When people think of cleanrooms, they often picture sterile injectable medicines, with operators in full gowning working in Grade A or B environments. It is easy to assume that oral solid dose (OSD) manufacturing, with its tablets, capsules and powders, does not need the same level of rigour. After all, OSD products are not sterile. But the reality is that cleanroom controls in OSD facilities are just as critical, though the risks and priorities look different. Tablet Filling

HVAC and clean utilities occupy an unusual position in most pharmaceutical quality systems. They are validated. They are maintained. They appear in the contamination control strategy, referenced as supporting controls alongside more visible elements such as gowning, environmental monitoring, and cleaning. Most organisations would describe them as managed, and by the conventional measures of day-to-day operations, they are. Equipment is running. Alarms are set. Maintenance is

"Contamination Control Strategy" appears in almost every quality system. It is referenced in audit responses, cited in risk assessments, and submitted during regulatory submissions. Most organisations can point to a document that carries the name, and most of those organisations believe, reasonably, that its existence demonstrates compliance with the requirement. The document is present, it covers the expected elements, and it has been reviewed within the required timeframe.