Bioreactor / fermentor for the pharmaceutical industry

processdisposablewith magnetic stirrer

Overview
Morimatsu combines equipment fabrication and engineering experience in the biopharmaceutical industry with detailed analysis of product quality attributes and production processes. The company identifies critical process parameters by correlating product quality features with process steps. Based on a customized URS or equivalent process documents, Morimatsu develops tailored designs including PFD (process flow diagram) and performs iterative reviews. Designs comply with regulatory requirements and support CIP and SIP to enable straightforward operation and maintenance while minimizing product loss. A risk-based control strategy ensures the final process system risk is controllable and aligned with expectations.

Provided systems

• Bioreactor / fermentation system
• Media preparation system
• Harvesting system
• Purification system
• Sterile preparation conditioning system
• Buffer conditioning and storage system
• Inactivation and CIP workstation system
• Single-use magnetic mixing system
• Single-use storage system
• Inline conditioning system

Key features

• Customized engineering design based on URS and process documentation
• PFD (process flow diagram) design and multi-stage review process
• Regulatory-compliant designs supporting CIP (Cleaning-in-Place) and SIP (Sterilization-in-Place)
• Designed for easy operation and maintenance with minimal product loss
• Risk-based control of the whole process to ensure controllable system risk

Technical characteristics

• Scope: overall upstream and downstream process systems
• Customization: URS-driven tailored designs
• Documentation output: PFD (process flow diagram) and engineering reviews
• Hygiene design: CIP and SIP compatible systems
• Single-use options available (magnetic mixing, storage)
• Includes systems for media preparation, harvesting, purification, buffer conditioning, inactivation and inline conditioning