PS&S was requested to develop the program and design for a vial packaging line and gowning rooms. The projects utilized all in-house disciplines including architecture, structural, mechanical, plumbing, fire protection and electrical.
To design vial packaging areas to meet cGMP requirements for controlled not classified (CNC) packaging area, along with a staging / vial run set-up area. Program elements included men’s & women’s gowning, mezzanine space for offices and conference spaces overlooking the process area. Another requirement was that the design needed to match the material & process flow within the already existing facility.
THE PS&S SOLUTION
The vial packaging facility housed the Hectoral vial packaging line designed to meet ISO-8 requirements, provide a material staging area, packaging line suite utilizing a two story curtain wall system for office mezzanine viewing. The Aseptic gowning included a cGMP transitioning facility from unclassified through ISO 5 Aseptic filling. Project also included material and personnel flow, mechanical HVAC cascading pressurization and electrical infrastructure upgrades.