In the pharmaceutical and food industries, sanitary valves are the core equipment to ensure product safety and compliant production. Its design needs to meet strict health standards (such as GMP, FDA, EC1935/2004), and prevent microbial pollution, cross-contamination and chemical migration through material selection, structural design, cleaning and maintenance and other multi-dimensional guarantees. It is the "safe" that runs through the whole process of raw material processing, production and processing, filling and packaging. The whole gate". 

 Core characteristics and standard requirements 

 1. The material is non-toxic and corrosion-resistant 

 The main body is mostly made of 316L stainless steel (corrosion-resistant and easy to clean), and PTFE, EPDM, FDA-certified silicone and other non-toxic materials are used for the diaphragm/seal to avoid the precipitation of metal ions or the migration of harmful substances. For example, pharmaceutical valves need to pass the USP Class VI biocompatibility test to ensure that there is no reaction in direct contact with drugs. 

 Surface treatment requirements are high: the inner wall is polished to Ra≤0.6μm (mirror level) to reduce media residue; the outer surface is anti-rust treatment to adapt to the high-temperature and high-pressure environment of CIP/SIP (in-situ cleaning/steam sterilization). 

 2. Structure design without dead angle 

 Adopt a streamlined flow channel (such as spherical valve cavity, bevel design) to eliminate grooves, threads and other areas that are easy to hide dirt. For example, the "full diameter" design of the sanitary ball valve ensures that the fluid passes through without obstruction; the "filler-free" structure of the diaphragm valve prevents the medium from seeping into the stem gap. 

 The modular design supports rapid disassembly, such as clamp connections and sleeve joints, which are convenient for online cleaning (CIP) and sterilization (SIP) to reduce the risk of pollution caused by manual intervention. 

 3. Sealing and leakage control 

 The double sealing design (such as diaphragm + seat seal) ensures zero leakage and meets the ISO 5208/API 598 standard. For example, the feed valve of the pharmaceutical reactor needs to withstand high-frequency opening and closing without dripping to prevent waste or pollution of valuable raw materials. 

 The pneumatic/electric actuator is isolated from the medium to avoid corrosive gas or liquid erosion of the drive parts, extend the life of the equipment and ensure the safety of operation. 

 4. Traceability and verification support 

 The valve needs to be equipped with material certificate, surface roughness test report, sterilization verification record and other documents to support the electronic record requirements of FDA 21 CFR Part 11. For example, sterile filling line valves in biopharmaceuticals need to pass FAT (factory acceptance test) and SAT (on-site acceptance test) to ensure that each batch of production meets the process parameters. 

 Application scenarios in the pharmaceutical industry 

 ● API production: In synthetic reaction, crystallization, filtration and other processes, the sanitary valve controls the precise flow rate of acid and alkali, solvent and catalyst to prevent cross-contamination. For example, in the production of antibiotics, the diaphragm valve is used to transport high-concentration culture medium to avoid metal ions from affecting the activity of bacteria. 

 ● Agent filling: In the sterile filling line, the sanitary ball valve or diaphragm valve is used to control the opening and closing of the drug solution, injection water and nitrogen protective gas to ensure that there is no microbial invasion during the filling process. For example, the filling of Xilin bottles in vaccine production needs to be sterilized by SIP, and the valve needs to withstand high-temperature steam at 121℃. 

 ● Public system: in purified water, injection water and compressed air pipelines, sanitary valves ensure the purity of the medium. For example, the WFI (injection water) system adopts 316L stainless steel valves with regular CIP/SIP to ensure that the water quality meets the USP standard. 

 Application scenarios in the food industry 

 ● Dairy processing: In the process of milk sterilization, homogenization and filling, the sanitary valve controls the flow of high-temperature milk and CIP cleaning liquid. For example, the valve in the UHT (ultra-high temperature instantaneous sterilization) system needs to withstand high temperatures above 135℃, and is designed without dead angles to avoid milk burning residue. 

 ● Beverage production: In the production line of carbonated drinks and juices, the valves need to adapt to sugary and acidic media, and at the same time meet the needs of high-frequency opening and closing. For example, the PET bottle filling valve adopts a pneumatic diaphragm valve to ensure that it opens and closes several times per second without leakage, and is easy to clean and residue-free. 

 ● Brewing and seasonings: The feed/outlet valves of beer fermentation tanks and soy sauce aging tanks should be corrosion-resistant, high-temperature-resistant, and support CIP cleaning. For example, the beer malt pulp conveying valve adopts a polished stainless steel ball valve to reduce the adhesion of bacteria and ensure the stability of the product flavor. 

 Key values and industry impact 

 ● Compliance and brand trust: Sanitary-grade valves that meet GMP, FDA and other standards are the basis for pharmaceutical/food enterprises to obtain market access through audits. For example, the European Union EC1935/2004 requires that food contact materials need to pass the migration test, and unqualified valve materials will lead to product recall. 

 ● Production efficiency and cost optimization: easy-to-clean and corrosion-resistant characteristics reduce downtime and maintenance costs. For example, after a dairy company adopts modular sanitary valves, the CIP cycle is shortened by 30%, saving millions of yuan in annual production costs. 

 ● Product safety and consumer protection: prevent microbial pollution and chemical migration, and ensure the efficacy of drugs and food safety. For example, in 2018, a pharmaceutical company caused a batch of drugs to be contaminated due to the failure of the valve seal, which triggered a large-scale recall, highlighting the importance of sanitary valves. 

 Future trends and innovation directions 

 ● Intelligence and digitalization: integrate sensors and Internet of Things technology to realize real-time monitoring and predictive maintenance of valve status. For example, intelligent sanitary valves can feedback opening, temperature and pressure data, and support production data traceability and process optimization. 

 ● Application of new materials: Develop more corrosion-resistant, high-temperature-resistant and adhesive coating materials (such as ceramic coatings, nanocomposites) to extend the service life of the valve. For example, the improved material of PTFE diaphragm can withstand higher temperatures and chemical corrosion. 

 ● Green manufacturing and sustainability: promote the lightweight design of valves and the application of recyclable materials to reduce resource consumption and environmental pollution in the production process. For example, 3D printing technology is used to make complex channel structures to reduce material waste. 

 Sanitary valves are not only the "gatekeepers" of the pharmaceutical and food industries, but also the "lifeline" to ensure product quality, patient safety and consumer health. With the progress of technology and the tightening of regulations, its design, materials and intelligence levels will continue to be upgraded, providing solid support for the high-quality development of the industry.