Containment issues are becoming an increasingly important aspect of solid dose drug production. Active pharmaceutical ingredients (APIs) are becoming progressively more effective and, at the same time, more than 50% of all new chemical entities (NCEs) are being classified as potent (OEL <10µg/m3).
In addition, the health and protection of operators all over the world is being put under an increasingly intense spotlight. During production, particular attention must be paid to both preventing operators from exposure to the drug being processed and eliminating cross-contamination. In recent years, the focus of operator protection has shifted from cumbersome personal protection equipment (PPE) to contained solutions to avoid operator and product contact.
PPE protects only the operator. The hazardous substance being processed is not contained, which means that the associated problems are exacerbated: changing filters and cleaning rooms and equipment inside and out become major containment issues.
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Cleanroom Technology.
Subscribe now Already a subscriber? Sign in here.
