GMP 10ML Setrile Ophthalmic Bottle Filling Plugging Capping Machine, Eye Drop Packing Line
THE RELIANCE RVFE sterile eye drop filling, plugging, and capping machine is a high-performance, fully automated production solution exclusively for sterile ophthalmic formulations. Engineered to meet the GMP, FDA 21 CFR Part 11, and EU GMP standards, this all-in-one machine integrates automatic bottle unscrambling, fill, plugger-in, and torque-controlled capping, 15″ HMI, all servo drive system, high precision ceramic pump, preservative-free ophthalmic solutions, and sensitive eye care products
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技术规格
DESCRIPTION
Ideal for sterile eye drop production in pharmaceutical, biotech, and ophthalmic industries, including preservative-free eye drops, artificial tears, dry eye relief solutions, antibiotic eye drops, anti-allergic eye drops, post-ophthalmic surgery care solutions, and other sensitive ophthalmic formulations. It is also suitable for small-volume sterile liquid products such as sterile serum and biological reagents, supporting both single-dose ampoules and multi-dose bottles production.
THE RELIANCE RVFE sterile eye drop filling, plugging, and capping machine is a high-performance, fully automated production solution exclusively for sterile ophthalmic formulations. Engineered to meet the GMP, FDA 21 CFR Part 11, and EU GMP standards, this all-in-one machine integrates automatic bottle unscrambling, fill, plugger-in, and torque-controlled capping, 15″ HMI, all servo drive system, high precision ceramic pump, preservative-free ophthalmic solutions, and sensitive eye care products.
Designed for large-scale and high-precision production, the machine adopts advanced servo-driven technology and ISO 5 (Class 100) cleanroom-compatible design, ensuring every bottle of eye drop meets the highest sterility and quality standards. It is fully compatible with various bottle sizes (3ml/5ml/10ml/15ml) and cap types (dropper caps, screw caps, tamper-evident caps), supporting both single-dose and multi-dose sterile eye drop production, and can be easily integrated into existing ophthalmic production lines for maximum operational flexibility.
Sterile Eye Drop Filling Machine, Monoblock Filling, Aseptic Eye Drops Filling, Filling Stoppering Capping, Reliance Machinery
FEATURE
✅ Fully Automatic & Aseptic Operation – Integrates bottle unscrambling, filling, stoppering, capping, and quality inspection in one automated line; closed-loop design with A级 laminar flow/RABS isolation and BFS sterile filling option, ensuring 100% sterile, pyrogen-free production without contamination risk.
✅ GMP & FDA Compliant – Meets global ophthalmic standards, including GMP, FDA 21 CFR Part 11, EU GMP, and ISO 13485; supports IQ/OQ/PQ validation, batch data logging, and full audit trail for regulatory compliance.
✅ High-Precision Filling & Stoppering – Equipped with servo-driven ceramic/peristaltic pumps, filling volume 0.1-50ml adjustable, filling accuracy ≤±0.5%; vacuum stoppering with 50-80N adjustable pressure, stoppering qualification rate ≥99.9% to ensure tight sealing and product integrity.
✅ Intelligent Torque-Controlled Capping – Automatic cap feeding, positioning, and torque-adjustable capping (0.5-5N·m), ensuring consistent, tamper-resistant sealing; supports different cap types, capping qualification rate ≥99.8% with real-time torque data traceability.
✅ Flexible & Efficient Production – Servo-driven system with quick format change (≤30 minutes) for different bottle sizes and eye drop formulations; production capacity 1000-12000 bottles/hour, adaptable to small-batch and large-scale production needs.
✅ Easy Operation & Low Maintenance – PLC+HMI touch screen interface, with parameter one-click switching, recipe storage (up to 50+ recipes), and real-time production monitoring; contact parts made of 316L stainless steel (Ra≤0.4μm), easy to disassemble, clean, and sterilize (SIP/CIP compatible).
✅ Advanced Quality Control – Built-in sensors for 100% in-process control (IPC), automatically detecting no-bottle no-filling, under-filling, missing stoppers, and cap misalignment, rejecting defective products to maintain consistent quality.
