Six Process Safety Tips for Hospitals + Pharmacies Making Hand Sanitizer

Carson Cook, PE

As hospitals and pharmacies produce sanitizer to meet demand during COVID-19, fire and life safety should remain a priority.

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Due to the current shortage of hand sanitizer as a result of the COVID-19 pandemic, many countries around the world are now being challenged to fill the gap in supply to meet soaring demand. For example, in the U.S., most states have issued executive orders authorizing licensed pharmacies and pharmacists to compound hand sanitizer for use within their facilities and for sale over the counter. And in the UK, pharmacists at a London hospital made their own hand sanitizer to stave off a predicted shortage. Hospitals and pharmacies around the world are taking advantage of these expanded licenses due to the significant internal demand and the cost savings associated with in-house production.

While federal regulations are permitting temporary compounding in accordance with published guidelines, such as those by the FDA, WHO and USP, they are not waiving the requirement for compliance with local building and fire code requirements pertaining to flammable or combustible liquid storage, dispensing and use. If you are a pharmacist or hospital temporarily compounding hand sanitizer it is important to be aware of the key fire and life safety requirements associated with such an operation.

Maximum Allowable Quantities for Hazardous Materials

The building code permits the presence of hazardous materials up to a maximum allowable quantity (MAQ) on each floor of a building within a certain number of compartments (Control Areas) that are separated by fire-resistance rated construction. Once these thresholds are exceeded, additional fire and life safety provisions are triggered which may not currently exist in your temporary production or storage areas, so it is important to be aware of, and stay under, these thresholds.

Electrical Code Review

The presence of electrical equipment (e.g. lighting, outlets, electrical wiring) in areas where hazardous material operations occur present a fire and explosion risk. Depending on the hazardous materials in question, and the probability of the operation resulting in vapor concentrations being present that could produce an explosion or fire, any electrical equipment nearby may be required to comply with material and installation guidelines set forth in the National Electric Code.

Ventilation

Compounding locations within an existing building should occur in areas with ventilation and exhaust rates designed to accommodate the produced chemical vapors. Depending on the concentrations of flammable liquid vapor present, a dedicated hazardous exhaust system may be necessary.

Fire Protection

Like ventilation, it is important that storage and compounding operations occur in area featuring sprinkler protection with the appropriate spacing and design discharge density. For example, a space previously utilized as an office may feature sprinklers that are not adequately designed for the protection of flammable liquid operations. The required sprinkler discharge criteria will depend on the quantity of hazardous materials both in storage and in use.

Separation of Incompatible Materials

Liquids stored or utilized in quantities exceeding half gallon that create a greater fire hazard when in the presence of each other are required to be separated by a prescribed distance, non-combustible construction or using approved hazardous materials storage cabinets. For example, Hydrogen Peroxide and Ethanol / Isopropyl Alcohol, both utilized in the WHO published formulations, are considered incompatible and therefore must be properly separated when present in excess of half gallon.

Emergency Action Plan

An Emergency Action Plan (EAP) coordinated with the available equipment and personnel should be established to respond to fire and other emergencies. Additionally, the local Authority Having Jurisdiction (AHJ) may require a Hazardous Materials Inventory Statement identifying the maximum expected quantities of hazardous materials stored along with the associated Safety Data Sheets (SDS).

If you are a pharmacy or hospital temporarily making hand sanitizer it is important to ensure the process is in accordance with the applicable building and fire code requirements pertaining to flammable and combustible liquids. If hand sanitizer storage and compounding are occurring in a room or space of your building not intended for such an operation, it is recommended a detailed code and regulatory review be performed to establish the required fire and life safety features.

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