THE OPPORTUNITY
The client is investing in an expansion project for its Highly Active Pharmaceutical Ingredients (HAPI) Pilot Plant to enhance a safe working environment and promote operational flexibility. The client handles HAPI compounds that are categorized as OEB (Occupational Exposure Band) 3 (10 to <100 micrograms/meter cubed). The OEB 3 compounds are handled in a Potent Compound Handling Area during the following processes:
- Dispensing & Compounding
- Analytical Tasks
- Lyophilization & Filling/Stoppering/Crimping
- Process Development Mixing/Emulsions/Suspensions/Solvent Removal
The expansion project for the Pilot Plant will allow all these processes to occur in one dedicated space. The expansion will also be designed in accordance with OEB 4 handling/Pilot Plant design guidelines to allow handing of OEB 4 Compounds ((1 to <10 micrograms/meter cubed).
THE CHALLENGE
The objective was for a new HAPI Pilot Plant with high level engineering design criteria to achieve the following critical objectives:
- Provide a safe working environment that delivers effective personnel exposure control
- Engineering controls and facility design to eliminate cross contamination of various products and processes simultaneously occupying the pilot plant
- Provide a cost effective facility driven by capital and operating costs
- Facilitate cleaning, maintenance, and safe, compliant operations
- Adhere to industrial hygiene, environmental and building codes and regulations
- Facilitate efficient operations for the personnel required to work within the facility
THE PS&S SOLUTION
The design strategy for the new HAPI Pilot Plant and Analytical Laboratory has taken into consideration containment requirements for OEB 4/5 compounds with the utilization of isolator technology within a flexible cGMP facility. Personnel gowning procedures with entrance and exit airlocks with strict pressurization controls provided containment and personnel protection. cGMP facility finishes provided the cleanliness criteria for surface and material selections for smooth, durable and clean appearances. Process utility enclosures provided the pathways for clean utilities with aseptic connections including WFI, Clean Compressed Air, Steam, Nitrogen, and Power.