מתקן תהליך ביו-פרמצבטי GMP לפלזמה

Brinox

For sale is a fully procured, modular GMP process system for the production of C1-Esterase Inhibitor (C1-INH) from human plasma.

The plant was professionally engineered, procured, and has successfully completed FAT, but has never been installed or put into operation. This is expressly not a used line, but a factory-new project and module package.

Year of manufacture: 2020
Condition: brand new, in original packaging
Operating hours: 0
Storage: temperature-controlled warehouse

SCOPE OF SUPPLY (EXCERPT WITH QUANTITIES)

Adsorption / Chromatography (Bay 2 & 3):
- 2 adsorption lines (DEAE / QAE)
- 2 buffer tanks
- 2 pigging systems
- 2 cooled transfer lines (pipe-in-pipe)
- 4 filter press racks
- 4 cooling cascades
- 4 CIP loops

Precipitation PRE:
- 3 pre-precipitation tanks (incl. 1,000 L)
- 3 main precipitation tanks
- 3 CIP stations
- 3 multi-layer filters
- 1 vacuum station

Buffer Preparation (Bay 2 & 3):
- 6 buffer vessels (NaCl, DEAE, QAE buffer)
- 6 temperature control skids
- 4 media/WFI/CIP distribution units

LEP 2.3 – Washing & Elution Solutions:
- 2 washing solution tanks (up to 9,000 L)
- 2 elution solution tanks
- 4 temperature control units

LEP 13 – Ammonium Sulfate System:
- 1 preparation tank (3,500 L)
- 2 storage/distribution tanks
- Solid material crusher
- Dosing & neutralization system
- Heat-traced pipes

Media Distribution:
- 1 pharmaceutical NaOH 1M system
- 1 technical NaOH 32% system
- 1 acetic acid 60% system
- Pump and dosing stations
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Additional Process Tanks:
- >15 stainless steel tanks 316L (1,000–9,000 L)
- Various skids, distribution and instrumentation units

GMP & DOCUMENTATION

- URS / requirement specifications per LEP
- P&ID diagrams
- Layout and sectional drawings
- EMSR & instrumentation documentation
- FAT documentation
- Complete weld certification (digital)
- Extensive photo documentation

The project documentation is fully available both digitally and additionally physically archived, structured in 316 folders.

Process control system connection with pre-configured MES interface is foreseen. Cleanroom integration according to specification.

SALE

Preferably as a complete system. Modular sale possible if the entire package is not sold.

Suitable for plasma fractionators, biopharma manufacturers, CDMOs, or new site establishment projects.

Availability: short notice
Inspection: by appointment
Price: on request

המודעה תורגמה אוטומטית. ייתכנו שגיאות בתרגום.