Pharmatec Process Systems are designed for the production of small and large volume parenteral (SVP/LVP) and infusion (IV) pharmaceutical products as well as buffer and media preparation. The liquid preparations are carried out in modular temperature-controlled stainless steel tanks with the appropriate functionality to carry out the full range of customer product recipes. All applicable compendial (e.g. USP, EP) as well as regulatory (e.g. DIN, ASME, GMP and FDA/EMA) pharmaceutical manufacturing guidelines are followed
Benefits
- NEW: SVP Essential as a cost-efficient variant of the proven SVP system with fast delivery in 6 months or less
- Standardized, data-based project management
- Unitized process systems for multiple operations
- Adaptable design to specific room conditions and floor plan due to flexible, modular construction
- Concept development with all necessary steps by use of pre-tested software modules to ensure high process stability
- CIP/SIP design according to the latest GMP requirements
- Product contact parts standard of stainless steel 1.4404/1.4435 (AISI 316L)
- Use of control components from Siemens, Allen Bradley, Mitsubishi and others by customer request
- Simple operation with self-explanatory menu navigation
- Highest possible safety for product and user by continuous process monitoring
- FAT at Pharmatec with all necessary process media and data-based creation of system and qualification documentation
- Commissioning and qualification activities (IQ/OQ, i.a. PQ support, SAT) at customer site
