Workplace Safety in the Pharmaceutical Industry: Risks & Protective Measures

The pharmaceutical industry plays an important role in developing and manufacturing medicines that support public health. However, behind the production of these medicines are workers who may be exposed to a range of occupational hazards, from airborne pharmaceutical powders and chemical substances to potentially hazardous cleaning agents and manufacturing processes.

For workers involved in pharmaceutical manufacturing, laboratory testing and chemical handling, understanding these risks is essential. Some active pharmaceutical ingredients (APIs), for example, can produce biological effects at very low doses, making appropriate exposure controls particularly important.

But how do pharmaceutical workplaces determine which protective measures are necessary? And how do they decide what type of personal protective equipment (PPE) workers should wear?

The answer begins with identifying hazards, assessing potential exposure and selecting suitable control measures.

In this article, we'll explore common occupational risks in the pharmaceutical industry, explain how Occupational Exposure Bands (OEBs) and Control Banding (CB) help inform risk management, and discuss the role of PPE in protecting pharmaceutical workers.

What are the common occupational risks in the pharmaceutical industry?

Pharmaceutical workplaces involve a variety of processes, from handling raw materials and weighing ingredients to manufacturing, packaging, cleaning and laboratory testing.

Depending on the activities involved, workers may encounter several types of occupational hazards.

Chemical exposure

Chemical exposure is an important consideration in pharmaceutical manufacturing.

Workers may handle active pharmaceutical ingredients (APIs), solvents, cleaning agents and other chemical substances during production and laboratory operations.

Some substances may cause irritation or other adverse health effects following exposure, while certain APIs can have potent biological effects even in relatively small quantities. The level of risk depends on the substance's properties, how it is handled and the amount of exposure that may occur.

Airborne dust and pharmaceutical powders

Processes such as weighing, transferring, mixing and dispensing powdered ingredients can release particles into the air. If these particles are inhaled, workers may be exposed to substances capable of causing respiratory irritation, sensitisation or other health effects.

The potential risk depends on factors including the substance's toxicity, particle characteristics, airborne concentration and duration of exposure.

Biological hazards

Some pharmaceutical workplaces, particularly those involved in biological medicines, vaccine production or microbiological testing, may involve exposure to biological materials.

Depending on the activity, workers may need protection against potentially infectious microorganisms or other biological hazards. However, biological hazards are not present in every pharmaceutical manufacturing environment, and the necessary controls depend on the specific work being performed.

Physical and ergonomic hazards

Not all occupational risks in pharmaceutical workplaces involve chemical or biological exposure.

Workers may also encounter hazards associated with machinery, moving equipment, repetitive movements, manual handling and prolonged standing. These risks require their own assessments and control measures.

How can workers be exposed to hazardous substances?

Exposure to hazardous substances may occur through several pathways:

• Inhalation: Breathing in airborne powders, dust, mists, gases or vapours.

• Skin contact: Direct contact with hazardous substances, including contamination of exposed skin.

• Eye contact: Exposure to splashes, droplets or airborne particles.

• Accidental ingestion: Swallowing hazardous substances following hand-to-mouth contact or poor hygiene practices.

Understanding these exposure pathways is important because different hazards may require different protective measures.

How are occupational exposure risks assessed?

Before selecting PPE or implementing other protective measures, pharmaceutical workplaces need to understand the hazards associated with their processes.

An occupational risk assessment considers both the potential harm a substance can cause and the circumstances in which workers may be exposed to it.

An important distinction is the difference between hazard and risk.

A hazard is something with the potential to cause harm, such as a toxic pharmaceutical ingredient.

Risk considers the likelihood and consequences of harm occurring under particular exposure conditions.

For example, a potent pharmaceutical powder may present a significant hazard. However, the actual exposure risk may differ considerably between handling the powder in an enclosed system and transferring it manually in an open environment.

Identifying hazardous substances

The first step involves identifying the chemicals, APIs and other potentially hazardous materials used in the workplace.

This may include reviewing ingredient information, manufacturer documentation, Safety Data Sheets (SDS) and relevant toxicological information.

An SDS provides information about a hazardous chemical's properties, potential health effects, handling precautions and recommended controls.

However, not every pharmaceutical ingredient has a conventional SDS containing all the information needed for occupational exposure assessment. Additional pharmaceutical or toxicological information may be required.

Assessing exposure conditions

The next step is to consider how exposure might occur during normal operations and foreseeable incidents.

Relevant factors include:

• The quantity and concentration of the substance being handled.

• Whether the substance is a powder, liquid, gas or vapour.

• How frequently and for how long workers perform the task.

• Whether the process is open or enclosed.

• The potential for spills, splashes, dust generation or airborne emissions.

• Existing ventilation, containment and other protective measures.

Where appropriate, occupational hygiene monitoring may also be used to assess workplace exposure.

Determining appropriate controls

Once hazards and exposure conditions have been assessed, the workplace can identify suitable measures to eliminate or minimise risks.

