Surface Finish Integrity
All fluid paths and tablet tooling undergo electro-passivation, achieving surface finishes polished to Ra under 0.38 microns. Every contact heat includes full mill test certification and metallurgical origin logs.
Zero-dead-leg valves and crevice-free mechanical joints eliminate micro-bacterial traps, guaranteeing complete clean-in-place cycles under 45 minutes.
Compliance Guarantee
Encrypted Audit Trail Compliance
Multi-tier user permissions, automated batch record generation, and continuous tamper-evident logging standard across all PLC controllers.
Audit Performance
FDA Inspection Results
Vektra FAT validation package cleared our QA review in 48 hours. Zero observations during our FDA pre-approval inspection.
Dr. Marcus Vance, VP Quality Assurance
The 21 CFR Part 11 audit trails integrated directly into our MES without custom middleware. Essential for our batch releases.
Elena Rostova, Director of Compliance
Receive full sample FAT/SAT validation protocols, material mill certificates, and software validation scripts for your engineering team.