Hello good people of the world! Today we’re going to talk about isolation and containment considerations in oral solid dose manufacturing. The purpose of isolation and containment is to control the level of pharmaceutical ingredient exposure to personnel and the environment. It is typically not possible to eliminate all exposures, so we try to reduce it to a tolerable level, which must be defined.
The CFRs and other regulations require manufacturers to limit exposure to customers of any undesirable substance. Limits have been established by industry group and regulatory bodies, and quantify things such as Allowable Daily Exposure (ADE).
Things to look at when considering isolation and containment include:
- Material flow
- Personnel flow
- Operator interventions
- Sampling
- Waste flow
- Maintenance procedures
- Utility interactions
Isolation and containment risks must be evaluated and mitigated to get a solid handle on the implications. A multi-disciplinary approach must be used. Migations may include:
- Physical barriers
- Air control
- Cleaning procedures
- Disposables
- Training
What considerations come in to play in your isolation/containment strageties? Comment below!
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