These may include enclosed handling systems, local exhaust ventilation, safer work procedures and appropriate PPE.

Understanding Occupational Exposure Bands (OEBs)

In pharmaceutical manufacturing, some substances may not have an established occupational exposure limit.

This can make it difficult to determine appropriate exposure-control requirements, particularly for newly developed or highly potent pharmaceutical ingredients.

One approach used in occupational hygiene is Occupational Exposure Banding (OEB).

What is an Occupational Exposure Band?

An Occupational Exposure Band is a category assigned to a substance based on available information about its potential health hazards.

Banding systems help occupational health professionals organise substances into hazard categories and inform decisions about exposure management.

Some systems use categories ranging from A to E, with higher bands generally representing substances of greater concern and correspondingly lower exposure ranges.

However, the precise definitions and exposure ranges can vary depending on the methodology or organisation using the system.

How are exposure bands determined?

Occupational Exposure Bands may be informed by toxicological information, including:

• Acute and repeated-dose toxicity.

• Respiratory or skin sensitisation.

• Reproductive and developmental toxicity.

• Carcinogenicity and genetic toxicity.

• Other relevant health effects.

In pharmaceutical manufacturing, information about an ingredient's pharmacological activity and potency may also be relevant to the assessment.

The objective is to provide a structured way to assess potential hazards and support exposure-control decisions.

Are OEBs the same as occupational exposure limits?

No. Although the two concepts are related, they are not interchangeable.

An Occupational Exposure Limit (OEL) is a specified airborne exposure concentration, typically expressed over a defined period.

An Occupational Exposure Band (OEB) represents a range or category used to help characterise potential health hazards and inform exposure management.

OEBs are particularly useful when a substance lacks a substance-specific OEL, but they do not automatically establish a legally applicable exposure limit.

For Australian workplaces, relevant workplace exposure standards and WHS requirements must still be considered.

What is Control Banding and how does it work?

While Occupational Exposure Banding helps characterise a substance's potential health hazards, workplaces also need to consider how that substance is used.

This is where Control Banding (CB) can be useful.

Control Banding is a risk-management approach that combines information about a substance's hazards with factors affecting potential exposure to help identify appropriate control measures.

It can be particularly useful when detailed exposure measurements are unavailable, although its suitability depends on the method and task being assessed.

How does Control Banding work?

Control Banding methods may consider several factors, including:

• The substance's hazard classification or exposure band.

• The quantity being handled.

• Its physical form, such as a fine powder or liquid.

• The potential for dust, mist or vapour generation.

• The nature of the work process.

• Existing containment and ventilation arrangements.

Based on these factors, the method may recommend a category of controls, such as general ventilation, local exhaust ventilation, enclosed handling or specialist containment.

An example in pharmaceutical manufacturing

Consider two tasks involving the same pharmaceutical ingredient.

Scenario A: Handling a small quantity in an enclosed system

A worker transfers a small quantity of powdered material using equipment designed to contain airborne emissions. 

Because the process is enclosed, opportunities for exposure may be reduced, provided the equipment is functioning correctly.

Scenario B: Transferring the same ingredient in an open process

Another worker manually transfers the powder between containers in an open work area. This process may generate airborne particles and create opportunities for skin or surface contamination.

Although the substance is the same, the potential exposure differs because of the handling conditions. As a result, the two tasks may require different control measures.

Does Control Banding replace a risk assessment?

Control Banding is a tool for supporting risk-management decisions, not a substitute for a complete assessment.

The recommendations produced by a banding method need to be evaluated against the actual workplace conditions, available hazard information and applicable safety requirements. For complex processes or highly potent substances, specialist occupational hygiene advice may be necessary.

How can pharmaceutical workplaces control occupational exposure?

Once occupational hazards and potential exposure risks have been identified, the next step is to implement appropriate control measures.

Australian workplace safety guidance recommends using the hierarchy of controls, which prioritises measures that eliminate hazards or reduce exposure at the source.

The hierarchy includes the following approaches.

Elimination

Elimination involves removing the hazard entirely.

Where reasonably practicable, this is the most effective way to prevent exposure. However, eliminating a hazardous pharmaceutical ingredient may not be possible when the substance is essential to manufacturing a particular medicine.

Substitution

Substitution involves replacing a hazardous substance or process with a safer alternative where feasible.

For example, a workplace may investigate whether a less hazardous cleaning chemical can perform the required function without compromising product quality or regulatory requirements.

Engineering controls

Engineering controls are designed to isolate workers from hazards or reduce exposure through equipment and workplace design.

In pharmaceutical manufacturing, examples may include:

• Enclosed powder-handling systems.

• Local exhaust ventilation.

• Containment booths or isolators.

• Automated transfer and dispensing systems.

These controls are particularly important where airborne exposure could occur.

Administrative controls

Administrative controls involve procedures and work practices intended to reduce exposure.

Examples include worker training, restricted access, standard operating procedures, equipment maintenance and documented cleaning practices. Although these measures are important, they generally rely on consistent implementation and worker behaviour.

