Description
Figh-throughput pharmaceutical washer
FDA 21 CFR 211.67 compliant vial washer.
Cross-contamination free vial processing.
GMP Rotary Washer for Large-Volume Blood Substitute Vials & Penicillin Containers
Dedicated to aseptic processing of infusion solutions and antibiotics, this high-throughput system handles:
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Large BKZ Vials: 50ml, 109ml, 250ml, 450ml (blood substitutes, parenterals).
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Penicillin Vials: 10-20ml with K2-20 neck finish.
Three-Stage Decontamination:
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Purified Water (PW) cascade rinse (70°C, 0.45µm filtered).
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Ultrasonic cavitation (40 kHz for particulate removal).
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Pure Steam Sterilization (SIP capable, 121°C).
*Seamlessly integrates with sterile filling lines for LVP/SVP solutions. IQ/OQ validation per EU Annex 1 & FDA 211.67.
Critical Additions:
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FDA Regulation Reference: Explicit mention of 21 CFR 211.67 (equipment cleaning standards).
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Containment Specs: H2O2 vapor sterilization capability between batches.
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Material Safety: 316L SS construction with electropolished surfaces (Ra ≤0.4µm).
Competitive Differentiation:
⚙️ Competitive Positioning Table
| Feature | LBR-1000 | VarioClean | LPC |
|---|---|---|---|
| Throughput | 8,000 vials/h | 6,500 vials/h | 7,200 vials/h |
| Penicillin Safety | Dedicated fluid paths | Shared components | Optional module (+$45k) |
| Changeover | <15 min (CIP/SIP) | 25 min manual cleaning | 15 min |
| Compliance Docs | Included | Extra cost | Extra cost |
⚙️ Technical Specifications
| Parameter | Blood Substitute Vials | Penicillin Vials |
|---|---|---|
| Capacity | 50-450ml | 10-20ml |
| Throughput | 1,200 vials/h (450ml) | 8,000 vials/h (20ml) |
| Neck Finish | Wide neck (BKZ) | K2-20 ISO standard |
| Sterilization | Pure Steam SIP | H2O2 vapor + Steam |
| Compliance | Ph. Eur. 3.2.9 (PVC-free) | FDA penicillin dedication |
🌍 Regional Adaptations
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Global Voltage: 220V/380V/480V (configurable for SE Asia/Africa).
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Certifications: CE, EAC, WHO-GMP, PIC/S compliant.
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Environmental:
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Air consumption: ≤35 m³/h.
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Waste reduction: 76% less effluent vs. conventional washers.
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✅ Technical Specifications Integration
Mandatory Pharma Specs Table:
| Parameter | Value | Standard |
|---|---|---|
| Throughput | 8,000 vials/hour | ISO 9001 |
| Vial Sizes | 10-100ml | ISO 8362-1 |
| Residual Contaminants | ≤0.1 µg/ml penicillin | FDA CDER guidance |
| Air Quality | ISO Class 5 (GMP Grade A) | EU Annex 1 |
| Material Contact | 316L SS, EP rubber | USP <661> |
🛡️ GMP Critical Features
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Contamination Control:
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Double mechanical seals on rotary joints.
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HEPA-filtered air curtain at unloading zone.
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Traceability:
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SCADA system with electronic batch records (21 CFR Part 11).
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RFID tracking of vial carriers.
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Cleaning Validation:
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Swab test points pre-installed.
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Particle counters in final rinse line.
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🌍 Regional Compliance Highlights
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EU: Full traceability per EU Annex 1 (2022).
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SE Asia: WHO-GMP compliant; 40°C/95% RH operation.
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LatAm: ANVISA/COFEPRIS validation support.
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✅ GMP Critical Features
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Cross-Contamination Prevention:
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Dedicated tooling for BKZ/penicillin vials.
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Separate PW/WFI loops with duplex filtration.
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Material Safety:
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316L SS electropolished surfaces (Ra ≤0.5µm).
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Extractables/leachables testing reports available.
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Automation:
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Robotic unloading into RTPs (Restricted Access Barrier).
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SCADA with 21 CFR Part 11 electronic records.
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💡 Competitor-Beating Claims
Zero detectable penicillin carryover — validated per FDA CDER guidance with 0.01 µg/ml detection limit.
45% lower operating costs vs. diffrent systems — patented closed-loop water recycling.
📜 Schedule virtual airflow visualization test.
💡 Mention your: Target market (EU/US/Global South), Active ingredient, Required throughput.
🔬 Schedule virtual factory acceptance test with our engineers.
🏷️ Request Compliance Audit: Free gap analysis with throughput simulation.
Ready to Eliminate Production Bottlenecks?
Need Industrial Production Automation?
✅ GMP Compliance Guarantee
✅ 24/7 Multilingual Support
✅ 24-month performance guarantee
✅ Local technicians in 18 countries
Start small, get a free production layout designed for your growth trajectory. Scale smarter with engineering support!
📥Free line configuration for your products, throughput validation testing!
🎓Contact Specialists for Packaging Equipment:
📄 On-Demand Engineering: Product-specific configurations in 1-2 weeks.
🔧 Spare Parts Kits: Region-specific inventory for <24hr delivery.
🌡️ For a free product compatibility test using your materials.
Compliance Roadmap:
- CE, EAC, ISO 9001 certifications.
- GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
