The area and filling operations were having major FDA issues and required a fast track renovation to continue production with a minimum of downtime.
Primary focus was in the verified sterilization of components and product, and the complete rebuild of the aseptic filling system. The line was reconfigured for optimum material flow, automated product sampling, and overall process control.
- Vial & closure component sterilization
- Low volume vial powder filling
- Automated product sampling
- Semi-automatic vial inspection
- Stopper insertion
- CIP/SIP systems
- New labeling system
- Complete line reconfiguration with GMP design conveying systems
- Investigated new powder filling options
- Process Plus directed the site team in the identification of non-compliant elements of the
material handling and packing system. Made engineering recommendations, assisted in
budget and schedule development, provided detail design documents, and oversaw the
implementation of changes that eventually brought the filling operation to compliance.
- Process Plus also interfaced with the validation team to insure completed systems conformed to
all validation requirements.