DRUG MANUFACTURING FACILITY
Estimated Project Cost: $30,000,000
Project Description
The project involved the planning, design, installation and startup of a facility to produce and package an injectable drug. Extensive building modifications were required to meet regulations, sterile environments, and Good Manufacturing Practices (CGMP). The facility featured automation of utility systems, mixing, transfer, packaging, Clean in Place (CIP) and Sterlize in Place (SIP).
Engineering
Services
Process Results provided the following services:
- On-site project support
- Drawing review
- Lab renovation
- Start-up and Commissioning of utility and process systems
- Lead Failure Mode and Effects Analysis (FMEA) for process
- Human Machine Interface (HMI) development
- Three dimensional process modeling and enhancement
- Wastewater / washwater collection
- Standard Operating Procedures (SOP)
- Construction Management support.
