industry pain points
– Pharmaceutical processes have extremely high requirements for fluid purity, necessitating strict control over impurities such as microorganisms and particulates to avoid drug contamination;
– The equipment must comply with international compliance standards such as GMP and FDA, with stringent requirements for surface finish and material safety;
– Pharmaceutical processes are mostly batch-based, with frequent cleaning and disinfection of equipment, necessitating the assurance of the equipment’s ease of cleaning and disinfection resistance.
Core content of the solution
1. Sanitary filtration system: We develop sanitary filter cartridges that comply with GMP and FDA standards (available in 316L stainless steel, PTFE, and polypropylene). Utilizing hot melt welding technology, our filters are free of dead spaces and leaks, with a filtration accuracy of up to 0.22μm. They effectively retain impurities such as microorganisms, bacteria, and particulates, ensuring the purity of pharmaceuticals. We offer sterilization filters and liquid precision filters, suitable for various process steps including active pharmaceutical ingredient production and formulation filling.
2. Compliant valve products: We produce sanitary quick-release ball valves and diaphragm valves, with a surface roughness of Ra≤0.8μm. Adopting a design without dead spaces, they can achieve CIP (Cleaning in Place) and SIP (Sterilization in Place), withstand high-temperature sterilization at 135℃, and fully meet the hygiene requirements of the pharmaceutical industry. The valve materials have all passed FDA certification, ensuring no migration pollution when in contact with drugs.
3. Full-process compliance assurance: Provide a complete equipment compliance document package, including material certification, performance testing reports, GMP validation guidelines, cleaning validation schemes, etc. The equipment production process strictly follows the ISO 13485 quality management system to ensure that each piece of equipment is traceable.
4. Customized adaptation: Based on the batch production capacity and process parameters of pharmaceutical companies, we customize the specifications and interface forms of filtration and valve systems, adapting to different production equipment and process layouts to enhance equipment compatibility.
Solution Advantages
Fully compliant with international standards such as GMP and FDA, the risk of drug contamination is nearly eliminated, equipment cleaning and disinfection efficiency is increased by 40%, and batch production stability is enhanced, all of which assist pharmaceutical companies in successfully passing compliance audits.
