Food Grade ZX Series Candle Filter for Beverage & Brewing Clarification

The ZX Series self-cleaning candle filter is a GMP-compliant, fully enclosed precision clarification system engineered for pharmaceutical API and intermediate purification. All product-contact surfaces are constructed from 316L stainless steel with electropolished finish Ra ≤ 0.4 μm, meeting FDA 21 CFR Part 211 and EU GMP Annex 1 guidelines. The system supports integrated CIP/SIP for validated cleaning and sterilization between batches.

• 316L Electropolished Product-Contact Surfaces: All wetted parts constructed from pharmaceutical-grade 316L SS with Ra ≤ 0.4 μm electropolished finish, eliminating contamination risks and ensuring full drainability with sanitary tri-clamp connections throughout.
• GMP/FDA Compliant Enclosed Design: Fully sealed system designed per FDA 21 CFR Part 211, EU GMP Annex 1, and ICH Q7 guidelines for API manufacturing. Comprehensive documentation packages (DQ/IQ/OQ/PQ) available for regulatory filing.
• Integrated CIP/SIP System: Built-in Clean-in-Place spray balls with detergent and WFI (Water for Injection) circulation, plus Steam-in-Place capability validated to 121°C for 30 minutes, enabling fully documented cleaning cycles without vessel disassembly.
• Filter Cake Washing & Drying: Recover maximum API yield through controlled multi-stage cake washing and vacuum/heat drying directly in the filter vessel, reducing product loss during intermediate isolation steps.
• Sterile Gas Backflush: Pharmaceutical-grade nitrogen or compressed air backflush for aseptic dry cake discharge into containment isolators or gloveboxes.
• 21 CFR Part 11 Batch Documentation: PLC with audit trail records all process parameters (pressure, temperature, flow, cycle times) for electronic batch record compliance and regulatory submission.

• API crystal recovery and washing after crystallization
• Activated carbon decolorization of pharmaceutical intermediates
• Catalyst removal from hydrogenation reactions (Pd/C, Pt/C recovery)
• Clarification filtration prior to sterile membrane filtration
• Fermentation broth clarification and biomass separation