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.