Pharmaceutical Dust Collection and Filtration

Because You Can't Afford to Let Your Packaging Dust Get Out of Control

Few industries are as highly regulated as the manufacture of pharmaceuticals. And with good reason: consumers expect that every batch of medicine they take will unfailingly meet the highest standard. Manufacturers are under enormous pressure, both from consumer expectation and from regulatory statutes. To meet these high standards, exceptional manufacturing practices must include the effective management of airborne dust in the manufacturing process.

As manufacturing lines get faster and more complex, plant managers can't afford to let dust get out of control. It is important that pharmaceutical products not just be pure, they must look perfect, as well. A blister pack with impurities in it is unacceptable.

However, worker health is the best reason to invest in dust collection systems. Pharmaceutical dust isn't like ordinary dust, and personal exposure to active pharmaceutical ingredients (API's) is a serious concern in the industry.

Exposure Risks for Pharmaceutical Dust

Most pharmaceutical dust is generated during the production and packaging processes in pharmaceutical manufacturing plants. A drug goes through many possible steps before becoming a pill—granulating, drying, mixing, pressing, coating, grinding and so on—and any of these steps can produce dust. Even the cleaning of equipment can produce dust, as anyone who has ever used compressed air to clean something knows. In short, a pharmaceutical plant has countless sources of dust generation.

Cross-contamination is a serious concern for pharmaceutical manufacturers. Few other industries must maintain such high standards for purity. Dust can carry active pharmaceutical ingredients across a factory, and intercepting this dust before it reaches other manufacturing lines is crucial.

Personal exposure levels to these API’s are another major concern. Drugs that might travel in pharmaceutical dust include anesthetics, hormones, anti-viral drugs and more. Exposure to the wrong drug could cause skin rashes, birth defects, organ toxicity, fertility problems, allergic reactions or worse.

Besides the very serious concerns for product purity and worker health, a manufacturer must also address pharmaceutical dust to comply with federal regulations. The Occupational Safety Health Administration (OSHA) publishes and enforces regulations for manufacturers across most industries. Regulatory compliance is a major responsibility for every manufacturer.

Dust Control Regulations for Pharmaceutical Manufacturers

Two federal regulatory agencies force manufacturers to think about pharmaceutical dust: OSHA and the U.S. Food and Drug Administration (FDA). OSHA was created in 1970 with a mission to “assure safe and healthful working conditions for working men and women.” OSHA has issued many standards for air quality, most of which are contained in Standard 29 CFR Part 1910 Subpart Z. OSHA regulations are part of the legal code, and failure to comply with them can lead to serious fines.

FDA regulations governing pharmaceutical manufacturing concern product quality. These regulations are known as the Current Good Manufacturing Practice (CGMP) rules. These “provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” In short, a drug manufacturer must maintain a clean facility. Failure to comply with CGMP rules can also lead to serious fines. Breaching any of these regulations carries more downsides than fines, of course. Other possible costs include those of plant shutdowns, possible claims from employees or customers, and more.

Another organization to look to for guidance on permissible exposure levels (PELs) to dust and other harmful substances—albeit one without regulatory authority—is the American Conference of Governmental Industrial Hygienists (ACGIH). The ACGIH publishes guidelines for PELs for hundreds of dangerous substances. In general, ACGIH guidelines are more strict than OSHA standards. Many leading manufacturers, however, strive to meet ACGIH guidelines.

Pharmaceutical Dust Collectors and Source Capture Solutions

A variety of equipment exists to eliminate pharmaceutical dust. These dust collectors will help pharmaceutical manufacturers comply with OSHA regulations and protect workers’ health. The equipment will also help meet FDA standards for a clean manufacturing environment. Whether a manufacturer needs a source capture solution, an ambient capture one, or a combination of the two, RoboVent offers a wide variety of dust collectors and engineering services to meet any challenge.

Configurations