一．Product Introduction
The Sterile Sampling Valve is a precision-engineered device designed for contamination-free sample collection in highly regulated industries such as pharmaceuticals, biotechnology, food & beverage, and cosmetics. It is specifically engineered to maintain sterility throughout the sampling process, ensuring that samples remain unaltered by external contaminants and accurately reflect the quality of the process stream.
Ideal for use in sterile pipelines, bioreactors, or storage vessels, this valve eliminates dead spaces where bacteria or residues could accumulate, adhering to strict hygiene standards (e.g., FDA, EMA, GMP). Its design allows for aseptic sampling without disrupting the integrity of the closed process system, making it critical for applications where product purity and regulatory compliance are non-negotiable.
二．Product Features
- Sterility Assurance: Constructed with smooth, crevice-free surfaces and sanitary-grade materials to prevent microbial growth, ensuring no cross-contamination between samples or the process stream. Compatible with steam-in-place (SIP) and clean-in-place (CIP) protocols for easy sterilization.
- Dead Space Elimination: Optimized internal geometry (e.g., self-draining design) eliminates hidden areas where product residues could accumulate, reducing the risk of bacterial growth and ensuring sample accuracy.
- High-Quality Materials: Wetted parts made from 316L stainless steel (or higher-grade alloys like Hastelloy) with FDA-approved seals (PTFE, EPDM) to resist corrosion, chemical degradation, and maintain sterility.
- Aseptic Operation: Features a sealed actuation mechanism (e.g., encapsulated lever or pneumatic drive) to prevent operator contact with the process stream, minimizing contamination risks during sampling.
- Regulatory Compliance: Designed to meet global standards such as FDA 21 CFR Part 11, GMP, and EMA guidelines, ensuring suitability for use in highly regulated industries.
- Versatile Integration: Compatible with sanitary connections (e.g., tri-clamp, SMS) and adaptable to various pipeline sizes, supporting both manual and automated sampling workflows.
三．Technical Data
| Parameter | Specification |
|---|---|
| Wetted Material | 316L Stainless Steel (Hastelloy optional) |
| Connection Type | Tri-Clamp (DN15–DN50), SMS, or sanitary flange |
| Max Operating Temperature | -20°C to 140°C (SIP: up to 134°C for 30 minutes) |
| Max Operating Pressure | 10 bar (145 psi) |
| Seal Material | PTFE (food-grade, chemical-resistant) or EPDM |
| Actuation Type | Manual (lever), Pneumatic, or Electric |
| Sterilization Compatibility | SIP (steam-in-place) and CIP (clean-in-place) |
| Sampling Volume Range | 5–500 mL (adjustable via valve control) |
| Compliance | FDA, GMP, EMA, ASME BPE |