BY CHRISTOPHER W. DORKO
A small chemical fire breaks out after hours in the lab of a biotechnology company developing a promising new therapeutic drug. The building’s smoke detector activates a central station alarm, and your team arrives at the scene within eight minutes. Because the fire is small and in a relatively secluded area, it is not big enough to trigger the building’s sprinkler system and most likely will be promptly extinguished. But you and your team are unfamiliar with the facility and cannot quantify the risk your personnel would face by entering the building. At the sight of biohazard warning signs, you know you need to first seek more information to quantify the risks for your team. By the time company personnel arrive to explain the facility’s operations, 40 minutes have passed and the fire has grown.
After the fire has been extinguished, it is found on inspection that the company’s cell cultures sustained smoke damage and spoilage, which set back the company’s research and development program almost two years. The company lost a seven-figure milestone payment, which it still had not recovered more than a year later. What simply could have been an unfortunate but manageable event had turned into a financial catastrophe.
Although this particular scenario is fictional, the consequences are all too real. Although most pharmaceutical and biotechnology companies have the local fire department tour their facilities at least once a year, many do not realize that the personnel who make these tours are not members of the fire suppression team but most likely code enforcement officers who will not be the responders if there’s an emergency at 3:00 a.m. Fire departments and utility companies need to develop stronger relationships with their local life sciences labs to arm themselves with the information that will enable them to respond to emergencies at those facilities in an expeditious and effective manner.
UNIQUE CHALLENGES
After a considerable adverse event, such as a fire, a flood, or an explosion, a pharmaceutical facility or biotechnology company may be faced with the loss of raw materials and finished product; damage to the physical plant; and, in the most extreme cases, lost lives. The life sciences industry has its own set of unique challenges, such as losing validation and compliance in terms of good manufacturing, laboratory, and clinical practices. Following a substantially harmful event, it can take six to 18 months before a plant is revalidated and able to begin manufacturing product again. In that time, the company faces an interruption of research and development activity, which results in the postponement of market approvals; the loss of market capitalization because customers or investors flee to companies in more robust health; and, often, the interruption of investment income. For small, start-up companies that rely heavily on investors, a marketable product may still be a distant goal. Even just one missed milestone payment can spell the end for these businesses.
In the wake of a fire, flood, power failure, or other event, a life sciences business is not confronted just with sodden walls, carpets, and product. Even when the water is gone, there are unwanted biological contaminations, such as mold, that it leaves behind. Smoke can blacken offices, labs, and storage areas; it can also kill lab animals or damage cell cultures. Also, a change in environmental controls, such as a loss of refrigeration or broken heat lamps, can destroy years of research.
WORKING WITH LOCAL BUSINESSES
Firefighters protect life first and property second. It is your job to evaluate danger to employees as well as special hazards to responders. Establishing a relationship with local business owners is important first and foremost so that your team can enter their facilities with confidence. Because required hazard warning signs do not always indicate the level of risk, facility personnel should explain to you the actual hazard level in each area. A biosafety level 1 agent presents a relatively low hazard as compared with a highly infectious pathogen. You wouldn’t want to refrain from extinguishing a lab fire for fear of pathogens that are, in fact, low-risk biological agents such as the pathogen for a common cold.
It is also important that your team understand the potential effects various threats might have on a laboratory’s operation. For example, for your own safety, it is fairly regular practice to request that all power to a building be cut in an emergency. If you and your team are aware, however, that the loss of refrigeration can affect cell cultures or that the loss of power can reduce the pressure gradient in a clean room, thereby allowing contaminants in, you can first attempt to cut the power going only to the affected area. If that is not a viable option, you can make every effort to restore power to critical areas promptly. Instead of removing smoke through the nearest exit, when that exit is through a clean room, your team will also be able to preplan expedient alternatives, if those details are built into the facility firefighting plan.
Be sure to get an overview of operations so that you can memorize what chemical, biological, radiological, or mechanical hazards exist. Tour critical production and lab areas, vivaria, and mechanical spaces. Understand the facility’s HVAC, water, steam, and smoke-control systems. If you can, obtain floor plans to keep for review at the firehouse so your team can refresh their memories every so often. Though utility company personnel will work primarily outside the facility during an adverse event, field supervisors should have extensive information about facility electrical and water systems that will help them restore service as soon as possible. The infrastructure of most utilities is owned by the utility company up to the point where it penetrates a building. Therefore, it is also important to work with local power and water companies on preventive maintenance to be sure that in an emergency, when they are most needed, transformers, pumps, and gas and water mains will be in good repair.
Make sure you and your team understand any in-house emergency contingency plans the facility has put in place and have contact information for key personnel to get help promptly once you are on-site. There is nothing better at 3 a.m. than knowing the facility manager is only 10 minutes away or that there are other options if the call to the facility manager goes unanswered.
The well-being of personnel should be the most important consideration for first responders. You won’t be able to help others if your people are in peril. Representatives from each shift should attend a tour of local facilities at least once a year and also every time a major change is made to a building. With respect to the fire department, a tour by the actual fire suppression team would supplement the usual tour by code enforcement officers but not replace it.
NEW FACILITIES
Companies building a new facility have the opportunity to engage their local fire departments, utility companies, and insurance carriers in plan reviews during the preconstruction phase and to get the special support they need from those third parties during construction. From a risk management point of view, the goal in facility design is a high level of compartmentalization so that critical areas can be isolated from fire, smoke, and contamination, along with proper design of protection systems that will contain adverse events. Pay particular attention to smoke control, utility reliability, and utility redundancy, such as backup generators, to ensure uninterrupted power supply.
It’s also wise to introduce field supervisors from your team to facility owners early in the construction phase. Remind them to maintain adequate water supply for fire suppression and to minimize combustible loading during the critical stage when fire protection systems have yet to be installed. Advise facility personnel to plan on installing and activating those systems as early as possible. Keep in mind that one of the simplest safety measures on a construction site is often the most overlooked; no matter how quick your response to an alarm, if you cannot make your way to the building, you cannot put out the fire, control the flood, or restore power. All it takes to keep help from arriving in time to prevent a minor incident from turning into a major one is a muddy, unpaved road into the building site, construction materials partially blocking a road, or a bulldozer left in the wrong place.
Geographic and regional events, such as tropical storms and floods, are times when fire departments and power companies are stretched thin and competing priorities can lead to a slower response. Make sure that local facility personnel understand that when a regional event is already in play, the emergency operator is not in a position to make an assessment of their greater level of need. If they establish a strong relationship with your department and fire suppression team now, they will be permanently near the top of your priority list.
CHRISTOPHER W. DORKO has been a career firefighter for the Summit (NJ) Fire Department for 17 years. He is also a senior life science loss control specialist for the Chubb Group of Insurance Companies. He previously worked in facility safety and risk management in the pharmaceutical and medical device industry.
