Introduction:
Aseptic flanges (also known as sanitary flanges) are pipe/equipment connection components designed specifically for aseptic production scenarios. Their core purpose is to ensure that the connection parts are free of dead corners and residues and can be sterilized. They are widely used in industries with extremely high requirements for hygiene and sealing, such as pharmaceuticals, vaccines, bioengineering, dairy products, and food.
Core Structure and Design Features
Material Selection: The main body is mostly made of 316L stainless steel (corrosion resistant, no heavy metal leaching). Electrolytically polished 316L stainless steel is used in some high-end applications to ensure material hygiene and safety.
Structural Design: A dead-angle-free sealing structure is adopted. The flange sealing surface is mostly raised face (RF) or flat butt joint type, combined with sanitary gaskets (such as PTFE, EPDM materials) to avoid media residue and microbial growth.
Connection Method: Sealing is achieved through bolt tightening. The bolt holes are evenly distributed to ensure balanced force and a tight seal, eliminating the risk of leakage.
Surface Treatment: The inner surface roughness Ra≤0.4μm (some aseptic grades require Ra≤0.38μm). The outer surface can be matte or polished for easy cleaning and disinfection.
Core features and advantages
**Sterility Compliance:** Meets GMP, FDA, USP, and other industry standards. Connections are free of dents and blind pipes. Supports Clean-in-Place (CIP) and Sterilization-in-Place (SIP) to meet aseptic production requirements.
**Reliable Sealing Performance:** Gaskets fit tightly to the sealing surface, resulting in extremely low leakage rates. Effectively isolates external contaminants and prevents leakage of toxic, corrosive, or high-purity media.
**Adaptability to Harsh Operating Conditions:** Withstands high temperatures (typically -20~150℃, up to 121~135℃ in sterilization conditions) and high pressures (typically 0.1~1.6MPa). Compatible with various media including water, acid and alkali cleaning agents, and disinfectants.
**Easy Maintenance:** Simple structure, easy disassembly and assembly, facilitating regular cleaning, gasket replacement, and equipment maintenance without disrupting production continuity.
Main types and applicable scenarios
Welded aseptic flange:Flanges are welded to pipes/equipment, providing stronger sealing and eliminating the risk of loosening. They are suitable for long-term operation scenarios where frequent disassembly is not required (e.g., pharmaceutical reactor interfaces, dairy storage tank outlets).
Quick-install aseptic flanges: These use clamps for quick fastening, offering high disassembly efficiency and facilitating daily cleaning and maintenance. They are suitable for pipe connections requiring frequent disassembly and assembly (e.g., vaccine production equipment interfaces, food preparation tank piping).
Threaded aseptic flanges: These use sanitary threaded connections, featuring a compact structure. They are suitable for small-diameter pipes (typically DN≤50) or space-constrained scenarios (e.g., laboratory equipment, small fermenters).
Typical Application Industries:
Pharmaceutical/Vaccine Industry: Connections to aseptic mixing tanks, fermentation tanks, and injection production line piping to ensure drug sterility and purity.
Biotechnology Industry: Connections to cell culture reactors, culture medium delivery pipelines, and interfaces for biological product purification equipment to prevent microbial contamination.
Dairy/Food Industry: Connections to yogurt fermentation tanks, ultra-high temperature sterilizer piping, and aseptic filling equipment to prevent cross-contamination.
Cosmetics Industry: Connections to aseptic serum storage tanks and emulsification kettle discharge pipelines to meet cosmetic hygiene and safety standards.
