A contract manufacturing facility in the Pharmaceutical industry required automation and controls for a new Spray Dryer Process line consisting of skid-mounted equipment and requiring the highest level of versatility and portability for product change-overs, as well as capacity for future expansion to control a second line.
Our client requested assistance with the automation implementation, including instrumentation and controls, for their new API processing facility in a repurposed pharmaceutical manufacturing building. The project required a turn-key approach, including full GAMP documentation (FRS, DDS, FAT, SAT), system implementation, commissioning and qualification. QSPEC Solutions delivered a design for an integrated manufacturing process involving both stick-built and modular skidded systems at both pilot and production scales.
QSPEC Solutions’ client is a major supplier of beef cattle. The client wanted to increase the facility’s capacity from 40,000 head to 65,000 head, but could just barely make enough feed to keep up with the current volume.
QSPEC Solutions’ client is an integrated pharmaceuticals manufacturer. The client’s existing Wonderware InBatch Servers required upgrading to meet regulatory requirements.
Two S-88 compliant Batch systems that control and document a compounding and an API bio-fermentation process and the associated HMI systems were upgraded.
The entire project brief is available here: Batch System Upgrade