Application

Pharmaceutical Critical Process Applications

1. Bioprocessing Systems

• Fermentation Vessels: Tri-clamp diaphragm valves with 0.001 Ra surface finish

• Chromatography: Multi-port valves with ≤0.5% cross-contamination risk

• Viral Filtration: Integrity-testable sterile barrier valves (SIP/CIP capable)

2. Sterile Formulation

• Lyophilization: Cold trap isolation valves (-80°C operational stability)

• Ointment Lines: Jacketed mix-proof valves for high-viscosity transfer

• Injectable Prep: Double-seat valves with steam barrier protection

3. Final Product Handling

• Aseptic Filling: RTP-compliant butterfly valves (ISO 14644-1 Class 5)

• Freeze-Drying: Ultra-high vacuum valves (10^-7 mbar leakage rate)

• Packaging: Cleanroom-certified pneumatic actuators (ISO Class 7)

Material Science Excellence

*Validation Case: Supplied 850+ valves for Roche’s mAb production line, achieving zero contamination findings through 3-year FDA audit cycles.*

Smart Pharma 4.0 Integration

Data Integrity Assurance

• 21 CFR Part 11 compliant electronic records:
  • Valve cycle counters with blockchain-secured logs
  • Sterilization parameter auto-verification (F0 value tracking)

Process Automation

• PAT-enabled models with:
  • In-line conductivity monitoring (USP <645>)
  • Real-time TOC detection (0-50 ppb sensitivity)
  • Pressure decay test initiation via SCADA

Containment Technologies

• OEB Level 5 containment valves:
  • Double bellows stem seals (≤1μg/m³ leakage)
  • Split-body design for contained maintenance

Global Compliance Matrix

Quality Systems

• ISO 13485:2016 Medical device QMS

• EU GMP Annex 1 (2022) particulate control

• PIC/S PE 009-14 (Part II) validation

Material Certifications

• USP Class VI biocompatibility testing

• EP 3.1.9 Extractables/Leachables profiles

• WFI compatibility (EP 2.2.38/Ph.Eur. 0169)

Sustainability

• CleanSteam™ compatible (HTM 2031 compliant)

• 100% recyclable material tagging

COVNA Pharma Value Proposition
✅ Risk Mitigation

• FMEA-based valve design (pFMEA score <50)

• 100% helium leak tested (1×10^-9 mbar·L/s)

✅ Operational Efficiency

• 60-second clamp-to-clamp changeover

• 360° radial port accessibility

✅ Global Support

• 24/7 CSV (Computer System Validation) support

• FAT/SAT protocols aligned with GAMP 5

✅ Innovation Pipeline

• Single-use assembly prototypes

• AI-driven predictive maintenance models