Category: Life Sciences
What is Combustible Dust?
Combustible dust is any finely divided solid material (wood, plastics, paper, rubber, combustible metals, etc.) that can present an explosion hazard when suspended in air or when accumulated in a confined space and subject to pressure build-up. Examples of combustible dust include aluminum and magnesium: they do not easily burn as larger pieces; however, they can be explosible in dust form when not properly managed.
The life science industry is not immune to the risk posed by combustible dust. Many pharmaceutical production processes, such as batching, compression, dispensing, granulating, and mixing, create dust hazards. Common airborne combustible dust particles which are a by-product of these operations, and may present an explosion risk if not controlled, include calcium, lactose, lithium, magnesium, potassium, sulfur, and sodium.
What Causes a Combustible Dust Explosion
For a fire to occur, three distinct characteristics within the “fire triangle” must be present:
- Combustible dust (fuel)
- Ignition source (heat)
- Oxygen in the air
Where combustible dust is the fuel, the uncontrolled dispersion of dust particles, or the accumulation of dust in a confined area, are contributing factors to the risk of fire.
The surface area of the particulate dispersion can have a tremendous impact on the explosion. For example, in a small room (200 ft2), dust accumulations would present a severe secondary explosion hazard; in a large room (20,000 ft2), a covering of dust in a 200 ft2 area would not present as significant of a hazard. As a general good practice measure, 1/16 in. of dust, which is close to the thickness of a quarter, is cause for cleanup to minimize the explosive risk. A more practical technique to determine the plausibility of a dust explosion would be to run your finger through the accumulation. If your finger leaves a mark, this indicates that the dust is subject to dispersion, presenting an explosive hazard.
A prime example of a combustible dust explosion in the life science industry occurred in 2003 at a West Pharmaceutical Services’ rubber-manufacturing plant in Kinston, North Carolina. The facility produced rubber stoppers and other products for medical use. According to the U.S. Chemical Safety and Hazard Investigation Board, the fuel for the explosion was a fine plastic powder, which accumulated above a suspended ceiling over a manufacturing area at the plant and ignited. The vast explosion not only destroyed the manufacturing facility, but caused six deaths, dozens of injuries, and hundreds of job losses.
Prevention of Combustible Dust
Several prevention measures can be followed to prevent combustible dust explosions. The three “Cs” for controlling and avoiding incidents include:
Contain the dust within process equipment engineered to handle combustible dust safely. If dust cannot be contained within the process equipment, collect the dust at the point of release before it escapes into a work area.
Install dust collection systems and use vacuum systems designed for combustible dust collection. When capturing and containing dust, it is recommended that companies use high-efficiency particulate air (HEPA) vacuum systems. Air-operated industrial strength vacuum systems do not have electric motors, like shop-type vacuums, and therefore allow dust to be contained without the risk of a spark hazard from the hot motor while operating.
Combustible dust must be cleaned regularly with soft natural brooms or brushed before being collected in an approved or rated vacuum cleaner. Areas to be cleaned regularly to minimize dust accumulation include walls, floors, equipment, ledges, and rafters, and the area above suspended ceilings and other concealed areas. If ignition sources (bearings, belts, buckets, milling machinery, etc.) are present, practice the above cleaning methods only if they do not generate dust clouds.
Other Control Methods include:
- Control of Ignition Sources. Periodic inspections, lubrication of machinery parts, and vibration detection methods (heat-sensitive tape) are ways to control ignition sources. Installing appropriately rated electrical equipment, equipment grounding and bonding, and limiting exposed flames also control ignition sources.
- Damage Control. Isolate the dust hazard by using distance or barrier. Explosion venting serves as a relief panel to safely vent the explosion away from work areas and property structures, thus minimizing damage to equipment or injury to workers. Explosion suppression is another control measure that will allow systems to enact a pressure sensor when ignition occurs, thus sending a release signal to stop the explosion before it becomes dangerous.
NFPA Prevention of Combustible Dust Standards
When uncertain if dust particles are combustible or non-combustible, it is advisable to perform a Dust Hazard Analysis (DHA). This involves employing trained professionals to conduct sampling and test for dust combustibility hazards. Laboratory testing can be performed to determine if powders are combustible or explosive, ignition sensitivity (minimum energy of electrostatic needed to ignite dispersed dust), dust flammability (minimum oxygen concentrations needed for fire) limits, and dust explosion severity. The DHA will also include an analysis of processes and equipment where dust may be present, a review of existing controls and suitability, and, if necessary, additional recommendations to manage hazards.
