FDA COMPLIANCE UPGRADE
An upgrade was performed on a cGMP Oral Solid Dosage (OSD) Antibiotic manufacturing facility to expand the operation as well as to meet FDA compliance. JNE Consulting, working with an outside architect, was the principal consultant on the project which required all work to be completed while maintaining full production.
Phase 1 was a 3-storey addition to accommodate a warehouse and shipping/handling area. This phase also included a major review and upgrade of all plant services, as well as a warehouse and racking system, to ensure adequate supplies for the future phases.
The mechanical service space was upgraded, including boilers and compressors, high pressure washing system, hot glycol, tempered water, C.I.P., softened and purified water systems, domestic hot/cold water, steam and condensate, general housekeeping vacuum, natural gas, nitrogen, HVAC, dust collection, clean steam humidification, firefighting water drainage and Building Automation System upgrade. In addition, process services were upgraded for V-Blenders, Coating and Flammable Liquid Dispensing.
Phase 2 included engineering and construction for the ultrasonic washing area, control and testing lab, primary & secondary packaging, equipment clean-up rooms, flexible production rooms, solvent storage facility, sugar handling system, housekeeping rooms, gowning rooms and service spaces.
Phase 3 included engineering and construction for an office building, electrical and mechanical maintenance rooms, sampling room, general storage room, first aid room, locker room, washrooms and lunchroom.
JNE Consulting provided full engineering services, as well as construction support and commissioning for all three phases.