SARS COV 2 vaccination: The stress test for pharmaceutical logistics
COVID-19 makes logistics face a very big challenge. Our best chance to get out of it, the RNA-based BNT162b2 vaccine, must be stored at a maximum temperature of -70°C. As a result, temperature-sensitive transports in pharmaceutical logistics will reach a previously unimaginable dimension. According to forecasts, more than 15,000 flights and 200,000 pallet shipments will be required to combat the pandemic.
Hazardousness of dry ice (solid carbon dioxide)
Temperature control is not the only risk associated to logistics of these vaccines. The required cooling capacity is only possible with hazardous material dry ice. As soon as the solid carbon dioxide gets warmer than -78.4 °C, it directly transforms into gaseous, odorless carbon dioxide. In air transport, hazardous materials may only be shipped by IATA-DGR (International Air Transport Association - Dangerous Goods) trained personnel. In the case of the mRNA vaccine, logisticians need the approval of the aviation authorities to coordinate the transport volume of the refrigerated packages. The smaller the free volume in the hold, the higher the concentration of carbon dioxide is, that generates a risk to both air and road transport. Consequently, packaging must be able to withstand the very low temperatures and still be airtight. Gas venting to prevent a buildup of pressure must be possible and any risk of asphyxiation due to improper compartmentalization must be eliminated. These requirements alone demand a high level of process control.
Weaknesses in pharmaceutical logistics
In principle, a continuous supply chain with cryogenic temperatures can be established. However, even with conventional pharmaceuticals, storage and transport sometimes face substantial challenges. This became apparent in the delivery problems of protective equipment at the beginning of the Corona pandemic. In audits, we often see that the required storage conditions are not maintained throughout the transport route due to a lack of protection against thermal influences. Similarly, we see deficiencies in warehouses with unmaintained temperature sensors, structural shortcomings. In some cases, local temperature increase can occur due to a lack of ventilation, especially under storeroom roofs, and refrigerators are not sufficiently available in transshipment warehouses. Primary packaging may also be damaged during handling.
In the EU (Directive) or locally (In Germany, DIN SPEC 91323 standard) regulate the air conditioning of commercial vehicles for the transport of pharmaceuticals. And, in accordance with GDP (Good Distribution Practice) requirements, fully-supplied pharmaceutical wholesalers, transporters and logistics service providers have invested considerably: from temperature and humidity control of vehicles and warehouses to IT-based networking with cold chain and serial number tracking (full traceability process). But the problems of warehousing and distribution systems go deeper. They are structural and could also affect SARS-CoV-2 vaccine supply chains. If deviations occur - such as in the duration of transport or the opening of climate-controlled containers - the recipient must be informed in good time to allow the shipment to be properly separated. It is precisely at these organizational interfaces that gaps or improper handling may occur in practice.
Respect of GDP as a critical point
For some time now, regulatory authorities have been shifting away from ensuring quality through testing and towards quality assurance planning strategies and the integration of all those involved in the process. With GDP, wholesaler safety responsibilities have been raised to production and manufacturing levels. Logistics companies are therefore well advised to have the quality specifications, such as temperature requirements and manufacturer-specified transport containers before shipping is planned. Manufacturer specifications are linked to the approval of the medical product. Emergency approvals of the mRNA vaccine in Great Britain in the USA, as well as in EU approval, have put manufacturers, transporters and logistic providers under pressure to act quickly while ensuring the utmost quality assurance.
Necessary implementation of a full risk management system
It is not in the spirit of GDP to make the assumption that incoming goods are fully compliant. The organizational structure, processes and resources must ensure that the quality and integrity of the medical product are maintained at all stages of supply. All critical distribution processes and significant changes should be justified and - if necessary - validated. Similarly, the quality system should be fully documented and its effectiveness monitored.
It is not in the spirit of GDP to make the assumption that incoming goods are fully compliant. The organizational structure, processes and resources must ensure that the quality and integrity of the medical product are maintained at all stages of supply. All critical distribution processes and significant changes should be justified and - if necessary - validated. Similarly, the quality system should be fully documented and its effectiveness monitored.
To ensure the success of the SARS COV 2 inoculation campaign, it is vitally important to completely document all relevant temperature, withdrawal and damage process data. In response to time constraints, this can only be done electronically using software compliant with the requirements of EU GMP Annex 11 and FDA 21 CFR Part 11. There are also strict requirements for IT security. Corona vaccine distribution channels have to be classified as critical infrastructure, which must be secured against manipulation with an information security management system (ISMS). The physical securing of transports by means of mechanical or electronic sealing is an additional concern for logistics professionals.
Last but not least, personal protective equipment in transshipment warehouses and the general COVID-19 hygiene protection measures are remaining of central importance. Low ambient temperatures are known to favor the spread of Corona viruses, that is why employees must also take the greatest possible care with hygiene measures.
Risk awareness
Safety is only achieved with continuous lived risk assessment and management. Every link in the supply chain must be able to recognize and communicate a relevant failure or defect. If temperature measurement is not possible at one point in the supply chain, a risk assessment must be carried out that takes into account, among other things, the duration of the journey, outside temperatures, the vehicle used, the transport box, or written confirmations from the manufacturer. Here, a thorough and accurate documented risk assessment can have more effect in individual cases than non- controlled monitored measurement systems.
About the author: Andreas Biermann is an auditor and Head of Logistics, Supply and Waste Management at DEKRA Certification GmbH, Stuttgart.