Rooms that are running right now.
Six delivered projects, each with the constraint that made it difficult. All handed over with the qualification dossier complete.
Sterile injectable block, bare shell to signed dossier in fourteen months.
Grade A through D across 1,850 m²: four dedicated air handlers, a WFI loop, dynamic pass boxes at every classified boundary, and continuous environmental monitoring. Passed an FDA pre-approval inspection and a client-commissioned EU-standard audit on first inspection.
Oral solid dosage expansion
Six ISO 8 granulation and compression rooms added to a live plant. Adjacent production never stopped, which set every sequencing decision on the job.
Four modular operating theatres
Laminar ceiling systems and antibacterial envelopes for a 400-bed private hospital, with redundant air handlers so a service visit never closes a theatre.
Chilled packing hall & cold store
Washdown-rated air handling over a wet line, plus a 600-pallet cold store with redundant plant for a dairy processor running seven days.
BSL-3 containment laboratory
Sealed envelope, negative cascade, bag-in/bag-out exhaust filtration, and a room integrity test before a single sample entered the building.
Purified water & clean steam plant
RO–EDI train feeding a 6 m³/h sanitisable loop, with sample point mapping and a full qualification campaign across sixteen user points.
Device assembly cleanroom
ISO 7 assembly and ISO 8 packing with ESD flooring, qualified against ISO 13485 expectations for an export-only manufacturer.