Validation/Process
Paulus, Sokolowski & Sartor (PS&S) consistently promotes an interactive team approach with engineers, owners, and equipment/systems suppliers to enhance the effectiveness of the total process design and validation. This cooperative approach eliminates the duplication of documentation efforts and reduces field execution time, which consequently accelerates current Good Manufacturing Practice (cGMP) production.
BioPharmaceutical Services
- Conceptual Design
- Schematic Design
- Detailed Engineering
- Master Planning
- Critical Utilities
- Clean-in-Place (CIP)
- cGMP Audits
- Commissioning
- Validation
Types of Facilities
- Fermentation
- Cell Culture
- Vaccine Manufacturing
- Active Pharmaceutical Ingredients (API)
- Solid Dosage
- Formulation, Fill and Finish
- Laboratories
- Pilot Plants