Tag Archives: WHO

ORAL SOLID DOSE – Architectural Considerations

Hello good people of the world! Today we’re talking about architectural considerations in the design of oral solid dose (OSD) manufacturing facilities.

In addition to normal architectural standards, the following must be considered for OSD manufacturing facilities:

  • Manufacturing process flow
  • Personnel flow
  • Equipment flow (clean and dirty)
  • Waste flow

Risks to consider when mapping flows include:

  • Risk of contamination from outside contaminates
  • Risk of cross-contamination
  • Risk of mix-up

Risk mitigations should consider:

  • Process containment
  • Isolators
  • Environmental controls
  • Room size
  • Transition spaces and airlocks
  • Personnel controls such as gowning
  • Administrative controls such as frequency of operation

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!