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{"title":"TL Series Industrial Pressure Cartridge Filter for Petrochemical, Paint, Ink and","imgUrl":"https:\/\/img.chinax.com\/nimg\/da\/3d\/a5a3386b5be1393cca209ac70584-200x200-1\/tl_series_industrial_pressure_cartridge_filter_for_petrochemical_2c_paint_2c_ink_and_oil_processing_applications.jpg","attrs":{"Minimum Order Quantity":"1 Set","Price":"USD 500-5000 \/ Set","Filtration Precision":"0.5-100 \u03bcm","Inlet\/Outlet Size":"DN40-DN100 (customizable)"}}
{"title":"Customized Candle Filter Purification 15um 25um Candle Filter For Pharma","imgUrl":"https:\/\/img.chinax.com\/nimg\/2b\/87\/d0fc6694134438f60dbb3b4b13ff-200x200-1\/customized_candle_filter_purification_15um_25um_candle_filter_for_pharma.jpg","attrs":{"Certification":"CE ISO","Payment Terms":"T\/T, L\/C","Supply Ability":"40 set \/ months","Delivery Time":"60 working days"}}
{"title":"DL Series Food\u2011Grade Stainless Steel Precision Bag Filter for Food and Beverage","imgUrl":"https:\/\/img.chinax.com\/nimg\/4f\/73\/e226d420663d71a1172ab4e59b19-200x200-1\/dl_series_food_e2_80_91grade_stainless_steel_precision_bag_filter_for_food_and_beverage_industry.jpg","attrs":{"Certification":"ISO 9001:2015, CE, FDA Compliant Materials","Payment Terms":"T\/T,L\/C,Western Union","Supply Ability":"200 Sets per Month","Design Pressure":"0.4 MPa"}}
{"title":"DL Series Compact Closed-Loop Bag Filter with Integrated Reinforced Mesh Basket","imgUrl":"https:\/\/img.chinax.com\/nimg\/f8\/39\/762103c98f531146d674c5966da7-200x200-1\/dl_series_compact_closed_loop_bag_filter_with_integrated_reinforced_mesh_basket.jpg","attrs":{"Model Number":"DL-1P1S","Delivery Time":"7-15 working days","Micron Rating Range":"1-800 microns","Flow Rate":"10-640 m3 per hour"}}
{"title":"Food Grade ZX Series Candle Filter for Beverage & Brewing Clarification","imgUrl":"https:\/\/img.chinax.com\/nimg\/0a\/43\/66e7550f2b618273ec58121f1479-200x200-1\/food_grade_zx_series_candle_filter_for_beverage_26_brewing_clarification.jpg","attrs":{"Minimum Order Quantity":"1 Set","Model Number":"ZX-CF-BV-30","Price":"USD 5,000-50,000 \/ Set","Payment Terms":"T\/T,L\/C,Western Union"}}
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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.
Juneng Machinery Group comprises Juneng Machinery (China) Co., Ltd., Jiangsu Juneng Machinery Co., Ltd., Jiangsu Hexiang Biochemical Equipment Co., Ltd., and Liaoning Fuyi Machinery Co., Ltd. It primarily engages in the research, development, manufacturing, and application of filtration and se...
Juneng Machinery Group comprises Juneng Machinery (China) Co., Ltd., Jiangsu Juneng Machinery Co., Ltd., Jiangsu Hexiang Biochemical Equipment Co., Ltd., and Liaoning Fuyi Machinery Co., Ltd. It primarily engages in the research, development, manufacturing, and application of filtration and se...