Food Grade ZX Series Candle Filter for Beverage & Brewing Clarification
Price:
USD 5,000-50,000 / Set
MOQ:
1 Set
Delivery Time:
25-45 working days after order confirmation
Brand:
Juneng Machinery
Product Description
Food Grade ZX Series Candle Filter for Beverage & Brewing Clarification
ZX Series Candle Filter for Pharmaceutical API & Intermediate Purification
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.
Key Features
- 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.
Applications in Pharmaceutical Industry
- 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
Technical Specifications
| Model | ZX-CF-PH-5 | ZX-CF-PH-15 | ZX-CF-PH-30 |
|---|---|---|---|
| Filtration Area (m²) | 5 | 15 | 30 |
| Flow Rate (m³/h) | 3-5 | 8-15 | 15-30 |
| Filter Element Qty | 6 | 19 | 37 |
| Operating Pressure | 0.1-0.6 MPa | ||
| Product-Contact Material | SS 316L (Electropolished, Ra ≤ 0.4 μm) | ||
| Housing Material | SS 316L (Electropolished Interior) | ||
Frequently Asked Questions
Q1: Is the ZX Series compliant with FDA and EU GMP requirements for API manufacturing?
Yes. The pharmaceutical-grade ZX Series is designed with GMP principles throughout: 316L electropolished product-contact surfaces (Ra ≤ 0.4 μm), sanitary tri-clamp connections, full drainability, integrated CIP/SIP compatibility, and comprehensive batch documentation with audit trail. Full DQ/IQ/OQ documentation packages are provided for regulatory submission.
Q2: Can the filter be validated for sterile filtration of injectable-grade products?
The ZX Series candle filter is designed for clarification and bulk intermediate filtration. For terminal sterile filtration (0.22 μm), we recommend a downstream validated membrane filter. Our system provides reliable pre-filtration that significantly extends the service life of sterile membrane filters by removing the particulate load upstream.
Q3: How is cross-contamination prevented between different API product batches?
The system supports fully automated CIP sequences with spray balls, detergent circulation, and WFI rinsing. SIP validation at 121°C for 30 minutes ensures sterility between batches. All product-contact surfaces are 316L electropolished (Ra ≤ 0.4 μm) to minimize residue adhesion. Cleaning validation protocols can be developed as part of the qualification package.
Q4: Can the PLC integrate with our site-wide SCADA or MES system?
Yes. The ZX Series PLC supports standard industrial communication protocols including Modbus TCP, Profibus, and Ethernet/IP. Batch data can be exported to CSV/PDF or integrated directly with your Manufacturing Execution System (MES) for CFR 21 Part 11 electronic records and electronic signature compliance.
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Company
Juneng Machinery (China) Co., Ltd.
Location
Chaoyang Road, Zhotie Town,Yixing City Jiangsu Province.China
Contact Person
Doris.zhou