Pharmaceutical Manufacturing: Where Simple Compounds Can Become Hazardous

  

Pharmaceutical manufacturing may not conjure images of Zone 1 hazardous sites, but the reality is that many of the components that go into pharmaceutical manufacturing are hazardous and toxic to workers and the environment. Volatile compounds, like solvents, are often used to manufacture medications' active and inactive ingredients.

Are Fillers (Excipients) Inert?

Pharmaceuticals have active and inactive ingredients. What is the difference? An active ingredient is a chemical intended to directly affect the diagnosis, prevention, mitigation, cure, treatment, or prevention of a disease, or to affect the structure or function of the body. The drug label will list the active ingredient(s) with dosage and side effects information. The inactive ingredients are any other components, excluding the active ingredients. This does not mean the chemical or compound is inert or has no effects. The opposite could be true. Usually, the inactive ingredient is the mechanism for delivering the active ingredient to the intended part of the body. The Food and Drug Administration (FDA) reviews the inactive ingredients in formulations and regulates their potency and maximum daily exposure when approving new medications or formulations. For example, the cream base may increase the active ingredient's absorption rate of a topical medication. Additionally, ingredients may be active or inactive, depending on the product formulation. The FDA gives alcohol as an example where the formulation's intent determines the type and the amount of information required on the label.

What's Not on the Label?

Active and inactive ingredients are listed on the label, but the FDA doesn't require manufacturers to list intermediate chemicals, such as solvents or processes like fractional distilling. Manufacturing steps can be difficult to discover due to trade secret protections.

Hazardous Medications

The National Institute for Occupational Safety and Health (NIOSH) provides guidance on handling medications that are in and of themselves dangerous to workers. These pharmaceuticals include "cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs." These drugs may or may not be toxic to the patient but may be to the healthcare worker. For example, a bioengineered medication intended to target a specific person could have significant unintended consequences if used or entering someone other than the intended patient.

Manufacturing of Pharmaceuticals

Another sneaky place for dangerous chemicals is that chemicals used to manufacture inactive ingredients are not included in the formulation or regulated by the FDA. Pharmaceutical manufacturing uses potent and hazardous chemicals in the processing of medications. Many pharmaceutical manufacturing processes include organic compounds, such as alcohols like methanol, ketones like acetone, aromatic compounds like benzene and toluene, halogenated hydrocarbons, and more. The list reads like any industrial manufacturing facility. Acetaminophen is an example of this. The multistep manufacturing process includes using sulfuric acid, sodium nitrate, sodium borohydride, and acetic anhydride. None of these chemicals are on the label because they are not part of the final formulation.

Digital Data Collection — Keeping Pharmaceutical Manufacturing Safe for Workers

Pharmaceutical manufacturing has more in common with chemical manufacturing than almost any other industry. As with petrochemical and chemical manufacturing, pharmaceutical manufacturing facilities must maintain worker safety with hazardous feedstock, intermediaries, and processes. Digital monitoring for Zone 1 and other hazardous work sites can streamline environmental regulatory reporting, improve worker safety, and reduce the risk of an undetected spill or incident through continuous digital data collection.