Hazards in the Pharmaceutical Industry Are Common—Here's How to Handle Them Safely

Every job in every industry comes with its own unique set of safety risks and health hazards. Pharmaceutical manufacturing, which involves frequent work with and around chemicals, toxic fumes, flammable materials, and other hazardous agents, is certainly no exception. This article explores the top five safety hazards in the pharmaceutical industry and how workers can help mitigate them.

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What is the Pharmaceutical Manufacturing Industry?

Pharmaceutical manufacturing is an arm of the broader pharmaceutical industry involved in the primary and secondary processing of chemical materials intended for use as medications in humans or animals. Primary processing includes the production of an active ingredient or drug; secondary processing includes the conversion of active ingredients into products that are suitable for use.

As described by the International Finance Corporation, products made within the pharmaceutical manufacturing industry include:

• Proprietary ethical products or prescription-only medicines (POM)
• Over-the counter (OTC) or nonprescription medicines
• General ethical products, which are standard prescription-only medicines made to a recognized formula

These products, which are available in a range of formats (e.g., tablets, capsules, liquid solutions, gels, injectables, creams, ointments, and aerosols) range from antibiotics and vaccines to vitamins and synthetic hormones.

According to Grandview Research, the global pharmaceutical manufacturing industry was worth more than $405.5 billion (USD) in 2020. Given the enormous progress, innovations, and transformations within this industry, it has a projected compound annual growth rate (CAGR) of 11.34% between 2021 and 2028.

The U.S. Bureau of Labor Statistics (BLS) documented 1.6 nonfatal occupational injuries per 100 full-time workers within the pharmaceutical manufacturing industry in 2020.

5 Top Safety Risks in the Pharmaceutical Industry

The pharmaceutical industry faces at least five distinct hazards that employers and employees should be aware of:

Flammable and Combustible Materials

Combustible and flammable materials present within pharmaceutical manufacturing facilities can cause uncontrolled fires, leading to extensive and often costly property damage. Accidents involving flammable materials can also lead to serious and potentially fatal worker injury (e.g., burns, smoke inhalation).

Hazardous Chemicals

Working with, handling, transporting, and storing chemicals is a primary component of the pharmaceutical manufacturer's workday. Many chemicals used in both primary and secondary processing can be extremely hazardous to human health if accidentally ingested or inhaled.

Biological Hazards

The pharmaceutical industry continues to make rapid advances in the prevention and treatment of infectious pathogens, including bacteria, viruses, and fungi. To drive this innovation, pharmaceutical workers, scientists, and researchers must routinely handle these hazardous organisms, along with any chemicals and materials needed for the development of vaccines and other types of medicines.

To reduce the risk of accidental exposure to biological hazards, tightly controlled primary and secondary containment methods should be utilized. These methods include even the simplest strategies, such as routine handwashing, up to and including advanced ventilation systems.

Carbon Monoxide Exposure

Carbon monoxide can develop as a byproduct of certain chemical reactions. This odorless and colorless gas is toxic to humans and can cause dizziness, weakness, vomiting, and even death when inhaled.

Protecting workers from carbon monoxide and other toxic fumes should include the use of (and regular inspection of) carbon monoxide detectors and appropriate signage wherever this gas is stored or potentially created.

UV Radiation

We typically think of ultraviolet (UV) radiation in the context of sunlight. However, the pharmaceutical manufacturing industry may use UV radiation for operations such as vitamin D production.

Excessive exposure to UV radiation has been associated with an increased risk of cataracts, skin cancer, and burns on the eyes and skin. When applicable, pharmaceutical workers should be offered apparel and accessories that can protect their eyes and skin from UV light.

Personal Protective Equipment in the Pharmaceutical Industry

It is important to consider that the health and safety hazards typical of the pharmaceutical manufacturing industry can affect individuals other than direct staff. Due to issues such as cross-contamination and accidental environmental exposure, workers within the pharmaceutical manufacturing industry can unintentionally expose their families, fellow community members, and domesticated and wild animals to toxic or otherwise harmful materials.

To reduce this risk of accidental exposure both inside and outside the workplace, it is imperative for company leaders within this industry to make safety their leading priority. Company leaders should establish protocols that help standardize and streamline safety procedures. When relevant, safety protocols should also comply with local and national regulatory boards, including the Occupational Health and Safety Administration (OSHA).

