Fully Automatic Washer
A GMP-compliant intelligent washer delivering ≤10 ppm residue, ≥99.99% microbial removal, and full traceability for vials, filters, and bioprocessing components—ideal for global sterile manufacturing.
This advanced intelligent cleaning system is purpose-built for pharmaceutical and biotech facilities to deliver validated, residue-free, and microbiologically safe cleaning of critical process equipment. It achieves 100% cleaning pass rates, removing proteins, sugars, lipids, and drug residues to levels ≤10 ppm, fully compliant with GMP cleanliness standards.
The system combines high-pressure spray (0.3–0.8 MPa) with optional ultrasonic cleaning, ensuring cleaning blind spots ≤0.1%—even on complex geometries like filling nozzles, valves, filter housings, and internal pipe walls. Microbial reduction ≥99.99% is achieved via integrated hot water (85–95°C), steam (121°C), or chemical disinfection (H₂O₂/peracetic acid), meeting stringent aseptic production requirements.
Post-cleaning surfaces are spot-free, odorless, and non-wetting, with residual moisture ≤0.2% after drying. All wetted parts use 316L stainless steel and PTFE, certified to USP Class VI, with zero leachables and adsorption ≤0.1%. Cleaning parameters are tightly controlled: water temperature ±1°C, spray time error ≤±10 sec, and cleaning agent dosing accuracy ≤±1%.
Equipped with real-time online monitoring of pH, conductivity, and TOC, the system validates cleaning efficacy in real time. It supports gentle yet effective cleaning of precision components, preventing scratches and preserving seal integrity.
Fully compliant with GMP, FDA 21 CFR Part 11, EU GMP Annex 1, and ASME BPE, it features tamper-proof EBR, Ra ≤0.4 μm surface finish, and full traceability via barcode/QR code linking object, batch, and process data. With capacities from 500 to 20,000 units/hour, it handles vials (1–1000 mL), IV bags (50–2000 mL), pipes (Φ10–100 mm), and more.
Operated via PLC + touchscreen, it offers 100+ encrypted cleaning recipes, remote monitoring, self-diagnosis, and integrated wash-disinfect-dry cycles. Energy and water savings exceed 30% through heat recovery and recirculation. Backed by CE, ISO 9001, and modular design, this system ensures safe, efficient, and audit-ready cleaning across R&D, pilot, and commercial-scale operations worldwide.
| Category | Specification / Feature |
|---|---|
| Cleaning Efficacy | Residue ≤10 ppm; 100% pass rate; removes proteins, lipids, sugars, APIs |
| Cleaning Modes | High-pressure spray (0.3–0.8 MPa) + optional ultrasonic; blind zones ≤0.1% |
| Microbial Reduction | ≥99.99%; via hot water (85–95°C), steam (121°C), or chemical (H₂O₂/peracetic acid) |
| Post-Cleaning Quality | No water spotting, stains, or odor; residual moisture ≤0.2% |
| Wetted Materials | 316L SS, PTFE; USP Class VI; no leachables; adsorption ≤0.1% |
| Process Control | Temp ±1°C; spray time error ≤±10 sec; cleaning agent dosing ±1% |
| Real-Time Monitoring | Online pH, conductivity, TOC sensors for cleaning validation |
| Component Compatibility | Gentle cleaning for filling heads, valves, filters—no scratches or damage |
| Regulatory Compliance | GMP, FDA 21 CFR Part 11, EU GMP Annex 1, ASME BPE |
| Data Integrity | Tamper-proof EBR; logs temp, pressure, time, chemical dose |
| Surface Finish | Ra ≤0.4 μm; no dead legs; easy to clean |
| Traceability | Barcode/QR links cleaned item, batch, parameters |
| User Access Control | Role-based permissions; recipe encryption |
| Certifications | CE, ISO 9001, ASME BPE |
| Compatible Items | Vials (1–1000 mL), ampoules, IV bags (50–2000 mL), pipes (Φ10–100 mm), tanks, filters |
| Cleaning Methods | Spray, soak, ultrasonic, CIP; switchable based on contamination level |
| Throughput | 500 – 20,000 units/hour; batch or continuous mode |
| Integrated Workflow | Wash → Disinfect → Dry in one cycle; no manual transfer |
| Cleaning Agent Flexibility | Supports acidic, alkaline, neutral food/pharma-grade detergents |
| Modular Design | Customizable chambers, spray arms, ultrasonic modules, dryers |
| Automation Level | Fully automatic loading → cleaning → drying → unloading; 80% faster than manual |
| Control System | PLC + color touchscreen; manual/auto modes |
| Remote Operation | Real-time monitoring via PC/mobile; multi-language support |
| Fault Diagnosis | Auto-detect clogged nozzles, pump failure, temp fault; alarm + log |
| Safety Features | Door interlock, overheat protection, emergency stop, leakage protection |
| Energy & Water Efficiency | Heat recovery + VFD; 30% lower energy; water reuse ≥80% |
| Maintenance | Low-failure international components; easy-replace nozzles/seals/filters; service ≥6 mo |