Layout for Injection Manufacturing Unit : Pharmaguideline

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Layout for Injection Manufacturing Unit

Diagrammatic representation of the sterile manufacturing plant including doors and passboxes.
Area maintenance in sterile manufacturing is a difficult task because most of the areas in sterile manufacturing are of a higher grade than oral manufacturing.

The material is transferred through pass boxes to avoid the generation of contamination. Past boxes should have an interlocking system to avoid the simultaneous opening of the doors.

Higher grade area must have higher pressure to avoid the entrance of the contamination through the openings and the doors. For instance, if two rooms of Grade C and Grade B have a door between them then Grade B room should have at least 10 mmHg higher pressure than Grade C room. All doors should open to higher pressure to avoid the leakage of pressure from the area.
Related: Requirement of Airlocks in Sterile Area

Change rooms are used for gowning. Previously sterilized gowns are kept in change rooms in sterile cabinets having UV light. Hand sanitizer should be applied in the change rooms to avoid the contamination.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

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  1. there is no area defined for visual inspection cool zone area.


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