Recommended pharmaceutical PPE varies considerably, but generally includes:

• Protective apparel, including gowns and coveralls
• Gloves
• Shoe covers
• Eye protection, including face masks and goggles
• Respiratory protection, which includes N95 respirators and powered air-purifying respirators (PAPR)

Specific PPE requirements may exist depending on the hazardous material being handled. For example, personnel working with biological hazards will likely require PPE that pass ASTM F1670 & F1671 tests for protection against blood, bodily fluids, and blood-borne pathogens. Workers at risk of chemical splash should be provided with protective garments that meet ISO 6350 and EN 368 protection standards for penetration and repellency.

Employers should always ensure their workforce has access to high quality and durable pharmaceutical PPE that provides adequate protection without impairing worker mobility, gross motor function, vision, productivity, and general comfort. It is also the employer's responsibility to ensure that all personnel are thoroughly trained on how to properly don, doff, store, and if necessary, dispose of PPE to further mitigate the risk of hazardous conditions or exposure.

When choosing PPE for the pharmaceutical workforce, look for industrial safety companies, such as International Enviroguard, that provide cost-effective solutions that will meet the needs of the workforce and meet the standards set by organizations such as the American National Standards Institute (ANSI) or ASTM International. Disposable PPE options can be especially valuable for reducing the risk of cross-contamination or community exposure.

In addition to wearing proper PPE, pharmaceutical manufacturing workers can take additional steps to maximize their safety on the job:

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• Keep Safety Data Sheets accessible
• Thoroughly and routinely document all risk assessments, safety protocols, and other related information
• Ensure that workspaces remain tidy and quickly clean up any spills or messes by following the appropriate containment protocol(s)
• Practice proper hand hygiene and never eat or smoke within work areas
• Routinely inspect PPE, equipment, etc. for damage and replace as needed
• Keep chemicals in their original containers and ensure all containers are properly labeled and stored
• Keep entryways clear
• Ensure appropriate ventilation systems are in place, including biological safety cabinets when indicated
• Position eye washing and handwashing stations close to work areas

Finally, remember that all other health and safety concerns that are typical of other industries (e.g., falls, accidents, loud noises, heavy machinery, improper equipment use, equipment damage, etc.) still apply to pharmaceutical manufacturing, as well. Employers should remain vigilant as they routinely assess for risks and establish a culture of safety within their organization.

Conclusion

The pharmaceutical industry is growing rapidly, which means pharmaceutical manufacturing will be growing right along with it. As an industry, pharmaceutical manufacturing exposes workers to a variety of unique hazards, ranging from hazardous biological pathogens, poisonous fumes, and flammable materials. The risks associated with these health hazards can be minimized by ensuring that workers have proper PPE that provides a protective barrier to skin, eyes, mucous membranes, hair, and clothing.

Of course, appropriate PPE is just one piece of the puzzle when it comes to preventing workplace injury within this important industry. Employers should consult with local and national regulatory agencies to ensure they remain in compliance with all relevant safety standards.

Do you have questions about workplace PPE for your pharmaceutical manufacturing team? Contact International Enviroguard today to speak with our team and find out how we can help you keep your team safe.

4. CMOs can help ensure regulatory compliance.

CMOs typically have strict quality control procedures in place, producing APIs to high standards in accordance with Good Manufacturing Practices (GMP). 

5. CMOs enable a faster time-to-market.

Contracting API production to CMOs can help pharmaceutical companies bring drugs to market quickly. CMOs typically achieve faster manufacturing by leveraging streamlined processes and economies of scale when compared to in-house manufacturing.

Types of Drugs Produced by CMOs

CMOs manufacture a wide range of pharmaceutical products, including:

• Active Pharmaceutical Ingredients (APIs)

• Small Molecules

• Generic Drugs

• Biologics

• Biosimilars

• Over-The-Counter (OTC) drugs

• Pharmaceutical Intermediates 

APIs vs. Pharmaceutical Drugs

APIs refer to one or more active substances within a drug, while the drug is the final product administered to the consumer.  

APIs vs. Pharmaceutical Intermediates

Pharmaceutical intermediates are chemical compounds synthesized during the API manufacturing process. 

Intermediates are not intended for final use by consumers, but are essential components that are subjected to additional processing to manufacture the API. In contrast, APIs are biologically active compounds associated with the effect of the drug.

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