Breathing easy

Working with unusual ?and potentially dangerous ?substances, employees ?at pharmaceutical ?manufacturing firms ?benefit from tougher ?respiratory protections

A five-o’clock shadow may be in fashion for men of modern taste. But this style makes Jim Duthie itch if he sees workers at Valeant Pharmaceuticals sporting it.

Duthie, the health, safety and environment manager at Valeant’s Steinbach, Man., facility, explains that a man’s facial hair compromises the seal between a respirator and the wearer’s skin. This gap could let dangerous gases, vapours or particulates bypass the respirator’s protection mechanisms. If the worker inhaled a toxic substance, he could fall ill or even die. 

This facial hair matter threatens to skirt corporate health and safety
processes. As Duthie explains, a worker may arrive for a respirator fit test with no hint of stubble. In that case, the respirator seals the wearer away from contaminants just fine.

“But if, on the following Monday, he’s still a bit unshaven from the weekend, the seal is gone,” Duthie says. To deal with this, Valeant supervisors
vigilantly monitor workers to make sure employees are close-shaven as per company rules.

Working dangerously

Respirator fit testing is just one of the challenges for health and safety professionals who support the pharmaceutical industry. This is a dangerous sector. Employees involved in research, development and manufacturing face exposure to particles, gases or vapours emitted by products or produced during the manufacturing process, explains Lynn Feiner, a product-line leader at Honeywell Safety Products in Cranston, R.I.

“The newest trend is micron particles,” she says, referencing miniscule items that measure in the millionths of a metre. “Scientists are still debating the risks these may have.”

The culture of innovation that drives the sector also drives up the risk count. Drug manufacturers work with peculiar substances, attempting to beat competitors by creating unique products. In this inventive environment, workers may be exposed to material that is so new, no government or regulator has established exposure limits for it yet.

“Sometimes we have no good way to determine how much of a biological agent is too much,” says Dan Curts, senior technical specialist at 3M Canada in London, Ont. “It’s really difficult to determine the thresholds at which the body will react.”

New protocols boost protection

To address these longstanding concerns — which affect not just pharmaceutical companies, but other businesses as well — the Canadian Standards Association (CSA) updated its standard for respirator use and care. Known as CSA Z94.4-11, this latest edition builds on the previous version from 2002 and provides new criteria for respirator fit testing. It also describes how to mitigate risks from certain substances for which there are no defined exposure limits.

For an employee who dons a respirator to perform his work, the device must fit as snugly as possible. Fit testing ensures a respirator creates a perfect seal and keeps the wearer from inhaling anything other than air. New fit-testing protocols in CSA Z94.4-11 guide health and safety officers through testing best practices. The protocols also talk about factors involved in ensuring worker safety. 

For example, the standard explains that the person who conducts the fit test should:

• use methods applicable to the type of respirator (most respirator manufacturers offer fit testing guidelines)

• verify that the person wearing the device knows how to create an
effective seal

• know how to interpret test results

• document user and respirator performance. 

Sean Donovan, a Toronto-based senior product-line manager at MSA, notes in previous versions of the standard, the fit testing processes “left too much open to interpretation.”

He welcomes CSA’s update. But, he adds, fit tests alone are not enough.

Echoing Duthie, Donovan points out companies need to enforce personal-hygiene policies. Meanwhile, Dennis Capizzi, MSA’s respiratory product-line manager in Cranberry, Pa, says businesses should make sure employees who must wear facial hair long (for religious reasons, for example) also wear appropriate respiratory protection, such as hoods rather than masks.

“As long as the beard isn’t so long as to break the seal around the neck, (the seal is) effective,” Capizzi says.

Zap risks with control banding

Regarding substances with no exposure limits, CSA Z94.4-11 prescribes “control banding” as a way to manage risks. Developed by the pharmaceutical industry itself, control banding matches controls such as ventilation to a range or “band” of hazards, covering everything from eye irritation to risk of cancer. 

Control banding enables health and safety professionals to pinpoint appropriate protections even when no one knows how much is too much of a substance. It’s particularly effective in the pharmaceutical sector, where each company uses unique materials and compounds. 

“What’s required is going to be different for every workplace,” says Chris Liddy, occupational health and safety specialist with the Canadian Centre for Occupational Health and Safety (CCOHS) in Hamilton.

CSA Z94.4-11 suggests control banding specifically for “bioaersols.” These are airborne particles that contain or come from living organisms. 

According to the standard: “Bioaerosols include living or dead microorganisms, fragments, toxins and particulate waste products from all variety of living things. They are capable of causing infection or adverse or allergic response.” 

The standard offers charts to help health and safety officers identify the appropriate protection for the hazard level. The document also explains in some detail how control banding works and how it applies to respirator selection.

Curts from 3M points out that control banding might make life more complicated for health and safety professionals. Still, it’s worth the effort. 

“There’s a lot of upfront work, but at the end you know exactly what you need,” he says.

Along the same lines, Feiner from Honeywell suggests every health and safety specialist involved in protecting workers from exposure risks should know and understand CSA Z94.4-11. Yes, the document is long, “but the information is critical,” she says.

New technology

New standards are all well and good, but of course companies also need to invest in personal protective equipment. A number of manufacturers stand ready with advanced respirator technologies.

The latest powered air-purifying respirators (PAPRs) warn users when the devices require maintenance. 

“These are respirators that use a blower to provide a steady flow of filtered air,” Feiner says. “Some companies… have added alarms that alert the user when the battery is getting low and when the filters are clogged.” 

Health and safety experts point out pharmaceutical companies also employ targeted ventilation systems and documented procedures to maintain workers’ respiratory health. Curts adds that organizations rely on monitoring by supervisors and vigilance on the part of the company’s joint health and safety committee to assess risks. 

As a whole, these protective mechanisms offer pharmaceutical employees — five o’clock shadow or not — peace of mind, even though they work in a potentially dangerous field.

Stefan Dubowski is a freelance writer based in Ottawa. He can be reached at [email protected]