PROCESS HAZARD ANALYSIS IN VACCINE MANUFACTURING + SUPPLY CHAIN

Jeremy Lebowitz, PE

A Process Hazard Analysis is more important than ever for vaccine manufactures as they race to meet global demand.

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Shipments of COVID-19 vaccines are rolling out across the world just a year after the virus was detected, a testament to the effort to manufacture and distribute vaccines at an unprecedented global scale. Along the way vaccine manufacturers, logistics companies and healthcare providers have had to consider new hazards brought on by novel vaccine therapy. If left unaddressed, these hazards can threaten business continuity, the safety of workers and the pace of vaccinating the public. More than ever, companies can benefit from applying the steps of a process hazard analysis (PHA) to prevent and mitigate their safety and business continuity risks related to vaccine distribution.

What New Threats to Business Continuity Need to Be Considered?

The Pfizer-BioNTech COVID-19 vaccine was the first to be approved by the United Kingdom, followed quickly by the United States in early December 2020. It is based on a technology that uses synthetic mRNA to activate the immune system against the virus and needs to be kept at minus 70 degrees Celsius (-94 F) or below. This cold storage requirement presents a challenge for distribution and storage.

Dry Ice

To solve for this temperature requirement, many vaccine distributors are relying on dry ice, the frozen form of carbon dioxide, to help keep the vaccines cold while shipping across the world. However, dry ice presents a hazard as it warms and goes from a solid to a gas (also known as sublimation). If carbon dioxide gas is released in sufficient quantities while in transport or in storage, such as within a walk-in freezer, the carbon dioxide can cause unconsciousness and respiratory arrest.

Ultra-Low Temperature Freezers

Once the vaccines are delivered, they must be transferred to an ultra-low temperature freezer for storage in preparation for vaccination. To add to the complexity, the leading vaccine manufacturers have separate temperature storage points, requiring separate, specialized units.

All refrigeration equipment contains refrigerant, a substance that cools down the inside of the freezer by changing from gas to liquid during a refrigeration cycle. The most prevalent ultra-low temperature refrigerants are the flammable gases propane and ethane. It is critical that these units are handled with caution, especially in areas where ignition sources such as electrical sparks or open flame could be present.

Malicious Actors

Vaccine distribution and transitory storage inherently involves numerous human touchpoints. Unfortunately, there are some who would steal, misdirect or intentionally destroy such valuable material. During COVID-19, Interpol has warned that there could be a significant increase in fake or stolen COVID-19 vaccines from crime groups, fueling a black market of COVID-19 vaccines. Additionally, the Department of Homeland Security has issued a warning about cyber attacks aimed at companies delivering and storing the vaccine. Consideration of the various access points and incorporating key safeguards, such as monitoring and surveillance, spot audits, and mandating the “rule of two” can help reduce the risk of human error and malicious activity at each potential failure point.

Process Hazard Analysis for Vaccine Manufacturing

As manufacturers consider new hazards related to vaccine distribution, a process hazard analysis (PHA) revalidation should be performed to evaluate the changes to their process safety information. A PHA is a structured, team-based activity that identifies hazards and risk scenarios and leads to the development of action items to mitigate and prevent these risks where necessary. It is best practice for manufacturers to establish, implement, and maintain effective processes and procedures that comply with relevant vaccine manufacturing standards and safeguard their supply chains. This is especially critical for the COVID-19 vaccine manufacturing process given the critical need for the product.

During the PHA for a COVID-19 vaccine, transportation and storage key issues should be identified and mitigated to ensure successful delivery of frozen vaccines to distribution centers or maintaining electrical supply to freezers through sufficiently redundant systems. Once the manufacturer has identified the new hazards, a risk analysis and evaluation can inform what safety systems and emergency procedures are needed. For instance, engineering may need to verify emergency shutdown systems, pressure relief devices and venting systems. Experts may also need to provide physical and security assessments or evaluate existing explosion and fire protection systems.

Why It Matters

Emphasis on process development is a major success factor in business continuity, especially when applied to safely shipping and distributing new vaccines. Vaccine manufacturers are being challenged to balance the competing goals of speed to market and process optimization. As with any industry, it can be a good idea to work with those who have experience in process safety management at all stages of operations.

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