Pharmaceutical / Medical Equipment Solutions
Strict GMP compliance requirements […]
Industry Pain Points
Strict GMP compliance requirements: Pharmaceutical production demands extremely high compressed air cleanliness, meeting GMP standards with strict limits on moisture, oil, and microorganism content.
Microorganism contamination risk: Moisture and oil in compressed air can become breeding grounds for microorganisms, leading to drug contamination and endangering patient safety.
Validation documentation & traceability: The pharmaceutical industry requires complete equipment validation documents (IQ/OQ/PQ), material certificates, and test reports, which ordinary suppliers struggle to provide.
Aseptic process requirements: Sterile drug production demands strict sterility of compressed air, requiring sterile-grade filters with regular validation.
Solutions
Combined drying + filtration integrated system: Use combined dryers with multi-stage precision filtration (including sterile filters), ensuring oil-free, sterile, ultra-low dew point air supply compliant with GMP standards.
Stainless steel material & electropolishing: Dryer and filter housings adopt 304/316L stainless steel with internal electropolishing to prevent microorganism adhesion, meeting cleanroom requirements.
Complete validation documentation package: Provide mechanical test reports, material certificates, pressure vessel certificates, IQ/OQ validation protocols and other complete documents, supporting customer audits and validation.
Sterile filtration & integrity testing: Equip with 0.01μm sterile-grade filters, supporting online or offline integrity testing to ensure sterile process air safety.
Recommended Products
Combined Air Dryer—DM110ZHMR
Micro-Heated Desiccant Air Dryer—DM15MR / DM40MR
Refrigerated Air Dryer—DM015APF / DM026APF
Stainless Steel Precision Filter
Recommended Equipment
Optimized hardware for Pharmaceutical / Medical Equipment applications.
Explosion-Proof Air Dryer