Validation of Automated Polysaccharide Transfer Skid

The Automated Polysaccharide Transfer Area Project is designed to provide closed system transfer of polysaccharides from the Final Fill Tank to the Storage and Shipping Drums. This transfer skid will reduce the download cycle time and operational constraint in the Filling Room.

A&J provided the conceptual design for the project. A&J is providing Project Management, Commissioning and Validation services on this project, which includes the following equipment/systems:

1. Automated Product Transfer Skid (Sartorius) and Local PLC Control System
    - Enhanced Commissioning of Product Transfer Skid
    - Cleaning Validation
    - SIP of Product Transfer Skid
    - Media Simulation
    - Process Validation

2. HVAC System
    - Air Handling Units 13 & 14
    - Environment Qualification
    - Honeywell PLC Control System

3. Chill Room/Freezer # 186 (Luwa) 2° to 8° C - Chill Room Mode / -15° to -25° - Freezer Mode
    - Temperature Distribution Mapping Studies

4. Biosafety Cabinet

5. Utility Tie - Ins
    - Water For Injection (WFI), Clean Steam, Process Air, CIP, Instrument Air

6. Tie-In of Product Transfer Skid to existing Honeywell DCS System (OPC Connection)

7. Tie-In of HVAC Local Honeywell Control System to existing Honeywell DCS System

8. Tie-In of Chill Room/Freezer# 186 to Honeywell DCS System