Description
Complete Aseptic Processing for Penicillin and Sterile Injectables
The LSPC-1000 automatic complex provides an all-in-one solution for critical sterile drug manufacturing. It seamlessly integrates multiple processes to fill penicillin vials and securely seal them with a rubber stopper and a tamper-evident aluminum cap, all within a validated cleanzone to ensure the highest product sterility .
Key Features and Technical Advantages
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Integrated Stopper Insertion & Crimping: The machine combines an automatic rubber stopper feeding and insertion module with a smooth aluminum cap (flip-off) crimping station. This ensures a hermetic seal and tamper-evident integrity for the final product .
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Designed for Cleanroom Integration: The entire complex is engineered for operation within a cleanzone (e.g., ISO 5 Class A or ISO 7 Class C), maintaining the required air purity levels for aseptic processing .
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Precision Sterile Filling: Utilizes high-accuracy filling technology suitable for the 10-20ml volume range, ensuring consistent fill volumes for liquid or lyophilized products.
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GMP-Compliant Design: Constructed with pharmaceutical-grade materials (e.g., 316L Stainless Steel) on all product contact surfaces. The design supports full validation and meets cGMP, FDA, and EU GMP requirements .
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Automatic Cap & Stopper Handling: Features vibratory bowl feeders that correctly orient and supply rubber stoppers and aluminum caps to the sealing stations, with systems in place to reject incorrectly oriented components .
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User-Friendly Control & Safety: A PLC-based control system with a Touch Screen (HMI) allows for easy operation and recipe management. The machine includes automatic safety stops to prevent damage if components are missing .
Technical Specifications
| Parameter | Specification / Placeholder |
|---|---|
| Machine Model | LSPC-1000 |
| Vial Sizes | 10ml and 20ml Penicillin Vials |
| Processes | Filling, Rubber Stopper Insertion, Aluminum Cap Crimping |
| Cleanroom Classification | Designed for integration into a specified cleanzone (e.g., ISO 5/7) |
| Control System | PLC with Touchscreen HMI |
| Construction Materials | 316L Stainless Steel (product contact), cGMP-compliant finishes |
📜 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.
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✅ Local technicians in 18 countries
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📥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.
🧼Compliance Roadmap:
- CE, EAC, ISO 9001 certifications.
- GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
- ATEX options for chemical solvents.
