What Is Pharmaceutical Containment?

Pharmaceutical containment is the process of preventing cross-contamination. But it also includes protecting the product, the workers, and the environment from exposure to hazardous substances. Containment solutions in pharmaceutical manufacturing range from simple packaging to sophisticated containment systems. Including technology such as isolators and high-containment equipment.

During The Manufacturing Process

Pharmaceutical ingredients used in the manufacturing process may include highly potent active pharmaceutical ingredients (HPAPIs). Which as a result, require a higher level of containment due to their hazardous nature. The Occupational Exposure Limit (OEL) and the Occupational Exposure Band (OEB) are used to determine the level of containment required for HPAPIs.

When your product moves through different production steps it is often handled in different drums, sacks, or bulk bags. Handling these contained transfers can be challenging. For some hazardous chemicals / bio-hazards, legal occupational exposure limits (OEL) have been determined. OEL regulation sets an upper limit on the acceptable concentration of a hazardous substance in workplace air.

Total Containment: When no legal guidance is available, you go through the process of control banding to ensure proper risk assessment. Control banding ranks hazards in different occupational exposure bands (OEB). This ranges anywhere from “light skin and eye irritants” up to “very toxic on single exposure”. Total containment not only protects humans but also needs to protect the environment while preventing cross-contamination.

Rules and Regulations

The pharmaceutical industry has many rules when it comes to the production and distribution of products. For example, GMP regulations ensure that manufacturers follow the correct protocols and procedures for containing pharmaceutical ingredients. This includes labeling, handling, and storage. Containment in this industry aims to minimize the risks of exposing humans and the environment to hazardous substances. But also, to prevent the pharma products from getting contaminated. Which could have disastrous effects on the end-user. Manufacturers must ensure that they can produce certification for their products. And also to undergo rigorous testing before they can enter the market as treatments.