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This project was a build out of a multi-product manufacturing suite in Ohio. This project included installation of an aseptic vial filling line for sterile injectable products. This included the facilities and HVAC systems necessary for personnel and materials access control and well as sterile processing. The addition of a shipping warehouse and conditioned storage facilities for finished products was provided. This project was a continuation of a program that included multiple process rooms for manufacturing the sterile compounds.
System Includes
- Freezers and conditioning chambers for storage of bulk product
- Product screening in Class A laminar flow area
- Dry, low volume vial filling with semi-automatic vial inspection
- UPS & diesel emergency power systems
- Common and clean utility systems
- CIP/SIP systems
- Redundant HVAC systems for Class A zones
- Raw material and refrigerated finished product warehouses
Services Provided
- GMP evaluation/recommendation
- Facility planning
- Existing utility evaluation
- Facility design (architectural, structural, mechanical/HVAC , electrical
- Procurement services
- Construction support by design team and on site personnel
Value Provided by Process Plus
- For this fast-track manufacturing increase, Process Plus provided services within the client's integrated project team, augmenting their existing technical expertise and project structure.
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$8 million
March 2004
Operational December 2004
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