Automated Degradation System

Continuous degradation. Fully automated. SIP/CIP built in.

简介

Our Automated Degradation System is purpose-built for hygienic biopharmaceutical processing, using high pressure to drive material through micro-slits at high speed. The combined effects of shear, cavitation, and impact deliver cell disruption, particle size reduction, and homogenization/emulsification. A fully automated control system precisely regulates homogenization pressure, processing temperature, and cycle parameters, with inline pressure and level monitoring to ensure stable and repeatable processing.

特点

Automatic SIP and automatic CIP
Supports multiple, continuous degradation cycles
Fast pressure build-up, quick stabilization, automatic degradation pressure adjustment
Level alarms and automatic degassing for process protection
Automatic buffer replenishment and automatic process -parameter tuning

应用场景

Cell disruption and extraction of intracellular products from E. coli, yeast and other microorganisms
Preparation of liposomes, fat emulsions, vaccine adjuvants and nanosuspensions
Covers multi-stage needs from lab-scale trials to large-scale production

技术参数

其他

GMP Deliverable Document List:

Product Risk Assessment

Quality Project Plan QPP, System Classification SC, Critical Component Assessment CCA, Risk Assessment RA

Design Qualification / Design Review

Design Qualification DQ, Functional Specification FS, Hardware Design Specification HDS, Software Design Specification SDS

C&Q Testing and Documentation
Factory Acceptance Test FAT, Site Acceptance Test SAT, Installation Qualification IQ, Operational Qualification OQ
Certification Documents
Product Inspection Report, Wetted Material Certification, Product Certificate of Conformance, Product Quality Certificate, Calibration Certificate
Process Documentation
Surface Roughness Documentation, Pickling & Passivation Documentation, Welding Documentation
List-type Documents
I/O List, Alarm List AL, Parts List PL, Consumable/Wear Parts List CL