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11 questions to help you protect pharma packaging personnel

Concerns over contamination often overshadow concerns for workers’ safety. Highlighted here are key questions to ask during your risk evaluation.

A banding system is used by cross-functional teams to categorize the risk levels of drug properties. Image provided by IPS – Integrated Project Services, Inc.
A banding system is used by cross-functional teams to categorize the risk levels of drug properties. Image provided by IPS – Integrated Project Services, Inc.

Stringent regulations in API processing are a given when it comes to ensuring product quality, but personnel safety during Oral Solid Dose (OSD) drug packaging is largely overlooked across the industry. Regardless of the drug being packaged—whether it's a cancer drug, contraceptive, supplement, etc.—there are hazards specific to each formulation and a proper evaluation must be performed.

Integrated Project Services’ Kevin Swartz, Senior Packaging Engineer, and Len Pauzer, Senior Process Engineer, emphasize the need for performing an evaluation on each individual packaging site to ensure that workers are protected day in and day out.

Increasing importance

While operator safety has always been important, the pharmaceutical climate is changing in ways that are making it more hazardous for packaging operators, who may spend upwards of eight hours a day handling products.

• Drugs are becoming more potent, meaning that daily exposure limits are decreasing.

• Mergers and acquisitions happen quickly, which creates two issues. There may not be time for the global procedures of the buying company to be implemented at the local sites (which may be in other countries), so there is inconsistency among procedures and safety precautions from site to site. Additionally, people want to get the most utilization out of their equipment.

Pauzer notes, “One company may acquire another and say, ‘This site has a blister machine—we’ll package tablets there,’ but they don’t take into account that the machine is not built for potent compounds.” Often, the proper assessment is not performed and controls may not be in place for worker safety.

Risk analysis for personnel

“We’re talking about people’s lives and health. A risk analysis must be done to determine the level of personnel protection,” says Pauzer. “You have to validate and document that process.” Most of the equipment is already built to certain GMP standards, but the purpose of this evaluation is to consider containment from a worker’s perspective.

According to most regulatory bodies, “safe” means that the benefits of a drug outweigh the risks, so “safe” means different things for patients than it does for packaging personnel.

• For a patient, the risk of taking a certain drug is typically outweighed by the benefit (health, or even life).

• The drug’s benefit to the packaging worker is that they receive a job/paycheck, so the risks of exposure must be significantly lower to be considered safe.

ISPE’s RiskMapp guideline references this based on which perspective you are looking from, whether it’s industrial hygiene (worker perspective) or quality (patient perspective).

Swartz says, “The risk of unintentional exposure as an operator working in a primary packaging suite is not the same risk as a patient who has all of the side effects and possible interactions listed right on the bottle or insert or explained by the doctor. You’re still asking ‘Does the benefit outweigh the risk?’ But from a worker perspective, the safety needs to come much closer to zero because their benefit—a job—is not particularly high.”

The assessment and controls depend on what your drug is—so there is not a catchall solution. Pauzer elaborates, “Some drugs can be absorbed, some can be inhaled, some can be ingested, and some therapeutics can be all three. So you have to build in safety systems for all three methods of transportation into the worker’s body.” Rather than develop these safety systems for every drug individually, the guidelines suggest building a banding system that is used for all drugs.

The point of building a banding system is to categorize the risk levels of drug properties. Through a team represented by toxicology, health and safety, engineering, quality, validation, and operations, those categories are delineated into bands based on the control processes (including process, operational, engineering, and procedural controls) that the packager can implement. Examples of controls include containment systems, housekeeping, room ventilation, material transfers, and airflow controls. Then during the individual drug assessment, a drug is assigned to a band based on the comparison of the drug properties vs the band properties.

After developing your banding system, Swartz and Pauzer suggest a three-part plan:

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