21 CFR & PHARMACEUTICAL COMPLIANCE
21 CFR & Pharmaceutical Compliance
Compliance-Ready BFS Engineering
Pharmaceutical manufacturing equipment must operate within a controlled and documented environment.
Friscohn incorporates 21 CFR-related requirements and pharmaceutical engineering considerations into BFS machine refurbishment, modernization, automation and turnkey project solutions where applicable.
Our objective is to help customers develop compliance-ready BFS systems aligned with their process, validation and regulatory requirements.
Supporting Modern Pharmaceutical Manufacturing
When an existing BFS machine is refurbished or modernized, compliance considerations can extend beyond mechanical performance.
They may include:
Control system modernization
PLC & HMI architecture
User access management
Electronic records and data handling
Audit trail functionality
Alarm and event management
Recipe and parameter control
Data integrity considerations
System documentation
Equipment configuration management
FAT / SAT support
Validation documentation support
21 CFR Part 11 Considerations
Where electronic records and electronic signatures are applicable, BFS automation and control systems may require consideration of 21 CFR Part 11 requirements.
Friscohn can incorporate relevant control-system and automation considerations into modernization projects based on the customer's URS, validation strategy and applicable regulatory requirements.
Compliance Starts with Engineering
Modernizing a BFS machine is not only about replacing obsolete components.
The engineering process should consider:
User Requirements → System Design → Controls & Automation → Data Handling → Documentation → Testing → Validation
Friscohn works with customers to align the engineering scope with their pharmaceutical manufacturing and validation requirements.
Supporting Existing BFS Machines
For established Rommelag, Weiler and Brevetti Angela BFS machines, modernization may provide an opportunity to address obsolete controls, improve system architecture and introduce contemporary automation capabilities while retaining the value of the existing equipment platform.
Compliance-Ready. Engineering-Led.
Friscohn brings together:
BFS Equipment
Engineering Design
Automation & Controls
Refurbishment & Modernization
Mould & Tooling
Turnkey Project Support
to create BFS solutions designed around the customer's technical and regulatory requirements.
Discuss Your BFS Modernization Requirement
Talk to Friscohn →
Engineering Better BFS Performance
Trademark Disclaimer
Rommelag, Weiler and Brevetti Angela are trademarks of their respective owners. Friscohn is an independent company and is not affiliated with, sponsored by, authorized by, or endorsed by these manufacturers, unless expressly stated. All other trademarks and brand names referenced on this website remain the property of their respective owners.
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