The NFPA (National Fire Protection Association) 652 publication, Standards on the Fundamentals of Combustible Dust, describes a technical standard outlining the basic requirements for identifying and managing fire, flash fire, and explosion hazards of combustible dust. The NFPA 652 standard applies to operations that manufacture, process, mix, repackage, or handle combustible dust or particulate solids. If properly adopted and utilized, the NFPA 652 and the NFPA 654 (Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling of Combustible Particulate Solids) publications will help protect the industrial facility, the workers in and around the facility, and, ultimately, the community.
As evidenced by the West Pharmaceutical Services tragedy, combustible dust can have catastrophic impacts on life science operations if not addressed and controlled appropriately. There are several different types of materials and processes within the life science industry that are susceptible to combustible dust explosions. Identifying the hazards, along with the materials that may be subject to ignition, are critical first steps to controlling combustible dust explosions. Practicing safe-housekeeping practices and completing Dust Hazard Analyses of materials and processes can ensure the facility, the workers, and the surrounding community remain unharmed from deadly dust explosions.
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(It all began with Teflon…)
Per- and poly-fluoroalkyl substances (PFAS) are synthetic chemicals that may be toxic to human health. PFAS accumulate in the environment, such as in waterways, in the fish that swim in those waterways, and in public drinking water systems. Blood serum tests of male and female subjects between the ages of 12 and 80 found PFAS in 98% of those tested. Links have been established between human exposure to PFAS and adverse effects on the immune, endocrine, metabolic, and reproductive systems (including fertility and pregnancy outcomes) and an increased risk for cancer.
The first PFAS, a heat-resistant chemical with non-stick and lubricating properties, later patented as Teflon, was accidentally developed at DuPont during an experiment with gases to develop a better coolant. Teflon became widely used in cookware in the 1950s and 1960s, and its discovery also led to years of research and the development of thousands of additional PFAS chemicals. The beneficial properties of PFAS chemicals, such as their stability under intense heat or use as a surfactant, made them attractive for industrial and military use (firefighting foams, lubrication of machinery, aircraft, and electronics manufacturing), and for use in consumer products (food packaging, textiles, cosmetics, stain-resistant carpeting). Life science companies have used PFAS as coatings on medical devices such as nebulizers and sutures, and in some pharmaceuticals.
Who Should Worry about PFAS Litigation Lawsuits
Because of recent high-profile lawsuits brought by states and communities against the manufacturers of these “forever chemicals,” PFAS are gaining wide recognition as potentially hazardous to human and environmental health. At the end of June 2023, 3M, for many years one of the primary manufacturers of PFAS, agreed to a $10.3 billion settlement to be used for cleaning up PFAS-contaminated drinking water systems in 300 communities. This follows close on the heels of another settlement in June 2023, this time a $1.185 billion settlement by PFAS manufacturers DuPont, Chemours, and Corteva.
Pharmaceuticals that contain PFAS, include antidepressants (fluoxetine) and antibiotics (levofloxacin). These drugs have been reviewed and approved by the FDA and are considered safe and effective following extensive clinical studies. However, many medical devices do not undergo similar clinical testing, and as such, there is limited human data on the impact of PFAS from these products. Testing methods for PFAS continue to improve and scientists are now able to measure smaller levels of specific PFAS chemicals in human blood serum and tissue. Research on health impacts is growing. Testing standards for both pharmaceuticals and medical devices are likely to continue to evolve.
Most PFAS litigation to date focuses on lawsuits against the manufacturers of PFAS, alleging personal injury from PFAS exposure. The regulatory environment is also changing in the U.S. and the European Union. In the U.S., the Biden Administration has secured funding for the US Environmental Protection Agency (EPA) to establish acceptable, legally enforceable levels of PFAS in drinking water. In March 2023, the EPA proposed the National Primary Drinking Water Regulation (NPDWR) that would establish and regulate enforceable levels for six PFAS in drinking water. These six chemicals include perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA), hexafluoropropylene oxide dimer acid (HFPO-DA, commonly known as GenX Chemicals), perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS). In addition, the Administration has called for federal agencies to boost research aimed at improving PFAS detection through testing and screening, assessing PFAS health effects, developing remediation technologies, and identifying PFAS alternatives.
In February of this year, the European Chemicals Agency proposed a ban on the manufacture, import, and use of PFAS above a certain concentration level. The proposal is currently in the public comment stage, with new PFAS restrictions likely by 2025. The proposed ban indicated that exemptions may be warranted for some products in the life science area, including pharmaceuticals and medical devices, due to limited feasibility and availability of appropriate substitutes. The proposed regulations note that the banning of PFAS could have adverse outcomes for patients unless other suitable materials with an improved safety profile are developed. The industry will need to follow these proposals to determine if the regulations are enacted and if similar regulations are adopted in other countries, including the United States.