Personal Protective Equipment (PPE)

PPE provides a protective barrier between the worker and certain workplace hazards.

Depending on the risk assessment, this may include protective gloves, respirators, eye protection and protective clothing. However, PPE is generally considered the last line of defence because its effectiveness depends on correct selection, fit, use, maintenance and replacement.

In pharmaceutical workplaces, PPE should complement appropriate engineering and administrative controls rather than serve as the sole means of protection.

How to choose the right protective clothing for pharmaceutical work

Protective clothing selection is an important part of occupational risk management, particularly when workers may encounter hazardous pharmaceutical powders, chemical splashes or contaminated surfaces. However, selecting a garment involves more than choosing a disposable coverall or laboratory gown.

The appropriate protection depends on the substance, the task and the potential exposure conditions.

Step 1: Identify the hazard

Begin by identifying the substances or materials that workers may encounter. Consider whether the hazard involves airborne particles, liquid chemicals, biological materials or other forms of contamination.

The substance's hazardous properties and the available safety information should guide the assessment.

Step 2: Determine the potential exposure

Assess how the substance could contact the worker. For example, a task involving occasional liquid splashes may require different protective clothing from one involving continuous contact with a hazardous liquid or exposure to fine airborne powders.

Exposure duration, concentration and the amount of material handled also matter.

Step 3: Review the required protective performance

Protective garments have different performance characteristics and may be tested against different hazards.

Depending on the task, relevant considerations may include:

• Resistance to liquid penetration or permeation.

• Protection against hazardous airborne particles.

• Material compatibility with the substance.

• Seam and closure performance.

• Mechanical durability.

• Relevant protective clothing standards and certifications.

Garments should be selected using verified manufacturer specifications rather than appearance or general marketing descriptions alone.

Step 4: Consider fit and compatibility with other PPE

Protective clothing should allow workers to perform their tasks without unnecessarily restricting movement or creating additional hazards.

The garment also needs to be compatible with other protective equipment, such as gloves, respiratory protection and eyewear. For example, gaps between gloves and protective sleeves may create opportunities for skin exposure if the protective ensemble is not selected and worn appropriately.

Step 5: Establish correct use and removal procedures

Even suitable protective clothing may provide inadequate protection if it is worn incorrectly. Workers should receive training in appropriate donning and doffing procedures, garment inspection and the handling of contaminated clothing.

This is particularly important when removing PPE after tasks involving hazardous substances, as incorrect removal can transfer contamination onto the skin or other surfaces.

Step 6: Review PPE suitability

PPE selection should be reviewed when workplace processes, materials or exposure conditions change. For example, introducing a new API, changing a cleaning chemical or modifying a powder-handling process may require a reassessment of protective equipment.

This helps ensure that the selected PPE remains appropriate for the work being performed.

Best practices for maintaining PPE effectiveness

Selecting suitable PPE is only one part of maintaining worker protection. Pharmaceutical workplaces also need procedures to ensure that protective equipment is used correctly and remains effective.

Provide appropriate training

Workers should understand why particular PPE is required, what hazards it is intended to address and what its limitations are. Training should also cover correct use, removal, storage and replacement.

Inspect PPE before use

Protective equipment should be checked for visible damage, deterioration or other defects before use. For example, damaged gloves, torn coveralls or poorly fitting respiratory protection may compromise the intended protection.

Follow respiratory protection requirements

Where tight-fitting respirators are used, workplaces should implement appropriate respiratory protection procedures, including fit testing and training. Workers should also perform a user seal check each time they put on a tight-fitting respirator, in accordance with the manufacturer's instructions.

Replace contaminated or damaged equipment

Disposable PPE should be replaced according to its intended use, manufacturer instructions and workplace procedures. Contaminated equipment must be handled appropriately to avoid spreading hazardous substances.

Review workplace risks regularly

Risk assessments and PPE requirements should be reviewed when new hazards are introduced, work processes change or existing controls are found to be inadequate. This is particularly important in pharmaceutical manufacturing, where changes in ingredients, equipment or production methods can affect exposure conditions.

Conclusion: Why risk assessment matters for pharmaceutical workplace safety

Managing occupational risks in the pharmaceutical industry requires more than simply providing workers with gloves, masks or protective clothing. Effective protection begins with understanding the substances being handled, identifying how exposure may occur and selecting suitable control measures.

Approaches such as Occupational Exposure Banding and Control Banding can help inform these decisions, particularly when managing hazardous pharmaceutical ingredients.

However, they should be used alongside appropriate workplace risk assessments, occupational hygiene practices and relevant safety requirements.

PPE remains an important part of worker protection, but its effectiveness depends on choosing equipment that is suitable for the specific hazard and ensuring that it is used correctly.

Ultimately, a systematic approach to hazard assessment, exposure control and PPE selection helps pharmaceutical workplaces create safer working environments while supporting responsible manufacturing practices.

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