable for the distribution of the vaccine carrying case.This article contains an interesting video which was introduced in detail their efforts for the development of the shipping crate.The video shows the shipping case when facing difficult situation in the environment space hot like figure, you will see the temperature sensor cable (probably thermocouple) from some because being put in the top down or side down and the problems in the box.
"Softbox success help Pfizer realize COVID - 19 vaccine cold-chain distribution"
In Europe, CSafe Global developed can be used for the transport of heat preservation box distribution Pfizer/BioNtech vaccine.About the CSafe design for more information, please refer to the brief article about the transport box.
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