Application
Pharmaceutical
Advanced Valve Solutions for Pharmaceutical Critical Processes – Powered by COVNA
In pharmaceutical manufacturing, precision, sterility, and regulatory compliance are non-negotiable. COVNA offers a full spectrum of high-performance valve technologies specifically engineered for critical pharmaceutical applications—ensuring safe, efficient, and validated fluid control across the entire drug production lifecycle.
In bioprocessing systems, our tri-clamp diaphragm valves with ultra-smooth 0.001 Ra surface finishes are the standard in fermentation vessels, minimizing microbial adhesion. Multi-port valve configurations reduce cross-contamination to below 0.5% in chromatography applications, while SIP/CIP-capable sterile barrier valves enable integrity testing in viral filtration systems—ensuring robust performance under strict aseptic conditions.
During sterile formulation, our cold trap isolation valves maintain operational stability down to -80°C, essential for lyophilization stages. For high-viscosity ointment lines, jacketed mix-proof valves allow precise thermal control and hygienic transfer. In injectable preparations, steam-barrier protected double-seat valves provide an added layer of sterility in high-risk environments.
When it comes to final product handling, we supply RTP-compliant butterfly valves that meet ISO 14644-1 Class 5 cleanroom standards for aseptic filling lines. Freeze-drying operations benefit from our ultra-high vacuum valves capable of achieving leakage rates as low as 10⁻⁷ mbar. For packaging areas, cleanroom-certified pneumatic actuators support ISO Class 7 compliance for particle-sensitive operations.
COVNA's commitment to material science excellence is evident in every component. All wetted parts are fabricated from ASTM A270 316L-EP stainless steel with Ra ≤0.25μm surface finish and full compliance to ASME BPE 2022 standards. PTFE-encapsulated spring seals combined with FDA-grade FKM elastomers ensure chemical resistance and biocompatibility. All surface treatments follow ASTM A967 Nitric 5 electropolishing and passivation protocols, and we provide full PMI traceability with EN 10204 3.2 certification.
Our solutions are already validated in the field, with over 850 valves supplied to Roche’s monoclonal antibody (mAb) production lines—demonstrating zero contamination findings over three consecutive FDA audit cycles.
In line with Pharma 4.0, COVNA valves support smart manufacturing integration. Our 21 CFR Part 11-compliant systems offer blockchain-secured electronic valve cycle logs and automated sterilization verification (including F0 value tracking). PAT-enabled models feature in-line USP <645> conductivity monitoring, real-time TOC detection with 0–50 ppb sensitivity, and SCADA-triggered pressure decay testing.
Our containment technologies meet OEB Level 5 standards, including double-bellows stem seals with leakage containment below 1μg/m³ and split-body designs that allow safe, isolated maintenance.
COVNA aligns with the industry's global compliance matrix, adhering to ISO 13485:2016, EU GMP Annex 1 (2022), and PIC/S PE 009-14 standards. Our materials pass USP Class VI biocompatibility, EP 3.1.9 extractables/leachables testing, and are suitable for WFI (Water for Injection) systems under EP 2.2.38.
Beyond compliance, we support sustainable manufacturing with CleanSteam™-compatible designs, recyclable material tagging, and HTM 2031 adherence.
The COVNA Pharma Value Proposition is built on:
✅ Risk Mitigation – pFMEA-optimized designs, 100% helium leak tested to 1×10⁻⁹ mbar·L/s
✅ Operational Efficiency – 60-second clamp-to-clamp changeovers and 360° radial port accessibility
✅ Global Support – 24/7 CSV service, FAT/SAT protocols aligned with GAMP 5
✅ Innovation – Single-use assembly R&D and AI-driven predictive maintenance models
From upstream to final fill, COVNA is your trusted partner in building safer, smarter, and fully compliant pharmaceutical manufacturing lines.
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