一．Product Introduction
The In-line Sterilization Sampling Valve is a specialized device engineered for seamless integration into continuous process lines, enabling sterile sample collection while supporting in-line sterilization (e.g., steam-in-place, SIP) without disrupting the production workflow. It is widely used in pharmaceutical, biotech, and high-purity food & beverage industries, where maintaining process sterility and sample integrity is critical for regulatory compliance and product quality.
Designed to eliminate dead spaces and minimize contamination risks, this valve allows for repeated sterilization cycles directly within the pipeline, ensuring that both the valve and the sampled medium remain free from microbial or particulate contaminants. Its robust construction and compatibility with automated process systems make it ideal for high-throughput production environments requiring strict adherence to GMP, FDA, and EMA standards.
二．Product Features
- In-line Sterilization Capability: Integrates with SIP (steam-in-place) or CIP (clean-in-place) systems, enabling thorough sterilization of internal surfaces without removing the valve from the pipeline, reducing downtime and operational complexity.
- Sterility Maintenance: Features a crevice-free, self-draining design with smooth polished surfaces (Ra ≤ 0.8 μm) to prevent residue buildup and microbial growth, ensuring long-term sterility between sampling cycles.
- Contamination-Free Sampling: Equipped with a sealed actuation mechanism (e.g., pneumatic or electric drive) that isolates the operator from the process stream, eliminating manual contact risks and ensuring sample purity.
- High-Temperature and Pressure Resistance: Constructed to withstand SIP temperatures (up to 134°C) and process pressures, maintaining seal integrity and structural stability during repeated sterilization cycles.
- Regulatory Compliance: Built with 316L stainless steel wetted parts and FDA-approved seals (PTFE, EPDM), meeting global standards such as GMP, FDA 21 CFR Part 11, and ASME BPE for high-purity applications.
- Seamless Process Integration: Compatible with sanitary pipeline connections (tri-clamp, SMS) and adaptable to automated control systems, supporting real-time sampling in continuous production lines.
三．Technical Data
| Parameter | Specification |
|---|---|
| Wetted Material | 316L Stainless Steel (Hastelloy C276 optional) |
| Connection Type | Tri-Clamp (DN15–DN40), SMS, or sanitary flange |
| Max Operating Temperature | -10°C to 140°C (SIP: 134°C @ 3 bar for 30 min) |
| Max Operating Pressure | 16 bar (232 psi) |
| Seal Material | PTFE (temperature-resistant) or EPDM (food-grade) |
| Actuation Type | Pneumatic (preferred for in-line systems), Electric, or Manual (lever) |
| Sterilization Method | SIP (steam-in-place) compatible; CIP-ready |
| Sampling Volume Range | 10–1000 mL (adjustable via flow control) |
| Surface Finish (Wetted Parts) | Ra ≤ 0.8 μm (electropolished optional) |
| Compliance | FDA, GMP, EMA, ASME BPE, ISO 13485 |