Biopharmaceutical Purification Systems
Source: Syntegon Pharma Technology Inc.
Pharmatec Purification Systems are designed for the production of complex solutions of harvest systems with multiple process steps (e. g. preparation, centrifugation, filtration). Production of pharmaceutical liquida is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals with or without nutrient solutions. Filtration units can be offered as stand-alone units. All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.
Benefits:
- Standard structured data-based project management
- Unitized process systems for different quantities
- Adaptable to specific room conditions due to flexible construction regarding design and floor plan
- Concept development of all necessary steps by use of pre-tested software modules to secure high process balance
- CIP/SIP design according to the latest GMP requirements
- Product contiguous parts standard of stainless steel 1.4404/ 1.4435 (AISI 316L)
- Use of control components from Siemens, Allen Bradley, Mitsubishi and others
- Simple handling by self-explanatory menu navigation
- Highest possible safety for product and user by permanent process monitoring
- FAT on manufacturer plant with all necessary process media as well as commissioning and qualification activities (IQ / OQ, i. a. PQ support, SAT) at customer site and data-based creation of system and qualification documentation
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