Mitigating the Risks of “Forever Chemicals”
PFAS create multiple challenges for life science companies. PFAS contamination continues to occur, and litigation is expanding rapidly. As noted above, multiple regulatory agencies both in the United States and abroad are looking closely at safety concerns around these substances; however, at this time, no comprehensive regulatory guidance exists on how companies should manage PFAS in their products or disclose their presence to the consumer.
That said, companies can take steps to proactively mitigate their exposure to PFAS contamination and the potential for product litigation. Suggested approaches include:
- Monitoring both regulatory evolution and developing litigation related to PFAS;
- Conducting risk assessments of company products and supply chains to identify susceptibility to PFAS contamination;
- Ensuring that raw materials and water sources are tested for PFAS;
- Testing finished products to confirm the absence of PFAS or confirming the use of PFAS-containing materials is within specifications for your product;
- Evaluating whether to include information about the presence of PFAS product labels.
At this point in time, there is minimal regulation of per- and poly-fluoroalkyl substances (PFAS) in medical and other life science products. This likely will change in the next few years. Consumers also are becoming more aware that “forever chemicals” are potentially toxic to human health and the environment. This will impact both litigation and buying behavior. Life sciences companies are well-advised to act proactively now to identify PFAS-related risk and to mitigate that risk through a hybrid strategy of insurance protections, testing, transparency in informing consumers of the presence or absence of PFAS, and, where possible, finding alternatives to the use of PFAS chemicals.
1 Ryan C. Lewis, Lauren E. Johns, and John D. Meeker, ‘Serum Biomarkers of Exposure to Perfluoroalkyl Substances in Relation to Serum Testosterone and Measures of Thyroid Function among Adults and Adolescents from NHANES 2011–2012’, NIH.gov, Int J Environ Res Public Health. 2015 Jun; 12(6): 6098–6114. Published online 2015 May 29, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483690/ (accessed June 2023).
2 Bevin E. Blake and Suzanne E. Fenton, ‘Early life exposure to per- and polyfluoroalkyl substances (PFAS) and latent health outcomes: A review including the placenta as a target tissue and possible driver of peri- and postnatal effects’, NIH.gov, Toxicology. 2020 Oct; 443: 152565.
Published online 2020 Aug 27. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7530144/ (accessed June 2023).
3 Jeffrey Kluger, ‘3M's Historic $10 Billion 'Forever Chemical' Payout Is Just The Tip of the PFAS Iceberg’, Time.com, June 24, 2023, https://time.com/6289893/3m-forever-chemical-pfas-settlement/ (accessed June 2023).
Examples of Perishable Property
Life Science organizations often maintain or work with perishable property critical to the company’s ongoing operations. Perishable property refers to a business’s personal property that is susceptible to spoilage, rapid decay, or deterioration, often due to an unwanted change in environmental conditions. Examples of perishable property used by life science companies include:
- Biological property (cells, blood product, human/animal tissue samples, necropsy samples, microorganisms, etc.)
- Select drug products, including clinical samples
- Chemical libraries
- General work in progress/media/raw materials
- Scientific animals
Before COVID-19, decentralized clinical trials (DCTs) adoption was slow due to regulatory factors, technological limitations, and resistance to change within the clinical research community. Since then, the pandemic has acted as a catalyst for the growth of DCTs.
Due to the pandemic, many ongoing clinical trials have faced disruptions due to restrictions on participant travel. As a result, researchers and sponsors quickly adapted their trial protocols to incorporate remote and decentralized approaches. This led to increased adoption of DCTs across a wide range of therapeutic areas. This article discusses the development of decentralized clinical trials and how companies can benefit from their increased prevalence.
Berkley Life Sciences Fleet Safety Newsletter Article Series – Article 1 Why do I need a fleet management program?
Did you know that a motor vehicle crash occurs every 5 seconds and every 12 minutes someone dies in a motor vehicle crash?1 Your company’s potential exposure to car accidents increases with the number of drivers, the number of vehicles, and the number of miles driven. With these odds, you want to be sure you have a solid program in place to manage your fleet and drivers and reduce your exposure. (more…)
Did you know . . . Berkley Life Sciences' LS Prime® Online offers qualified risks up to $10,000,000 in Products Completed Operations Liability and Clinical Trials Liability coverage. Quotes are still available on-line in real time without underwriter involvement in most instances. (more…)