常见问题解答
1. What is a 10mL ophthalmic bottle filling and capping machine?
A 10mL ophthalmic bottle filling and capping machine is designed for automatic filling, plugging, and capping of sterile eye drop bottles. It is suitable for pharmaceutical and ophthalmic production lines and can provide consistent filling accuracy and reliable container sealing.
2. Is this eye drop filling machine suitable for sterile production?
Yes. The machine can be configured for GMP-compliant sterile ophthalmic production. Its filling, plugging, and capping processes are designed to minimize product exposure and support hygienic manufacturing requirements.
3. What bottle sizes can the machine handle?
The machine is primarily designed for 10mL ophthalmic bottles. Depending on the machine configuration and change parts, it can also accommodate other bottle sizes and formats.
4. How accurate is the filling volume?
The filling accuracy depends on the product characteristics, filling system, and machine configuration. The equipment can be customized to achieve stable and precise filling performance according to specific production requirements.
5. Can this machine be integrated into a complete eye drop packaging line?
Yes. The machine can be integrated with upstream and downstream equipment, such as bottle feeding, washing, sterilization, labeling, inspection, and secondary packaging systems, to create a complete ophthalmic production line.
GMP & SAFTY
1.Product Protection & Contamination Control (GMP)
These features ensure the product remains sterile, unadulterated, and consistent from the first bottle to the last.
Material Compatibility:
1.1 Product-contact parts must be made of AISI 316L stainless steel, medical-grade silicone, or FDA-approved plastics to prevent chemical leaching and corrosion.
1.2 Sanitary Design: Machines require smooth surfaces, minimal crevices, and tri-clamp connections to eliminate areas where bacteria can grow.
1.3 CIP/SIP Capabilities: Clean-in-Place (CIP) and Sterilization-in-Place (SIP) systems allow automated cleaning and steaming of fluid pathways without dismantling the machine.
1.4 Laminar Airflow & Isolation: RABS (Restricted Access Barrier Systems) or Isolators supply HEPA-filtered air to maintain a sterile zone over the open containers.
1.5 Drip and Splash Controls: Anti-drip nozzles and diving nozzles (which lower into the bottle during filling) prevent product from spilling onto the container rims, which could ruin the cap seal.
2. Operator Safety & Machine Protection
These features protect the workers operating the line and prevent catastrophic machine damage.
2.1 Interlocked Physical Enclosures: Transparent polycarbonate or tempered glass doors prevent operators from reaching into moving parts. Opening a door instantly cuts power to the moving components.
2.2 Emergency Stop (E-Stop) Buttons: Highly visible, mushroom-headed buttons must be placed at multiple accessible points around the machine to halt operations immediately.
2.3 Capping Torque Control: Magnetic clutches or servo-driven capping heads prevent over-torqueing (which can shatter glass or strip plastic caps) and under-torqueing (which causes leaks).
2.4 Low Noise Levels: Sound-dampening enclosures keep noise levels below OSHA-mandated limits (usually under 85 dBA), especially around noisy cap-sorting bowls.
3. Data Integrity & Quality Control
GMP requires strict verification to ensure that every container leaves the line correctly filled and sealed.
3.1 Weight & Fill Verification: In-line checkweighers or vision systems instantly reject under-filled or over-filled containers without stopping the line.
3.2 Cap Detection Systems: Vision sensors detect missing, crooked, or high caps, automatically pushing faulty products to a rejection tray.
3.3 Audit Trails & 21 CFR Part 11: For pharmaceuticals, the machine’s software must track all operator logins, setting changes, and alarms in a secure, unalterable electronic log.
WHY RELIANCE
Shanghai Reliance Machinery Co., Ltd. is a professional manufacturer of pharmaceutical liquid filling and packaging equipment, providing complete turnkey solutions for sterile liquid production.
1. Our oral spray filling systems feature:
2. Customized engineering solutions
3. High-speed servo filling technology
4. Automatic spray pump assembly
5. Intelligent vision inspection
6. FDA & GMP compliant hygienic design
7. Validation documentation (DQ, FAT, SAT, IQ, OQ, PQ)
8. Global installation and technical support
9. SCADA and MES integration
10. Long-term spare parts and after-sales service
